RLY-2608

Phase 2Small molecule

RLY-2608 is one of 31 small molecule programs targeting PIK3CA-related Overgrowth Spectrum (PROS). It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerRecruiting

Recruiting

Breast CancerPhase 1

Recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Lexiscan

Astellas

Preclinical

1 2

Voltaren

Novartis

Preclinical

1 3

RLY-2608

Relay Therapeutics

Phase 2

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 5

Tricor

JJagotec

Preclinical

1 6

Ablavar

LLantheus Medical Imaging

Preclinical

2 7

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 8

4SCAR T Cells

SShenzhen Geno-Immune Medical Institute

Preclinical

1 9

Tc99m Sestamibi

MM.D. Anderson Cancer Center

Preclinical

1 10

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Recruiting

Breast Cancer

NCT05216432

Q4 2031

Phase 2Recruiting

PIK3CA-Related Overgrowth Spectrum (PROS)

NCT06789913

Phase 3Recruiting

PIK3CA Mutation

NCT06982521

Clinical

Trials by Indication[1]

Breast Cancer1 trial

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

Recruiting· Relay Therapeutics logo

Relay Therapeutics·Phase 1·NCT05216432·930 enrolled

PIK3CA Mutation1 trial

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor

Recruiting· Relay Therapeutics logo

Relay Therapeutics·Phase 3·NCT06982521·540 enrolled

PIK3CA-related Overgrowth Spectrum (PROS)1 trial

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

Recruiting· Relay Therapeutics logo

Relay Therapeutics·Phase 2·NCT06789913·277 enrolled

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for RLY-2608. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — RLY-2608 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for RLY-2608. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Relay Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Relay Therapeutics

RLY-2608

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2031

Trials by Indication[1]

Breast Cancer1 trial

PIK3CA Mutation1 trial

PIK3CA-related Overgrowth Spectrum (PROS)1 trial

References

Drug Info

Quick Facts

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