Drug · Small Molecule
Thalidomide
CI-DRUG-00000790Explore in graph →CHEMBL468 Approved
Regulatory
Approvals (5)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
openfdaProvenance
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2012-02-03 (see label) | approved | Feb 3, 2012 | openfda |
| US FDA | Multiple Myeloma | THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). | approved | Jul 16, 1998 | openfda |
| US FDA | — | THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. | approved | Jul 16, 1998 | openfda |
Data updated 11 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 12 | 4 | 47 | 235 | 5 | EU, US | Jul 16, 1998 | 1995-09 |
| Non-Hodgkin Lymphoma | Approved | Phase 4 | 6 | 0 | 29 | 95 | 3 | EU, US | Jul 16, 1998 | 1998-02 |
| Multiple Myeloma | Approved | Phase 4 | 5 | 0 | 28 | 80 | 3 | EU, US | Jul 16, 1998 | 1998-02 |
| Malignant Gastric Neoplasm | Phase4 | Phase 4 | 0 | 0 | 0 | 1 | 0 | — |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
No curated evidence item mentions this therapy yet.
Clinical trials
Trials with this intervention (236)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00182663 | Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant | completed | Phase 2 | 30 | Fred Hutchinson Cancer CenterOTHER | 1 | Jun 26, 2017 | clinicaltrials |
| NCT01548573 | Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment | terminated |