Wednesday, July 8, 2026

Drug profile · INN

lenalidomide

lenalidomide (LENALIDE) 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 NMPA: clinical trials Antineoplastic and immunomodulating agents (L04) L04AX07
US status approved
Patents linked 4
Pipeline programs 65
News articles 0
Drug details — lenalidomide
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
4
Programs
65
Data quality
0.89

Quick answer

lenalidomide (LENALIDE) 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 lenalidomide
Brand LENALIDE
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 L04AX07

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
NMPA clinical trials

Pipeline programs

  1. 214828 Phase 3 · GSK Glaxo Smith · Multiple myeloma
  2. 54767414MMY3019 Phase 3 · Janssen-Cilag International N.V · Multiple Myeloma
  3. 64007957MMY3005 Phase 3 · Janssen-Cilag International N.V · Multiple Myeloma
  4. 68284528MMY3002 Phase 3 · Janssen-Cilag International N.V · Relapsed and Lenalidomide-Refractory Multiple Myeloma
  5. 68284528MMY3004 Phase 3 · Janssen-Cilag International N.V · Multiple Myeloma
  6. APHP240920 Phase 3 · PARItec · Cutaneous lupus erythematosus
  7. BB2121-MM-003 Phase 3 · Celgene · Multiple myeloma (MM) with at least 2 prior therapies includ
  8. CA073-1003 Phase 3 · Celgene · Relapsed/Refractory Follicular Lymphoma

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 11253591

    Combination of lenalidomide and polypeptide construct, and uses thereof

    Expires Mon Feb 17 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10342869

    Compositions comprising anti-CD38 antibodies and lenalidomide

    Expires Mon Jul 04 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10232041

    Combination of lenalidomide and polypeptide construct, and uses thereof

    Expires Mon Mar 14 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9636334

    Combination of lenalidomide and polypeptide construct, and uses thereof

    Expires Mon Apr 27 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is lenalidomide?

lenalidomide (LENALIDE) 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 lenalidomide?

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

What is the US approval status of lenalidomide?

lenalidomide 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.