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romidepsin

Trade name: istodax

Small moleculeapprovedOrphan Drug FDA

Approved

Nov 5, 2009

Romidepsin, sold under the brand name Istodax, is an anticancer agent used in cutaneous T-cell lymphoma (CTCL) and other peripheral T-cell lymphomas (PTCLs). Romidepsin is a natural product obtained from the bacterium Chromobacterium violaceum, and works by blocking enzymes known as histone deacetylases, thus inducing apoptosis. It is sometimes referred to as depsipeptide, after the class of molecules to which it belongs. Romidepsin is branded and owned by Gloucester Pharmaceuticals, a part of Celgene. — Wikipedia

Clinical trial activity

98 trials · 92 clinical orgs · 7 marketing orgs

Phase 1
59
Phase 2
63
Phase 3
5
Phase 4
0

Earliest trial started Aug 1, 1997 (NCT00019318)

Timeline

1990s

  1. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Sep 30, 2004

    Orphan Drug Designation

  3. Nov 5, 2009

    Gloucester Pharmaceuticals — Earliest FDA Approval

  4. Nov 5, 2009

    Gloucester Pharmaceuticals — NDA Organization

  5. Nov 5, 2009

    Celgene — NDA Secondary Org

  6. Nov 5, 2009

    Bristol-Myers — Marketing Organization

  7. Nov 5, 2009

    Bristol-Myers Squibb — NDA Secondary Org

2010s

  1. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Mar 13, 2020

    Teva — Marketing Organization

  2. Mar 13, 2020

    Teva — NDA Secondary Org

  3. Oct 12, 2021

    Fresenius — Marketing Organization

  4. Jun 2, 2026

    Amneal Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 5, 2009

Chemistry & pharmacology

Loading structure…

SMILES

C/C=C1\NC(=O)[C@H]2CSSCC/C=C/[C@H](CC(=O)N[C@H](C(C)C)C(=O)N2)OC(=O)[C@H](C(C)C)NC1=O
Mol. weight
540.71 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Prodrug

Sources

Also known as

  • astella pharma brand of romidepsin
  • chromadax
  • chromadax
  • chromadax
  • chromodax
  • depsipeptide
  • depsipeptide
  • fk228
  • fk228
  • fk228
  • fk228
  • fk-228
  • fk-228
  • fr901228
  • fr901228
  • fr901228
  • fr901228
  • fr 901228
  • fr-901228
  • fr-901228
  • fr-901228
  • istodax
  • istodax
  • istodax
  • istodax
  • istodax
  • istodax
  • l-valine, n-(3-hydroxy-7-mercapto-1-oxo-4-heptenyl)-d-valyl-d-cysteinyl-(z)-2,3-didehydro-2-aminobutanoyl-, xi-lactone, cyclic (1-2)-disulfide, (s-(e))-
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin
  • romidepsin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06963346Phase 1Jun 24, 2025AstraZeneca, University of South Florida
NCT05230368Phase 1Apr 15, 2022Government of France
NCT04774068Phase 1Sep 1, 2021Ohio State University
NCT04747236Phase 2Feb 19, 2021Celgene, University of Virginia
NCT04639843Phase 1Jan 8, 2021National Cancer Institute (NCI)
NCT04447027Phase 1Dec 17, 2020National Cancer Institute (NCI)
NCT04257448Phase 1/Phase 2 (Phase 2)Mar 31, 2020AstraZeneca, Celgene, GWT-TUD GmbH, Institute for Developmental Cancer Therapeutics
NCT04233697Phase 1Feb 29, 2020Bayer, Columbia University
NCT03770000Phase 1/Phase 2 (Phase 2)Mar 12, 2019Rhizen Pharmaceuticals SA
NCT03703375Phase 3Nov 6, 2018Celgene
NCT03619278Phase 1/Phase 2 (Phase 2)Nov 1, 2018Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona
NCT03355768Phase 3Sep 30, 2018Columbia University
NCT03593018Phase 3Sep 30, 2018APHP - Hôpital Necker, Celgene, CHU Henri Mondor, Saitama Medical University, The Lymphoma Academic Research Organisation
NCT03547700Phase 1/Phase 2 (Phase 2)Sep 26, 2018Big Ten Cancer Research Consortium, Takeda, University of Michigan
NCT03432741Phase 1Mar 27, 2018Mayo Clinic, National Cancer Institute (NCI)
NCT03278782Phase 1/Phase 2 (Phase 2)Nov 14, 2017Merck, University of Texas at Houston
NCT03161223Phase 1/Phase 2 (Phase 2)Jun 15, 2017Columbia University
NCT02616965Phase 1Feb 22, 2017Celgene, Seattle Genetics, Temple University
NCT03041012Phase 2Jan 20, 2017Aalborg University, Aarhus University, Herning Hospital, University of Cologne, University of Copenhagen, University of Southern Denmark
NCT02850016Phase 2Dec 1, 2016Aarhus University, Rockefeller University, University of Cologne
Showing 20 of 98 trials
Page 1 / 5

Organizations

Research & Development (92)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government382731997
CelgeneFor profit351232003
University of Texas at HoustonAcademic/Hospital7322005
Cornell UniversityAcademic/Hospital6522002
Columbia UniversityAcademic/Hospital5532013
Aarhus UniversityAcademic/Hospital3112014
Gloucester PharmaceuticalsFor profit3012003
Johns Hopkins UniversityAcademic/Hospital3212012
Northwestern UniversityAcademic/Hospital3222010
Ohio State UniversityAcademic/Hospital3222002
The Lymphoma Academic Research OrganisationAcademic/Hospital3322011
AmgenFor profit2022013
AstraZenecaFor profit2022020
Duke UniversityAcademic/Hospital2122004
Fondazione Italiana Diabete OnlusAcademic/Hospital2212013
Mayo ClinicAcademic/Hospital2222016
MerckFor profit2022015
Peter MacCallum Cancer CentreAcademic/Hospital2112006
Southwest Oncology GroupAcademic/Hospital2212004
The University of Texas, DallasAcademic/Hospital2112004
92 organizations
Page 1 / 5

Marketing (8)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGJun 2, 2026
Bristol-MyersFor profitMKTGNov 5, 2009
Bristol-Myers SquibbFor profitNDA2Nov 5, 2009
CelgeneFor profitNDA2Nov 5, 2009
FreseniusFor profitMKTGOct 12, 2021
Gloucester PharmaceuticalsFor profitNDANov 5, 2009
TevaFor profitMKTGMar 13, 2020
TevaFor profitNDA2Mar 13, 2020