Thalidomide
- Generic Name
- Thalidomide
- Brand Names
- Thalomid, Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed
- Drug Type
- Small Molecule
- Chemical Formula
- C13H10N2O4
- CAS Number
- 50-35-1
- Unique Ingredient Identifier
- 4Z8R6ORS6L
- Background
A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, thalidomide was withdrawn from the market due to teratogenic effects.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
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
- Conditions
- HIV InfectionsHIV Wasting Syndrome
- First Posted Date
- 2001-08-31
- Last Posted Date
- 2005-06-24
- Lead Sponsor
- Celgene Corporation
- Registration Number
- NCT00002157
- Locations
- 🇺🇸
Celgene Corp, Warren, New Jersey, United States
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
- Conditions
- Mycobacterium Avium-Intracellulare InfectionHIV InfectionsTuberculosis, Mycobacterium Infection
- First Posted Date
- 2001-08-31
- Last Posted Date
- 2005-06-24
- Lead Sponsor
- Aaron Diamond AIDS Research Center
- Registration Number
- NCT00002104
- Locations
- 🇺🇸
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ, New York, New York, United States
🇺🇸Bellevue Hosp Ctr, New York, New York, United States
A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection
- Conditions
- HIV Infections
- First Posted Date
- 2001-08-31
- Last Posted Date
- 2021-10-28
- Target Recruit Count
- 36
- Registration Number
- NCT00000812
- Locations
- 🇺🇸
University of Colorado Hospital CRS, Aurora, Colorado, United States
🇺🇸University of Minnesota, ACTU, Minneapolis, Minnesota, United States
🇺🇸Memorial Sloan-Kettering Cancer Ctr., New York, New York, United States
Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
- Conditions
- HIV InfectionsStomatitis, Aphthous
- First Posted Date
- 2001-08-31
- Last Posted Date
- 2021-11-04
- Target Recruit Count
- 164
- Registration Number
- NCT00000790
- Locations
- 🇺🇸
Northwestern Univ Med School, Chicago, Illinois, United States
🇺🇸Louis A Weiss Memorial Hosp, Chicago, Illinois, United States
🇺🇸Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, United States
Thalidomide and Dacarbazine for Metastatic Melanoma
- Conditions
- Melanoma
- First Posted Date
- 2000-09-11
- Last Posted Date
- 2005-06-24
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Registration Number
- NCT00006200
- Locations
- 🇺🇸
Kaplan Comprehensive Cancer Center, New York, New York, United States
Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
- Conditions
- Liver Cancer
- First Posted Date
- 2000-09-11
- Last Posted Date
- 2005-06-24
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Registration Number
- NCT00006198
- Locations
- 🇺🇸
Kaplan Comprehensive Cancer Center, New York, New York, United States
Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- First Posted Date
- 2000-02-21
- Last Posted Date
- 2018-05-22
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 159
- Registration Number
- NCT00004635
- Locations
- 🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States
🇺🇸Wayne State University Hutzel Hospital, Detroit, Michigan, United States
🇺🇸University of Washington, Seattle, Washington, United States
Pilot Study of Thalidomide to Treat Sjogren's Syndrome
- Conditions
- Sjogren's SyndromeXerostomia
- First Posted Date
- 1999-11-04
- Last Posted Date
- 2008-03-04
- Lead Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Target Recruit Count
- 28
- Registration Number
- NCT00001599
- Locations
- 🇺🇸
National Institute of Dental And Craniofacial Research (NIDCR), Bethesda, Maryland, United States
Thalidomide to Treat Oral Lesions in HIV-Infected Patients
- Conditions
- Acquired Immunodeficiency SyndromeBurning Mouth SyndromeHIV Infection
- First Posted Date
- 1999-11-04
- Last Posted Date
- 2008-03-04
- Lead Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Target Recruit Count
- 110
- Registration Number
- NCT00001524
- Locations
- 🇺🇸
National Institute of Dental And Craniofacial Research (NIDCR), Bethesda, Maryland, United States
Randomized Study of Beta Interferon and Thalidomide in Patients With Adrenoleukodystrophy
- Conditions
- Adrenoleukodystrophy
- First Posted Date
- 1999-10-19
- Last Posted Date
- 2015-03-25
- Lead Sponsor
- FDA Office of Orphan Products Development
- Target Recruit Count
- 60
- Registration Number
- NCT00004450
Drug Development Updates
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