Drug

Thalidomide

Approved · EMA

ClassCRL4(CRBN) E3 ubiquitin ligase inhibitorEmerging researchLate-stage developmentSteady momentum

Also known as 3-Phthalimidoglutarimide, N-Phthaloylglutamimide, N-Phthalyl-glutaminsaeure-imid, N-Phthalylglutamic acid imide+13 more

3-Phthalimidoglutarimide, N-Phthaloylglutamimide, N-Phthalyl-glutaminsaeure-imid, N-Phthalylglutamic acid imide, Talidomida, Thalomid, alpha-(N-Phthalimido)glutarimide, alpha-N-Phthalylglutaramide, (+)-Thalidomide, (+-)-Thalidomide, (±)-thalidomide, (+-)-N-(2,6-dioxo-3-Piperidyl)phthalimide, (±)-N-(2,6-dioxo-3-piperidyl)phthalimide, 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)isoindoline, 2,6-dioxo-3-phthalimidopiperidine, N-(2,6-dioxo-3-piperidyl)phthalimide, Thalidomidum.

RxNorm10432 ChEMBLCHEMBL468 ATCL04AX02UNII4Z8R6ORS6L

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(TM))(MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta Thalassemia: a Prospective 12 Months Study

Clinical trial2026-06-29Results expected Q2 2027 · ClinicalTrials.gov

GEMINI: Phase II Study Using Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors

Clinical trial2026-06-26Results expected Q2 2029 · ClinicalTrials.gov

Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease: A Prospective, Single-Arm, Multicenter, Open-Label Study

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Approval: Thalidomide Lipomed (EMA)

Regulatory2022-09-19EMA

Drug Safety Update: Thalidomide: reduced starting dose in patients older than age 75 years

Regulatory2015-12-14MHRA

Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma.

Research2015-06-02The New England journal of medicine

Drug Safety Update: Thalidomide: risk of arterial and venous thromboembolism

Regulatory2014-12-11MHRA

Drug Safety Update: Thalidomide: risk of second primary malignancies

Regulatory2014-12-11MHRA

Lenalidomide after stem-cell transplantation for multiple myeloma.

Research2012-05-01The New England journal of medicine

Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma.

Research2010-06-01Cancer

Thalidomide and rituximab in Waldenstrom macroglobulinemia.

Research2008-08-19Blood

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Thalidomide

Aliases & brands

3-PhthalimidoglutarimideN-PhthaloylglutamimideN-Phthalyl-glutaminsaeure-imidN-Phthalylglutamic acid imideTalidomidaThalomidalpha-(N-Phthalimido)glutarimidealpha-N-Phthalylglutaramide(+)-Thalidomide(+-)-Thalidomide(±)-thalidomide(+-)-N-(2,6-dioxo-3-Piperidyl)phthalimide(±)-N-(2,6-dioxo-3-piperidyl)phthalimide1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)isoindoline2,6-dioxo-3-phthalimidopiperidineN-(2,6-dioxo-3-piperidyl)phthalimideThalidomidum

RxNorm CUI

10432

ChEMBL ID

CHEMBL468

ATC codes

L04AX02

UNII

4Z8R6ORS6L

Primary mechanism

CRL4(CRBN) E3 ubiquitin ligase inhibitor

Regulatory jurisdictions

emamhra

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Protein cereblon

CRBN · Q96SW2

INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor

DNA damage-binding protein 1

DDB1 · Q16531

INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor

Cullin-4A

CUL4A · Q13619

INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor

E3 ubiquitin-protein ligase RBX1

RBX1 · P62877

INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2008-04-16

Latest approval

2022-09-19

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 2 events

2022-09-19Approval

Approval: Thalidomide Lipomed (EMA)

Indication: Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ? 65 years or ineligible… Show full indication

Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ? 65 years or ineligible for high dose chemotherapy. Thalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).

