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AML

12
Pipeline Programs
22
Companies
22
Clinical Trials
7 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
6
5
1
0
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
375%
Cell Therapy
125%
+ 19 programs with unclassified modality

Competitive Landscape

22 companies ranked by most advanced pipeline stage

Bayer
BayerLEVERKUSEN, Germany
2 programs
1
1
Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1HPhase 21 trial
IdarubicinPhase 1/21 trial
Active Trials
NCT00542971Completed78Est. May 2011
NCT00533923Completed25Est. Jan 2007
Essen Biotech
Essen BiotechDE - Newark
1 program
1
CD123/CD33 CARTPhase 1/2Cell Therapy1 trial
Active Trials
NCT06420063Recruiting85Est. Dec 2026
MacroGenics
MacroGenicsMD - Rockville
1 program
1
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days offPhase 1/21 trial
Active Trials
NCT02152956Terminated244Est. Jul 2022
Oncotherapy Science
Oncotherapy ScienceJapan - Kawasaki
1 program
1
OTS167IVPhase 1/21 trial
Active Trials
NCT02795520Terminated32Est. Sep 2021
Martin Pharmaceuticals
1 program
1
TranylcyprominePhase 1/21 trial
Active Trials
NCT02261779Unknown16Est. Sep 2017
CERo Therapeutics
CERo TherapeuticsCA - South SF
1 program
1
CER-1236Phase 11 trial
Active Trials
NCT06834282Recruiting18Est. Dec 2029
Sandoz
SandozAustria - Kundl
1 program
1
RAD 001Phase 11 trial
Active Trials
NCT01074086Completed31Est. Dec 2012
TScan Therapeutics
TScan TherapeuticsMA - Waltham
1 program
1
SOC + TSC-100Phase 11 trial
Active Trials
NCT05473910Recruiting75Est. Jun 2026
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
VenetoclaxPhase 11 trial
Active Trials
NCT05287568Recruiting35Est. Mar 2029
Lomond Therapeutics
1 program
1
ZE46-0134 or placeboPhase 11 trial
Active Trials
NCT06399315Completed112Est. Aug 2025
BGI
BGIChina - Hong Kong
1 program
1
targeted AML1-ETO neoantigen cytotoxic T cellsPhase 11 trial
Active Trials
NCT06499025Enrolling By Invitation16Est. Dec 2027
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
ASP2215N/A1 trial
Active Trials
NCT03315299No Longer Available
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
Leptin: A Marker for AML Chemo-SensitivityN/A1 trial
Active Trials
NCT07163728Recruiting86Est. Dec 2026
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
allo-HSCTN/A1 trial
Active Trials
NCT05339204UnknownEst. Feb 2026
Glycostem
GlycostemNetherlands - Oss
1 program
oNKord®N/A1 trial
Active Trials
NCT05290662Recruiting50Est. Mar 2028
Novartis
NovartisBASEL, Switzerland
1 program
RAD 001PHASE_1
Bristol Myers Squibb
1 program
VenetoclaxPHASE_11 trial
Active Trials
NCT05168202Terminated56Est. Jul 2024
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
VolasertibPHASE_1Small Molecule1 trial
Active Trials
NCT02905994Withdrawn0Est. Feb 2017
Kura Oncology
Kura OncologySAN DIEGO, CA
1 program
ZiftomenibPHASE_1Small Molecule1 trial
Active Trials
NCT06001788Recruiting171Est. Aug 2027
FUJIFILM Pharma
FUJIFILM PharmaMA - Cambridge
1 program
FF-10501-01PHASE_1_21 trial
Active Trials
NCT02193958Completed55Est. Oct 2019
IQVIA
IQVIADURHAM, NC
1 program
NKR-2PHASE_1_21 trial
Active Trials
NCT03466320Completed21Est. Feb 2021
Daiichi Sankyo
Daiichi SankyoChina - Shanghai
1 program
QuizartinibPHASE_3Small Molecule1 trial
Active Trials
NCT02039726Completed367Est. Sep 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Daiichi SankyoQuizartinib
BayerCyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H
Essen BiotechCD123/CD33 CART
IQVIANKR-2
Oncotherapy ScienceOTS167IV
Martin PharmaceuticalsTranylcypromine
FUJIFILM PharmaFF-10501-01
MacroGenicsFlotetuzumab 3 ng/kg/day, 4 days on and 3 days off
BayerIdarubicin
CERo TherapeuticsCER-1236
Kura OncologyZiftomenib
BGItargeted AML1-ETO neoantigen cytotoxic T cells
Lomond TherapeuticsZE46-0134 or placebo
Colorado TherapeuticsVenetoclax
TScan TherapeuticsSOC + TSC-100

