Vidaza

(Azacitidine)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Azacitidine is used to treat certain types of blood cancers and bone marrow disorders, particularly myelodysplastic syndromes. It works by helping to restore normal function to abnormal blood cells.[2] Vidaza is currently approved and in use across 93 indications[4].[1]

Vidaza is one of 857 small molecule programs targeting Chronic Myelomonocytic Leukemia. It is currently in Approved.

Indications

528

Total Trials

Active Trials

856

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Chronic Myelomonocytic LeukemiaTerminated

Acute Myeloid LeukemiaRecruiting

Leukemia, Myeloid, AcuteActive, not recruiting

Relapsed or RefractoryCompleted

Induction ChemotherapyUnknown status

Hematological MalignanciesActive, not recruiting

Maintenance TherapyUnknown status

Lymphoma, T Cell, PeripheralRecruiting

Recurrent Acute Myeloid LeukemiaRecruiting

Higher-Risk Myelodysplastic SyndromeRecruiting

Chronic Myelomonocytic LeukemiaPhase 3

Terminated

Acute Myeloid LeukemiaApproved

Recruiting

Leukemia, Myeloid, AcutePhase 3

Active, not recruiting

Relapsed or RefractoryPhase 2

Completed

Induction ChemotherapyPhase 2

Unknown status

Hematological MalignanciesPhase 2

Active, not recruiting

Maintenance TherapyPhase 3

Unknown status

Lymphoma, T Cell, PeripheralPhase 1

Recruiting

Recurrent Acute Myeloid LeukemiaPhase 1

Recruiting

Higher-Risk Myelodysplastic SyndromePhase 3

Recruiting

Showing 10 of 93 indications

Competition

Competitive Landscape

375 competitors in Lymphoma

#DrugCompanyPhaseTrials

Vidaza

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

10 2

Zofran

Novartis

Preclinical

2 3

Norvir

AbbVie

Preclinical

1 4

Cabenuva

GSK

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 9

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—10

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Treatment

NCT05788679

Phase 3Active, not recruiting

AIN

NCT04229979

Q1 2027

Phase 1/2Active, not recruiting

Acute Myeloid Leukemia

NCT04086264

Phase 1Active, not recruiting

Maintenance Therapy

NCT03613532

Q2 2027

Phase 1/2Not yet recruiting

Acute Myeloid Leukemia

NCT06387420

Phase 2Active, not recruiting

Myelodysplastic Syndrome

NCT01787487

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia39 trials

A Study of Safety, Efficacy and Pharmacodynamics of Azacitidine in Children and Young Adults With Acute Myeloid Leukemia.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02450877·7 enrolled

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

Terminated· Gilead logo

Gilead·Phase 3·NCT04778397·258 enrolled

Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure

Recruiting·BBrian Jonas·Phase 2·NCT04905810·20 enrolled

Show 36 more trials

An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02577406·319 enrolled

Azacitidine and Lenalidomide for Acute Myeloid Leukemia

Completed·WWashington University School of Medicine·Phase 1/2·NCT01016600·31 enrolled

Elderly Patients With Acute Myeloid Leukemia (AML), Maintenance Phase After Complete Remission (CR)

Completed·FFrench Innovative Leukemia Organisation·Phase 2·NCT01301820·120 enrolled

Avelumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT02953561·19 enrolled

Acute Myeloid Leukemia Real World Treatment Patterns

Withdrawn· Pfizer logo

Pfizer··NCT04230564

AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia

Terminated· Amgen logo

Amgen·Phase 1·NCT02675452·141 enrolled

A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia

Terminated· Pfizer logo

Pfizer·Phase 1·NCT02954653·8 enrolled

Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia

Terminated·HHutchison Medipharma Limited·Phase 1·NCT03483948·7 enrolled

A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01358734·88 enrolled

A Study of DCLL9718S in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Participants With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy

Completed· Roche logo

Roche·Phase 1·NCT03298516·19 enrolled

Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)

Completed·SStanford University·Phase 1/2·NCT00890929·45 enrolled

Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT04146038·5 enrolled

A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Not yet recruiting·AAkeso·Phase 1/2·NCT06387420·180 enrolled

Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT06386302·184 enrolled

IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

Active, not recruiting· AbbVie logo

AbbVie·Phase 1/2·NCT04086264·218 enrolled

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT02993523·443 enrolled

Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition

Active, not recruiting·UUniversity Hospital, Toulouse··NCT03284593·199 enrolled

Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.

