Eganelisib (IPI-549) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Eganelisib (IPI-549) is being evaluated across multiple clinical trials in Phase I and Phase II, targeting indications such as advanced solid tumors, urothelial carcinoma, triple-negative breast cancer, head and neck squamous cell carcinoma, acute myeloid leukemia, and myelodysplastic syndromes. Sponsored by pharmaceutical companies—including Infinity Pharmaceuticals, Bristol-Myers Squibb, and Stelexis BioSciences—alongside academic principal investigators, trial statuses range from actively recruiting to completed. Completed research includes a clinical trial evaluating urothelial cancer and a clinical trial assessing dose escalation in advanced solid malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07439211	RECRUITING	Leukemia, Myeloid; Leukemia; Acute Myeloid Leukemia; Refractory Leukemia	Jacqueline Garcia, MD	2026-04-13	PHASE1
NCT06533761	RECRUITING	AML, Adult; MDS	Stelexis BioSciences	2025-04-28	PHASE1
NCT03961698	UNKNOWN	Breast Cancer; Renal Cell Carcinoma	Infinity Pharmaceuticals, Inc.	2019-12-17	PHASE2
NCT03795610	COMPLETED	Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer; Head and Neck Carcinoma; Head and Neck Cancer Stage IV; Head and Neck Cancer Stage III; HPV-Related Carcinoma; HPV-Related Malignancy; HPV-Related Squamous Cell Carcinoma	Assuntina G. Sacco, MD	2020-03-06	PHASE2
NCT02637531	UNKNOWN	Advanced Solid Tumors (Part A/B/C/D); Non-small Cell Lung Cancer (Part E); Melanoma (Part E); Squamous Cell Cancer of the Head and Neck (Part E); Triple Negative Breast Cancer (Part F); Adrenocortical Carcinoma (Part G); Mesothelioma (Part G); High-circulating Myeloid-derived Suppressor Cells (Part H)	Infinity Pharmaceuticals, Inc.	2015-12	PHASE1
NCT03719326	COMPLETED	TNBC - Triple-Negative Breast Cancer; Ovarian Cancer	Arcus Biosciences, Inc.	2018-10-15	PHASE1
NCT03980041	COMPLETED	Bladder Cancer; Urothelial Carcinoma; Solid Tumor; Advanced Cancer	Infinity Pharmaceuticals, Inc.	2019-09-25	PHASE2
NCT03980041	Completed	Bladder Cancer\|Urothelial Carcinoma\|Solid Tumor\|Advanced Cancer	Infinity Pharmaceuticals Inc.\|Bristol-Myers Squibb	2019-09-25	Phase 2
NCT02637531	Unknown status	Advanced Solid Tumors (Part A/B/C/D)\|Non-small Cell Lung Cancer (Part E)\|Melanoma (Part E)\|Squamous Cell Cancer of the Head and Neck (Part E)\|Triple Negative Breast Cancer (Part F)\|Adrenocortical Carcinoma (Part G)\|Mesothelioma (Part G)\|High-circulating Myeloid-derived Suppressor Cells (Part H)	Infinity Pharmaceuticals Inc.	2015-12	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the Eganelisib (IPI-549) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eganelisib selectively binds to phosphoinositide 3-kinase gamma (PI3Kγ) with an IC50 of 16 nM, blocking downstream AKT signaling pathways and reprogramming immunosuppressive tumor-associated myeloid cells into a pro-inflammatory phenotype. This immune microenvironment remodeling restores T-cell-mediated antitumor cytotoxicity, inhibiting disease progression in clinical settings such as urothelial carcinoma, triple-negative breast cancer, and acute myeloid leukemia.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).