Wednesday, July 8, 2026

Drug profile · INN

lurbinectedin

lurbinectedin (ZEPZELCA) is a dna negative modulator. Associated with Jazz Pharmaceuticals Ireland Limited. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved EMA: unknown Antineoplastic and immunomodulating agents (L01) L01XX69
US status approved
Patents linked 0
Pipeline programs 14
News articles 0
Drug details — lurbinectedin
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INTRAVENOUS
Patents
0
Programs
14
Data quality
0.89

Quick answer

lurbinectedin (ZEPZELCA) is a dna negative modulator. Associated with Jazz Pharmaceuticals Ireland Limited. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN lurbinectedin
Brand ZEPZELCA
Mechanism DNA negative modulator
Target DNA
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INTRAVENOUS
Formulation POWDER
ATC code L01XX69

Mechanism of action

DNA negative modulator

Primary target: DNA

Approval history

Authority Status Date
FDA approved
EMA unknown

Pipeline programs

  1. GO43104 Phase 3 · HOFFMANN-LA ROCHE · Small-Cell Lung Cancer (SCLC)
  2. PM1183-C-008-21 Phase 3 · Anaxis Pharma · Small Cell Lung Cancer (SCLC)
  3. IRINOTECAN, lurbinectedin Phase 2 · Anaxis Pharma · Selected Advanced Solid Tumors
  4. Lurbinectedin Phase 2 · Jazz Pharmaceuticals Ireland · Small Cell Lung Cancer ( SCLC )
  5. Lurbinectedin Phase 2 · Jazz Pharmaceuticals Ireland · Ewing Sarcoma
  6. Lurbinectedin Phase 2 · Jazz Pharmaceuticals Ireland · Extensive-stage Small-cell Lung Cancer
  7. Lurbinectedin Phase 2 · Jazz Pharmaceuticals Ireland · Locally Advanced Soft Tissue Sarcoma
  8. Lurbinectedin Phase 2 · Jazz Pharmaceuticals Ireland · Refractory Ewing Sarcoma

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. acyclovir Human herpesvirus 1 DNA polymerase inhibitor
  3. acyclovir sodium Human herpesvirus 1 DNA polymerase inhibitor
  4. anagrelide Antineoplastic and immunomodulating agents (L01)
  5. apremilast Antineoplastic and immunomodulating agents (L04)
  6. arsenic trioxide Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is lurbinectedin?

lurbinectedin (ZEPZELCA) is a dna negative modulator. Associated with Jazz Pharmaceuticals Ireland Limited. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for lurbinectedin?

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

What is the US approval status of lurbinectedin?

lurbinectedin 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.