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 82 indications[4].[1]

Vidaza is one of 1197 small molecule programs targeting Glioma. It is currently in Approved.

Indications

509

Total Trials

Active Trials

1,196

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

EpendymomaApproved

Non-Hodgkins LymphomaApproved

ParagangliomaApproved

Childhood EpendymomaApproved

Central Nervous System CancerApproved

Unspecified Peripheral T-Cell LymphomaApproved

Lung CancerActive, not recruiting

T-Cell Non-Hodgkin LymphomaActive, not recruiting

ThrombocytopeniaApproved

GliomaPhase 1

Active, not recruiting

EpendymomaApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

ParagangliomaApproved

Approved

Childhood EpendymomaApproved

Approved

Central Nervous System CancerApproved

Approved

Unspecified Peripheral T-Cell LymphomaApproved

Approved

Lung CancerPhase 1

Active, not recruiting

T-Cell Non-Hodgkin LymphomaPreclinical

Active, not recruiting

ThrombocytopeniaApproved

Approved

Showing 10 of 82 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Vidaza

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

3 2

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Adenocard

Astellas

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 7

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 8

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 9

Dextromethorphan Hydrobromide

Boehringer Ingelheim

Preclinical

1 10

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 2Not yet recruiting

Acute Myeloid Leukemia

NCT05554419

Phase 2Recruiting

Stem Cell Transplantation

NCT04061239

Q4 2026

Phase 2Recruiting

Treatment

NCT05788679

Phase 3Recruiting

Acute Myeloid Leukemia

NCT05907057

Phase 2Active, not recruiting

Metastatic Melanoma

NCT02816021

Phase 2Active, not recruiting

Acute Myeloid Leukemia

NCT04128501

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia48 trials

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

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Recruiting·BBeat AML, LLC·Phase 1/2·NCT03013998·3,000 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

Show 45 more trials

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

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

Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality

Recruiting·VVirginia Commonwealth University·Phase 4·NCT06370000·12 enrolled

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

Recruiting·JJacqueline Garcia, MD·Phase 1/2·NCT07148180·31 enrolled

A Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia (AML)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06773208·30 enrolled

Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Terminated· Pfizer logo

Pfizer·Phase 3·NCT02785900·240 enrolled

A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Recruiting·SStemline Therapeutics, Inc.·Phase 2·NCT06456463·83 enrolled

Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01249430·24 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

Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03683433·50 enrolled

Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients

Completed·ZZhujiang Hospital·N/A·NCT05471700·40 enrolled

Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia (AML) Following Initial Treatment

Not yet recruiting·EEastern Cooperative Oncology Group·Phase 2·NCT05628623·184 enrolled

A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia

Active, not recruiting·AAkeso·Phase 1/2·NCT04980885·68 enrolled

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01074047·488 enrolled

A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia

Suspended·SSt. Jude Children's Research Hospital·Phase 2·NCT05955261·70 enrolled

Uproleselan, Azacitidine, and Venetoclax for the Treatment of Treatment Naive Acute Myeloid Leukemia

Terminated·BBrian Jonas·Phase 1·NCT04964505·16 enrolled

Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy

Recruiting·—·Phase 2·NCT06782542·16 enrolled

Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia

Active, not recruiting·UUniversity of Colorado, Denver·Phase 2·NCT03573024·36 enrolled

Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia

Completed·UUniversity of Colorado, Denver·Phase 2·NCT01743859·37 enrolled

Aclarubicin Plus With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia

Not yet recruiting·SShanghai Jiao Tong University School of Medicine·Phase 1/2·NCT07486726·112 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

An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.

Recruiting·SServier Affaires Médicales·Phase 3·NCT05907057·245 enrolled

Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04128501·100 enrolled

Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Treatment, The ERASE Study (A MyeloMATCH Treatment Trial)

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554419·184 enrolled

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

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02399917·36 enrolled

Azacitidine, Mitoxantrone Hydrochloride, and Etoposide in Treating Older Patients With Poor-Prognosis Acute Myeloid Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT01260714·13 enrolled

A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05834244·32 enrolled

A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

Recruiting·SShanghai Tong Ren Hospital·Phase 2·NCT05736965·58 enrolled

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

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

Regorafenib in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia

Suspended·—·Phase 1·NCT06454409·20 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

Study to Assess Adverse Events and Change in Disease Activity of Oral Venetoclax in Combination With Subcutaneous (SC) or Intravenous (IV) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Standard Induction Therapy in India

Recruiting· AbbVie logo

AbbVie·Phase 4·NCT07044687·100 enrolled

High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML)

Not yet recruiting·KKittika Poonsombudlert·Phase 1·NCT07177079·30 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

