Repotrectinib History and Updates

42 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 (2026-07-08)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-08Download 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)

2026

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Primary completion: NCT07599007
Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06552234
Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC

Past events

2026
Trial started· ClinicalTrials.gov
Trial started: NCT07599007
Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06140836
A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-po
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07223671
Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
2025
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07223671
Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06408168
Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negat
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06352528
A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05828277
A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06315010
REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis
2024
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06493409
A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06552234
Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06493409
A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06408168
Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negat
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06352528
A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
2023
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06140836
A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-po
2022
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05828277
A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients
2021
2020
2019
2017

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.