Acute Myeloid Leukemia (AML)

Oncology
35
Pipeline Programs
18
Companies
50
Clinical Trials
13 recruiting
5
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
10
7
9
0
3
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
8100%
+ 26 programs with unclassified modality

On Market (5)

Approved therapies currently available

U
AZACITIDINEApproved
azacitidine
Unknown Company
intravenous, subcutaneous2016
U
KOMZIFTIApproved
ziftomenib
Unknown Company
Menin Inhibitor [EPC]oral2025
Bristol Myers Squibb
ONUREGApproved
azacitidine
Bristol Myers Squibb
Nucleoside Metabolic Inhibitor [EPC]oral2020
AbbVie
VENCLEXTAApproved
venetoclax
AbbVie
BCL-2 Inhibitor [EPC]oral2016
Bristol Myers Squibb
VIDAZAApproved
azacitidine
Bristol Myers Squibb
Nucleoside Metabolic Inhibitor [EPC]intravenous, subcutaneous2004

Competitive Landscape

18 companies ranked by most advanced pipeline stage

AbbVie
AbbVieNORTH CHICAGO, IL
5 programs
3
1
1
VenetoclaxPhase 41 trial
VenetoclaxPhase 31 trial
ABBV-184Phase 11 trial
ABBV-744Phase 11 trial
VenetoclaxPhase 15 trials
Active Trials
NCT04272203Terminated14Est. Jun 2022
NCT03360006Terminated30Est. Dec 2020
NCT03592576No Longer Available
+6 more trials
Bristol Myers Squibb
2 programs
1
AzacitidineN/A1 trial
Oral azacitidineN/A1 trial
Active Trials
NCT07458542Active Not Recruiting44Est. Mar 2026
NCT06565975Completed112Est. Jan 2026
Genentech
GenentechCA - Oceanside
2 programs
1
1
AzacitidinePhase 3
VenetoclaxPhase 1
Kura Oncology
Kura OncologySAN DIEGO, CA
1 program
1
ZiftomenibPhase 3Small Molecule1 trial
Active Trials
NCT07007312Recruiting1,300Est. Nov 2031
Astellas
AstellasChina - Shenyang
7 programs
2
3
1
GilteritinibPhase 2Small Molecule1 trial
ASP7517Phase 1/21 trial
GilteritinibPhase 1/2Small Molecule1 trial
gilteritinibPhase 1/2Small Molecule1 trial
GilteritinibPhase 1Small Molecule1 trial
+2 more programs
Active Trials
NCT03409081No Longer Available
NCT05756777Recruiting36Est. Feb 2027
NCT04079296Completed43Est. Apr 2023
+3 more trials
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
3 programs
2
CPX-351Phase 21 trial
CPX-351Phase 21 trial
Vyxeos liposomalN/A1 trial
Active Trials
NCT06143839Completed113Est. Oct 2025
NCT02238925Completed26Est. Jan 2016
NCT02269579Withdrawn0Est. Jun 2017
Karyopharm Therapeutics
3 programs
1
2
SelinexorPhase 21 trial
SelinexorPhase 21 trial
SelinexorPhase 11 trial
Active Trials
NCT02212561CompletedEst. Dec 2015
NCT02088541CompletedEst. Jan 2018
NCT03071276TerminatedEst. Apr 2019
ADC Therapeutics
ADC TherapeuticsNJ - New Providence
1 program
1
ADCT-301Phase 21 trial
Active Trials
NCT04639024TerminatedEst. Nov 2022
Bio-Path Holdings
Bio-Path HoldingsBELLAIRE, TX
1 program
1
BP1001 in combination with Ventoclax plus decitabinePhase 21 trial
Active Trials
NCT02781883RecruitingEst. Dec 2028
Fresenius Kabi
Fresenius KabiGermany - Bad Homburg
1 program
1
OMEGAVENPhase 21 trial
Active Trials
NCT01999413Completed30Est. Apr 2018
Takeda
TakedaTOKYO, Japan
1 program
1
PevonedistatPhase 2Small Molecule5 trials
Active Trials
NCT04985656Withdrawn0Est. Nov 2024
NCT04266795Completed164Est. Oct 2025
NCT03814005Completed17Est. Apr 2022
+2 more trials
Mendus
MendusSweden - Stockholm
1 program
1
DCP-001Phase 1/21 trial
Active Trials
NCT01373515CompletedEst. May 2013
Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
IdasanutlinPhase 1/23 trials
Active Trials
NCT04029688Terminated38Est. May 2024
NCT03287245Terminated27Est. Mar 2020
NCT03362723Completed48Est. Jun 2019
Sutro Biopharma
Sutro BiopharmaSOUTH SAN FRANCISCO, CA
1 program
1
Luveltamab tazevibulinPhase 1/21 trial
Active Trials
NCT06679582Terminated24Est. Jun 2025
Zentalis Pharmaceuticals
1 program
1
ZN-d5 ZN-c3Phase 1/21 trial
Active Trials
NCT05682170TerminatedEst. Jul 2024
Aptevo Therapeutics
1 program
1
APVO436Phase 11 trial
Active Trials
NCT06634394RecruitingEst. Mar 2028
DS
Daiichi SankyoChina - Shanghai
1 program
1
QuizartinibPhase 1Small Molecule1 trial
Active Trials
NCT03723681Completed7Est. Mar 2022
CT
1 program
1
TQB3455 tablet+Azacitidine for InjectionPhase 11 trial
Active Trials
NCT06550713RecruitingEst. Dec 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
AbbVieVenetoclax
AbbVieVenetoclax
Kura OncologyZiftomenib
AbbVieVenetoclax
AbbVieVenetoclax
AbbVieVenetoclax
AbbVieVenetoclax
AbbVieVenetoclax
AbbVieVenetoclax
AbbVieVenetoclax
AbbVieVenetoclax
AbbVieVenetoclax
TakedaPevonedistat
AbbVieVenetoclax
AbbVieVenetoclax

