Palazestrant
Olema Pharmaceuticals, Inc. OLMA · Breast Cancer; ER Positive Breast Cancer; HER2 Negative Breast Carcinoma; Metastatic Breast Cancer; Advanced Breast Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Olema Pharmaceuticals, Inc. OLMA Source: Company record for Olema Pharmaceuticals, Inc. (opens in a new tab)
- Indications
- Breast Cancer; ER Positive Breast Cancer; HER2 Negative Breast Carcinoma; Metastatic Breast Cancer; Advanced Breast Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 16 Nov 20232 linked trials
- Filed Not yet
- Approved Not yet
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 Palazestrant. Editors add each one with its source.
Filed application
No filed application is on record for Palazestrant. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Palazestrant.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07085767ClinicalTrials.gov record for NCT07085767 (opens in a new tab)OPERA-02 | Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer | Phase 3 | Recruiting | 1,000 (estimated) | Dec 2028 (estimated) | No |
| NCT06016738ClinicalTrials.gov record for NCT06016738 (opens in a new tab)OPERA-01 | OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer | Phase 3 | Active, not recruiting | 510 (estimated) | 31 Oct 2026 (estimated) | No |
Publications listing OPERA-01 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
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
No FDA approvals on record for this drug.
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)
EMA's medicines data lists no human medicine with the same active substance as Palazestrant.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT07085767 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06016738 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.