Showing 15 of 21 trials with date data

Clinical Trials (22)

Total enrollment: 1,573 patients across 22 trials

NCT02039726Daiichi SankyoQuizartinib

(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

Start: May 2014Est. completion: Sep 2020367 patients
Phase 3Completed
NCT00533923BayerCyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H

Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders

Start: Dec 2002Est. completion: Jan 200725 patients
Phase 2Completed
NCT06420063Essen BiotechCD123/CD33 CART

Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML

Start: Jul 2024Est. completion: Dec 202685 patients
Phase 1/2Recruiting
NCT03466320IQVIANKR-2

DEPLETHINK - LymphoDEPLEtion and THerapeutic Immunotherapy With NKR-2

Start: Sep 2018Est. completion: Feb 202121 patients
Phase 1/2Completed
NCT02795520Oncotherapy ScienceOTS167IV

Pharmacological Study of Intravenous OTS167 in Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Advanced Myelodysplastic Syndromes, Advanced Myeloproliferative Neoplastic Disorders, or Advanced Chronic Myelogenous Leukemia

Start: Apr 2016Est. completion: Sep 202132 patients
Phase 1/2Terminated
NCT02261779Martin PharmaceuticalsTranylcypromine

Phase I/II Trial of ATRA and TCP in Patients With Relapsed or Refractory AML and no Intensive Treatment is Possible

Start: Sep 2014Est. completion: Sep 201716 patients
Phase 1/2Unknown
NCT02193958FUJIFILM PharmaFF-10501-01

Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies

Start: Jul 2014Est. completion: Oct 201955 patients
Phase 1/2Completed
NCT02152956MacroGenicsFlotetuzumab 3 ng/kg/day, 4 days on and 3 days off

Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)

Start: Jun 2014Est. completion: Jul 2022244 patients
Phase 1/2Terminated
NCT00542971BayerIdarubicin

Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)

Start: Oct 2007Est. completion: May 201178 patients
Phase 1/2Completed
NCT06834282CERo TherapeuticsCER-1236

CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)

Start: Apr 2025Est. completion: Dec 202918 patients
Phase 1Recruiting
NCT06001788Kura OncologyZiftomenib

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Start: Feb 2024Est. completion: Aug 2027171 patients
Phase 1Recruiting
NCT06499025BGItargeted AML1-ETO neoantigen cytotoxic T cells

Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL)

Start: Feb 2024Est. completion: Dec 202716 patients
Phase 1Enrolling By Invitation
NCT06399315Lomond TherapeuticsZE46-0134 or placebo

Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

Start: Jul 2023Est. completion: Aug 2025112 patients
Phase 1Completed
NCT05287568Colorado TherapeuticsVenetoclax

CC-486 and Venetoclax for Acute Myeloid Leukemia

Start: Dec 2022Est. completion: Mar 202935 patients
Phase 1Recruiting
NCT05473910TScan TherapeuticsSOC + TSC-100

A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation

Start: Nov 2022Est. completion: Jun 202675 patients
Phase 1Recruiting
NCT05168202Bristol Myers SquibbVenetoclax

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

Start: Jan 2022Est. completion: Jul 202456 patients
Phase 1Terminated
NCT02905994Boehringer IngelheimVolasertib

Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia

Start: Sep 2016Est. completion: Feb 20170
Phase 1Withdrawn
NCT01074086SandozRAD 001

Phase I Study in RAD 001 Patients With Relapse AML

Start: Feb 2008Est. completion: Dec 201231 patients
Phase 1Completed
NCT03315299Angeles TherapeuticsASP2215

Individual Patient Expanded Access Gilteritinib (ASP2215)

N/ANo Longer Available
NCT07163728UNION therapeuticsLeptin: A Marker for AML Chemo-Sensitivity

Leptin: A Marker for AML Chemo-Sensitivity

Start: Aug 2025Est. completion: Dec 202686 patients
N/ARecruiting
NCT05290662GlycostemoNKord®

Registry of Patients Having Received oNKord®

Start: Jun 2022Est. completion: Mar 202850 patients
N/ARecruiting
NCT05339204T-Therapeuticsallo-HSCT

The Role of Allo-HSCT in MRD-negative Patients With AML Under the Age of 60 Years in the First Complete Remission

Start: Feb 2021Est. completion: Feb 2026
N/AUnknown

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

7 actively recruiting trials targeting 1,573 patients
22 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.