# Eganelisib

Source: https://onco.cc/drugs/eganelisib/  
OnCo record `eganelisib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-11-03
- Also known as: IPI-549
- Tags: pipeline; ctgov-ingest
- Code: eganelisib
- Modality: Oral small-molecule kinase inhibitor
- Mechanism: An oral inhibitor of the enzyme PI3K-gamma, whose catalytic subunit is encoded by PIK3CG.

## Sources

- Stelexis BioSciences: stelexis.com: https://stelexis.com/pipeline/
- Stelexis BioSciences: clinicaltrials.gov: https://clinicaltrials.gov/study/NCT06533761
- Stelexis BioSciences: clinicaltrials.gov: https://clinicaltrials.gov/study/NCT07439211
- Stelexis BioSciences: clinicaltrials.gov: https://clinicaltrials.gov/study/NCT03980041
- ClinicalTrials.gov: trials of eganelisib: https://clinicaltrials.gov/search?intr=eganelisib

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms](https://onco.cc/cancers/cmml/), [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Higher-risk myelodysplastic syndromes](https://onco.cc/cancers/mds-higher-risk/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- targets: [PIK3CG](https://onco.cc/targets/pik3cg/)
- companies: [Stelexis BioSciences](https://onco.cc/companies/stelexis-biosciences/)
- trials: [A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549](https://onco.cc/trials/nct02637531/), [Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia](https://onco.cc/trials/nct07439211/), [Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS](https://onco.cc/trials/nct06533761/), [Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)](https://onco.cc/trials/nct03980041/)

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