Gandotinib (LY2784544) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Eli Lilly and Company have evaluated the safety, pharmacokinetics, and efficacy of Gandotinib (LY2784544). These studies investigated hematologic malignancies and myeloproliferative neoplasms—including polycythemia vera, essential thrombocythemia, primary myelofibrosis, and JAK2 V617F-positive disorders—as well as drug disposition in healthy male volunteers. Recruitment status across these trials includes both completed studies and those marked as active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01520220	COMPLETED	Myeloproliferative Neoplasms of; Polycythemia Vera; Essential Thrombocythemia; Myelofibrosis	Eli Lilly and Company	2012-06-11	PHASE1
NCT01594723	ACTIVE_NOT_RECRUITING	Neoplasms, Hematologic	Eli Lilly and Company	2012-05-22	PHASE2
NCT01134120	COMPLETED	Myeloproliferative Disorders; Thrombocythemia, Essential; Polycythemia Vera; Primary Myelofibrosis	Eli Lilly and Company	2010-04	PHASE1
NCT01520220	Completed	Myeloproliferative Neoplasms of\|Polycythemia Vera\|Essential Thrombocythemia\|Myelofibrosis	Eli Lilly and Company	2012-06-11	Phase 1
NCT01577355	COMPLETED	Healthy Male Volunteers	Eli Lilly and Company	2012-04	PHASE1
NCT01594723	Active not recruiting	Neoplasms Hematologic	Eli Lilly and Company	2012-05-22	Phase 2
NCT01577355	Completed	Healthy Male Volunteers	Eli Lilly and Company	2012-04	Phase 1
NCT01134120	Completed	Myeloproliferative Disorders\|Thrombocythemia Essential\|Polycythemia Vera\|Primary Myelofibrosis	Eli Lilly and Company	2010-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2017-04-12)

Check the Gandotinib (LY2784544) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gandotinib selectively binds to and inhibits the mutant Janus kinase 2 (JAK2 V617F) enzyme, blocking downstream STAT5 phosphorylation and suppressing mutant cell proliferation while inducing apoptosis. This targeted inhibition of aberrant JAK-STAT pathway signaling underlies its clinical application in treating myeloproliferative neoplasms such as polycythemia vera, essential thrombocythemia, and primary myelofibrosis.

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>).