Drugs / RLY-2608
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05216432 | Dec 2021 → Apr 2027 expected | Her2-receptor negative breast cancer, PIK3CA-related overgrowth spectrum | Relay Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06789913 | Jun 2025 → Jul 2031 expected | CLOVES syndrome, angioosteohypertrophic syndrome, lymphatic malformation, megalencephaly-capillary malformation-polymicrogyria syndrome +1 | Relay Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06982521 | Aug 2025 → Apr 2028 expected | hormone receptor-positive breast cancer | Relay Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-08-06 | Relay Therapeutics, Inc. | Results Relay Therapeutics Reports Second Quarter 2026 Financial Results and Corporate Updates relaytx.com ↗
In the Part 1 dose randomization portion of the study for adults and adolescents ages 12 and up, 60% of patients achieved a volumetric response at the earliest time point (12 weeks) |
| 2026-05-19 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Initial Clinical Data Demonstrating That Zovegalisib Has Potential for Differentiated Safety and Efficacy in Patients with PIK3CA-Driven Vascular Anomalies relaytx.com ↗ |
| 2026-04-27 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Clinical Data for Zovegalisib plus Atirmociclib Triplet Combination Supportive of Further Development in Frontline Metastatic Breast Cancer relaytx.com ↗ |
| 2026-03-16 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Data from Zovegalisib + Fulvestrant at the Phase 3 Dose of 400mg BID Fed at ESMO Targeted Anticancer Therapies Congress 2026 relaytx.com ↗
“As supported by the data presented, the 400mg BID fed regimen maintains robust efficacy with a safety profile consistent with mutant-selective PI3Kα inhibition,” said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. |
| 2026-02-03 | Relay Therapeutics, Inc. | Regulatory Relay Therapeutics Announces Zovegalisib Granted Breakthrough Therapy Designation by U.S. FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer relaytx.com ↗
This Breakthrough Therapy designation underscores the FDA’s recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date. |
| 2025-12-12 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Efficacy Subset Analysis of Zovegalisib (RLY-2608) + Fulvestrant in Breast Cancer Patients Pre-Treated with SERD or with ESR1 Mutations at SABCS 2025 relaytx.com ↗ |
| 2025-06-02 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Updated Data for RLY-2608 + Fulvestrant Further Demonstrating Clinically Meaningful Progression Free Survival at ASCO 2025 relaytx.com ↗
They show a median progression free survival (PFS) of 11.0 months in second line (2L) patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer who received RLY-2608 600mg twice daily (BID) + fulvestrant. |
| 2024-12-11 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Updated Interim Data for RLY-2608 + Fulvestrant Demonstrating Continued Maturation of Clinically Meaningful Progression Free Survival relaytx.com ↗
New interim data show 11.4-month median PFS in 2L patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer at RP2D |
| 2024-09-09 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Positive Interim Data for RLY-2608 Demonstrating Clinically Meaningful Progression Free Survival relaytx.com ↗
The data showed that despite heavy pre-treatment, patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer who received RLY-2608 600mg BID + fulvestrant demonstrated clinically meaningful progression free survival (PFS). |
| 2023-08-08 | Relay Therapeutics, Inc. | Results Relay Therapeutics Reports Second Quarter 2023 Financial Results and Corporate Highlights relaytx.com ↗
Updated RLY-2608 600mg BID + fulvestrant data: interim clinical benefit rate of 86% (6 of 7 evaluable patients) & 1 of 5 patients with measurable disease achieved a partial response |
| 2023-04-18 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Initial Clinical Data Demonstrating that RLY-2608 Selectively Targets Multiple PI3Kα Mutations relaytx.com ↗
Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today announced initial clinical data for RLY-2608, the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα. |
| 2021-10-07 | Relay Therapeutics, Inc. | Results Relay Therapeutics Announces Preclinical Data that Support RLY-2608 as the First Known Allosteric Pan-Mutant Selective Inhibitor of PI3Kα relaytx.com ↗
The data presented at the conference show that in preclinical models, RLY-2608 preferentially binds mutant PI3Kα at a novel allosteric site discovered by the Dynamo™ platform. |
All press releases naming this drug 20 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RLY-2608 | “RLY-2608 (zovegalisib)” NCT06982521 ↗ |
| Known as | zovegalisib | “This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (RLY-2608), in adults and children with PIK3CA...” NCT06789913 ↗ |
| Action | Inhibit | “PI3Kα inhibitor” NCT05216432 ↗ |
| Modality | Small molecule | — CHEMBL6068523 ↗ |
| Route | Oral | “Multiple doses of RLY-2608 for oral administration.” NCT05216432 ↗ |