Terminated· Novartis logo

Novartis·Phase 1/2·NCT04623216·24 enrolled

A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT04102020·112 enrolled

A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia

Completed· Pfizer logo

Pfizer·Phase 3·NCT03416179·730 enrolled

Tagraxofusp to Eradicate Measurable Residual Disease in Patients With Acute Myeloid Leukemia

Withdrawn·JJonsson Comprehensive Cancer Center·Phase 1·NCT05720988

A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT02677922·130 enrolled

Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia

Completed·UUniversity of Nebraska·Phase 2·NCT03226418·75 enrolled

A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT03164057·206 enrolled

Pevonedistat With Azacitidine Versus Azacitidine Alone in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT03745352

Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Completed·HHelsinn Healthcare SA·Phase 2·NCT01912274·50 enrolled

Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06445907·32 enrolled

Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT03699384

Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia

Suspended· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1/2·NCT04485052·222 enrolled

Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03701295·1 enrolled

Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia

Completed·UUniversity of Chicago·Phase 1·NCT01839240·50 enrolled

A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

Completed· Astellas logo

Astellas·Phase 3·NCT02421939·371 enrolled

A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 3·NCT06389292·486 enrolled

Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Completed·UUniversity Hospital Muenster·Phase 2·NCT00915252·214 enrolled

Dexamethasone in Refractory or First Relapsed Acute Myeloid Leukemia

Terminated·UUniversity Hospital, Toulouse·Phase 3·NCT03765541·73 enrolled

A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy

Completed· AbbVie logo

AbbVie·Phase 3·NCT03941964·60 enrolled

Myelodysplastic Syndrome33 trials

Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Terminated·MMirati Therapeutics Inc.·Phase 2·NCT00666497·6 enrolled

Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT03813147·12 enrolled

Azacitidine Plus Amifostine in Treating Patients With Myelodysplastic Syndrome

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT00005598

Show 30 more trials

A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment

Completed·OOncoVerity, Inc.·Phase 1·NCT04241549·6 enrolled

The Efficacy of Azacitidine +/- Lenalidomide in High-risk Myelodysplastic Syndrome (MDS)and Acute Myeloid Leukemia (AML) With Del(5q).

Unknown status·NNordic MDS Group·Phase 2·NCT01556477·72 enrolled

Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT04487106·21 enrolled

Azacitidine and Pembrolizumab in Treating Patients With Myelodysplastic Syndrome

Unknown status·MM.D. Anderson Cancer Center·Phase 2·NCT03094637·40 enrolled

Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)

Completed·TTechnische Universität Dresden·Phase 2·NCT01462578·93 enrolled

CX-01 Combined With Azacitidine in the Treatment of Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia

Completed·WWashington University School of Medicine·Phase 1·NCT02995655·20 enrolled

A Trial of AK117 (Anti-CD47) in Patients With Myelodysplastic Syndrome

Active, not recruiting·AAkeso·Phase 1/2·NCT04900350·136 enrolled

Intensified Azacitidine in High Risk Myelodysplastic Syndrome (MDS)

Completed·GGroupe Francophone des Myelodysplasies·Phase 1/2·NCT01305460·27 enrolled

Ruxolitinib Phosphate and Azacytidine in Treating Patients With Myelofibrosis or Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01787487·121 enrolled

Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents

Completed· Amgen logo

Amgen·Phase 2·NCT00321711·69 enrolled

Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia

Completed·AAsociación Andaluza de Hematología y Hemoterapia·Phase 2·NCT01338337·40 enrolled

Glutaminase Inhibitor CB-839 and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT03047993·28 enrolled

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) in Combination With Azacitidine for the Treatment of Myelodysplastic Syndrome (MDS)

Completed·WWashington University School of Medicine·Phase 1·NCT01065129·28 enrolled

Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00004871

Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome

Terminated· AbbVie logo

AbbVie·Phase 1·NCT04912063·40 enrolled

Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01168219·68 enrolled

Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT04160052·51 enrolled

A Study of Azacitidine in Myelodysplastic Syndrome (MDS) Associated to Systemic Auto-immune and Inflammatory Disorders

