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Olema Pharmaceuticals (OLMA) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Letrozole, Ribociclib, Palazestrant | Breast Cancer, Metastatic Breast Cancer, Her2 Negative Breast Carcinoma, Er Positive Breast Cancer, Locally Advanced Breast Cancer | Phase III | Not Yet Recruiting | Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer | Jul 08, 2025 | ― |
| Fulvestrant, Palazestrant, Op-3136 | Metastatic Breast Cancer, Advanced Or Metastatic Er+ Her2- Breast Cancer (Mbc), Advanced Or Metastatic Non-Small Cell Lung Cancer (Nsclc), Advanced Or Metastatic Castration-Resistant Prostate Cancer (Mcrpc), Fulvestrant, Palazestrant | Phase I | Recruiting | Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors | Jan 14, 2025 | ― |
| Fulvestrant, Letrozole, Anastrozole, Exemestane, Palazestrant | Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Her2 Negative Breast Carcinoma, Er Positive Breast Cancer | Phase III | Recruiting | OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer | Aug 17, 2023 | ― |
| Op-1250 | Hormone Receptor Positive Breast Carcinoma, Her2-Negative Breast Cancer | phase1AndPhase2 | Completed | A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer | Jul 21, 2020 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Letrozole, Ribociclib, Palazestrant | Phase III | Breast Cancer, Metastatic Breast Cancer, Her2 Negative Breast Carcinoma, Er Positive Breast Cancer, Locally Advanced Breast Cancer | Not Yet Recruiting | Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer | Jul 08, 2025 | ― |
| Fulvestrant, Palazestrant, Op-3136 | Phase I | Metastatic Breast Cancer, Advanced Or Metastatic Er+ Her2- Breast Cancer (Mbc), Advanced Or Metastatic Non-Small Cell Lung Cancer (Nsclc), Advanced Or Metastatic Castration-Resistant Prostate Cancer (Mcrpc), Fulvestrant, Palazestrant | Recruiting | Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors | Jan 14, 2025 | ― |
| Fulvestrant, Letrozole, Anastrozole, Exemestane, Palazestrant | Phase III | Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Her2 Negative Breast Carcinoma, Er Positive Breast Cancer | Recruiting | OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer | Aug 17, 2023 | ― |
| Op-1250 | phase1AndPhase2 | Hormone Receptor Positive Breast Carcinoma, Her2-Negative Breast Cancer | Completed | A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer | Jul 21, 2020 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Olema Pharmaceuticals, Inc. (OLMA) have in its pipeline
Olema Pharmaceuticals OLMA is currently developing the following drugs: Letrozole, Ribociclib, Palazestrant, Fulvestrant, Palazestrant, Op-3136, Fulvestrant, Letrozole, Anastrozole, Exemestane, Palazestrant, Op-1250. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
