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Relay Therapeutics (RLAY)
NASDAQ:RLAY
Fulvestrant, Capivasertib, Rly-2608
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Positive Tumor, Pik3ca Mutation, Her2- Negative Breast Cancer
Phase III
Recruiting
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
May 08, 2025
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Rly-2608
Pik3ca Mutation, Pik3ca-Related Overgrowth Spectrum (Pros), Lymphatic Malformations, Vascular Malformations, Cloves Syndrome, Klippel Trenaunay Syndrome, Megalencephaly-Capillary Malformation Polymicrogyria Syndrome (Mcap)
Phase II
Recruiting
A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation
Jan 17, 2025
Abemaciclib, Ribociclib, Palbociclib, Fulvestrant, Rly-5836
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Positive Tumor, Solid Tumor, Adult, Unresectable Solid Tumor, Her2-Negative Breast Cancer, Pik3ca Mutation
Phase I
Completed
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
Jan 23, 2023
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Fulvestrant, Rly-2608, Palbociclib 125Mg, Ribociclib 400Mg, Ribociclib 600Mg, Pf-07220060 100Mg, Pf-07220060 300 Mg
Endometrial Cancer, Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Solid Tumor, Adult, Unresectable Solid Tumor, Her2-Negative Breast Cancer, Pik3ca Mutation
Phase I
Recruiting
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer
Dec 20, 2021
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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 Relay Therapeutics (RLAY) have in its pipeline
RLAY is currently developing the following drugs: Fulvestrant, Capivasertib, Rly-2608, Rly-2608, Abemaciclib, Ribociclib, Palbociclib, Fulvestrant, Rly-5836. These drug candidates are in various stages of clinical development as the company works toward FDA approval.