Product Description
OP-1250 is a small molecule Complete Estrogen Receptor ANtagonist (CERAN). OP-1250 potently competes with the endogenous activating estrogenic ligand 17-beta estradiol for binding in the ligand binding pocket. OP-1250 blocks estrogen-driven transcriptional activity, inhibits estrogen-driven breast cancer cell growth, and induces degradation of the estrogen receptor.
Mechanisms of Action: ER Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Breast Cancer|Oncology Solid Tumor Unspecified *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Olema Pharmaceuticals
Company Location: SAN FRANCISCO CA 94107
Company CEO: Sean Bohen
Additional Commercial Interests: Aurigene Discovery Technologies
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Korea, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Spain, Taiwan, Thailand, United Kingdom, United States
Active Clinical Trial Count: 7
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Olema Pharmaceuticals announced they will present P3 Breast Cancer results on 2025-12-12 for Palazestrant
- Clinical Outcomes Reported - Olema Pharmaceuticals presented P3 Breast Cancer results on 2025-06-02 for Palazestrant
- Clinical Outcomes Reported - Olema Pharmaceuticals presented P0 Breast Cancer results on 2025-04-28 for Palazestrant
Highest Development Phases
Phase 3: Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| OPERA-01 | P3 |
Recruiting |
Breast Cancer |
2026-06-30 |
12% |
2025-05-29 |
Primary Endpoints|Treatments|Trial Status |
| OP-1250-002 | P1 |
Active, not recruiting |
Breast Cancer |
2025-01-01 |
4% |
2024-06-07 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| ACTRN12621001419853 | P1 |
Recruiting |
Breast Cancer |
2022-12-31 |
2025-11-03 |
Treatments |
|
| OP-1250-003 | P1 |
Recruiting |
Breast Cancer |
2027-12-31 |
50% |
2025-10-23 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| OPERA-02 | P3 |
Not yet recruiting |
Breast Cancer |
2028-12-01 |
27% |
2025-07-26 |
Primary Endpoints |
| OP-1250-301 | P3 |
Recruiting |
Breast Cancer |
2027-11-30 |
2025-05-02 |
Treatments |
|
| OP-1250-001 | P2 |
Completed |
Breast Cancer |
2024-07-30 |
37% |
2025-08-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/03/2025 |
News Article |
Olema Oncology to Participate in Upcoming Investor Conferences |
|
10/30/2025 |
News Article |
Olema Oncology to Present Trial-in-Progress Poster for Phase 3 OPERA-02 Trial of Palazestrant Plus Ribociclib at SABCS 2025 |
|
10/02/2025 |
News Article |
Olema Oncology Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) |
|
09/03/2025 |
News Article |
Olema Oncology Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) |