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 6,777 patients across 50 trials

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

Start: Jul 2025Est. completion: Nov 2027100 patients
Phase 4Recruiting

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

Start: Jan 2022Est. completion: Mar 202644 patients
Phase 4Active Not Recruiting

Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

Start: Sep 2025Est. completion: Nov 20311,300 patients
Phase 3Recruiting

A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Start: Aug 2024Est. completion: Mar 2028170 patients
Phase 3Recruiting

Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Start: Oct 2022Est. completion: Apr 203198 patients
Phase 3Recruiting

A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)

Start: Oct 2020Est. completion: Apr 202114 patients
Phase 3Completed

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

Start: Sep 2020Est. completion: Mar 2026531 patients
Phase 3Active Not Recruiting

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

Start: Mar 2020Est. completion: Jun 2026112 patients
Phase 3Active Not Recruiting

A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Start: Feb 2020Est. completion: Sep 2025465 patients
Phase 3Terminated

An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

Start: Sep 2019Est. completion: Aug 2027165 patients
Phase 3Active Not Recruiting

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

Start: Aug 2019Est. completion: Mar 202260 patients
Phase 3Completed

A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.

Start: Oct 2018Est. completion: Nov 2027265 patients
Phase 3Active Not Recruiting
NCT03268954TakedaPevonedistat

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)

Start: Nov 2017Est. completion: Oct 2024454 patients
Phase 3Completed

A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Start: May 2017Est. completion: Aug 2025211 patients
Phase 3Completed

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

Start: Feb 2017Est. completion: Jan 2026443 patients
Phase 3Active Not Recruiting

A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).