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

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

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

Withdrawn·JJonsson Comprehensive Cancer Center·Phase 1·NCT05720988

Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03862157·40 enrolled

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

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

Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Recruiting·SSt. Jude Children's Research Hospital·Phase 1·NCT06177067·24 enrolled

Myelodysplastic Syndrome25 trials

Pacritinib With Aza for Upfront Myelodysplastic Syndrome

Not yet recruiting·TThomas Jefferson University·Phase 1/2·NCT07387354·25 enrolled

Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT01812252·50 enrolled

A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2/3·NCT05469737·230 enrolled

Show 22 more trials

A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)

Terminated·TTJ Biopharma Co., Ltd.·Phase 3·NCT05709093·10 enrolled

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

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

Ascorbate in Myelodysplastic Syndrome

Recruiting·PPrajwal Dhakal·Phase 2·NCT07283900·38 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

A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06616636·24 enrolled

VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

Completed·NNantes University Hospital·Phase 2·NCT01541280·30 enrolled

Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01892371·73 enrolled

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

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

Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Completed·NNational Cancer Institute (NCI)·Phase 2/3·NCT03092674·76 enrolled

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT04401748·531 enrolled

Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06419634·105 enrolled

Intensified Azacitidine in High Risk Myelodysplastic Syndrome (MDS)

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

A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Recruiting·EEdgewood Oncology Inc.·Phase 1·NCT04243785·80 enrolled

PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT04022785·43 enrolled

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

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

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

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

Azacitidine and Pembrolizumab in Treating Patients With Myelodysplastic Syndrome

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

Myelodysplastic Syndromes14 trials

Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

Terminated·JJonsson Comprehensive Cancer Center·Phase 1·NCT00234000·1 enrolled

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02281084·65 enrolled

Azacitidine and Erythropoietin Versus Azacitidine Alone for Patients With Low-Risk Myelodysplastic Syndromes

Terminated·LLarry Cripe, MD·Phase 2·NCT00379912·15 enrolled

Show 11 more trials

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes

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

An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01186939·40 enrolled

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05168202·56 enrolled

Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00102687·151 enrolled

A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT02942290·129 enrolled

APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)

Completed·AAprea Therapeutics·Phase 3·NCT03745716·154 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

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

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

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

Newly Diagnosed11 trials

Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

Terminated·IIGM Biosciences, Inc.·Phase 1·NCT04553692·272 enrolled

Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT07159620·27 enrolled

Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML

Recruiting·—·Phase 2·NCT07078591·50 enrolled

Show 8 more trials

Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML

Completed·HHospital Universitario Dr. Jose E. Gonzalez·Phase 2·NCT05048615·15 enrolled

A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

Recruiting·OOncoVerity, Inc.·Phase 2·NCT06384261·120 enrolled

Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT06429098·40 enrolled

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

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

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

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

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

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

Lymphoma8 trials

Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 1/2·NCT02701673

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

Show 5 more trials

Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05182957·40 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

Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT00336063·18 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

65 more indications

Chronic Myelomonocytic Leukemia6 trials

AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia

Terminated· Amgen logo

Amgen·Phase 1·NCT05209152·7 enrolled

MS-275 and Azacitidine in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00101179·63 enrolled

Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02201329·5 enrolled

Show 3 more trials

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

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

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

Recruiting·UUma Borate·Phase 1/2·NCT06523556·52 enrolled

Leukemia4 trials

ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML)

Withdrawn·AAcute Leukemia French Association·Phase 3·NCT01067274

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

Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia

Terminated·MMedical College of Wisconsin·Phase 1·NCT04172844·16 enrolled

Show 1 more trial

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

Maintenance Therapy3 trials

Trial Evaluating Induction Therapy With Idarubicin and Etoposide Plus Sequential or Concurrent Azacitidine and Maintenance Therapy With Azacitidine

Completed·UUniversity of Ulm·Phase 2·NCT01180322·277 enrolled

AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2/3·NCT05404906·124 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

Glioma3 trials

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

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

Treatment With Azacitidine of Recurrent Gliomas With IDH1/2 Mutation

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT03666559·8 enrolled

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

Safety and Efficacy3 trials

Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01519011·34 enrolled

Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine

Unknown status·GGroupe Francophone des Myelodysplasies·Phase 1/2·NCT03588078·53 enrolled

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

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

Myeloid Malignancies3 trials

APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

Completed·AAprea Therapeutics·Phase 1·NCT04214860·51 enrolled

ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 1·NCT06656494·266 enrolled

Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies

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

Stem Cell Transplantation3 trials

Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML

Recruiting·GGWT-TUD GmbH·Phase 2·NCT04061239·150 enrolled

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

Non-Small Cell Lung Cancer3 trials

Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01281124·1 enrolled

Azacitidine in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

Completed·—·Phase 1·NCT02009436·8 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

