Primary completion· ClinicalTrials.gov
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Palazestrant History and Updates
15 events · 2021 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
0
FDA Approvals
0
Label Revisions
15
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-18Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Palazestrant since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
Primary completion· ClinicalTrials.gov
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Primary completion· ClinicalTrials.gov
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Past events
2026
Primary completion· ClinicalTrials.gov
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
2025
Trial started· ClinicalTrials.gov
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Trial registered· ClinicalTrials.gov
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Trial registered· ClinicalTrials.gov
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
2024
Trial started· ClinicalTrials.gov
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
2023
Trial started· ClinicalTrials.gov
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Trial registered· ClinicalTrials.gov
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
2022
Trial started· ClinicalTrials.gov
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Trial registered· ClinicalTrials.gov
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Trial registered· ClinicalTrials.gov
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
2021
Trial started· ClinicalTrials.gov
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
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.