Wednesday, July 8, 2026

Drug profile · INN

thalidomide

thalidomide (THALOMID) is a crl4(crbn) e3 ubiquitin ligase inhibitor. Associated with Bristol-Myers Squibb Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L04) L04AX02
US status approved
Patents linked 5
Pipeline programs 12
News articles 0
Drug details — thalidomide
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
5
Programs
12
Data quality
0.84

Quick answer

thalidomide (THALOMID) is a crl4(crbn) e3 ubiquitin ligase inhibitor. Associated with Bristol-Myers Squibb Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN thalidomide
Brand THALOMID
Mechanism CRL4(CRBN) E3 ubiquitin ligase inhibitor
Target CRL4(CRBN) E3 ubiquitin ligase
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation CAPSULE
ATC code L04AX02

Mechanism of action

CRL4(CRBN) E3 ubiquitin ligase inhibitor

Primary target: CRL4(CRBN) E3 ubiquitin ligase

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. HM16/047 Phase 3 · Takeda · Multiple Myeloma
  2. Thalidomide Phase 3 · Celgene · Multiple Myeloma
  3. Thalidomide Phase 3 · United Therapeutics Europe · Prostate Cancer
  4. Two Anti-angiogenesis Drugs(Endostar and Thalidomide) Phase 3 · First People's Hospital · Colorectal Neoplasms
  5. glutamine combined with thalidomide Phase 3 · Chinese Academy of · Mucositis Oral
  6. Luspatercept combined with low-dose thalidomide Phase 2 · First People's Hospital · Transfusion-dependent β-thalassemia Patients
  7. Thalidomide and methotrexate Phase 2 · Chinese Academy of · T-LGL Leukemia
  8. placebo Phase 2 · First People's Hospital · COVID-19 Thalidomide

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 10836721

    Thalidomide analogs and methods of use

    Expires Mon Nov 12 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10730835

    Thalidomide analogs and methods of use

    Expires Mon Jul 30 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 8716315

    Analogs of thalidomide as potential angiogenesis inhibitors

    Expires Mon May 01 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 7973057

    Thalidomide analogs

    Expires Mon Jun 30 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 7320991

    Analogs of thalidomide as potential angiogenesis inhibitors

    Expires Mon Jan 17 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is thalidomide?

thalidomide (THALOMID) is a crl4(crbn) e3 ubiquitin ligase inhibitor. Associated with Bristol-Myers Squibb Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for thalidomide?

THALOMID is a marketed brand name for thalidomide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of thalidomide?

thalidomide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.