Anemia

7 original drugs

Novel Drugs

Reformulations

Active Trials

Drug Targets

Anemia has 7 FDA-approved novel treatments, led by AGIOS PHARMS INC across 12 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Anemia Market Leaders

Companies with the most FDA-approved novel Anemia drugs.

Phase 3 Readouts Pro

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

Full calendar →

Q3 2026

—

Cerus Corporation

Estimated · fresh NCT03037164

Q2 2029

Elritercept

Takeda

Estimated · fresh NCT07422480

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.

Anemia Treatments by Mechanism

Top 6 mechanisms across 31 industry trials with a known mechanism of action.

See full pipeline →

Erythropoietin Receptor

13 trials 3 sponsors

Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor

10 trials 1 sponsor

Erythropoiesis-stimulating Agent

5 trials 2 sponsors

Interferon alpha

1 trials 1 sponsor

Thalidomide Analog

1 trials 1 sponsor

Parenteral Iron Replacement

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.

Anemia Clinical Pipeline by Phase

143 industry-sponsored trials across 47 sponsors

Showing 15 of 15 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Pharmanutra S.p.a.	Ferric Maltol (Feraccru®)	—	RECRUITING	2026-05	NCT07308769
Bristol-Myers Squibb	Luspatercept	—	ACTIVE NOT RECRUITING	2028-12-16	NCT05891249
Laboratoire Innotech International	TOT'HEMA	—	COMPLETED	2023-10-06	NCT04309669
Roche	Methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2018-04-23	NCT01191983
Amgen	Epoetin alfa	Erythropoietin Receptor	COMPLETED	2016-04-27	NCT02253654
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2013-01	NCT01156363
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2012-11-30	NCT01342640
Roche	Pegasys	Interferon alpha [EPC]	COMPLETED	2011-11	NCT00560274
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2010-11-30	NCT00922116
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2010-07	NCT00922610
Roche	methoxy polyethylene glycol-epoetin beta	Erythropoietin Receptor	COMPLETED	2009-12-31	NCT00642668
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2009-10	NCT00737711
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2009-09-12	NCT00737464
Amgen	Peginesatide	—	TERMINATED	2013-03	NCT01737879
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	TERMINATED	2011-09-30	NCT01066000

