Lexibulin (CYT997) Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

The clinical development landscape for Lexibulin (CYT997) encompasses several clinical trials sponsored by Gilead Sciences, all of which have been terminated. These early-to-mid phase studies evaluated the compound in combination with carboplatin for relapsed glioblastoma multiforme and as a standalone intervention for relapsed and refractory multiple myeloma. Consequently, active clinical investigation of Lexibulin under these specific protocols has ceased.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00650949	Terminated	Glioblastoma Multiforme	Gilead Sciences	2009-11	Phase 1\|Phase 2
NCT00664378	Terminated	Relapsed and Refractory Multiple Myeloma	Gilead Sciences	2008-01	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Lexibulin (CYT997) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lexibulin (CYT997) directly binds to tubulin and inhibits microtubule polymerization, which suppresses mitotic spindle assembly, arrests cells in the G2/M cell-cycle phase, and triggers caspase-3-mediated apoptotic signaling cascades. This dual mechanism of direct cytotoxicity and tumor vascular disruption impairs endothelial network integrity and restricts neoplastic blood flow, providing a rationale for its investigation in aggressive malignancies such as glioblastoma multiforme and multiple myeloma.

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>).