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Acute Myeloid Leukemia

Oncology 11 original drugs

Novel Drugs

Reformulations

Active Trials

Drug Targets

Oncology indication. Acute Myeloid Leukemia has 11 FDA-approved novel treatments, led by Pfizer across 18 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Acute Myeloid Leukemia Market Leaders

Companies with the most FDA-approved novel Acute Myeloid Leukemia drugs.

Phase 3 Readouts Pro

10 active Phase 3 trials with confidence-graded completion dates.

Full calendar →

Q2 2027

mocravimod

Priothera SAS

Estimated · fresh NCT05429632

Q3 2027

XY0206

Shijiazhuang Yiling Pharmaceutical Co. Ltd

Estimated · stale NCT05876832

Q3 2027

Venetoclax

AbbVie

Estimated · fresh NCT03844048

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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Acute Myeloid Leukemia Treatments by Mechanism

Top 12 mechanisms across 49 industry trials with a known mechanism of action.

See full pipeline →

Menin Inhibitor

5 trials 5 active 2 sponsors

BCL-2 Inhibitor

13 trials 3 active 1 sponsor

Nucleoside Metabolic Inhibitor

11 trials 3 active 7 sponsors

IDH1

2 trials 2 active 2 sponsors

Kinase Inhibitor

7 trials 1 active 2 sponsors

Telomerase/hTR

1 trials 1 active 1 sponsor

DNA

3 trials 3 sponsors

Alkylating Drug

2 trials 2 sponsors

Programmed Death Receptor-1 Blocking Antibody

2 trials 1 sponsor

Nuclear Export Inhibitor

1 trials 1 sponsor

CD30-directed Immunoconjugate

1 trials 1 sponsor

DNA polymerase alpha/DNA primase/Ribonucleotide reductase

1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Acute Myeloid Leukemia Clinical Pipeline by Phase

507 industry-sponsored trials across 264 sponsors

Showing 4 of 4 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Rigel Pharmaceuticals	Olutasidenib	IDH1	RECRUITING	2027-04-30	NCT07486713
Novartis	ruxolitinib	—	RECRUITING	2027-09-16	NCT02386800
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	RECRUITING	2027-11	NCT07044687
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	ACTIVE NOT RECRUITING	2026-03	NCT05144243

