pomalidomide
Trade name: pomalyst
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
Earliest trial started Sep 1, 2003 (NCT00072722)
Timeline
2000s
2010s
- Jan 1, 2010
- Feb 8, 2013
Celgene — Earliest FDA Approval
- Feb 8, 2013
Celgene — NDA Organization
- Feb 8, 2013
Bristol-Myers — Marketing Organization
- Feb 8, 2013
Bristol-Myers Squibb — NDA Secondary Org
2020s
- Oct 30, 2020
Esteve Labs — Marketing Organization
- Oct 30, 2020
Eugia Pharma — Marketing Organization
- Apr 20, 2021
Dr. Reddy's Laboratories — Marketing Organization
- Jan 26, 2022
Mylan — Marketing Organization
- May 4, 2022
Teva — Marketing Organization
- Jun 11, 2024
Apotex — Marketing Organization
- Sep 26, 2024
Hetero Labs Ltd — Marketing Organization
- Mar 24, 2026
Sun Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
- Aging · Phase 2
- Amyloid · Phase 2
- Amyloidosis · Phase 2
- Anemia, Sickle Cell · Phase 1
- Blood Protein Disorders · Phase 2
- Burkitt Lymphoma · Phase 1
- Carcinoma, Small Cell · Phase 1/Phase 2
- Central Nervous System Neoplasms · Phase 2
- Chromosome Disorders · Phase 2
- Comorbidity · Phase 2
- Corneal Diseases · Phase 1/Phase 2
- Drugs, Generic · Phase 1
- Endoscopy · Phase 2
- Genetic Diseases, Inborn · Phase 2
- Glioma · Phase 1
- Graft vs Host Disease · Phase 2
- Healthy Volunteers · Phase 1
- Hematologic Diseases · Phase 2
- Hematologic Neoplasms · Phase 1
- Hematology · Phase 1/Phase 2
- HIV · Phase 2
- HIV Infections · Phase 1/Phase 2
- Hodgkin Disease · Phase 1
- Immunoglobulin Light-chain Amyloidosis · Phase 2
- Immunoglobulin Light Chains · Phase 1
- Intraocular Lymphoma · Phase 1
- Kidney Failure, Chronic · Phase 2
- Leukemia, B-Cell · Phase 1
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 2
- Leukemia, Plasma Cell · Phase 2
- Lung Diseases, Interstitial · Phase 2
- Lymphoma · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 1/Phase 2
- Lymphoma, Non-Hodgkin · Phase 1
- Lymphoma, Primary Effusion · Phase 1/Phase 2
- Malaria, Falciparum · Phase 1
- Medulloblastoma · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Myeloproliferative Disorders · Phase 2
- Neoplasms · Phase 2
- Neoplasms by Histologic Type · Phase 2
- Neoplasms, Plasma Cell · Phase 2
- Neurofibromatosis 1 · Phase 1
- Pancreatic Neoplasms · Phase 1/Phase 2
- Paraproteinemias · Phase 2
- Pharmacology, Clinical · Phase 1
- Plasmablastic Lymphoma · Phase 1
- Plasmacytoma · Phase 2
- Polycythemia Vera · Phase 2
- Primary Myelofibrosis · Phase 3
- Prostatic Neoplasms · Phase 2
- Pulmonary Fibrosis · Phase 2
- Recurrence · Phase 2
- Sarcoma · Phase 2
- Sarcoma, Kaposi · Phase 2
- Scleroderma, Systemic · Phase 2
- Squamous Intraepithelial Lesions · Phase 2
- Telangiectasia, Hereditary Hemorrhagic · Phase 2
- Therapeutic Equivalency · Phase 1
- Thrombocytosis · Phase 2
- Vascular Diseases · Phase 1
- Waldenstrom Macroglobulinemia · Phase 1
Mechanism of action
- CRL4(CRBN) E3 ubiquitin ligaseINHIBITOR
CRL4(CRBN) E3 ubiquitin ligase inhibitor
Cereblon
Approval history
- approvedPriority reviewAcceleratedFast trackFeb 8, 2013
Chemistry & pharmacology
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
Sources
- WikipediaPomalidomide ↗
- NCATSD2UX06XLB5 ↗
- ChEMBLCHEMBL43452 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07222761 | Phase 3 | Jan 29, 2026 | Regeneron |
| NCT07227311 | Phase 2 | Jan 14, 2026 | GlaxoSmithKline |
| NCT07096778 | Phase 2 | Dec 1, 2025 | CellCentric Ltd. |
| NCT07138209 | Phase 3 | Oct 31, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT06948084 | Phase 2 | Oct 31, 2025 | ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI) |
| NCT07018050 | Phase 2 | Sep 12, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT07257510 | N/A | Aug 1, 2025 | Peking University |
| NCT06953960 | Phase 1/Phase 2 (Phase 2) | Jul 23, 2025 | AbbVie |
| NCT07011511 | Phase 1 | Jun 30, 2025 | Medicines for Malaria Venture, Quotient, The Doctors Laboratory Ltd |
| NCT07015021 | N/A | Jun 1, 2025 | Soochow University |
| NCT06879379 | Phase 2/Phase 3 (Phase 3) | Mar 31, 2025 | Peking University |
| NCT06924424 | N/A | Mar 1, 2025 | Peking University |
| NCT06615479 | Phase 3 | Feb 15, 2025 | Bristol-Myers Squibb, Celgene |
| NCT06742138 | Phase 3 | Jan 31, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT06855823 | Phase 1/Phase 2 (Phase 2) | Jan 14, 2025 | Sun Yat-Sen University |
| NCT06768489 | Phase 1 | Dec 4, 2024 | — |
| NCT06660498 | Phase 1/Phase 2 (Phase 2) | Nov 20, 2024 | Aarhus University |
| NCT06058689 | Phase 1 | Sep 15, 2024 | Azidus, Megalabs |
| NCT06832228 | N/A | Sep 1, 2024 | Chinese Academy of Medical Sciences |
| NCT06554561 | Phase 1/Phase 2 (Phase 2) | Aug 31, 2024 | Zhejiang University |
Organizations
Research & Development (204)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Celgene | For profit | 76 | 35 | 4 | 2003 |
| National Cancer Institute (NCI) | Government | 32 | 12 | 2 | 2007 |
| Bristol-Myers Squibb | For profit | 14 | 5 | 3 | 2012 |
| Janssen Pharmaceutica NV | For profit | 12 | 4 | 3 | 2018 |
| Harvard University | Academic/Hospital | 11 | 9 | 2 | 2010 |
| Mayo Clinic | Academic/Hospital | 11 | 11 | 2 | 2007 |
| GlaxoSmithKline | For profit | 10 | 5 | 2 | 2018 |
| AbbVie | For profit | 9 | 6 | 3 | 2015 |
| Sanofi | For profit | 9 | 6 | 3 | 2015 |
| Cornell University | Academic/Hospital | 8 | 6 | 2 | 2010 |
| Peking University | Academic/Hospital | 8 | 5 | 4 | 2021 |
| Takeda | For profit | 8 | 3 | 3 | 2015 |
| Amgen | For profit | 7 | 3 | 2 | 2011 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 5 | 3 | 4 | 2016 |
| Karyopharm Therapeutics Inc | For profit | 5 | 1 | 2 | 2015 |
| Multiple Myeloma Research Consortium | Academic/Hospital | 5 | 2 | 2 | 2012 |
| Qilu Pharmaceutical Co., Ltd. | For profit | 4 | 4 | 2 | 2021 |
| University of Texas at Houston | Academic/Hospital | 4 | 4 | 2 | 2009 |
| Washington University in St. Louis | Academic/Hospital | 4 | 3 | 2 | 2009 |
| Capital Medical University | Academic/Hospital | 3 | 0 | 3 | 2021 |
Marketing (11)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Apotex | For profit | MKTG | Jun 11, 2024 |
| Bristol-Myers | For profit | MKTG | Feb 8, 2013 |
| Bristol-Myers Squibb | For profit | NDA2 | Feb 8, 2013 |
| Celgene | For profit | NDA | Feb 8, 2013 |
| Dr. Reddy's Laboratories | For profit | MKTG | Apr 20, 2021 |
| Esteve Labs | For profit | MKTG | Oct 30, 2020 |
| Eugia Pharma | For profit | MKTG | Oct 30, 2020 |
| Hetero Labs Ltd | For profit | MKTG | Sep 26, 2024 |
| Mylan | For profit | MKTG | Jan 26, 2022 |
| Sun Pharmaceuticals | For profit | MKTG | Mar 24, 2026 |
| Teva | For profit | MKTG | May 4, 2022 |