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 97 indications[4].[1]

Vidaza is one of 903 small molecule programs targeting Chronic Myelomonocytic Leukemia. It is currently in Approved.

Indications

526

Total Trials

Active Trials

902

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Chronic Myelomonocytic LeukemiaTerminated

Myelodysplastic SyndromeCompleted

Acute Myeloid LeukemiaRecruiting

GliomaUnknown status

Acute LeukemiaRecruiting

Leukemia, Myeloid, AcuteActive, not recruiting

Relapsed or RefractoryCompleted

PTCLRecruiting

Induction ChemotherapyRecruiting

Hematological MalignanciesActive, not recruiting

Chronic Myelomonocytic LeukemiaPhase 3

Terminated

Myelodysplastic SyndromePhase 3

Completed

Acute Myeloid LeukemiaApproved

Recruiting

GliomaPhase 2

Unknown status

Acute LeukemiaPhase 2

Recruiting

Leukemia, Myeloid, AcutePhase 3

Active, not recruiting

Relapsed or RefractoryPhase 2

Completed

PTCLPhase 2

Recruiting

Induction ChemotherapyPhase 2

Recruiting

Hematological MalignanciesPhase 2

Active, not recruiting

Showing 10 of 97 indications

Competition

Competitive Landscape

401 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

Emend

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

Preclinical

1 5

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 6

Nuvigil

NNuvo Research GmbH

Preclinical

1 7

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 8

Elitek

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

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

AIN

NCT04229979

Phase 2Recruiting

Treatment

NCT05788679

Q1 2027

Phase 1Active, not recruiting

Acute Myeloid Leukemia

NCT03513484

Phase 1/2Active, not recruiting

Acute Myeloid Leukemia

NCT04086264

Phase 1Active, not recruiting

Maintenance Therapy

NCT03613532

Phase 2Recruiting

Lymphoma

NCT05958719

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia45 trials

Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03586609·145 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 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

Show 42 more trials

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

Withdrawn·JJonsson Comprehensive Cancer Center·Phase 1·NCT05720988

Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07458542·44 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

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

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

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

A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

Active, not recruiting·OOncoVerity, Inc.·Phase 2·NCT04023526·103 enrolled

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

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

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

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

TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia

Completed·UUma Borate·Phase 1·NCT04518345·3 enrolled

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

Terminated· Gilead logo

Gilead·Phase 3·NCT05079230·378 enrolled

Clinical Research for Azacitidine Combined With Low-dose Dasatinib in Maintenance Therapy of Acute Myeloid Leukemia

Unknown status·LLanZhou University·N/A·NCT05042531·30 enrolled

Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China

Active, not recruiting· AbbVie logo

AbbVie·Phase 4·NCT05144243·44 enrolled

A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

Terminated· Novartis logo

Novartis·Phase 1·NCT05155709·14 enrolled

Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 3·NCT07132684·240 enrolled

Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT03217838·50 enrolled

An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia

Terminated·HHelsinn Healthcare SA·Phase 3·NCT03151408·406 enrolled

A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)

Terminated·AALX Oncology Inc.·Phase 1·NCT04755244·14 enrolled

A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04336982·22 enrolled

Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia

Active, not recruiting·NNorthwestern University·Phase 1·NCT03513484·44 enrolled

Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Terminated·SSyros Pharmaceuticals·Phase 2·NCT04905407·66 enrolled

Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia

Recruiting·UUniversity of Colorado, Denver·Phase 1·NCT06429449·30 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

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 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

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

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

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

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

Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06565975·112 enrolled

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01757535·472 enrolled

A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06073769·154 enrolled

Myelodysplastic Syndrome31 trials

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

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 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

Show 28 more trials

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 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

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

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

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

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

5 Day Versus 7 Day Azacitidine in Lower Risk Myelodysplastic Syndrome

Unknown status·SSeoul St. Mary's Hospital·Phase 2·NCT01652781·92 enrolled

Venetoclax and Azacitidine for Treatment of Therapy Related or Secondary Myelodysplastic Syndrome

Active, not recruiting·UUma Borate·Phase 2·NCT05379166·33 enrolled

Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01720225·113 enrolled

A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·SSyros Pharmaceuticals·Phase 2·NCT02807558·155 enrolled

Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

Terminated·SSyros Pharmaceuticals·Phase 3·NCT04797780·246 enrolled

Tosedostat and Cytarabine or Azacitidine in Treating Older Participants With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01636609·18 enrolled

A Study of FF-10501-01 in Combination with Azacitidine in Patients with Myelodysplastic Syndrome