Showing 53 of 53 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Priothera SAS	mocravimod	—	RECRUITING	2027-05	NCT05429632
Servier Affaires Médicales	Ivosidenib 500mg Oral Tablet	—	RECRUITING	2027-10-15	NCT05907057
Taiho Oncology, Inc.	Azacitidine	Nucleoside Metabolic Inhibitor [EPC]	RECRUITING	2027-11-01	NCT04256317
Ascentage Pharma Group Inc.	APG-2575(Lisaftoclax )	—	RECRUITING	2028-05-25	NCT06389292
Hutchmed	HMPL-306 Regimen	—	RECRUITING	2028-12-31	NCT06387069
Syndax Pharmaceuticals	Revumenib	—	RECRUITING	2029-06	NCT07211958
Kura Oncology, Inc.	Ziftomenib	Menin Inhibitor [EPC]	RECRUITING	2031-11	NCT07007312
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	ACTIVE NOT RECRUITING	2027-08	NCT03844048
Sellas Life Sciences Group	Galinpepimut-S	—	ACTIVE NOT RECRUITING	2025-12	NCT04229979
Orca Biosystems, Inc.	Orca-T	—	ACTIVE NOT RECRUITING	2024-07-15	NCT05316701
Actinium Pharmaceuticals	Iomab-B	—	ACTIVE NOT RECRUITING	2022-06	NCT02665065
AbbVie	Azacitidine	Nucleoside Metabolic Inhibitor [EPC]	ACTIVE NOT RECRUITING	2021-12-01	NCT02993523
Shijiazhuang Yiling Pharmaceutical Co. Ltd	XY0206	—	NOT YET RECRUITING	2027-07-01	NCT05876832
Sichuan Baili Pharmaceutical Co., Ltd.	BL-M11D1	—	NOT YET RECRUITING	2027-12	NCT07255872
Actinium Pharmaceuticals	131I-apamistamab	—	NOT YET RECRUITING	2029-02	NCT07157514
AbbVie	Pivekimab Sunirine	—	NOT YET RECRUITING	2032-06	NCT07581002
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Liposomal cytarabine-daunorubicin for injection	—	NOT YET RECRUITING	2026-02	NCT06182592
Arog Pharmaceuticals, Inc.	Crenolanib	—	COMPLETED	2026-04-03	NCT03250338
Astellas	gilteritinib	—	COMPLETED	2023-03-10	NCT02752035
Astellas	gilteritinib	—	COMPLETED	2023-01-07	NCT02997202
Pfizer	Glasdegib	—	COMPLETED	2022-12-02	NCT04842604
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	COMPLETED	2022-09-29	NCT04102020
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	COMPLETED	2022-03-14	NCT03941964
Astex Pharmaceuticals, Inc.	ASTX727	—	COMPLETED	2021-09-10	NCT03306264
Daiichi Sankyo	Chemotherapy	—	COMPLETED	2021-08-13	NCT02668653
Novartis	Midostaurin	Kinase Inhibitor [EPC]	COMPLETED	2021-07-09	NCT03379727
Gamida Cell ltd	NiCord® (omidubicel)	—	COMPLETED	2021-04-29	NCT02730299
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	COMPLETED	2021-04-15	NCT04509622
Novartis	Midostaurin	Kinase Inhibitor [EPC]	COMPLETED	2021-02-12	NCT03512197
Astex Pharmaceuticals, Inc.	guadecitabine	—	COMPLETED	2020-01-20	NCT02920008
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	COMPLETED	2019-02-15	NCT03069352
Daiichi Sankyo	Quizartinib	—	COMPLETED	2018-02-22	NCT02039726
medac GmbH	Busulfan	Alkylating Drug [EPC]	COMPLETED	2018-01-25	NCT00822393
Cyclacel Pharmaceuticals, Inc.	Sapacitabine	—	COMPLETED	2016-12-15	NCT01303796
Mesoblast, Ltd.	Infusion of one MPC expanded cord unit and one unexpanded cord unit	—	COMPLETED	2016-09-23	NCT01854567
Jazz Pharmaceuticals	CPX-351	—	COMPLETED	2015-12-31	NCT01696084
Neovii Biotech	US-ATG-F	—	COMPLETED	2015-10-15	NCT01295710
Sunesis Pharmaceuticals	vosaroxin + cytarabine	—	COMPLETED	2014-09-26	NCT01191801
Bristol-Myers Squibb	Azacitidine	Nucleoside Metabolic Inhibitor [EPC]	COMPLETED	2014-01-22	NCT01074047
Clavis Pharma	Elacytarabine	—	COMPLETED	2013-02	NCT01147939
AstraZeneca	AZD1152	—	COMPLETED	2011-06	NCT00952588
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	TERMINATED	2025-09-23	NCT04161885
Gilead	Magrolimab	—	TERMINATED	2024-04-11	NCT05079230
GlycoMimetics Incorporated	Uproleselan	—	TERMINATED	2024-03-31	NCT03616470
Gilead	Magrolimab	—	TERMINATED	2024-03-25	NCT04778397
Kronos Bio	Entospletinib	—	TERMINATED	2023-03-30	NCT05020665
Jazz Pharmaceuticals	Dociparstat	—	TERMINATED	2022-05-16	NCT04571645
Kiadis Pharma	ATIR101	—	TERMINATED	2021-11-09	NCT02999854
Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Efprezimod alfa	—	TERMINATED	2021-11-05	NCT04095858
Cornerstone Pharmaceuticals	CPI-613 + High Dose Cytarabine and Mitoxantrone	—	TERMINATED	2021-10-25	NCT03504410
Helsinn Healthcare SA	Pracinostat	—	TERMINATED	2020-08-20	NCT03151408
Bellicum Pharmaceuticals	rivogenlecleucel	—	TERMINATED	2019-07-23	NCT03699475
Seagen Inc.	33A	—	TERMINATED	2017-10-03	NCT02785900

Showing 100 of 197 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
AB Science	AB8939	—	RECRUITING	2026-08	NCT05211570
Kyowa Kirin Co., Ltd.	ziftomenib	Menin Inhibitor [EPC]	RECRUITING	2027-03	NCT07623616
Beijing Biotech	Autologous CD19/CD22 dual-target CAR-T module	—	RECRUITING	2027-03-14	NCT07523555
CellCentric Ltd.	CCS1477	—	RECRUITING	2027-03-31	NCT04068597
Ellipses Pharma	EP0042	—	RECRUITING	2027-12	NCT04581512
Bio-Path Holdings, Inc.	BP1001 in combination with Ventoclax plus decitabine	—	RECRUITING	2027-12	NCT02781883
Syndax Pharmaceuticals	revumenib	—	RECRUITING	2027-12-15	NCT04065399
Sunshine Lake Pharma Co., Ltd.	Clifutinib Besylate	—	RECRUITING	2027-12-31	NCT05133882
Jacobio Pharmaceuticals Co., Ltd.	JAB-8263	—	RECRUITING	2028-01	NCT04686682
Incyte Biosciences International Sàrl	Ponatinib	—	RECRUITING	2028-02-01	NCT03934372
BeiGene	BGB-11417	—	RECRUITING	2028-02-08	NCT04771130
Stemline Therapeutics, Inc.	Tagraxofusp	—	RECRUITING	2028-02-09	NCT06456463
Chordia Therapeutics, Inc.	CTX-712	—	RECRUITING	2028-06	NCT05732103
Daiichi Sankyo	Quizartinib High Dose	—	RECRUITING	2028-06-06	NCT06824168
ARCE Therapeutics, Inc.	ARD103	—	RECRUITING	2028-10	NCT06680752
Kissei Pharmaceutical Co., Ltd.	Olutasidenib	IDH1	RECRUITING	2030-09	NCT07604064
Debiopharm International SA	Debio 1562M	—	RECRUITING	2031-11	NCT06969430
Advanced BioDesign	ABD-3001	—	RECRUITING	2026-06	NCT05601726
Ossium Health, Inc.	—	—	RECRUITING	2026-05-31	NCT05589896
Ryvu Therapeutics SA	RVU120	—	RECRUITING	2026-02	NCT06191263
Chongqing Precision Biotech Co., Ltd	CD123 targeted CAR-NK cells	—	RECRUITING	2025-12-31	NCT06006403
Tarapeutics Science Inc.	HYML-122; cytarabine	—	RECRUITING	2025-12-30	NCT05241093
Tarapeutics Science Inc.	HYML-122	—	RECRUITING	2025-12-30	NCT05241106
Shenzhen TargetRx Co., Ltd.	TGRX-814	—	RECRUITING	2025-02-28	NCT06206174
Changzhou Qianhong Bio-pharma Co., Ltd.	QHRD107 capsule，Venclexta and Azacitidine	—	RECRUITING	2025-02-10	NCT06532058
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	SKLB1028 Dose Escalation	—	RECRUITING	2024-10-31	NCT05445154
Guangdong Ruishun Biotech Co., Ltd	RC1012 injection (allo-DNT cells)	—	RECRUITING	2024-05-27	NCT05858814
AbbVie	Azacitidine	Nucleoside Metabolic Inhibitor [EPC]	ACTIVE NOT RECRUITING	2027-02	NCT04086264
Faron Pharmaceuticals Ltd	Bexmarilimab	—	ACTIVE NOT RECRUITING	2027-03	NCT05428969
Daiichi Sankyo	Quizartinib	—	ACTIVE NOT RECRUITING	2027-05-01	NCT03793478
Astellas	Gilteritinib	—	ACTIVE NOT RECRUITING	2028-07-31	NCT05520567