Completed·GGroupe Francophone des Myelodysplasies·Phase 2·NCT02985190·30 enrolled

A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Unknown status·IImmuneOnco Biopharmaceuticals (Shanghai) Inc.·Phase 1/2·NCT05140811·126 enrolled

A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

Recruiting·PPureTech·Phase 1·NCT05829226·90 enrolled

A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)

Terminated·AALX Oncology Inc.·Phase 1·NCT04417517·65 enrolled

Study of Vosaroxin With Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2

Completed·UUniversity of Ulm·Phase 2·NCT03338348·9 enrolled

Ibrutinib and Azacitidine for Treatment of Higher Risk Myelodysplastic Syndrome

Completed·BBrian Jonas·Phase 1·NCT02553941·21 enrolled

Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01254890·60 enrolled

Azacitidine Combined to Epoetin Beta in International Prognostic Scoring System (IPSS) Low-risk and Intermediate-1 Myelodysplastic Syndrome (MDS) Patients, Resistant to Erythropoetin-stimulating Agents (ESA)

Completed·GGroupe Francophone des Myelodysplasies·Phase 2·NCT01015352·98 enrolled

Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00569010·36 enrolled

Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome

Completed·HHelsinn Healthcare SA·Phase 2·NCT01873703·102 enrolled

Study of Azacitidine to Evaluate Safety and Effectiveness for Chinese Patients With Higher Risk Myelodysplastic Syndrome

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01599325·72 enrolled

Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00948064·110 enrolled

SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome

Terminated·PPETHEMA Foundation·Phase 2·NCT00495547·16 enrolled

Myelodysplastic Syndromes22 trials

Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic Syndromes

No longer available· Takeda logo

Takeda··NCT04484363

A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Terminated· Novartis logo

Novartis·Phase 3·NCT02158936·356 enrolled

Vosaroxin and Azacitidine in Treating Patients With Myelodysplastic Syndromes

Completed·WWashington University School of Medicine·Phase 1·NCT01913951·35 enrolled

Show 19 more trials

Best Promising Drug Association With Azacitidine in Higher Risk Myelodysplastic Syndromes

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT01342692·320 enrolled

A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes

Completed· Roche logo

Roche·Phase 1·NCT02508870·46 enrolled

Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Completed·TThe University of New South Wales·Phase 2/3·NCT00454480·2,000 enrolled

Trial of Volasertib With or Without Azacitidine in Patients With Myelodysplastic Syndromes

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02721875·1 enrolled

A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

Recruiting·AAkeso·Phase 2·NCT06196203·90 enrolled

Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT00118287·32 enrolled

Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01201811·44 enrolled

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes

Completed·—·Phase 1/2·NCT00352001·37 enrolled

Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes

Withdrawn·GGroupe Francophone des Myelodysplasies·Phase 1/2·NCT01324960

Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02599649·10 enrolled

A Phase II Study of Intravenous Azacitidine Alone in Patients With Myelodysplastic Syndromes

Completed·WWashington University School of Medicine·Phase 2·NCT00384956·25 enrolled

Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.

Terminated· Novartis logo

Novartis·Phase 2·NCT02159040·1 enrolled

A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)

Completed· AbbVie logo

AbbVie·Phase 1·NCT02966782·70 enrolled

Azacitidine Plus Deferasirox (ICL670) in Higher Risk Myelodysplastic Syndromes (MDS)

Terminated·SSunnybrook Health Sciences Centre·Phase 2·NCT02038816·1 enrolled

An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02775903·213 enrolled

Combination of 5-azacitidine and Lenalidomide in Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) Myelodysplastic Syndromes

Terminated·TTechnische Universität Dresden·Phase 1·NCT00923234

A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00071799·358 enrolled

TET2 Mutations in Myelodysplastic Syndromes and Acute Myeloid Leukemia With Azacitidine + Ascorbic Acid

Completed·—·Phase 2·NCT03397173·12 enrolled

A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes

Terminated·HHelsinn Healthcare SA·Phase 2·NCT03151304·64 enrolled

Chronic Myelomonocytic Leukemia10 trials

Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myelomonocytic Leukemia

Withdrawn·MM.D. Anderson Cancer Center·Phase 1/2·NCT06085638

Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00313586·197 enrolled

IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

Recruiting·IImmuneOnco Biopharmaceuticals (Shanghai) Inc.·Phase 3·NCT06647862·170 enrolled

