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idarubicin

Trade name: idamycin

Small moleculeapprovedOrphan Drug FDA

Approved

Sep 27, 1990

Idarubicin is an antineoplastic in the anthracycline class.Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. The absence of a methoxy group at position 4 of the anthracycline structure gives the compound a high lipophilicity which results in an increased rate of cellular uptake compared with other anthracyclines.Idarubicin possesses an antitumor effect against a wide spectrum of tumors, either grafted or spontaneous. Idarubicin in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. — NCATS

Clinical trial activity

244 trials · 215 clinical orgs · 12 marketing orgs

Phase 1
59
Phase 2
170
Phase 3
68
Phase 4
17

Earliest trial started Jan 1, 1993 (NCT00002532)

Timeline

1980s

  1. Jul 25, 1988

    Orphan Drug Designation

1990s

  1. Sep 27, 1990

    Pharmacia & Upjohn — Earliest FDA Approval

  2. Sep 27, 1990

    Pharmacia & Upjohn — NDA Organization

  3. Sep 27, 1990

    Pharmacia & Upjohn — NDA Secondary Org

  4. Sep 27, 1990

    Pfizer — Marketing Organization

  5. Sep 27, 1990

    Pfizer — NDA Secondary Org

  6. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

  7. Jan 1, 1993

    Earliest Phase 3 Sponsor(trial)

  8. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

2000s

  1. May 1, 2002

    Teva — Marketing Organization

  2. May 1, 2002

    Eu Yan Sang — Marketing Organization

  3. May 1, 2002

    Meitheal — Marketing Organization

  4. Dec 14, 2006

    West-Ward Pharmaceutical — Marketing Organization

  5. Dec 14, 2006

    Hikma — Marketing Organization

  6. Aug 4, 2009

    Fresenius — Marketing Organization

2010s

  1. Mar 29, 2011

    Sandoz — Marketing Organization

  2. Mar 29, 2011

    Novartis — Marketing Organization

  3. Oct 11, 2012

    Mylan — Marketing Organization

  4. Oct 11, 2012

    Rising Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewSep 27, 1990

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)[C@]1(O)Cc2c(O)c3c(c(O)c2[C@@H](O[C@H]2C[C@H](N)[C@H](O)[C@H](C)O2)C1)C(=O)c1ccccc1C3=O
Mol. weight
497.5 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • (1s,3s)-3-acetyl-3,5,12-trihydroxy-6,11-dioxo-1,2,3,4,6,11-hexahydronaphthacen-1-yl 3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranoside
  • (1s,3s)-3-acetyl-3,5,12-trihydroxy-6,11-dioxo-1,2,3,4,6,11-hexahydronaphthacen-1-yl 3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranoside
  • 4-demethoxydaunomycin
  • 4-demethoxydaunomycin
  • 4-demethoxydaunomycin
  • 4-demethoxydaunorubicin
  • 4-demethoxydaunorubicin
  • 4-demethoxydaunorubicin
  • 5,12-naphthacenedione, 9-acetyl-7-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,9,11-trihydroxy-, (7s-cis)-
  • 5,12-naphthacenedione, 9-acetyl-7-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,9,11-trihydroxy-, (7s-cis)-
  • demethoxydaunorubicin
  • idamycin
  • idamycin
  • idamycin
  • idamycin pfs
  • idamycin pfs
  • idarubcin
  • idarubicin
  • idarubicin
  • idarubicin
  • idarubicin
  • idarubicin
  • idarubicin
  • idarubicin
  • idarubicin
  • idarubicin
  • idarubicin
  • idarubicina
  • idarubicina
  • idarubicine
  • idarubicine
  • idarubicin hcl
  • idarubicin hcl
  • idarubicin hcl
  • idarubicin hydrochloride
  • idarubicin hydrochloride
  • idarubicin hydrochloride
  • idarubicin hydrochloride
  • idarubicin hydrochloride pfs
  • idarubicin hydrochloride pfs
  • idarubicinum
  • idarubicinum
  • imi-30
  • imi-30
  • zavedos
  • zavedos
  • zavedos

