{"entity":{"id":"eganelisib","kind":"drug","name":"Eganelisib","aka":["IPI-549"],"tldr":"Eganelisib is an experimental oral small-molecule kinase inhibitor from Stelexis BioSciences, in phase 2 trials for acute myeloid leukaemia, higher-risk myelodysplastic syndromes and chronic myelomonocytic leukaemia and other cancers.","summary":"Eganelisib (IPI-549) is an oral small-molecule kinase inhibitor from Stelexis BioSciences, with Infinity Pharmaceuticals as partner. An oral inhibitor of the enzyme PI3K-gamma, whose catalytic subunit is encoded by PIK3CG. Its furthest stage is phase 2, for acute myeloid leukaemia, higher-risk myelodysplastic syndromes, chronic myelomonocytic leukaemia and urothelial carcinoma (earlier Infinity trials). ClinicalTrials.gov registers it in 4 studies linked below. Highest stage reached is phase 2 under Infinity Pharmaceuticals (e.g. MARIO-275 in urothelial carcinoma, NCT03980041, completed). Under Stelexis: phase 1b in relapsed/refractory AML and higher-risk MDS recruiting (NCT06533761); investigator-sponsored GAVEL phase 1 with azacitidine and venetoclax in AML recruiting (NCT07439211, Stelexis collaborator). Company plans a first-line azacitidine + eganelisib study in PI3K-gamma-high HR-MDS starting 2H26. Whether it works in people has not been established unless a trial below reports it.","status":"phase-2","asOf":"2026-11-03","links":[{"label":"Stelexis BioSciences: stelexis.com","url":"https://stelexis.com/pipeline/"},{"label":"Stelexis BioSciences: clinicaltrials.gov","url":"https://clinicaltrials.gov/study/NCT06533761"},{"label":"Stelexis BioSciences: clinicaltrials.gov","url":"https://clinicaltrials.gov/study/NCT07439211"},{"label":"Stelexis BioSciences: clinicaltrials.gov","url":"https://clinicaltrials.gov/study/NCT03980041"},{"label":"ClinicalTrials.gov: trials of eganelisib","url":"https://clinicaltrials.gov/search?intr=eganelisib"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","mds-higher-risk","cmml","urothelial","tnbc","head-and-neck"],"sections":[],"technologies":[],"targets":["pik3cg"],"drugs":[],"companies":["stelexis-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06533761","nct07439211","nct03980041","nct02637531"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"eganelisib","modality":"Oral small-molecule kinase inhibitor","mechanism":"An oral inhibitor of the enzyme PI3K-gamma, whose catalytic subunit is encoded by PIK3CG.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/eganelisib/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"cmml","kind":"cancer","name":"Chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms","route":"/cancers/cmml/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"mds-higher-risk","kind":"cancer","name":"Higher-risk myelodysplastic syndromes","route":"/cancers/mds-higher-risk/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"pik3cg","kind":"target","name":"PIK3CG","route":"/targets/pik3cg/"}],"company":[{"id":"stelexis-biosciences","kind":"company","name":"Stelexis BioSciences","route":"/companies/stelexis-biosciences/"}],"trial":[{"id":"nct02637531","kind":"trial","name":"A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549","route":"/trials/nct02637531/"},{"id":"nct07439211","kind":"trial","name":"Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia","route":"/trials/nct07439211/"},{"id":"nct06533761","kind":"trial","name":"Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS","route":"/trials/nct06533761/"},{"id":"nct03980041","kind":"trial","name":"Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)","route":"/trials/nct03980041/"}]}}