Show 7 more trials

Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

Terminated·MMedical University of South Carolina·Phase 2·NCT00118196·1 enrolled

An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)

Completed· Takeda logo

Takeda·Phase 2·NCT02610777·120 enrolled

Venetoclax and Azacitidine for the Treatment of Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04550442·34 enrolled

A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04264806

Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)

Completed·NNordic MDS Group·Phase 2·NCT01048034·30 enrolled

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)

Completed· Takeda logo

Takeda·Phase 3·NCT03268954·454 enrolled

A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05365035·60 enrolled

MDS5 trials

Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS

Completed·MMirati Therapeutics Inc.·Phase 1/2·NCT02018926·18 enrolled

Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL

Terminated·TTetraLogic Pharmaceuticals·Phase 2·NCT02147873·118 enrolled

Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT02706899·19 enrolled

Show 2 more trials

Magrolimab in Combination with Azacitidine After Allogeneic HCTin Treating Patients with High-Risk AML or MDS

Withdrawn·—·Phase 1·NCT05823480

To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.

Terminated· Eisai logo

Eisai·Phase 4·NCT01011283·26 enrolled

59 more indications

Treatment4 trials

MRD-guided Treatment in NPM1mut AML Patients

Terminated·TTechnische Universität Dresden·Phase 2·NCT03769532·26 enrolled

A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS

Recruiting·KKarolinska University Hospital·Phase 2·NCT05788679·200 enrolled

Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat

Completed·UUniversity of Leipzig·Phase 2·NCT04712942·14 enrolled

Show 1 more trial

A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants

Withdrawn· Novartis logo

Novartis·Phase 1/2·NCT05367401

Newly Diagnosed4 trials

Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations

Recruiting·Yyuejun Liu·Phase 2·NCT07012447·32 enrolled

Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65

Terminated·EElizabeth Henry·Phase 2·NCT02341495·4 enrolled

Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT06578546·30 enrolled

Show 1 more trial

APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

Recruiting·AAptevo Therapeutics·Phase 1·NCT06634394·39 enrolled

Leukemia4 trials

Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)

Terminated· AbbVie logo

AbbVie·Phase 1·NCT02203773·212 enrolled

Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older

Completed· Takeda logo

Takeda·Phase 1·NCT01814826·64 enrolled

Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy

Unknown status·—·Phase 2·NCT00728520·40 enrolled

Show 1 more trial

Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia

Completed·UUnknown Sponsor·Phase 1/2·NCT01093573·34 enrolled

Chemotherapy4 trials

Nivolumab With Chemotherapy in Refractory MDS

Terminated·SSt. Petersburg State Pavlov Medical University·Phase 1/2·NCT03259516·2 enrolled

HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

Recruiting· Sunshine Lake Pharma Co., Ltd. logo

Sunshine Lake Pharma Co., Ltd.·Phase 3·NCT05586074·324 enrolled

Selinexor、Venetoclax and Azactidine in the Treatment of ND AML Patients Who Are Not Eligible for Intense Chemotherapy

Terminated·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT06449482·6 enrolled

Show 1 more trial

Daunorubicin, Cytarabine Liposomes Plus Venetoclax vs Azacitidine Plus Venetoclax in AML Patients Unfit for Intensive Chemotherapy

Withdrawn·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06770257

Multiple Myeloma4 trials

Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

Completed·—·Phase 1/2·NCT01155583·45 enrolled

Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00761722·31 enrolled

Daratumumab, Azacitidine, and Dexamethasone for Treatment of Patients With Recurrent or Refractory Multiple Myeloma Previously Treated With Daratumumab

Terminated·UUniversity of California, San Francisco·Phase 2·NCT04407442·5 enrolled

Show 1 more trial

A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma

Terminated· Pfizer logo

Pfizer·Phase 1·NCT03530683·189 enrolled

Non-Small Cell Lung Cancer3 trials

Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00006019

Azacitidine and Entinostat Before Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01935947·17 enrolled

Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01207726·13 enrolled

Lymphoma3 trials

Bortezomib and Azacitidine in Treating Patients With Relapsed or Refractory T-Cell Lymphoma

Completed·PPierluigi Porcu·Phase 1·NCT01129180·8 enrolled

Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03703375·93 enrolled

A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas

Recruiting·TThe Lymphoma Academic Research Organisation·Phase 1/2·NCT07018752·49 enrolled

CMML3 trials

A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML

Active, not recruiting·TTreadwell Therapeutics, Inc·Phase 1/2·NCT04730258·72 enrolled

A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients

Completed· Pfizer logo

Pfizer·Phase 1·NCT02367456·73 enrolled

Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML

Unknown status·BBiocity Biopharmaceutics Co., Ltd.·Phase 1·NCT05970822·32 enrolled

Myeloid Malignancies2 trials

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Terminated· Gilead logo

Gilead·Phase 2·NCT04778410·54 enrolled

Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies

Completed·MMayo Clinic·Phase 1·NCT02129101·63 enrolled

Advanced Malignancies2 trials

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Terminated· Incyte logo

Incyte·Phase 1/2·NCT02711137·137 enrolled

An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

Terminated· Incyte logo

Incyte·Phase 1/2·NCT02712905·116 enrolled

Transplantation2 trials

Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML

Unknown status·Gguomei·N/A·NCT05262465·300 enrolled

Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia

Withdrawn·SSherif Farag·Phase 1·NCT04128020

Elderly Patients2 trials

Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML

Unknown status·LLanZhou University·N/A·NCT05053425·30 enrolled

Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML

Terminated·KKarolinska University Hospital·Phase 2·NCT01794169·130 enrolled

Breast Cancer2 trials

Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01349959·58 enrolled

Azacitidine in Treating Patients With Triple Negative Stage I-IV Invasive Breast Cancer That Can Be Removed By Surgery

Withdrawn·UUniversity of Southern California·N/A·NCT01292083

Hematological Malignancies2 trials

A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies

Active, not recruiting·FFaron Pharmaceuticals Ltd·Phase 1/2·NCT05428969·181 enrolled

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies

Terminated·KKahr Medical·Phase 1·NCT04937166·25 enrolled

Advanced Solid Tumors2 trials

Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)

Terminated· Incyte logo

Incyte·Phase 1/2·NCT02959437·70 enrolled

Study of Azacitidine and Durvalumab in Advanced Solid Tumors

Completed·UUniversity Health Network, Toronto·Phase 2·NCT02811497·28 enrolled

Stem Cell Transplantation2 trials

Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation

Completed·UUniversity of California, San Francisco·Phase 2·NCT02458235·17 enrolled

Azacitidine in Patients Undergoing Matched Unrelated Stem Cell Transplantation

Terminated·WWashington University School of Medicine·Phase 1/2·NCT01747499·54 enrolled

Safety and Efficacy2 trials

A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS

Suspended· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT04511975·32 enrolled

Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Higher-risk MDS

Unknown status·—·Phase 2·NCT06109064·14 enrolled

AML2 trials

De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients

Recruiting·IInstitut Paoli-Calmettes·Phase 2·NCT06557421·50 enrolled

Venetoclax, Azacitidine, and Lintuzumab-Ac225 in AML Patients

Withdrawn·AActinium Pharmaceuticals·Phase 1/2·NCT03932318

Lenalidomide2 trials

Azacitidine, Lenalidomide and DLI as Salvage Therapy for MDS, CMML and sAML Relapsing After Allo-HSCT

Completed·HHeinrich-Heine University, Duesseldorf·Phase 2·NCT02472691·50 enrolled

Azacitidine + Lenalidomide Combo in the Elderly With Previously Treated AML & High-Risk MDS

Terminated·SStanford University·Phase 2·NCT01442714·33 enrolled

Acute Myeloid Leukaemia (AML)1 trial

Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients

Active, not recruiting·HHikma Pharmaceuticals LLC·N/A·NCT06572982·20 enrolled

Induction Therapy1 trial

Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML

Recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT06451861·240 enrolled

Blood Cancer1 trial

Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

Recruiting·UUniversity of Chicago·Phase 1·NCT03326310·18 enrolled

Bone Marrow Transplantation1 trial

Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation (Allo BMT)