Withdrawn·FFujifilm Pharmaceuticals U.S.A., Inc.·Phase 2·NCT03486353

Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

Terminated· Gilead logo

Gilead·Phase 3·NCT04313881·539 enrolled

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

Terminated·PPETHEMA Foundation·Phase 2·NCT00495547·16 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

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

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

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

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

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01566695·216 enrolled

Myelodysplastic Syndromes16 trials

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

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02721875·1 enrolled

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

Completed·—·Phase 2·NCT03397173·12 enrolled

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

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

Show 13 more trials

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

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

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

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

No longer available· Takeda logo

Takeda··NCT04484363

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

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

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes

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

Best Promising Drug Association With Azacitidine in Higher Risk Myelodysplastic Syndromes

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

Vosaroxin and Azacitidine in Treating Patients With Myelodysplastic Syndromes

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

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

Recruiting·AAkeso·Phase 2·NCT06196203·90 enrolled

Treatment of High Risk Myelodysplastic Syndromes (MDS) Not Candidates for Allogeneic Transplantation of Hematopoietic Progenitors (ALO-HSCT)

Unknown status·GGrupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias··NCT04602273·150 enrolled

Chronic Myelomonocytic Leukemia9 trials

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 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

Show 6 more trials

Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04140487·97 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

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

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 in Treating Patients With Chronic Myelomonocytic Leukemia

Completed·UUniversity of Leeds·Phase 2·NCT01235117·30 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

Newly Diagnosed9 trials

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

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

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

Show 6 more trials

Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old

Unknown status·PPETHEMA Foundation·Phase 1/2·NCT04687761·84 enrolled

Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2/3·NCT05175508·180 enrolled

Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy

Unknown status·RRuijin Hospital·Phase 2·NCT04480125·28 enrolled

A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 2·NCT06014489·142 enrolled

VAH vs VA in Newly Diagnosed Elderly AML

Not yet recruiting·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 3·NCT07469046·308 enrolled

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

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

60 more indications

MDS6 trials

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

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

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

Show 3 more trials

STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS

Terminated· Novartis logo

Novartis·Phase 2·NCT04878432·39 enrolled

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

Lymphoma6 trials

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

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

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

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

Show 3 more trials

Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05958719·37 enrolled

Oral Azacitidine Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma

Completed·MMedical University of South Carolina·Phase 1·NCT03450343·9 enrolled

CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma

Completed·JJoseph Tuscano·Phase 1·NCT04578600·8 enrolled

Treatment3 trials

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

Withdrawn· Novartis logo

Novartis·Phase 1/2·NCT05367401

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

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

MRD-guided Treatment in NPM1mut AML Patients

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

Leukemia3 trials

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

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

Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia

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

CMML3 trials

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

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

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

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

Breast Cancer2 trials

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

Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer

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

Elderly Patients2 trials

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

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

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

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

Myeloid Malignancies2 trials

Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies

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

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Terminated· Gilead logo

Gilead·Phase 2·NCT04778410·54 enrolled

Acute Lymphoblastic Leukemia2 trials

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

Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02828358·78 enrolled

Chemotherapy2 trials

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

Nivolumab With Chemotherapy in Refractory MDS

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

Non-Small Cell Lung Cancer2 trials

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

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

Trial2 trials

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

Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01957644·16 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

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

Maintenance Therapy2 trials

Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring in AML

Unknown status·GGe Zheng·Phase 3·NCT04490707·60 enrolled

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

Multiple Myeloma2 trials

Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma

Completed·VVirginia Commonwealth University·N/A·NCT01050790·17 enrolled

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

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

Relapsed or Refractory2 trials

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

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

Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients with Relapsed or Refractory AITL

Active, not recruiting·TThe Lymphoma Academic Research Organisation·Phase 3·NCT03593018·86 enrolled

Relapsed AML1 trial

Imetelstat Combinations in Relapsed AML

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

Advanced Solid Tumors1 trial

Study of Azacitidine and Durvalumab in Advanced Solid Tumors

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

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

AML1 trial

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

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

MACE1 trial

Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS

Active, not recruiting·UUniversity of Colorado, Denver·Phase 1/2·NCT03564873·28 enrolled

Temozolomide1 trial

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

Completed·—·Phase 1·NCT00629343·27 enrolled

CLE1 trial

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

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

Olverembatinib1 trial

Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT06757855·29 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

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

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

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

Myelodysplastic/Myeloproliferative Neoplasm1 trial

Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04493138·58 enrolled

Blood Cancer1 trial

Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

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

Esophageal Cancer1 trial

Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer

Completed·WWeill Medical College of Cornell University·Phase 1·NCT01386346·12 enrolled

