AML

10
Pipeline Programs
9
Companies
11
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
375%
ADC
125%
+ 6 programs with unclassified modality

On Market (1)

Approved therapies currently available

DS
VANFLYTAApproved
quizartinib
Daiichi Sankyo
oral2023

Competitive Landscape

9 companies ranked by most advanced pipeline stage

DS
Daiichi SankyoChina - Shanghai
1 program
1
1
QuizartinibPhase 3Small Molecule1 trial
Active Trials
NCT02039726Completed367Est. Sep 2020
Pfizer
PfizerNEW YORK, NY
1 program
1
Gemtuzumab ozogamicine - Cytarabine - GilteritinibPhase 2ADC1 trial
Active Trials
NCT05199051Active Not Recruiting19Est. Jul 2028
FUJIFILM Pharma
FUJIFILM PharmaMA - Cambridge
1 program
1
FF-10501-01Phase 1/21 trial
Active Trials
NCT02193958CompletedEst. Oct 2019
Aptevo Therapeutics
2 programs
2
APVO436Phase 11 trial
APVO436Phase 11 trial
Active Trials
NCT04973618WithdrawnEst. Jan 2027
NCT03647800UnknownEst. Jun 2023
Novartis
NovartisBASEL, Switzerland
1 program
1
RAD 001Phase 11 trial
Active Trials
NCT01074086Completed31Est. Dec 2012
Bristol Myers Squibb
1 program
1
VenetoclaxPhase 12 trials
Active Trials
NCT05287568Recruiting35Est. Mar 2029
NCT05168202Terminated56Est. Jul 2024
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
VolasertibPhase 1Small Molecule1 trial
Active Trials
NCT02905994Withdrawn0Est. Feb 2017
Kura Oncology
Kura OncologySAN DIEGO, CA
1 program
1
ZiftomenibPhase 1Small Molecule1 trial
Active Trials
NCT06001788Recruiting171Est. Aug 2027
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
allo-HSCTN/A1 trial
Active Trials
NCT05339204UnknownEst. Feb 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Daiichi SankyoQuizartinib
PfizerGemtuzumab ozogamicine - Cytarabine - Gilteritinib
FUJIFILM PharmaFF-10501-01
Aptevo TherapeuticsAPVO436
Kura OncologyZiftomenib
Bristol Myers SquibbVenetoclax
Bristol Myers SquibbVenetoclax
Aptevo TherapeuticsAPVO436
Boehringer IngelheimVolasertib
NovartisRAD 001
T-Therapeuticsallo-HSCT

Clinical Trials (11)

Total enrollment: 679 patients across 11 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
NCT05199051PfizerGemtuzumab ozogamicine - Cytarabine - Gilteritinib

A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

Start: Jun 2023Est. completion: Jul 202819 patients
Phase 2Active Not Recruiting
NCT02193958FUJIFILM PharmaFF-10501-01

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

Start: Jul 2014Est. completion: Oct 2019
Phase 1/2Completed
NCT04973618Aptevo TherapeuticsAPVO436

Study of APVO436 in Elderly or Unfit Patients With Newly Diagnosed AML

Start: Jan 2025Est. completion: Jan 2027
Phase 1Withdrawn
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
NCT05287568Bristol Myers SquibbVenetoclax

CC-486 and Venetoclax for Acute Myeloid Leukemia

Start: Dec 2022Est. completion: Mar 202935 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
NCT03647800Aptevo TherapeuticsAPVO436

Study of APVO436 in Patients With AML or MDS

Start: Dec 2018Est. completion: Jun 2023
Phase 1Unknown
NCT02905994Boehringer IngelheimVolasertib

Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia

Start: Sep 2016Est. completion: Feb 20170
Phase 1Withdrawn
NCT01074086NovartisRAD 001

Phase I Study in RAD 001 Patients With Relapse AML

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

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

1 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 679 patients
9 companies competing in this space