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A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/08 | Phase 4 | Recruiting | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2024/02/20 | Phase 2 | Recruiting | |||
2024/02/02 | Phase 2 | Completed | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | ||
2024/01/30 | Phase 2 | Recruiting | |||
2023/11/24 | Phase 3 | Completed | Blood Care Clinic | ||
2023/10/24 | Phase 1 | Completed | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2023/08/30 | Phase 3 | Recruiting | |||
2022/09/02 | Phase 4 | Active, not recruiting | |||
2022/09/01 | Phase 4 | UNKNOWN | |||
2022/03/04 | Phase 2 | UNKNOWN |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
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UK EMC Drug Information
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