Hematologic Malignancies2 trials

Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies

Recruiting·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1·NCT05476770·54 enrolled

A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies

Completed· Pfizer logo

Pfizer·Phase 1·NCT02038777·48 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

Azacitidine and Oxaliplatin In Treating Patients With Advanced Cancers Relapsed or Refractory to Any Platinum Therapy

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01039155·41 enrolled

Hematological Malignancies2 trials

Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

Terminated· Amgen logo

Amgen·Phase 1·NCT03465540·24 enrolled

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

Chemotherapy2 trials

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

A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy

Terminated· Novartis logo

Novartis·Phase 2·NCT04150029·90 enrolled

CMML2 trials

Pacritinib in CMML

Recruiting·UUnknown Sponsor·Phase 1/2·NCT06159491·26 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

High Risk2 trials

A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants

Terminated· Novartis logo

Novartis·Phase 2·NCT04812548·20 enrolled

Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

Completed· Novartis logo

Novartis·Phase 1·NCT03066648·241 enrolled

Lenalidomide2 trials

Study of Grifola Frondosa (Maitake), Azacitidine, and Lenalidomide

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01200004·1 enrolled

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

Treatment2 trials

Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT

Unknown status·FFujian Medical University·Phase 2/3·NCT04216355·20 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

MDS2 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

Tics1 trial

Pharmacokinetics, Tolerability and Safety of NEX-18a

Completed·NNanexa AB·Phase 1·NCT05048498·2 enrolled

Myeloid Neoplasm1 trial

A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)

Recruiting· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2/3·NCT04256317·316 enrolled

Squamous Cell Carcinoma1 trial

Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Terminated·UUniversity of Kansas Medical Center·Phase 1·NCT00443261·1 enrolled

Acute Lymphoblastic Leukemia1 trial

CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT06078306·20 enrolled

Phase 11 trial

Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML

Terminated·SShattuck Labs, Inc.·Phase 1·NCT05275439·106 enrolled

Neoplasms1 trial

Phase 1 Study of CC-486 in Japanese Subjects With Hematological Neoplasms

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01908387·2 enrolled

Monotherapy1 trial

AZA+Lus VS AZA Monotherapy in HR-MDS

Not yet recruiting·PPeking Union Medical College Hospital·Phase 3·NCT06927232·86 enrolled

Breast Cancer1 trial

A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer

Completed·UUniversity of Utah·Phase 1/2·NCT00748553·30 enrolled

Tuberculosis1 trial

Azacytidine During Anti-tuberculosis Therapy

Withdrawn·AAndrew Dinardo·Phase 1/2·NCT03941496

Azacytidine1 trial

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

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

Completed·FForma Therapeutics, Inc.·Phase 1·NCT02543879·94 enrolled

Elderly Patients1 trial

HAV Versus DAV/IAV Induction Regimen in Elderly Patients With AML

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06744556·60 enrolled

Refractory1 trial

Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05823701·23 enrolled

Thyroid Cancer1 trial

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

Completed·—·Phase 1·NCT00004062

Stem Cell Transplant1 trial

Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant

Recruiting·HHenry Ford Health System·Phase 2·NCT03850418·43 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

Acute Myeloid Leukaemia (AML)1 trial

Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)

Completed·HHikma Pharmaceuticals LLC·Phase 1·NCT06326697·32 enrolled

Phase 21 trial

Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA

Completed·HHelsinn Healthcare SA·Phase 2·NCT01993641·45 enrolled

HSCT1 trial

AZA Combined With NAC for PIT After HSCT

Not yet recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05126004·100 enrolled

Myelofibrosis1 trial

Azacitidine in Treating Patients With Myelofibrosis

Terminated·MMayo Clinic·Phase 2·NCT00381693·10 enrolled

Induction Chemotherapy1 trial

Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

Recruiting·MMassachusetts General Hospital·Phase 2·NCT04801797·172 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

Ovarian Cancer1 trial

Azacitidine With Carboplatin and Paclitaxel for Newly Diagnosed Ovarian Cancer

Withdrawn·LLoyola University·Phase 1·NCT00842582

Advanced Malignancies1 trial

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

Vaccination1 trial

Peptide Vaccination in Combination With Azacitidine for Patients With MDS and AML

Completed·DDaniel El Fassi·Phase 1·NCT02750995·5 enrolled

MRD1 trial

MRD-positive AML Clinical Study

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT07131059·120 enrolled

Efficacy1 trial

A Study to Assess Safety and Preliminary Efficacy of LP-108 Combined With Azacitidine In Subjects With AML, MDS, CMML