Evidence ↗

2008-04-16Approval

Approval: Thalidomide BMS (previously Thalidomide Celgene) (EMA)

Indication: Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose… Show full indication

Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 3 events

2015-12-14Safety communicationSafety

Drug Safety Update: Thalidomide: reduced starting dose in patients older than age 75 years

Evidence ↗

2014-12-11Safety communicationSafety

Drug Safety Update: Thalidomide: risk of second primary malignancies

Evidence ↗

2014-12-11Safety communicationSafety

Drug Safety Update: Thalidomide: risk of arterial and venous thromboembolism

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

195 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

195

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

123

Completed

Discontinued

PHASE DISTRIBUTIONn = 195

Early Phase 12Phase 112Phase 1 / 29Phase 2118Phase 2 / 35Phase 331Phase 47Phase N / A11

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial

CompletedPH IVBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladeshn=902026

A Comparative Study of Bortezomib-Thalidomide-Dexamethason and Bortezomib-Cyclophosphamide-Dexamethason in the Treatment of Monoclonal Immunoglobulin Light Chain Amyloidosis: A Prospective Randomized Controlled Trial（BTD-CHINA-TRIAL）

Unknown statusPH IVGuangdong Provincial People's Hospitaln=702023

EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial

CompletedPH IVInstitute of Hematology & Blood Diseases Hospital, Chinan=552020

The Efficacy of Thalidomide Plus Cyclophosphamide and Dexamethasone Following by Thalidomide and Prednisone Maintenance Therapy for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China

CompletedPH IVInstitute of Hematology & Blood Diseases Hospital, Chinan=442020

An Open-Label Phase IV Study of the Efficacy of Bortezomib-based Combination Therapy the Treatment of Subjects With Multiple Myeloma

Unknown statusPH IVShanghai General Hospital, Shanghai Jiao Tong University School of Medicinen=802018

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial

CompletedPH IVBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladeshn=902026

Safety and Efficacy of Immunomodulator Drug Thalidomide in Multi-transfused Thalassemia Patients: A Single Center Experience From South Punjab, Pakistan

CompletedN/AMuhammad Aamir Latifn=1212024

Safety & Efficacy of Thalidomide in Children With Transfusion Dependent Thalassemia: a Quasi Randomized Control Trial in a Tertiary Care Hospital in Bangladesh

CompletedPH IBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladeshn=602024

Anti-Angiogenic Therapy After Autologous Stem Cell Rescue (ASCR) for Pediatric Solid Tumors

CompletedPH IWashington University School of Medicinen=142023

A MULTIARM, OPEN LABEL, RANDOMIZED PHASE II STUDY OF MLN9708 PLUS ORAL DEXAMETHASONE or PLUS ORAL CYCLOPHOSPHAMIDE AND DEXAMETHASONE or PLUS ORAL THALIDOMIDE AND DEXAMETHASONE FOLLOWED BY MAINTENANCE WITH MLN9708 IN NEWLY DIAGNOSED ELDERLY MULTIPLE MYELOMA PATIENTS

CompletedPH IIMario Boccadoron=1752023

Deciphering Effects of Thalidomide on Red Blood Cells in Transfusion Dependents Beta Thalassemia Patients: A Pharmacodynamics and Pharmacogenetics Analysis

CompletedPH IIIBlood Care Clinicn=2002023

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20002015

Most influential

Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma.

The New England journal of medicine · 2015 · 1,019 cites

Lenalidomide after stem-cell transplantation for multiple myeloma.

The New England journal of medicine · 2012 · 808 cites

Activity of thalidomide in AIDS-related Kaposi's sarcoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2000 · 187 cites

Thalidomide and rituximab in Waldenstrom macroglobulinemia.

Blood · 2008 · 90 cites

Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma.

Cancer · 2010 · 39 cites

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications

Multiple Myeloma2

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Lenalidomide

Acts on the same molecular target as Thalidomide, with 2 overlapping disease areas.

4 shared targets2 shared diseases2 shared papers

Dexamethasone

Studied across the same disease area as Thalidomide in the shared literature.

1 shared disease1 shared paper

Elotuzumab

Studied across the same disease area as Thalidomide in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.