pomalidomide

Trade name: pomalyst

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Feb 8, 2013

Pomalidomide is a derivative of thalidomide marketed by Celgene, an analogue of thalidomide, is an immunomodulatory agent with antineoplastic activity. In in vitro cellular assays, pomalidomide inhibited proliferation and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis. Pomalidomide enhanced T cell- and natural killer (NK) cell-mediated immunity and inhibited production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. Pomalidomide demonstrated anti-angiogenic activity in a mouse tumor model and in the in vitro umbilical cord model. — NCATS

Clinical trial activity

255 trials · 204 clinical orgs · 11 marketing orgs

Phase 1
105
Phase 2
184
Phase 3
43
Phase 4
3

Earliest trial started Sep 1, 2003 (NCT00072722)

Timeline

2000s

  1. Jan 1, 2003

    Celgene — Earliest Phase 2 Sponsor(trial)

  2. Jan 15, 2003

    Orphan Drug Designation

  3. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Celgene — Earliest Phase 3 Sponsor(trial)

  2. Feb 8, 2013

    Celgene — Earliest FDA Approval

  3. Feb 8, 2013

    Celgene — NDA Organization

  4. Feb 8, 2013

    Bristol-Myers — Marketing Organization

  5. Feb 8, 2013

    Bristol-Myers Squibb — NDA Secondary Org

2020s

  1. Oct 30, 2020

    Esteve Labs — Marketing Organization

  2. Oct 30, 2020

    Eugia Pharma — Marketing Organization

  3. Apr 20, 2021

    Dr. Reddy's Laboratories — Marketing Organization

  4. Jan 26, 2022

    Mylan — Marketing Organization

  5. May 4, 2022

    Teva — Marketing Organization

  6. Jun 11, 2024

    Apotex — Marketing Organization

  7. Sep 26, 2024

    Hetero Labs Ltd — Marketing Organization

  8. Mar 24, 2026

    Sun Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackFeb 8, 2013

Chemistry & pharmacology

Loading structure…

SMILES

NC1=CC=CC2=C1C(=O)N(C3CCC(=O)NC3=O)C2=O
Mol. weight
273.2441 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • actimid
  • actimid
  • actimid
  • cc4047
  • cc 4047
  • cc-4047
  • cc-4047
  • cc-4047
  • cc-4047
  • imid3
  • imid3
  • imid-3
  • imid-3
  • imid3 cpd
  • imnovid
  • imnovid
  • imnovid
  • imnovid
  • pomalidomide
  • pomalidomide
  • pomalidomide
  • pomalidomide
  • pomalidomide
  • pomalidomide
  • pomalidomide
  • pomalidomide
  • pomalidomide
  • pomalidomide
  • pomalidomide
  • pomalyst
  • pomalyst
  • pomalyst
  • pomalyst
  • pomalyst

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07222761Phase 3Jan 29, 2026Regeneron
NCT07227311Phase 2Jan 14, 2026GlaxoSmithKline
NCT07096778Phase 2Dec 1, 2025CellCentric Ltd.
NCT07138209Phase 3Oct 31, 2025Qilu Pharmaceutical Co., Ltd.
NCT06948084Phase 2Oct 31, 2025ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
NCT07018050Phase 2Sep 12, 2025Qilu Pharmaceutical Co., Ltd.
NCT07257510N/AAug 1, 2025Peking University
NCT06953960Phase 1/Phase 2 (Phase 2)Jul 23, 2025AbbVie
NCT07011511Phase 1Jun 30, 2025Medicines for Malaria Venture, Quotient, The Doctors Laboratory Ltd
NCT07015021N/AJun 1, 2025Soochow University
NCT06879379Phase 2/Phase 3 (Phase 3)Mar 31, 2025Peking University
NCT06924424N/AMar 1, 2025Peking University
NCT06615479Phase 3Feb 15, 2025Bristol-Myers Squibb, Celgene
NCT06742138Phase 3Jan 31, 2025Qilu Pharmaceutical Co., Ltd.
NCT06855823Phase 1/Phase 2 (Phase 2)Jan 14, 2025Sun Yat-Sen University
NCT06768489Phase 1Dec 4, 2024
NCT06660498Phase 1/Phase 2 (Phase 2)Nov 20, 2024Aarhus University
NCT06058689Phase 1Sep 15, 2024Azidus, Megalabs
NCT06832228N/ASep 1, 2024Chinese Academy of Medical Sciences
NCT06554561Phase 1/Phase 2 (Phase 2)Aug 31, 2024Zhejiang University
Showing 20 of 255 trials
Page 1 / 13

Organizations

Research & Development (204)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CelgeneFor profit763542003
National Cancer Institute (NCI)Government321222007
Bristol-Myers SquibbFor profit14532012
Janssen Pharmaceutica NVFor profit12432018
Harvard UniversityAcademic/Hospital11922010
Mayo ClinicAcademic/Hospital111122007
GlaxoSmithKlineFor profit10522018
AbbVieFor profit9632015
SanofiFor profit9632015
Cornell UniversityAcademic/Hospital8622010
Peking UniversityAcademic/Hospital8542021
TakedaFor profit8332015
AmgenFor profit7322011
Chinese Academy of Medical SciencesAcademic/Hospital5342016
Karyopharm Therapeutics IncFor profit5122015
Multiple Myeloma Research ConsortiumAcademic/Hospital5222012
Qilu Pharmaceutical Co., Ltd.For profit4422021
University of Texas at HoustonAcademic/Hospital4422009
Washington University in St. LouisAcademic/Hospital4322009
Capital Medical UniversityAcademic/Hospital3032021
204 organizations
Page 1 / 11

Marketing (11)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGJun 11, 2024
Bristol-MyersFor profitMKTGFeb 8, 2013
Bristol-Myers SquibbFor profitNDA2Feb 8, 2013
CelgeneFor profitNDAFeb 8, 2013
Dr. Reddy's LaboratoriesFor profitMKTGApr 20, 2021
Esteve LabsFor profitMKTGOct 30, 2020
Eugia PharmaFor profitMKTGOct 30, 2020
Hetero Labs LtdFor profitMKTGSep 26, 2024
MylanFor profitMKTGJan 26, 2022
Sun PharmaceuticalsFor profitMKTGMar 24, 2026
TevaFor profitMKTGMay 4, 2022