Showing 66 of 66 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Takeda	Elritercept	—	RECRUITING	2029-04-30	NCT07422480
Biocad	BCD-131 (pegdarbepoetin beta)	—	RECRUITING	2026-05	NCT07119372
Cerus Corporation	—	—	ACTIVE NOT RECRUITING	2026-07-31	NCT03037164
Bristol-Myers Squibb	ACE-536	—	ACTIVE NOT RECRUITING	2025-05-26	NCT04717414
Takeda	Elritercept	—	NOT YET RECRUITING	2029-12-07	NCT07623161
Shenzhen Salubris Pharmaceuticals Co., Ltd.	SAL-0951 tablets	—	COMPLETED	2024-06-17	NCT06720025
Shield Therapeutics	Ferric Maltol	—	COMPLETED	2024-06-09	NCT05126901
Cerus Corporation	—	—	COMPLETED	2023-12-04	NCT03459287
Kyntra Bio	FG-4592	—	COMPLETED	2023-01-11	NCT03303066
Nanogen Pharmaceutical Biotechnology Joint Stock Company	Stimus (NNG-DEPO)	—	COMPLETED	2022-11-23	NCT05585645
Akebia Therapeutics	Vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	COMPLETED	2021-11-26	NCT04313153
Zydus Lifesciences Limited	Desidustat Oral Tablet	—	COMPLETED	2021-08-25	NCT04012957
Akebia Therapeutics	Vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	COMPLETED	2020-06-18	NCT02680574
Akebia Therapeutics	Vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	COMPLETED	2020-06-04	NCT02648347
Akebia Therapeutics	Vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	COMPLETED	2020-01-31	NCT02865850
Akebia Therapeutics	Vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	COMPLETED	2020-01-16	NCT02892149
Bayer	Molidustat (BAY85-3934)	—	COMPLETED	2019-08-07	NCT03543657
Bayer	Molidustat (BAY85-3934)	—	COMPLETED	2019-07-25	NCT03418168
Bayer	Molidustat (BAY85-3934)	—	COMPLETED	2019-07-05	NCT03350347
Bayer	Molidustat (BAY85-3934)	—	COMPLETED	2019-05-17	NCT03350321
Bayer	Molidustat (BAY85-3934)	—	COMPLETED	2018-10-23	NCT03351166
AstraZeneca	Roxadustat	—	COMPLETED	2018-10-04	NCT02174627
AstraZeneca	Roxadustat	—	COMPLETED	2018-09-26	NCT02174731
Kissei Pharmaceutical Co., Ltd.	JR-131	—	COMPLETED	2018-03	NCT02912533
Kissei Pharmaceutical Co., Ltd.	JR-131	—	COMPLETED	2017-09	NCT02912494
Astellas	Roxadustat	—	COMPLETED	2017-06-08	NCT02278341
Kyntra Bio	FG-4592	—	COMPLETED	2017-01-24	NCT02652819
Kyntra Bio	FG-4592	—	COMPLETED	2017-01-24	NCT02652806
Biocad	Darbepoetin alfa	Erythropoiesis-stimulating Agent [EPC]	COMPLETED	2017-01-08	NCT02506868
Novartis	HX575 epoetin alfa	—	COMPLETED	2014-05	NCT01693029
Bristol-Myers Squibb	Lenalidomide	Thalidomide Analog [EPC]	COMPLETED	2013-03-17	NCT01029262
Takeda	Epoetin	—	COMPLETED	2013-02	NCT01478971
Amgen	darbepoetin alfa	Erythropoiesis-stimulating Agent [EPC]	COMPLETED	2012-04	NCT00925587
Roche	Methoxy polyethylene glycol-epoetin beta	Erythropoietin Receptor	COMPLETED	2011-07-31	NCT00737477
Roche	Methoxy Polyethylene Glycol-epoetin Beta	Erythropoietin Receptor	COMPLETED	2011-07	NCT00717821
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2010-12	NCT00560404
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2010-12	NCT00661388
Roche	epoetin beta	—	COMPLETED	2010-12	NCT00773331
Roche	Methoxy polyethylene glycol-epoetin beta	Erythropoietin Receptor	COMPLETED	2010-11	NCT00660023
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2010-10	NCT00882713
Roche	Methoxy Polyethylene Glycol-epoetin Beta	Erythropoietin Receptor	COMPLETED	2010-08	NCT00642967
Roche	Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)	—	COMPLETED	2010-07	NCT00699348
Roche	methoxy polyethylene glycol-epoetin beta	Erythropoietin Receptor	COMPLETED	2010-06-22	NCT00661505
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	COMPLETED	2010-06	NCT00576303
Roche	Methoxy polyethylene glycol-epoetin beta	Erythropoietin Receptor	COMPLETED	2010-06	NCT00559637
Roche	methoxy polyethylene glycol-epoetin beta [C.E.R.A.]	—	COMPLETED	2010-03	NCT00576628
Roche	Methoxy Polyethylene Glycol-Epoetin Beta	Erythropoietin Receptor	COMPLETED	2010-03	NCT00773968
American Regent, Inc.	Ferric Carboxymaltose	—	COMPLETED	2010-01	NCT00704028
Roche	methoxy polyethylene glycol-epoetin beta	Erythropoietin Receptor	COMPLETED	2010-01	NCT00605293
Roche	methoxy polyethylene glycol-epoetin beta [C.E.R.A.]	—	COMPLETED	2009-12-09	NCT00642304
Vifor Pharma	Ferric carboxymaltose	—	COMPLETED	2009-12	NCT00810030
American Regent, Inc.	Ferric Carboxymaltose (FCM)	—	COMPLETED	2009-07	NCT00703937
American Regent, Inc.	Ferric Carboxymaltose	—	COMPLETED	2009-07	NCT00704353
Chugai Pharmaceutical	epoetin beta	—	COMPLETED	2009-05	NCT00628043
Kyntra Bio	Roxadustat	—	TERMINATED	2023-03-09	NCT03263091
Amgen	Darbepoetin alfa	Erythropoiesis-stimulating Agent [EPC]	TERMINATED	2017-06-07	NCT00858364
Azidus Brasil	Epoetin alpha	—	TERMINATED	2014-12	NCT01695759
Amgen	Darbepoetin Alfa	Erythropoiesis-stimulating Agent [EPC]	TERMINATED	2014-03-03	NCT00436748
Roche	Methoxy Polyethylene Glycol-epoetin Beta	Erythropoietin Receptor	TERMINATED	2011-04	NCT00462384
Roche	methoxy polyethylene glycol-epoetin beta [Mircera]	—	TERMINATED	2010-01	NCT00680563
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Epoetin alfa	Erythropoietin Receptor	TERMINATED	2010-01	NCT00695396
Repros Therapeutics Inc.	Proellex 25 mg	—	TERMINATED	2009-08	NCT00702702
Repros Therapeutics Inc.	Proellex 25 mg	—	TERMINATED	2009-08	NCT00785356
Akebia Therapeutics	Vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	WITHDRAWN	2018-02-12	NCT03242967
Targeted Medical Pharma	RBCPF	—	WITHDRAWN	2014-05	NCT01701531
Novartis	HX575 solution for s.c. administration	—	WITHDRAWN	2009-08	NCT00869856