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00350818·90 enrolled

Metastatic Melanoma1 trial

Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

Completed·UUniversity of California, San Diego·Phase 1·NCT00398450·12 enrolled

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00529022·36 enrolled

Temozolomide1 trial

Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide

Completed·—·Phase 1·NCT00629343·27 enrolled

Maintenance Treatment1 trial

Phase II Study of Azacitidine and Sargramostim as Maintenance Treatment for Poor-Risk AML or MDS

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01700673·25 enrolled

Relapsed AML1 trial

Imetelstat Combinations in Relapsed AML

Recruiting·UUnknown Sponsor·Phase 1·NCT07320235·36 enrolled

Chronic Kidney Disease1 trial

Demethylating Agent Azacitidine on Prevention of Acute Kidney Injury-chronic Kidney Disease Continuum

Recruiting·NNational Taiwan University Hospital·Phase 1/2·NCT05325099·60 enrolled

GIST1 trial

AVIDA The Vidaza® (Azacitidine) Patient Registry

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT00481273·479 enrolled

Relapsed or Refractory1 trial

Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00895934·52 enrolled

Trial1 trial

Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage

Terminated·DDelta-Fly Pharma, Inc.·Phase 3·NCT03926624·167 enrolled

B-cell Malignancies1 trial

PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies

Terminated·PPrelude Therapeutics·Phase 1·NCT05107856·21 enrolled

Hematologic Cancer1 trial

Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00351975·56 enrolled

Acute Monocytic Leukemia1 trial

Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05566054·92 enrolled

Age1 trial

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06511882·37 enrolled

Pancreatic Cancer1 trial

Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer

Completed·GGWT-TUD GmbH·Phase 1/2·NCT04257448·75 enrolled

Induction Chemotherapy1 trial

Induction Chemotherapy Sequential Sintilimab Combined With Dual Epigenetic Drugs for ENKTL-HLH

Unknown status·SSun Yat-sen University·Phase 2·NCT05008666·37 enrolled

Efficacy and Safety1 trial

The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP

Recruiting·PPeking University People's Hospital··NCT06390306·30 enrolled

Juvenile Myelomonocytic Leukemia1 trial

Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02447666·28 enrolled

Myeloid Leukemia1 trial

Azacitidine (AZA) in Minimal Residual Disease (MRD) Chronic Myeloid Leukemia (CML)

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01460498·3 enrolled

Thyroid Cancer1 trial

Azacitidine to Restore Thyroid Function in Patients With Persistent or Metastatic Thyroid Cancer

Completed·—·Phase 1·NCT00004062

Glioma1 trial

A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

Completed·FForma Therapeutics, Inc.·Phase 1/2·NCT03684811·93 enrolled

AIN1 trial

Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2

Active, not recruiting·SSellas Life Sciences Group·Phase 3·NCT04229979·127 enrolled

Allogeneic Stem Cell Transplantation1 trial

Pevonedistat and Azacitidine as Maintenance Therapy After Allogeneic Stem Cell Transplantation for Non-Remission AML

Terminated·MMilton S. Hershey Medical Center·Phase 2·NCT03709576·3 enrolled

CLE1 trial

Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486

Completed·KKirby Institute·Phase 2·NCT03493646·40 enrolled

Acute Lymphoblastic Leukemia1 trial

DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT04752163·17 enrolled

Acute Leukemia of Ambiguous Lineage1 trial

Study of Venetoclax in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT03194932·62 enrolled

MDS/MPN1 trial

Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.

Terminated·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1/2·NCT04866056·1 enrolled

Phase IB1 trial

A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1·NCT04275518·102 enrolled

Angioimmunoblastic T-Cell Lymphoma1 trial

Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT05179213·20 enrolled

Maintenance Therapy1 trial

Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN

Active, not recruiting·JJacqueline Garcia, MD·Phase 1·NCT03613532·102 enrolled

Chronic Myelogenous Leukemia1 trial

Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00813124·24 enrolled

Relapsed/Refractory AML1 trial

Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1/2·NCT04501120·458 enrolled

High Risk1 trial

Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS

Completed·UUniversity of Birmingham·Phase 2·NCT01617226·260 enrolled

Blastic Plasmacytoid Dendritic Cell Neoplasm1 trial

SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Recruiting·—·Phase 1·NCT03113643·72 enrolled

Azacytidine1 trial

Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML

Recruiting·LLudwig-Maximilians - University of Munich·Phase 2·NCT04913922·30 enrolled