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07223814Phase 3Dec 31, 2025German-Austrian Acute Myeloid Leukemia Study Group, HOVON - Dutch Haemato-Oncology Association
NCT07228273Phase 2Dec 24, 2025OHSU Knight Cancer Institute, Oregon Health and Science University
NCT07059975Early Phase 1 (Phase 1)Oct 22, 2025Baylor University
NCT07046078Phase 2Sep 26, 2025University of Washington
NCT06928662Phase 1/Phase 2 (Phase 2)Sep 23, 2025University of Washington
NCT07132684Phase 3Aug 31, 2025China Academy of Chinese Medical Sciences, People's Liberation Army of China
NCT07232134Phase 3Jul 24, 2025Federal Research Institute of Pediatric Hematology, Oncology and Immunology
NCT07078591Phase 2Jun 20, 2025People's Liberation Army of China
NCT07028073Phase 1/Phase 2 (Phase 2)May 15, 2025Soochow University
NCT06744504Phase 3Dec 25, 2024China Academy of Chinese Medical Sciences
NCT06744556Phase 2Dec 20, 2024China Academy of Chinese Medical Sciences
NCT06643962N/AOct 31, 2024Nantong University
NCT06497062Phase 2Sep 4, 2024BeOne Medicines, Jiao Tong University
NCT06492421Phase 2Jul 1, 2024Guangzhou Medical University
NCT06492408Phase 2Jul 1, 2024Guangzhou Medical University
NCT07131059N/AMay 11, 2024China Academy of Chinese Medical Sciences, People's Liberation Army of China
NCT06316960Phase 2Mar 1, 2024Soochow University
NCT06034470Phase 1Jan 13, 2024Immunogen, University of Washington
NCT06221683Phase 2Jan 1, 2024Soochow University
NCT06001788Phase 1Dec 31, 2023Kura Oncology, Inc.
Showing 20 of 244 trials
Page 1 / 13

Organizations

Research & Development (215)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government461841994
University of Texas at HoustonAcademic/Hospital282231994
European Organisation for Research and Treatment of CancerAcademic/Hospital131321993
PETHEMA FoundationAcademic/Hospital111141998
Gruppo Italiano Malattie EMatologiche dell'AdultoAcademic/Hospital10431995
J. W. Goethe UniversityAcademic/Hospital8731997
University of WashingtonAcademic/Hospital8832000
Soochow UniversityAcademic/Hospital7722014
Southern Medical UniversityAcademic/Hospital7642013
Radboud UniversityAcademic/Hospital6021995
University of UlmAcademic/Hospital6421998
Chinese Academy of Medical SciencesAcademic/Hospital5432012
Daiichi SankyoFor profit5332014
Harvard UniversityAcademic/Hospital5522003
University of ValenciaAcademic/Hospital5021998
Arog Pharmaceuticals, Inc.For profit4422015
China Academy of Chinese Medical SciencesAcademic/Hospital4432024
City of Hope National Medical CenterAcademic/Hospital4321994
Cornell UniversityAcademic/Hospital4411994
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital4321993
215 organizations
Page 1 / 11

Marketing (15)

OrganizationOrg typeRelationshipDate
Eu Yan SangFor profitMKTGMay 1, 2002
FreseniusFor profitMKTGAug 4, 2009
HikmaFor profitMKTGDec 14, 2006
MeithealFor profitMKTGMay 1, 2002
MylanFor profitMKTGOct 11, 2012
NovartisFor profitMKTGMar 29, 2011
PfizerFor profitMKTGSep 27, 1990
PfizerFor profitNDA2Sep 27, 1990
Pharmacia & UpjohnFor profitNDASep 27, 1990
Pharmacia & UpjohnFor profitNDA2Sep 27, 1990
Rising PharmaceuticalsFor profitMKTGOct 11, 2012
SandozFor profitMKTGMar 29, 2011
TevaFor profitMKTGMay 1, 2002
TevaFor profitSYNMay 1, 2002
West-Ward PharmaceuticalFor profitMKTGDec 14, 2006