Kura Oncology, Inc.	Ziftomenib	Menin Inhibitor [EPC]	ACTIVE NOT RECRUITING	2028-10-16	NCT04067336
Ryvu Therapeutics SA	RVU120	—	ACTIVE NOT RECRUITING	2026-02	NCT06268574
Novartis	Midostaurin	Kinase Inhibitor [EPC]	ACTIVE NOT RECRUITING	2026-01-19	NCT03591510
Treadwell Therapeutics, Inc	CFI-400945	—	ACTIVE NOT RECRUITING	2026-01	NCT04730258
Akeso	AK117	—	ACTIVE NOT RECRUITING	2025-09	NCT04980885
GCP-Service International West GmbH	Imetelstat sodium	Telomerase/hTR	ACTIVE NOT RECRUITING	2025-03-27	NCT05583552
Bristol-Myers Squibb	Oral Azacitidine	—	ACTIVE NOT RECRUITING	2025-01-27	NCT05197426
Taiho Oncology, Inc.	Decitabine and Cedazuridine (ASTX727)	—	ACTIVE NOT RECRUITING	2024-09-30	NCT04657081
Bellicum Pharmaceuticals	BPX-501 dose 1	—	ACTIVE NOT RECRUITING	2019-10-09	NCT01744223
Advesya SAS	—	—	NOT YET RECRUITING	2027-07	NCT06281847
Galecto Biotech AB	GB3226	—	NOT YET RECRUITING	2029-06-10	NCT07084584
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	SYHX1903	—	NOT YET RECRUITING	2026-06-20	NCT05055791
Akeso	AK117	—	NOT YET RECRUITING	2026-04	NCT06387420
CRISPR Therapeutics	CTX131	—	COMPLETED	2026-03-11	NCT06492304
Karyopharm Therapeutics Inc	KPT-8602	—	COMPLETED	2024-08-31	NCT02649790
Forma Therapeutics, Inc.	FT-2102 (olutasidenib)	—	COMPLETED	2023-12-28	NCT02719574
TJ Biopharma Co., Ltd.	TJ011133	—	COMPLETED	2023-12-15	NCT04202003
Astellas	ASP7517	—	COMPLETED	2023-04-21	NCT04079296
Menarini Group	MEN1703	—	COMPLETED	2023-04-13	NCT03008187
BioSight Ltd.	BST-236	—	COMPLETED	2023-03-16	NCT03435848
Syros Pharmaceuticals	Tamibarotene	—	COMPLETED	2023-01-25	NCT02807558
Novartis	Midostaurin	Kinase Inhibitor [EPC]	COMPLETED	2022-11-14	NCT03280030
Takeda	Pevonedistat	—	COMPLETED	2022-09-06	NCT04266795
Sellas Life Sciences Group	galinpepimut-S	—	COMPLETED	2022-07-05	NCT03761914
BerGenBio ASA	Bemcentinib	—	COMPLETED	2022-06-08	NCT02488408
Arog Pharmaceuticals, Inc.	Crenolanib besylate	—	COMPLETED	2022-05	NCT02400255
Cardiff Oncology	Onvansertib	—	COMPLETED	2021-11-17	NCT03303339
Synimmune GmbH	FLYSYN	—	COMPLETED	2021-09-27	NCT02789254
Aprea Therapeutics	APR-246	—	COMPLETED	2021-08-27	NCT03931291
Astellas	Gilteritinib	—	COMPLETED	2021-08-25	NCT02310321
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	COMPLETED	2021-08-10	NCT02287233
Astellas	Gilteritinib	—	COMPLETED	2021-05-25	NCT02927262
Astellas	gilteritinib	—	COMPLETED	2021-05-14	NCT03730012
AbbVie	azacitadine	—	COMPLETED	2021-03-12	NCT02265731