Metastatic Colorectal Cancer1 trial

A Phase 2 Study of Pembrolizumab (MK-3475) in Combination With Azacitidine in Subjects With Chemo-refractory Metastatic Colorectal Cancer

Completed·AAnuradha Krishnamurthy·Phase 2·NCT02260440·31 enrolled

Myelofibrosis1 trial

Ph II Study of Azacitidine in Myelofibrosis

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00569660·34 enrolled

Relapsed/Refractory1 trial

Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL

Terminated·HHackensack Meridian Health·Phase 2·NCT01241786·5 enrolled

Oral1 trial

A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine

Completed·SS*BIO·Phase 1·NCT00741234·85 enrolled

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT01886573·40 enrolled

Pancreatic Cancer1 trial

Azacitidine and Pembrolizumab in Pancreatic Cancer

Completed·—·Phase 2·NCT03264404·36 enrolled

Hematologic Malignancies1 trial

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Recruiting·—·Phase 1·NCT05292664·30 enrolled

Systemic Mastocytosis1 trial

Study of Elenestinib (BLU-263) in Advanced Systemic Mastocytosis (AdvSM) and and Other KIT Altered Hematologic Malignancies

Terminated·BBlueprint Medicines·Phase 1·NCT05609942·9 enrolled

Hematological Malignancies1 trial

Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies

Terminated· Gilead logo

Gilead·Phase 1·NCT03248479·258 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

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

Thyroid Cancer1 trial

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

Completed·—·Phase 1·NCT00004062

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

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

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

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

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

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

Lenalidomide1 trial

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

Terminated·SStanford University·Phase 2·NCT01442714·33 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

Glioma1 trial

Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma

Enrolling by invitation·—·Phase 1·NCT06896110·34 enrolled

Regulatory

FDA Approval Timeline[5]

May 19, 2004

VIDAZA

NDA NDA050794

Apr 29, 2016

AZACITIDINE

NDA NDA208216

Sep 1, 2020

ONUREG

NDA NDA214120

Sources

References

[1]
ClinicalTrials.gov — 526 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 NDA214120). 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

Trials by Indication[1]

Acute Myeloid Leukemia45 trials

Myelodysplastic Syndrome31 trials

Myelodysplastic Syndromes16 trials

Chronic Myelomonocytic Leukemia9 trials

Newly Diagnosed9 trials

MDS6 trials

Lymphoma6 trials

Treatment3 trials

Leukemia3 trials

CMML3 trials

Safety and Efficacy2 trials

Breast Cancer2 trials

Stem Cell Transplantation2 trials

Elderly Patients2 trials

Myeloid Malignancies2 trials

Acute Lymphoblastic Leukemia2 trials

Chemotherapy2 trials

Non-Small Cell Lung Cancer2 trials

Trial2 trials

Transplantation2 trials

Advanced Malignancies2 trials

Maintenance Therapy2 trials

Multiple Myeloma2 trials

Relapsed or Refractory2 trials

Relapsed AML1 trial

Advanced Solid Tumors1 trial

Myeloid Leukemia1 trial

AIN1 trial

AML1 trial

MACE1 trial

Temozolomide1 trial

CLE1 trial

Olverembatinib1 trial

Bone Marrow Transplantation1 trial

Maintenance Treatment1 trial

Hematologic Cancer1 trial

Induction Therapy1 trial

Myelodysplastic/Myeloproliferative Neoplasm1 trial

Blood Cancer1 trial

Acute Myeloid Leukaemia (AML)1 trial

Esophageal Cancer1 trial

Metastatic Colorectal Cancer1 trial

Myelofibrosis1 trial

Relapsed/Refractory1 trial

Oral1 trial

Phase II1 trial

Allogeneic Stem Cell Transplantation1 trial

Lung Cancer1 trial

Pancreatic Cancer1 trial

Hematologic Malignancies1 trial

Systemic Mastocytosis1 trial

Hematological Malignancies1 trial

Metastatic Melanoma1 trial

Chronic Kidney Disease1 trial

Thyroid Cancer1 trial

Acute Leukemia of Ambiguous Lineage1 trial

Induction Chemotherapy1 trial

Juvenile Myelomonocytic Leukemia1 trial

Angioimmunoblastic T-Cell Lymphoma1 trial

Chronic Myelogenous Leukemia1 trial

Relapsed/Refractory AML1 trial

Blastic Plasmacytoid Dendritic Cell Neoplasm1 trial

Lenalidomide1 trial

Azacytidine1 trial

Glioma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News