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Repotrectinib · Augtyro, BMS-986472

Small molecule · Inhibitor of ROS1, TRKA (NTRK1) and TRKB (NTRK2) · developed by Bristol

Approved FDA, Nov 2023

BMY Developer

1 Registered trials

What is Repotrectinib?

Repotrectinib is a kinase inhibitor of ROS1 and the tropomyosin receptor tyrosine kinases TRKA, TRKB, and TRKC. It inhibits cell proliferation driven by ROS1 and NTRK fusion proteins and mutations.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Augtyro, BMS-986472, TPX-0005
Drug type: Small molecule
Targets: ROS1, TRKA (NTRK1), TRKB (NTRK2), TRKC (NTRK3)
Mechanism: Inhibitor of ROS1, TRKA (NTRK1) and TRKB (NTRK2)
Pathways: cell proliferation, receptor tyrosine kinase signaling
Therapy area: Oncology
Developer: Bristol (BMY)
FDA status: Approved as Augtyro (November 15, 2023), NDA218213 · FDA label
UNII: 08O3FQ4UNP

✅ FDA-approved uses

ROS1-positive non-small cell lung cancer
NTRK gene fusion-positive solid tumors

From the indications section of the FDA label (version of Jun 13, 2024). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06140836	Phase 3	Carcinoma, Non-Small-Cell Lung	Active not recruiting	BMY

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Carcinoma, Non-Small-Cell Lung

Other drugs acting on ROS1 / NTRK1 / NTRK2 / NTRK3

Taletrectinib FDA approved Zidesamtinib FDA approved APG-2449 Phase 1 Milciclib Phase 2

More from Bristol

Apixaban FDA approved Belatacept FDA approved Deucravacitinib FDA approved Ipilimumab FDA approved Lisocabtagene Maraleucel FDA approved Luspatercept FDA approved Mavacamten FDA approved Nab-paclitaxel FDA approved Nivolumab FDA approved Ozanimod FDA approved Relatlimab FDA approved Xanomeline FDA approved

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the BMY page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z