Celyad Oncology SA	NKR-2	—	COMPLETED	2021-02-01	NCT03466320
Traws Pharma, Inc.	oral rigosertib	—	COMPLETED	2020-12-08	NCT01926587
Fate Therapeutics	ProTmune	—	COMPLETED	2020-12-04	NCT02743351
Astellas	Gilteritinib	—	COMPLETED	2020-07-28	NCT02561455
Arog Pharmaceuticals, Inc.	Crenolanib besylate	—	COMPLETED	2020-07-15	NCT02400281
Stemline Therapeutics, Inc.	Tagraxofusp	—	COMPLETED	2020-02-01	NCT02113982
Medigene AG	WT1/PRAME vaccination	—	COMPLETED	2019-11	NCT02405338
Fujifilm Pharmaceuticals U.S.A., Inc.	FF-10501-01	—	COMPLETED	2019-08-09	NCT02193958
Jazz Pharmaceuticals	Dociparstat sodium	—	COMPLETED	2019-06	NCT02873338
Novartis	Panobinostat (LBH589)	—	COMPLETED	2019-04-29	NCT00946647
Arog Pharmaceuticals, Inc.	Crenolanib besylate	—	COMPLETED	2019-04	NCT01657682
Actinium Pharmaceuticals	Cytarabine (Phase 1 only)	—	COMPLETED	2018-11	NCT02575963
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)	bomedemstat	—	COMPLETED	2018-10-30	NCT02842827
Nohla Therapeutics, Inc.	Cyclophosphamide	DNA	COMPLETED	2018-09-18	NCT01690520
Kiadis Pharma	ATIR101	—	COMPLETED	2018-07	NCT02500550
Novartis	Midostaurin	Kinase Inhibitor [EPC]	COMPLETED	2018-04-30	NCT01883362
Arog Pharmaceuticals, Inc.	Crenolanib	—	COMPLETED	2018-02	NCT02626338
Karyopharm Therapeutics Inc	Selinexor	Nuclear Export Inhibitor [EPC]	COMPLETED	2018-01-08	NCT02088541
Aeglea Biotherapeutics	Co-ArgI-PEG modified human arginase I	—	COMPLETED	2017-12	NCT02732184
Otsuka Pharmaceutical Co., Ltd.	OCV-501	—	COMPLETED	2017-11-16	NCT01961882
ERYtech Pharma	GRASPA	—	COMPLETED	2017-11-10	NCT01810705
Cellerant Therapeutics	CLT-008	—	COMPLETED	2017-09-22	NCT02282215
BioSight Ltd.	Astarabine (BST-236)	—	COMPLETED	2017-09-20	NCT02544438
Astellas	Gilteritinib	—	COMPLETED	2017-08-04	NCT02014558
BioMed Valley Discoveries, Inc	BVD-523	—	COMPLETED	2017-06-15	NCT02296242
Gamida Cell ltd	NiCord®	—	COMPLETED	2017-06	NCT01816230
Delta-Fly Pharma, Inc.	DFP-10917	—	COMPLETED	2017-01-18	NCT01702155
Pfizer	PF-04449913	—	COMPLETED	2017-01-03	NCT01546038
Prism Pharma Co., Ltd.	PRI-724	—	COMPLETED	2016-12-30	NCT01606579
Innate Pharma	IPH2102 at 0.1 mg/kg	—	COMPLETED	2016-11-17	NCT01687387
Helsinn Healthcare SA	Pracinostat	—	COMPLETED	2016-11-08	NCT01912274
Sellas Life Sciences Group	Galinpepimut-S	—	COMPLETED	2016-09-30	NCT01266083
Polaris Group	ADI-PEG 20	—	COMPLETED	2016-09-12	NCT01910012
Astex Pharmaceuticals, Inc.	Guadecitabine	—	COMPLETED	2016-07-22	NCT01261312
Kiadis Pharma	ATIR	—	COMPLETED	2016-06	NCT01794299