Unknown status·GGuangzhou Lupeng Pharmaceutical Company LTD.·Phase 1·NCT05641259·198 enrolled

Metastatic Melanoma1 trial

Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic Melanoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02816021·24 enrolled

Metastatic Colorectal Cancer1 trial

Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01105377·47 enrolled

Relapsed AML1 trial

Imetelstat Combinations in Relapsed AML

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

Osteosarcoma1 trial

Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03628209·21 enrolled

Renal Cell Carcinoma1 trial

A Study to Evaluate the Effectiveness of 5-Azacitidine and Bevacizumab in Advanced Renal Cell Carcinoma

Terminated·UUniversity of Kansas Medical Center·Phase 1/2·NCT00934440·11 enrolled

CHOP1 trial

AC-CHOP Versus CHOP in Patients With Previously Untreated PTCL-TFH

Enrolling by invitation·TTianjin Medical University Cancer Institute and Hospital·Phase 3·NCT05678933·200 enrolled

Untreated AML1 trial

Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML

Completed· Pfizer logo

Pfizer·Phase 3·NCT04842604·14 enrolled

Solid Tumors1 trial

A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems

Completed· Takeda logo

Takeda·Phase 1·NCT03814005·17 enrolled

Multiple Myeloma1 trial

Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma

Terminated·BBayside Health·Phase 2·NCT00412919·7 enrolled

Advanced Cancers1 trial

Azacytidine and Valproic Acid in Patients With Advanced Cancers

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00496444·69 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

AML1 trial

Cladribine Venetoclax in Monocytic AML

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT06232655·20 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

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

Juvenile Myelomonocytic Leukemia1 trial

A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia

Recruiting·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1/2·NCT05849662·58 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

Hematopoietic Cell Transplant1 trial

Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant

Recruiting·—·Phase 1·NCT06498973·43 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

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

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 — 509 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

Q3 2026

Q4 2026

Trials by Indication[1]

Acute Myeloid Leukemia48 trials

Myelodysplastic Syndrome25 trials

Myelodysplastic Syndromes14 trials

Newly Diagnosed11 trials

Lymphoma8 trials

Chronic Myelomonocytic Leukemia6 trials

Leukemia4 trials

Maintenance Therapy3 trials

Glioma3 trials

Safety and Efficacy3 trials

Myeloid Malignancies3 trials

Stem Cell Transplantation3 trials

Non-Small Cell Lung Cancer3 trials

Hematologic Malignancies2 trials

Relapsed or Refractory2 trials

Hematological Malignancies2 trials

Chemotherapy2 trials

CMML2 trials

High Risk2 trials

Lenalidomide2 trials

Treatment2 trials

MDS2 trials

Tics1 trial

Myeloid Neoplasm1 trial

Squamous Cell Carcinoma1 trial

Acute Lymphoblastic Leukemia1 trial

Phase 11 trial

Neoplasms1 trial

Monotherapy1 trial

Breast Cancer1 trial

Tuberculosis1 trial

Azacytidine1 trial

Targeted Therapy1 trial

Advanced or Metastatic Solid Tumors1 trial

Relapsed or Refractory Hematologic Malignancies1 trial

Elderly Patients1 trial

Refractory1 trial

Thyroid Cancer1 trial

Stem Cell Transplant1 trial

Acute Leukemia of Ambiguous Lineage1 trial

Acute Myeloid Leukaemia (AML)1 trial

Phase 21 trial

HSCT1 trial

Myelofibrosis1 trial

Induction Chemotherapy1 trial

Pancreatic Cancer1 trial

Ovarian Cancer1 trial

Advanced Malignancies1 trial

Vaccination1 trial

MRD1 trial

Efficacy1 trial

Metastatic Melanoma1 trial

Metastatic Colorectal Cancer1 trial

Relapsed AML1 trial

Osteosarcoma1 trial

Renal Cell Carcinoma1 trial

CHOP1 trial

Untreated AML1 trial

Solid Tumors1 trial

Multiple Myeloma1 trial

Advanced Cancers1 trial

Myeloid Leukemia1 trial

AML1 trial

Angioimmunoblastic T-Cell Lymphoma1 trial

Relapsed/Refractory AML1 trial

Juvenile Myelomonocytic Leukemia1 trial

Hematologic Cancer1 trial

Hematopoietic Cell Transplant1 trial

Induction Therapy1 trial

Blastic Plasmacytoid Dendritic Cell Neoplasm1 trial

FDA Approval Timeline[5]

References

Drug Info