NDAORALCAPSULEPriority Review
Approved
Jul 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
THALOMID (thalidomide) is an oral small-molecule immunomodulatory agent approved in 1998 for erythema nodosum leprosum (ENL) and multiple myeloma. It works through cereblon binding to degrade specific proteins and modulate immune function. The drug remains a cornerstone therapy in hematologic malignancies despite its historical safety concerns.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30), the brand team is likely consolidating and focusing on defensive strategies rather than expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Thalidomide, Cyclophosphamide and Dexamethasone for Recurrent/Refractory Adult Langerhans Cell Histiocytosis
Started Oct 2019
20 enrolled
Langerhans Cell Histiocytosis
A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation
Started Sep 2019
0Multiple Myeloma
Daratumumab, Thalidomide and Dexamethasone in Relapse and/or Refractory Myeloma
Started May 2018
100 enrolled
Relapse and / or Refractory Myeloma
Carfilzomib Thalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Started Sep 2017
100 enrolled
Relapsed and/or Refractory Multiple Myeloma
A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis
Started Feb 2017
30 enrolled
Myelofibrosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.