Showing 100 of 253 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Kura Oncology, Inc.	Ziftomenib	Menin Inhibitor [EPC]	RECRUITING	2026-08	NCT06001788
Nanjing Chia-tai Tianqing Pharmaceutical	NTQ2494 tablet	—	RECRUITING	2026-08	NCT06049667
Keystone Nano, Inc	Ceramide NanoLiposome (Ceraxa)	—	RECRUITING	2026-09-30	NCT04716452
Taiho Oncology, Inc.	ASTX727	—	RECRUITING	2026-12	NCT04953897
Taiho Oncology, Inc.	ASTX727	—	RECRUITING	2026-12	NCT04953910
Sichuan Baili Pharmaceutical Co., Ltd.	BL-M11D1	—	RECRUITING	2026-12	NCT05924750
SillaJen, Inc.	BAL0891	—	RECRUITING	2026-12-24	NCT05768932
Newave Pharmaceutical Inc	LP-118	—	RECRUITING	2026-12-31	NCT04771572
CERo Therapeutics Holdings, Inc.	CER-1236	—	RECRUITING	2026-12-31	NCT06834282
Solu Therapeutics, Inc	STX-0712	—	RECRUITING	2026-12-31	NCT06950034
SystImmune Inc.	BL-M11D1	—	RECRUITING	2026-12-31	NCT06714591
Kyowa Kirin Co., Ltd.	KK2845_1	—	RECRUITING	2026-12-31	NCT06812104
Hangzhou GluBio Pharmaceutical Co., Ltd.	GLB-001	—	RECRUITING	2026-12-31	NCT06378437
PharmaEngine	PEP07	—	RECRUITING	2026-12-31	NCT05659732
Crossbow Therapeutics, Inc.	CBX-250	—	RECRUITING	2027-01	NCT06994676
Cullinan Therapeutics Inc.	CLN-049	—	RECRUITING	2027-01	NCT05143996
Hemogenyx Pharmaceuticals LLC	Anti-FLT3 CAR-T cells	—	RECRUITING	2027-01	NCT06786533
Syndax Pharmaceuticals	SNDX-5613	—	RECRUITING	2027-02	NCT06226571
Bristol-Myers Squibb	BMS-986497	—	RECRUITING	2027-02-01	NCT06419634
Bio-Path Holdings, Inc.	BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide	—	RECRUITING	2027-03	NCT05190471
Apollo Therapeutics Ltd	APL-4098	—	RECRUITING	2027-03-01	NCT06372717
AvenCell Europe GmbH	R-TM123	—	RECRUITING	2027-05	NCT05949125
Beijing InnoCare Pharma Tech Co., Ltd.	ICP-248	—	RECRUITING	2027-06	NCT06656494
Seagen, a wholly owned subsidiary of Pfizer	SEA-CD70	—	RECRUITING	2027-07-04	NCT04227847
BlueSphere Bio, Inc	SOC+ BSB-2002	—	RECRUITING	2027-08	NCT07566585
Aptevo Therapeutics	APVO436	—	RECRUITING	2027-10	NCT06634394
Chongqing Precision Biotech Co., Ltd	Anti-CD123 CAR NK cells	—	RECRUITING	2027-10-30	NCT06690827
NovaOnco Therapeutics Co., Ltd.	XS-04 tablet	—	RECRUITING	2027-11-01	NCT06820268
Orca Biosystems, Inc.	OrcaGraft (Orca-Q)	—	RECRUITING	2027-12	NCT03802695
AbbVie	Pivekimab Sunirine	—	RECRUITING	2028-04	NCT07306832
iCell Gene Therapeutics	Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide	—	RECRUITING	2028-07-04	NCT07668557
Remedy Plan, Inc.	RPT1G	—	RECRUITING	2028-12-01	NCT07107126
Marker Therapeutics, Inc.	MT-401-OTS	—	RECRUITING	2029-09	NCT06552416
Nerviano Medical Sciences	NMS-03597812	—	RECRUITING	2029-09-15	NCT06549790
Genmab	GEN3018	—	RECRUITING	2029-10-18	NCT07384715
Kura Oncology, Inc.	Ziftomenib	Menin Inhibitor [EPC]	RECRUITING	2030-04	NCT05735184
GluBio Therapeutics Inc.	GLB-001	—	RECRUITING	2026-07-01	NCT06146257
Meryx, Inc.	MRX-2843	—	RECRUITING	2026-07	NCT04872478