Start: Dec 2016Est. completion: Dec 2021210 patients
Phase 3Completed

A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)

Start: Jun 2016Est. completion: Mar 2022258 patients
Phase 3Completed

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

Start: Dec 2014Est. completion: Aug 2025445 patients
Phase 3Completed

Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy

Start: Dec 2025Est. completion: Feb 202879 patients
Phase 2Recruiting

A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Start: Nov 2025Est. completion: Apr 202840 patients
Phase 2Recruiting

GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma

Start: Jan 2025Est. completion: Feb 202940 patients
Phase 2Recruiting

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

Start: Dec 2024Est. completion: Dec 2033100 patients
Phase 2Recruiting

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

Start: Nov 2024Est. completion: Aug 202837 patients
Phase 2Recruiting

Venetoclax, Rituximab and Nivolumab in Combination for the Treatment of Richter's Transformation Arising From Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Start: Mar 2024Est. completion: Dec 20310
Phase 2Withdrawn

Azacitidine Combined With Venetoclax in Patients With Higher-risk Chronic Myelomonocytic Leukemia (AVENHIR)

Start: Oct 2023Est. completion: Oct 202844 patients
Phase 2Active Not Recruiting

Venetoclax in Combination with 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy

Start: May 2023Est. completion: Jul 202545 patients
Phase 2Recruiting

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Start: Mar 2022Est. completion: Jan 202975 patients
Phase 2Recruiting

ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN

Start: Dec 2021Est. completion: Nov 2022
Phase 2Terminated
NCT04985656TakedaPevonedistat

A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes

Start: Oct 2021Est. completion: Nov 20240
Phase 2Withdrawn

A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma

Start: May 2021Est. completion: Jun 20266 patients
Phase 2Active Not Recruiting
NCT04266795TakedaPevonedistat

A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy

Start: Oct 2020Est. completion: Oct 2025164 patients
Phase 2Completed

A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia

Start: Jan 2020Est. completion: Nov 202114 patients
Phase 2Completed

A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy

Start: Apr 2019Est. completion: Aug 20190
Phase 2Withdrawn

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

Start: Nov 2018Est. completion: Jun 202736 patients
Phase 2Active Not Recruiting

Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL

Start: Sep 2018Est. completion: Oct 2025141 patients
Phase 2Completed
NCT03709576TakedaPevonedistat

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

Start: Jul 2018Est. completion: Jul 20193 patients
Phase 2Terminated
NCT03287245RocheIdasanutlin

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera

Start: Feb 2018Est. completion: Mar 202027 patients
Phase 2Terminated

Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)

Start: Jan 2017Est. completion: Jun 2027120 patients
Phase 2Active Not Recruiting

A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission

Start: Jan 2017Est. completion: Feb 202498 patients
Phase 2Completed
NCT02781883Bio-Path HoldingsBP1001 in combination with Ventoclax plus decitabine

Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML

Start: May 2016Est. completion: Dec 2028
Phase 2Recruiting

Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia

Start: Jan 2016Est. completion: Apr 2019
Phase 2Terminated

Pharmacokinetic and Pharmacodynamic Assessment of Treatment With CPX-351 (Cytarabine: Daunorubicin) Liposome for Injection in Acute Leukemias and MDS Patients With Moderate Hepatic Impairment

Start: Apr 2015Est. completion: Jun 20170
Phase 2Withdrawn

A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)

Start: Dec 2014Est. completion: Mar 2018163 patients
Phase 2Completed

An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients

Start: Jul 2014Est. completion: Jan 201626 patients
Phase 2Completed

Selinexor (KPT-330) in Older Patients With Relapsed AML

Start: Mar 2014Est. completion: Jan 2018
Phase 2Completed

Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients

Start: Nov 2013Est. completion: Apr 201830 patients
Phase 2Completed

HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

Start: Oct 2026Est. completion: Oct 203242 patients
Phase 1/2Not Yet Recruiting
NCT06679582Sutro BiopharmaLuveltamab tazevibulin

Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML

Start: Dec 2024Est. completion: Jun 202524 patients
Phase 1/2Terminated

A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

Start: Sep 2024Est. completion: Dec 20288 patients
Phase 1/2Recruiting

A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia

Start: Jan 2023Est. completion: Jul 202870 patients
Phase 1/2Active Not Recruiting

Related Jobs in Oncology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
13 actively recruiting trials targeting 6,777 patients
18 companies competing in this space