Wednesday, July 8, 2026

Drug profile · INN

sotorasib

sotorasib (LUMYKRAS) is a gtpase kras inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Antineoplastic and immunomodulating agents (L01) L01XX73
US status approved
Patents linked 0
Pipeline programs 14
News articles 6
Congress events 1
Drug details — sotorasib

Quick answer

sotorasib (LUMYKRAS) is a gtpase kras inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN sotorasib
Brand LUMYKRAS
Mechanism GTPase KRas inhibitor
Target GTPase KRas
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01XX73

Mechanism of action

GTPase KRas inhibitor

Primary target: GTPase KRas

Approval history

Authority Status Date
FDA approved
EMA approved

Recent coverage

Congress & event coverage

  • Presentation
    ASCO 2026

    1 presentation · oncology

Pipeline programs

  1. 20190009 Phase 3 · Amgen · Previously treated locally advanced and unresectable or meta
  2. 20190172 Phase 3 · Amgen · Colorectal Cancer (CRC)
  3. 20210081 Phase 3 · Amgen · Colorectal Cancer (CRC)
  4. BO45217 Phase 3 · HOFFMANN-LA ROCHE · KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lun
  5. 3134003 Phase 2 · Orion Laboratories Pty · Neoplasms benign malignant and unspecified (incl. cysts and
  6. DCC-3116-01-001 Phase 2 · Anaxis Pharma · Non-Small Cell Lung Cancer, Metastatic Solid Tumor, Advanced
  7. ENGIC 01-COLOSOTO Phase 2 · CERo Therapeutics · colorectal cancer
  8. LUMYKRAS 120 mg film-coated tablets Phase 2 · George Institute for · locally-advanced and unresectable or metastatic NSCLC with K

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)

Frequently asked questions

What is sotorasib?

sotorasib (LUMYKRAS) is a gtpase kras inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for sotorasib?

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

What is the US approval status of sotorasib?

sotorasib 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.