Johnson & Johnson	14C-bleximenib	—	RECRUITING	2026-06-14	NCT07295951
TScan Therapeutics, Inc.	SOC + TSC-100	—	RECRUITING	2026-06	NCT05473910
BlossomHill Therapeutics	BH-30236	—	RECRUITING	2026-06	NCT06501196
Hangzhou Weben Pharma Co., Ltd	WBC100 QD	—	RECRUITING	2026-06	NCT07014449
Tr1X, Inc.	TRX103	—	RECRUITING	2026-04-15	NCT06462365
Remix Therapeutics	REM-422	—	RECRUITING	2026-03-15	NCT06297941
Edgewood Oncology Inc.	BTX-A51	—	RECRUITING	2026-03	NCT04243785
Chengdu FenDi Pharmaceutical Co., Ltd.	FD-001	—	RECRUITING	2026-01-24	NCT06731699
Ascentage Pharma Group Inc.	APG-115	—	RECRUITING	2025-12-31	NCT04275518
Shijiazhuang Yiling Pharmaceutical Co. Ltd	XY0206	—	RECRUITING	2025-12-01	NCT07162116
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	TQB3455 tablet+Azacitidine for Injection	—	RECRUITING	2025-12	NCT06550713
Oryzon Genomics S.A.	Iadademstat	—	RECRUITING	2025-11-30	NCT05546580
Immune System Key Ltd	Nerofe	—	RECRUITING	2025-06-30	NCT04365179
Vincerx Pharma, Inc.	VIP943 (QW)	—	RECRUITING	2025-05-30	NCT06034275
Celyad Oncology SA	CYAD-02	—	RECRUITING	2021-12	NCT04167696
Auron Therapeutics, Inc.	AUTX-703	—	ACTIVE NOT RECRUITING	2027-04	NCT06846606
Polaris Group	ADI-PEG 20	—	ACTIVE NOT RECRUITING	2026-05	NCT05001828
Biomea Fusion Inc.	BMF-500	—	ACTIVE NOT RECRUITING	2026-04	NCT05918692
Foghorn Therapeutics Inc.	FHD-286	—	ACTIVE NOT RECRUITING	2025-09	NCT04891757
Orca Biosystems, Inc.	Orca-T	—	ACTIVE NOT RECRUITING	2025-04-30	NCT04013685
Cellectis S.A.	UCART123v1.2	—	ACTIVE NOT RECRUITING	2024-12-24	NCT03190278
Precigen, Inc	PRGN-3006 T Cells	—	ACTIVE NOT RECRUITING	2024-08-01	NCT03927261
Eli Lilly	LY3410738	—	ACTIVE NOT RECRUITING	2023-07-03	NCT04603001
Lomond Therapeutics Holdings, Inc.	ZE50-0134	—	NOT YET RECRUITING	2026-09	NCT07303660
Guangzhou Bio-gene Technology Co., Ltd	BG1805	—	NOT YET RECRUITING	2027-04	NCT06347458
Hangzhou Polymed Biopharmaceuticals, Inc.	HPB-092 tablet	—	NOT YET RECRUITING	2027-09-14	NCT07137637
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	FXS0683	—	NOT YET RECRUITING	2028-08-07	NCT07616089
Nuwacell Biotechnologies Co., Ltd.	NCR300 injection	—	NOT YET RECRUITING	2028-12-31	NCT06441084
TC Biopharm	TCB008	—	NOT YET RECRUITING	2026-06	NCT06463327
Johnson & Johnson	JNJ-74856665	—	COMPLETED	2025-08-25	NCT04609826
Lomond Therapeutics Holdings, Inc.	Rabeprazole, 20mg oral	—	COMPLETED	2025-06-30	NCT06399315
Prelude Therapeutics	PRT2527	—	COMPLETED	2025-06-12	NCT05665530
Wugen, Inc.	WU-NK-101	—	COMPLETED	2024-10-08	NCT05470140
Syndax Pharmaceuticals	Revumenib	—	COMPLETED	2024-07-29	NCT05326516
Novartis	siremadlin	—	COMPLETED	2024-04-17	NCT05155709
VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Zilovertamab vedotin	—	COMPLETED	2023-12-18	NCT03833180
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.	ZN-d5	—	COMPLETED	2023-12-12	NCT04500587
Sunshine Lake Pharma Co., Ltd.	Clifutinib Besylate	—	COMPLETED	2023-08-21	NCT04827069
