What's the most recent regulatory action in Acute promyelocytic leukemia, FAB M3?

Most recent: Retin-A — FDA approved.

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Last reviewed 2026-06-10 · How we verify

Acute promyelocytic leukemia, FAB M3 — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Acute promyelocytic leukemia, FAB M3 (disease) competitive landscape: 10 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

10 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Acute promyelocytic leukemia, FAB M3, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	First approval
Trisenox	ARSENIC TRIOXIDE	Cephalon	High Risk QT Prolonging Agents	Potassium voltage-gated channel subfamily H member 2	2000-01-01
Idamycin Pfs	Idarubicin Hydrochloride	Pfizer Inc.	Anthracycline topoisomerase inhibitor	DNA, Topoisomerase II	1990-01-01
Daunorubicin Hydrochloride	daunorubicin	Meiji Seika Pharma Co., Ltd	Anthracycline Topoisomerase Inhibitor	Histone deacetylase 6	1979-01-01
Retin-A	TRETINOIN	Bausch Health	Retinoid [EPC]	Nuclear receptor ROR-beta	1971-01-01
Cytarabine	Cytarabine	Nippon Shinyaku Co., Ltd.	Antimetabolite	DNA polymerase	1969-01-01
Purixan	MERCAPTOPURINE	Stason Pharms	mercaptopurine	Prostaglandin G/H synthase 1	1953-01-01
Xaluprine	Xaluprine	Kjeld Schmiegelow		Multidrug resistance-associated protein 4, Multidrug resistance-associated protein 5, Thiopurine S-methyltransferase
6-Mercaptopurine	6-mercaptopurine	Pfizer Inc.		Multidrug resistance-associated protein 4, Multidrug resistance-associated protein 5, Thiopurine S-methyltransferase
Trisenox	Trisenox	German AML Cooperative Group		Potassium voltage-gated channel subfamily H member 2, Thioredoxin reductase 1, cytoplasmic
Daunorubicine	Daunorubicine	Gruppo Italiano Malattie EMatologiche dell'Adulto		Multidrug resistance-associated protein 6, 72 kDa type IV collagenase, ATP-binding cassette sub-family G member 2

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

2026-03-25 — Retin-A · FDA · approved · US

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

Pfizer Inc. · 2 drugs in Acute promyelocytic leukemia, FAB M3
· 2 drugs in Acute promyelocytic leukemia, FAB M3
Cephalon · 1 drug in Acute promyelocytic leukemia, FAB M3
German AML Cooperative Group · 1 drug in Acute promyelocytic leukemia, FAB M3
Gruppo Italiano Malattie EMatologiche dell'Adulto · 1 drug in Acute promyelocytic leukemia, FAB M3
Kjeld Schmiegelow · 1 drug in Acute promyelocytic leukemia, FAB M3
Meiji Seika Pharma Co., Ltd · 1 drug in Acute promyelocytic leukemia, FAB M3
Nippon Shinyaku Co., Ltd. · 1 drug in Acute promyelocytic leukemia, FAB M3
Stason Pharms · 1 drug in Acute promyelocytic leukemia, FAB M3
Bausch Health · 1 drug in Acute promyelocytic leukemia, FAB M3

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Every new regulatory action, PDUFA date, or trial completion in Acute promyelocytic leukemia, FAB M3:

Cite this brief

Drug Landscape (2026). Acute promyelocytic leukemia, FAB M3 — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/acute-promyelocytic-leukemia-fab-m3. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing