{"entity":{"id":"zovegalisib","kind":"drug","name":"Zovegalisib","aka":[],"tldr":"Zovegalisib is an experimental small-molecule drug from Relay Therapeutics in phase 3 trials for HR-positive / HER2-negative breast cancer, aimed at PIK3CA / PI3K-alpha.","summary":"Zovegalisib is a small-molecule drug developed by Relay Therapeutics. Its target is PIK3CA / PI3K-alpha (the sponsor names PI3Kα (mutant-selective)). The sponsor states: Described as the first allosteric, pan-mutant (including kinase-domain mutations such as H1047X and helical-domain mutations such as E542X/E545X) and isoform-selective PI3Kα inhibitor, designed using cryo-EM structural analysis and molecular dynamics simulations to differentiate mutant from wild-type PI3Kα. ClinicalTrials.gov describes the intervention as: 400 mg orally BID administered daily on a 28-day treatment cycle. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT06982521 (Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer), in HR-positive / HER2-negative breast cancer. The largest, NCT06982521, plans to enrol 540 participants with primary completion expected 2028-04-30. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of Zovegalisib","url":"https://clinicaltrials.gov/search?intr=Zovegalisib"},{"label":"Sponsor pipeline page","url":"https://relaytx.com/pipeline/"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":["pik3ca"],"drugs":[],"companies":["relay-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06982521"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"small molecule","mechanism":"Described as the first allosteric, pan-mutant (including kinase-domain mutations such as H1047X and helical-domain mutations such as E542X/E545X) and isoform-selective PI3Kα inhibitor, designed using cryo-EM structural analysis and molecular dynamics simulations to differentiate mutant from wild-type PI3Kα.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/zovegalisib/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"target":[{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","route":"/targets/pik3ca/"}],"company":[{"id":"relay-therapeutics","kind":"company","name":"Relay Therapeutics","route":"/companies/relay-therapeutics/"}],"trial":[{"id":"nct06982521","kind":"trial","name":"Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer","route":"/trials/nct06982521/"}]}}