Regulatory

FDA Approval Timeline[5]

May 19, 2004

VIDAZA

NDA NDA050794

Jun 29, 2005

VIDAZA

NDA NDA050794

Jan 26, 2007

VIDAZA

NDA NDA050794

Feb 22, 2008

VIDAZA

NDA NDA050794

Aug 20, 2008

VIDAZA

NDA NDA050794

Aug 17, 2011

VIDAZA

NDA NDA050794

Aug 17, 2011

VIDAZA

NDA NDA050794

Jan 24, 2012

VIDAZA

NDA NDA050794

Dec 19, 2012

VIDAZA

NDA NDA050794

May 6, 2013

VIDAZA

NDA NDA050794

Jan 10, 2014

VIDAZA

NDA NDA050794

Feb 23, 2015

VIDAZA

NDA NDA050794

Dec 17, 2015

VIDAZA

NDA NDA050794

Apr 29, 2016

AZACITIDINE

NDA NDA208216

Aug 23, 2016

VIDAZA

NDA NDA050794

Jan 30, 2017

VIDAZA

NDA NDA050794

Jul 20, 2018

VIDAZA

NDA NDA050794

Mar 18, 2020

VIDAZA

NDA NDA050794

Sep 1, 2020

ONUREG

NDA NDA214120

May 20, 2022

VIDAZA

NDA NDA050794

Sep 23, 2022

VIDAZA

NDA NDA050794

Jun 28, 2024

VIDAZA

NDA NDA050794

Sources

References

[1]
ClinicalTrials.gov — 528 trial records for Azacitidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vidaza drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Azacitidine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Azacitidine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050794). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Vidaza. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA (cytosine-5)-Methyltransferase 1 Inhibitor; DNA (cytosine-5)-Methyltransferase 3a Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Patent Landscape[6]

Patent Cliff

May 14, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12053482May 14, 2029

11571436May 14, 2029

8846628Jun 3, 2030

Vidaza

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Acute Myeloid Leukemia39 trials

Myelodysplastic Syndrome33 trials

Myelodysplastic Syndromes22 trials

Chronic Myelomonocytic Leukemia10 trials

MDS5 trials

Treatment4 trials

Newly Diagnosed4 trials

Leukemia4 trials

Chemotherapy4 trials

Multiple Myeloma4 trials

Non-Small Cell Lung Cancer3 trials

Lymphoma3 trials

CMML3 trials

Myeloid Malignancies2 trials

Advanced Malignancies2 trials

Transplantation2 trials

Elderly Patients2 trials

Breast Cancer2 trials

Hematological Malignancies2 trials

Advanced Solid Tumors2 trials

Stem Cell Transplantation2 trials

Safety and Efficacy2 trials

AML2 trials

Lenalidomide2 trials

Acute Myeloid Leukaemia (AML)1 trial

Induction Therapy1 trial

Blood Cancer1 trial

Bone Marrow Transplantation1 trial

Metastatic Melanoma1 trial

Acute Leukemia1 trial

Olverembatinib1 trial

Ovarian Cancer1 trial

Temozolomide1 trial

Maintenance Treatment1 trial

Relapsed AML1 trial

Chronic Kidney Disease1 trial

GIST1 trial

Relapsed or Refractory1 trial

Trial1 trial

B-cell Malignancies1 trial

Hematologic Cancer1 trial

Acute Monocytic Leukemia1 trial

Age1 trial

Pancreatic Cancer1 trial

Induction Chemotherapy1 trial

Efficacy and Safety1 trial

Juvenile Myelomonocytic Leukemia1 trial

Myeloid Leukemia1 trial

Thyroid Cancer1 trial

Glioma1 trial

AIN1 trial

Allogeneic Stem Cell Transplantation1 trial

CLE1 trial

Acute Lymphoblastic Leukemia1 trial

Acute Leukemia of Ambiguous Lineage1 trial

MDS/MPN1 trial

Phase IB1 trial

Angioimmunoblastic T-Cell Lymphoma1 trial

Maintenance Therapy1 trial

Chronic Myelogenous Leukemia1 trial

Relapsed/Refractory AML1 trial

High Risk1 trial

Blastic Plasmacytoid Dendritic Cell Neoplasm1 trial

Azacytidine1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News