Overview
Pomalidomide, an analogue of thalidomide, is an immunomodulatory antineoplastic agent. FDA approved on February 8, 2013.
Background
Pomalidomide, an analogue of thalidomide, is an immunomodulatory antineoplastic agent. FDA approved on February 8, 2013.
Indication
Pomalidomide is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and have demonstrated disease progression on or within 60 days of completion of the last therapy. It is also indicated for the treatment of Kaposi's sarcoma (KS) in AIDS patients who have failed highly active antiretroviral therapy (HAART) and for the treatment of KS in HIV-negative patients.
Associated Conditions
- Kaposi's Sarcoma
- Multiple Myeloma (MM)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/12 | N/A | Active, not recruiting | |||
2025/06/12 | Phase 2 | Not yet recruiting | |||
2025/06/11 | Not Applicable | Not yet recruiting | The First Affiliated Hospital of Soochow University | ||
2025/05/04 | Phase 3 | Active, not recruiting | |||
2025/05/01 | Phase 1 | Not yet recruiting | |||
2025/04/29 | Phase 2 | Not yet recruiting | |||
2025/01/10 | Phase 1 | Recruiting | |||
2024/12/19 | Phase 3 | Not yet recruiting | |||
2024/10/28 | Phase 1 | Recruiting | |||
2024/09/26 | Phase 3 | Recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Celgene Corporation | 59572-502 | ORAL | 2 mg in 1 1 | 3/24/2023 | |
| Celgene Corporation | 59572-501 | ORAL | 1 mg in 1 1 | 3/24/2023 | |
| Celgene Corporation | 59572-503 | ORAL | 3 mg in 1 1 | 3/24/2023 | |
| Celgene Corporation | 59572-504 | ORAL | 4 mg in 1 1 | 3/24/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/24/2024 | ||
Authorised | 8/5/2013 | ||
Authorised | 7/24/2024 | ||
Authorised | 11/14/2024 | ||
Authorised | 7/26/2024 | ||
Authorised | 2/16/2024 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| POMALYST CAPSULE 2MG | SIN14714P | CAPSULE | 2 mg | 12/30/2014 | |
| POMAGEN CAPSULES 4MG | SIN16982P | CAPSULE | 4.0 mg | 4/12/2024 | |
| POMALYST CAPSULE 3MG | SIN14715P | CAPSULE | 3 mg | 12/30/2014 | |
| POMAGEN CAPSULES 1MG | SIN16983P | CAPSULE | 1 mg | 4/12/2024 | |
| POMALYST CAPSULE 4MG | SIN14716P | CAPSULE | 4 mg | 12/30/2014 | |
| POMAGEN CAPSULES 3MG | SIN16985P | CAPSULE | 3.0 mg | 4/12/2024 | |
| POMAGEN CAPSULES 2MG | SIN16984P | CAPSULE | 2.0 mg | 4/12/2024 | |
| POMALYST CAPSULE 1MG | SIN14713P | CAPSULE | 1 mg | 12/30/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Pomalidomide Capsules | 国药准字H20253721 | 化学药品 | 胶囊剂 | 3/25/2025 | |
| Pomalidomide Capsules | 国药准字H20253720 | 化学药品 | 胶囊剂 | 3/25/2025 | |
| Pomalidomide Capsules | 国药准字H20203573 | 化学药品 | 胶囊剂 | 11/10/2020 | |
| Pomalidomide Capsules | 国药准字H20243808 | 化学药品 | 胶囊剂 | 5/28/2024 | |
| Pomalidomide Capsules | 国药准字H20243809 | 化学药品 | 胶囊剂 | 5/28/2024 | |
| Pomalidomide Capsules | 国药准字H20243810 | 化学药品 | 胶囊剂 | 5/28/2024 | |
| Pomalidomide Capsules | 国药准字H20243811 | 化学药品 | 胶囊剂 | 5/28/2024 | |
| Pomalidomide Capsules | 国药准字H20203572 | 化学药品 | 胶囊剂 | 11/10/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| POMALYST pomalidomide 2 mg capsule blister pack | 212654 | Medicine | A | 7/1/2014 | |
| POMALIDOMIDE SANDOZ pomalidomide 1 mg capsule blister pack | 352569 | Medicine | A | 6/2/2022 | |
| POMALIDOMIDE JUNO pomalidomide 1 mg hard gelatin capsule blister pack | 335276 | Medicine | A | 5/18/2021 | |
| POMOLIDE pomalidomide 2 mg hard gelatin capsule blister pack | 335279 | Medicine | A | 5/18/2021 | |
| POMALIMED pomalidomide 2 mg capsule blister pack | 381432 | Medicine | A | 11/29/2022 | |
| POMALIDOMIDE SANDOZ pomalidomide 2 mg capsule blister pack | 352570 | Medicine | A | 6/2/2022 | |
| POMALIDOMIDE JUNO pomalidomide 3 mg hard gelatin capsule blister pack | 335281 | Medicine | A | 5/18/2021 | |
| POMOLIDE pomalidomide 1 mg hard gelatin capsule blister pack | 335277 | Medicine | A | 5/18/2021 | |
| POMALIDOMIDE JN pomalidomide 4 mg hard gelatin capsule blister pack | 335270 | Medicine | A | 5/18/2021 | |
| POMALIDOMIDE MEDICIANZ pomalidomide 1 mg capsule blister pack | 381436 | Medicine | A | 11/29/2022 |