Overview
A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of inflammatory disorders and cancers. Thalidomide displays immunosuppressive and anti-angiogenic activity through modulating the release of inflammatory mediators like tumor necrosis factor-alpha (TNF-a) and other cytokine action. Due to severe teratogenicity, pregnancy must be excluded before the start of treatment and patients must enrol in the THALIDOMID Risk Evaluation and Mitigation Strategy (REMS) program to ensure contraception adherence.
Indication
Thalidomide is primarily used for the acute treatment and maintenance therapy to prevent and suppress the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).
Associated Conditions
- Aphthous Stomatitis
- Chronic Graft-Versus-Host Disease
- Erythema Nodosum Leprosum
- Multiple Myeloma (MM)
- Primary Amyloidosis
- Uremic Pruritus
- Waldenström's Macroglobulinemia (WM)
- Moderate Erythema nodosum leprosum
- Refractory Graft versus host disease
- Severe Erythema nodosum leprosum
- Treatment naive multiple myeloma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/21 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2025/01/27 | Not Applicable | Recruiting | |||
2025/01/13 | Not Applicable | Not yet recruiting | |||
2024/09/27 | Phase 2 | Not yet recruiting | Yongquan Shi | ||
2024/07/31 | Phase 2 | Recruiting | |||
2024/07/08 | Phase 2 | Recruiting | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | ||
2024/07/08 | Phase 2 | Active, not recruiting | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | ||
2024/06/24 | Phase 2 | Completed | Shandong First Medical University | ||
2024/04/24 | N/A | Recruiting | |||
2024/03/08 | Phase 4 | Recruiting | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Celgene Corporation | 59572-210 | ORAL | 100 mg in 1 1 | 12/1/2022 | |
| Celgene Corporation | 59572-205 | ORAL | 50 mg in 1 1 | 12/1/2022 | |
| Celgene Corporation | 59572-220 | ORAL | 200 mg in 1 1 | 12/1/2022 | |
| Celgene Corporation | 59572-215 | ORAL | 150 mg in 1 1 | 12/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/16/2008 | ||
Authorised | 9/19/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DOMIDE CAPSULES 50mg | SIN16362P | CAPSULE | 50mg | 11/2/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| THALOMID thalidomide 50 mg hard capsule blister pack | 156729 | Medicine | A | 12/22/2009 | |
| THALOMID thalidomide 100 mg hard capsule blister pack | 156902 | Medicine | A | 12/22/2009 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| THALOMID | celgene inc | 02355213 | Capsule - Oral | 150 MG | N/A |
| THALOMID | bristol-myers squibb canada | 02355221 | Capsule - Oral | 200 MG | 2/17/2011 |
| THALOMID | bristol-myers squibb canada | 02355205 | Capsule - Oral | 100 MG | 2/17/2011 |
| THALOMID | bristol-myers squibb canada | 02355191 | Capsule - Oral | 50 MG | 11/1/2010 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TALIDOMIDA BMS 50 MG CAPSULAS DURAS | 8443001 | CÁPSULA DURA | Uso Hospitalario | Not Commercialized | |
| TALIDOMIDA ACCORD 50 MG CAPSULAS DURAS EFG | 85082 | CÁPSULA DURA | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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