Repotrectinib
Also known as Augtyro
BRISTOL MYERS SQUIBB CO BMY CELG-RI · Carcinoma, Non-Small-Cell Lung
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
NDA218213,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- BRISTOL MYERS SQUIBB CO BMY CELG-RI Source: Company record for BRISTOL MYERS SQUIBB CO (opens in a new tab)
- Indication
- Carcinoma, Non-Small-Cell Lung Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 218213 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 218213 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 21 Dec 20231 linked trial
- Filed Completed
- Approved Current stageFirst approval 15 Nov 2023
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Repotrectinib. Editors add each one with its source.
Filed application
No filed application is on record for Repotrectinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Repotrectinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06140836ClinicalTrials.gov record for NCT06140836 (opens in a new tab) | A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) | Phase 3 | Active, not recruiting | 190 (estimated) | 16 Feb 2027 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA218213Action letter for NDA218213 (opens in a new tab) | Supplement 1 Efficacy | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA218213Action letter for NDA218213 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
AuthorisedConditional
Augtyro (EMEA/H/C/006005)
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung;Cancer
- Marketing authorisation holder
- Bristol-Myers Squibb Pharma EEIG
- Active substance (INN)
- repotrectinib
- ATC code
- L01EX28
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Augtyro (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 218213 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06140836 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA218213 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.