{"entity":{"id":"serabelisib","kind":"drug","name":"Serabelisib","aka":[],"tldr":"Serabelisib is an experimental small-molecule drug from Faeth Therapeutics in phase 2 trials for HR-positive / HER2-negative breast cancer and endometrial cancer, aimed at PIK3CA / PI3K-alpha.","summary":"Serabelisib (FTH-001, MLN1117) is a small-molecule drug developed by Faeth Therapeutics. Its target is PIK3CA / PI3K-alpha. ClinicalTrials.gov describes the intervention as: Serabelisib is a selective, small molecule inhibitor of PI3Kα. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, in HR-positive / HER2-negative breast cancer and endometrial cancer. The largest, NCT06463028, plans to enrol 40 participants with primary completion expected 2028-09. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-2","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of Serabelisib","url":"https://clinicaltrials.gov/search?intr=FTH-001"},{"label":"Sponsor page","url":"https://www.faeththerapeutics.com"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","endometrial"],"sections":[],"technologies":[],"targets":["pik3ca"],"drugs":[],"companies":["takeda","celcuity"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06463028","nct07558733"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"FTH-001, MLN1117","modality":"small molecule","mechanism":"Small-molecule drug directed at PIK3CA / PI3K-alpha, as stated in the ClinicalTrials.gov intervention record; the detailed mechanism is not stated.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/serabelisib/","neighbours":{"cancer":[{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"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":"celcuity","kind":"company","name":"Celcuity","route":"/companies/celcuity/"},{"id":"takeda","kind":"company","name":"Takeda","route":"/companies/takeda/"}],"trial":[{"id":"nct07558733","kind":"trial","name":"Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer","route":"/trials/nct07558733/"},{"id":"nct06463028","kind":"trial","name":"Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial ","route":"/trials/nct06463028/"}]}}