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PIK3CA Mutation

3
Pipeline Programs
1
Companies
3
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
0
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

1 companies ranked by most advanced pipeline stage

Relay Therapeutics
Relay TherapeuticsMA - Cambridge
3 programs
2
1
RLY-2608Phase 31 trial
RLY-2608Phase 11 trial
RLY-5836Phase 11 trial
Active Trials
NCT05216432Recruiting930Est. Apr 2027
NCT05759949Completed41Est. Apr 2025
NCT06982521Recruiting540Est. Dec 2031

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Relay TherapeuticsRLY-2608
Relay TherapeuticsRLY-5836
Relay TherapeuticsRLY-2608

Clinical Trials (3)

Total enrollment: 1,511 patients across 3 trials

NCT06982521Relay TherapeuticsRLY-2608

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

Start: Aug 2025Est. completion: Dec 2031540 patients
Phase 3Recruiting
NCT05759949Relay TherapeuticsRLY-5836

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Start: Mar 2023Est. completion: Apr 202541 patients
Phase 1Completed
NCT05216432Relay TherapeuticsRLY-2608

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

Start: Dec 2021Est. completion: Apr 2027930 patients
Phase 1Recruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 1,511 patients
1 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.