Roche	RO7283420	—	COMPLETED	2023-08-09	NCT04580121
Cleave Therapeutics, Inc.	CB-5339	—	COMPLETED	2023-07-23	NCT04402541
AbbVie	chemotherapy	—	COMPLETED	2023-04-19	NCT03236857
Jiangsu HengRui Medicine Co., Ltd.	SHR-1702	—	COMPLETED	2023-02-28	NCT04443751
Sunshine Lake Pharma Co., Ltd.	Clifutinib with fed state	—	COMPLETED	2022-12-08	NCT05454098
Prelude Therapeutics	PRT543	—	COMPLETED	2022-11-16	NCT03886831
Cyclacel Pharmaceuticals, Inc.	CYC065	—	COMPLETED	2022-11-15	NCT04017546
BerGenBio ASA	Bemcentinib	—	COMPLETED	2022-09-23	NCT06469138
Jazz Pharmaceuticals	CPX-351	—	COMPLETED	2022-04-26	NCT04038437
Prelude Therapeutics	PRT1419	—	COMPLETED	2022-03-21	NCT04543305
Daiichi Sankyo Co., Ltd.	Quizartinib	—	COMPLETED	2022-03-03	NCT03723681
Nanexa AB	NEX-18a injection	—	COMPLETED	2022-02-10	NCT05048498
Jazz Pharmaceuticals	CPX-351	—	COMPLETED	2022-02-07	NCT04075747
AstraZeneca	AZD4573	—	COMPLETED	2021-09-30	NCT03263637
Oscotec Inc.	SKI-G-801	—	COMPLETED	2021-09-02	NCT03564288
Xencor, Inc.	XmAb14045	—	COMPLETED	2021-09	NCT02730312
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	COMPLETED	2021-08-31	NCT03625505
Astellas	Gilteritinib	—	COMPLETED	2021-07-26	NCT02236013
Opna Bio LLC	PLX2853	—	COMPLETED	2021-06-30	NCT03787498
Jazz Pharmaceuticals	CPX-351	—	COMPLETED	2021-05-26	NCT03555955
TC Biopharm	OmnImmune®	—	COMPLETED	2021-03-26	NCT03790072
CStone Pharmaceuticals	ivosidenib	Isocitrate Dehydrogenase 1 Inhibitor [EPC]	COMPLETED	2021-02-18	NCT04176393
Pfizer	PF-04449913	—	COMPLETED	2021-02-12	NCT02038777
AbbVie	Venetoclax	BCL-2 Inhibitor [EPC]	COMPLETED	2021-01-25	NCT03441555

Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in Acute Myeloid Leukemia

FLT3 (10) IDH1 (2) IDH2 (2) IDH1 mutation (1)

Novel Acute Myeloid Leukemia Drugs by Company (New molecular entities)

10 companies have an FDA-approved novel drug for Acute Myeloid Leukemia.

Reformulations (4 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

Acute Myeloid Leukemia Drug Targets

Molecular targets of approved and investigational Acute Myeloid Leukemia drugs — 18 targets tracked.

G-CSF receptor 5 FLT3 3 DNA 2 Topoisomerase II 2 Menin 2 IDH1 1 CD33 1 KMT2A 1 Smoothened 1 DNA polymerase 1 DNA methyltransferases 1 RNA methyltransferases 1 KIT 1 PDGFRα 1 PDGFRβ 1 +3 more

Biosimilars (4 BLA approved) Click to expand

Biosimilars are biological products highly similar to FDA-approved reference biologics with no clinically meaningful differences in safety, purity, or potency.

NYPOZI

TANVEX BIOPHARMA USA INC

2024

RELEUKO

KASHIV BIOSCIENCES LLC

2015

Related Indications

Other Oncology indications

View all Oncology

Drug Categories:

Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
Biosimilars: BLA-approved biologics highly similar to reference products
Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology