Repotrectinib History and Updates

0 events · 2017 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

2
FDA Approvals
0
Label Revisions
40
Trial Milestones
0
Pivotal Publications
Repotrectinib — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2017201820192020202120222023202420252026202720282029203020312032Trial: NCT07599007 2026-05-24 → 2027-12-30 (primary completion)Trial: NCT07223671 2025-12-31 → 2026-02-19 (primary completion)Trial: NCT06315010 2025-06-27 → 2027-03-31 (primary completion)Trial: NCT06552234 2024-10-01 → 2031-09-30 (primary completion)Trial: NCT06493409 2024-08-26 → 2024-12-07 (primary completion)Trial: NCT06408168 2024-08-08 → 2025-12-08 (primary completion)Trial: NCT06352528 2024-04-29 → 2025-09-16 (primary completion)Trial: NCT06140836 2023-12-21 → 2026-03-13 (primary completion)Trial: NCT05828277 2022-07-28 → 2025-08-31 (primary completion)Trial: NCT04772235 2022-02-11 → 2026-04-30 (primary completion)Trial: NCT05004116 2021-08-09 → 2028-08-31 (primary completion)Trial: NCT04094610 2020-03-12 → 2026-09-30 (primary completion)Trial: NCT03093116 2017-03-07 → 2028-02-29 (primary completion)FDA approval — 2023-11-15 FDA approved Augtyro (repotrectinib) (NDA 218213) Sponsor: BRISTOL. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2024-06-13 FDA approved supplemental application for Augtyro (repotrectinib) — Efficacy (NDA 218213 S-1) Sponsor: BRISTOL. Class: Efficacy.today (2026-06-17)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-17Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Repotrectinib since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (1)

Past events

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.