Wednesday, July 8, 2026

Drug profile · INN

repotrectinib

repotrectinib (AUGTYRO) is a cd74-ros1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EX28
US status approved
Patents linked 19
Pipeline programs 6
News articles 3
Drug details — repotrectinib

Quick answer

repotrectinib (AUGTYRO) is a cd74-ros1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN repotrectinib
Brand AUGTYRO
Mechanism CD74-ROS1 inhibitor
Target CD74-ROS1
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01EX28

Mechanism of action

CD74-ROS1 inhibitor

Primary target: CD74-ROS1

Approval history

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

Recent coverage

Pipeline programs

  1. CA127-1030 Phase 3 · Bristol-Myers Squibb Australia · Non small cell lung cancer (NSCLC)
  2. Repotrectinib Phase 3 · Bristol Myers Squibb · Carcinoma, Non-Small-Cell Lung
  3. Repotrectinib (TPX-0005) Phase 2 · Turn Therapeutics · Advanced Solid Tumors
  4. TPX-0005-07 Phase 2 · Turn Therapeutics · Advanced solid tumors
  5. CA127-1027 Phase 1 · Bristol-Myers Squibb Australia · Non-small Cell Lung Cancer (NSCLC)
  6. IOR-BMS-IST-002 Phase 1 · George Institute for · Non-small cell lung cancer (NSCLC)

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)

Related patents

  1. US 12310968

    Chiral diaryl macrocycles and uses thereof

    Expires Mon May 22 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12187739

    Diaryl macrocycle polymorph

    Expires Mon Jan 02 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11981684

    Macrocyclic compounds and uses thereof

    Expires Mon May 09 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11634433

    Macrocycles for use in treating disease

    Expires Mon Apr 20 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11590184

    Oncolytic rhabdovirus expressing IL12

    Expires Mon Feb 23 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11452725

    Chiral diaryl macrocycles and uses thereof

    Expires Mon Sep 22 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11286265

    Macrocyclic compounds for treating disease

    Expires Mon Mar 24 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11286264

    Macrocyclic compounds and uses thereof

    Expires Mon Mar 24 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11155563

    Macrocyclic compounds and uses thereof

    Expires Mon Oct 21 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11142533

    Macrocycles for use in treating disease

    Expires Mon Oct 07 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 11008337

    Chiral diaryl macrocycles as modulators of protein kinases

    Expires Mon May 13 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 10745416

    Macrocyclic compounds for treating disease

    Expires Mon Aug 13 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 10604741

    Compositions and methods for enhancing virus replication

    Expires Mon Mar 26 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 10603351

    Engineered synergistic oncolytic viral symbiosis

    Expires Mon Mar 26 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 10066214

    Compositions and methods for enhancing virus replication

    Expires Mon Aug 30 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 9896664

    Oncolytic rhabdovirus

    Expires Mon Feb 15 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 9572883

    Oncolytic rhabdovirus

    Expires Mon Feb 16 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 7073512

    Adhesion prevention and an endoscopic insufflation system therefor

    Expires Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 6428500

    Adhesion prevention and an endoscopic insufflation system therefor

    Expires Mon Aug 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is repotrectinib?

repotrectinib (AUGTYRO) is a cd74-ros1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for repotrectinib?

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

What is the US approval status of repotrectinib?

repotrectinib 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.