Showing 46 of 46 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Disc Medicine, Inc	DISC-0974	—	RECRUITING	2026-09	NCT05320198
Disc Medicine, Inc	DISC-0974	—	RECRUITING	2026-10	NCT07368972
Bristol-Myers Squibb	Luspatercept	—	RECRUITING	2027-07-16	NCT05664737
Shenzhen Salubris Pharmaceuticals Co., Ltd.	SAL-0951 tablets 4mg	—	RECRUITING	2025-12-31	NCT06737081
Incyte Corporation	INCB000928	—	ACTIVE NOT RECRUITING	2025-04-01	NCT04455841
Hansoh BioMedical R&D Company	HS-20106	—	NOT YET RECRUITING	2025-10-30	NCT06594965
Bristol-Myers Squibb	Luspatercept	—	COMPLETED	2022-07-18	NCT03194542
Roche	Mircera	Erythropoietin Receptor	COMPLETED	2021-07-19	NCT03552393
Akebia Therapeutics	Vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	COMPLETED	2020-06-05	NCT03799627
Kyntra Bio	Roxadustat	—	COMPLETED	2019-12-12	NCT01630889
Novo Nordisk	COR-001	—	COMPLETED	2018-12-11	NCT02868229
Biocad	BCD-131	—	COMPLETED	2018-12-01	NCT03519243
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA	Luspatercept	—	COMPLETED	2018-10-22	NCT01749514
Merck	Sotatercept	—	COMPLETED	2018-04-30	NCT01736683
Akebia Therapeutics	Vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	COMPLETED	2017-10-24	NCT03054350
Akebia Therapeutics	Vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	COMPLETED	2017-07-04	NCT03054337
Genexine, Inc.	GX-E2	—	COMPLETED	2017-04-20	NCT02044653
Bayer	Molidustat (BAY85-3934)	—	COMPLETED	2016-11-15	NCT02055482
Bayer	Molidustat (BAY85-3934)	—	COMPLETED	2016-10-19	NCT02064426
Bristol-Myers Squibb	Sotatercept	—	COMPLETED	2016-08-31	NCT01999582
Bristol-Myers Squibb	Sotatercept	—	COMPLETED	2016-03-07	NCT01146574
TME Pharma AG	Lexaptepid pegol (NOX-H94)	—	COMPLETED	2015-11	NCT02079896
Bayer	Molidustat (BAY 85-3934)	—	COMPLETED	2015-10-23	NCT01975818
Bayer	BAY85-3934	—	COMPLETED	2015-10-15	NCT02021409
Bayer	BAY85-3934	—	COMPLETED	2015-09-15	NCT02021370
Akebia Therapeutics	AKB-6548	—	COMPLETED	2015-07-22	NCT02260193
Akebia Therapeutics	AKB-6548	—	COMPLETED	2014-09-03	NCT01906489
Kyntra Bio	Roxadustat	—	COMPLETED	2013-01-10	NCT01414075
Kyntra Bio	Roxadustat	—	COMPLETED	2012-10-15	NCT01147666
Medgenics Medical Israel Ltd.	EPODURE (dermal Biopump for erythropoietin)	—	COMPLETED	2012-07	NCT00542568
Kyntra Bio	Roxadustat	—	COMPLETED	2012-06-13	NCT01244763
Akebia Therapeutics	AKB-6548	—	COMPLETED	2012-02-16	NCT01381094
Tarix Pharmaceuticals	TXA127	—	COMPLETED	2011-12	NCT00771810
AMAG Pharmaceuticals, Inc.	Ferumoxytol	Parenteral Iron Replacement [EPC]	COMPLETED	2011-07-19	NCT01052779
Akebia Therapeutics	AKB-6548	—	COMPLETED	2011-04-13	NCT01235936
Takeda	Peginesatide	—	COMPLETED	2010-05	NCT00752791
Takeda	Peginesatide	—	COMPLETED	2009-12	NCT00752609
Affymax	peginesatide	—	COMPLETED	2009-08	NCT00680043
Incyte Corporation	INCB000928	—	TERMINATED	2024-08-15	NCT04582539
Akebia Therapeutics	vadadustat	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]	TERMINATED	2018-03-21	NCT03140722
GSK	GSK1278863	—	TERMINATED	2016-03-01	NCT02075463
Medgenics Medical Israel Ltd.	Subcutan implantation of autologus skin graft after ex-vivo treatment	—	TERMINATED	2013-06	NCT01555515
Merck	Sotatercept 15 mg	—	TERMINATED	2012-09-21	NCT01284348
Merck	MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline	—	TERMINATED	2010-04	NCT00924781
Merck	MK2578	—	TERMINATED	2010-04	NCT00968617
BioAge Labs, Inc.	BGE-117	—	WITHDRAWN	2022-04	NCT04815603

