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Olema Pharmaceuticals (OLMA)
NASDAQ:OLMA
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
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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
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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
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Op-1250
Hormone Receptor Positive Breast Carcinoma, Her2-Negative Breast Cancer
Phase I/II
Completed
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
Jul 21, 2020
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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
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 (OLMA) have in its pipeline
OLMA is currently developing the following drugs: Letrozole, Ribociclib, Palazestrant, Fulvestrant, Palazestrant, Op-3136, Fulvestrant, Letrozole, Anastrozole, Exemestane, Palazestrant. These drug candidates are in various stages of clinical development as the company works toward FDA approval.