Showing 16 of 16 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Ascentage Pharma Group Inc.	APG-5918	—	RECRUITING	2027-12-31	NCT05773586
Rockwell Medical Technologies, Inc.	Triferic	—	COMPLETED	2017-07	NCT02909153
Pharmacosmos A/S	Iron Isomaltoside	—	COMPLETED	2017-06-04	NCT03013439
Bio Sidus SA	Epoetin Alfa 40000 UNT/ML	—	COMPLETED	2016-09	NCT03822884
Eli Lilly	LY2787106	—	COMPLETED	2014-12	NCT01340976
Bayer	BAY85-3934	—	COMPLETED	2013-09-05	NCT01318551
Bayer	BAY85-3934	—	COMPLETED	2013-05	NCT01332942
Chong Kun Dang Pharmaceutical	NESP 60μg	—	COMPLETED	2012-12-25	NCT01685671
Chong Kun Dang Pharmaceutical	NESP 60μg	—	COMPLETED	2012-11-13	NCT01684605
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA	ACE-536	—	COMPLETED	2012-09	NCT01432717
TME Pharma AG	NOX-H94	—	COMPLETED	2012-03	NCT01372137
Bayer	BAY85-3934	—	COMPLETED	2011-12	NCT01458028
Astellas	roxadustat	—	COMPLETED	2010-06-07	NCT01083888
Agios Pharmaceuticals, Inc.	AG-519	—	TERMINATED	2016-12	NCT02630927
Takeda	Peginesatide	—	TERMINATED	2008-06	NCT00629876
Amgen	Darbepoetin alfa	Erythropoiesis-stimulating Agent [EPC]	WITHDRAWN	2016-11	NCT01428154

Novel Anemia Drugs by Company (New molecular entities)

7 companies have an FDA-approved novel drug for Anemia.

AGIOS PHARMS INC 1 drug

Amgen 1 drug

HOFFMAN-LA ROCHE 1 drug

MIRCERA

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

GERON 1 drug

AKEBIA 1 drug

Bristol-Myers Squibb 1 drug

GSK 1 drug

MOMELOTINIB DIHYDROCHLORIDE

NDA 2023

Reformulations (2 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.

Anemia Drug Targets

Molecular targets of approved and investigational Anemia drugs — 12 targets tracked.

Erythropoietin Receptor 3 Cereblon 1 GnRH receptor 1 Pyruvate Kinase 1 Telomerase 1 hTR 1 HIF-prolyl-4-hydroxylases 1 TGF-β superfamily ligands 1 ACVR1 1 JAK1 1 JAK2 1 JAK2 V617F 1

Biosimilars (1 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.

RETACRIT

Pfizer

2018

Generic Drugs (1 ANDA approved) Click to expand

Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).

LENALIDOMIDE

ARROW INTL

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