Selisistat (EX-527) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Selisistat (EX-527) has been evaluated in several clinical trials across neurodegenerative and reproductive health indications. Completed Phase I safety, tolerability, and pharmacokinetic trials sponsored by Siena Biotech S.p.A. focused on patients with Huntington's disease. Additionally, a Phase II clinical trial sponsored by Wake Forest University Health Sciences investigated SIRT1 antagonist therapy in women with endometriosis, uterine diseases, and unexplained female infertility, but was ultimately withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04184323	WITHDRAWN	Endometriosis; Uterine Diseases; Endometrial Diseases; Infertility Unexplained; Infertility; Female, Nonimplantation	Wake Forest University Health Sciences	2022-01	PHASE2
NCT01485965	Completed	Huntington''s Disease	Siena Biotech S.p.A.	2011-11	Phase 1
NCT01521832	Completed	Huntington''s Disease	Siena Biotech S.p.A.	2009-10	Phase 1

(data from https://clinicaltrials.gov, updated on 2021-11-17)

Check the Selisistat (EX-527) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Selisistat selectively binds to and inhibits SIRT1 enzyme activity, thereby blocking the NAD+-dependent deacetylation of substrate proteins such as p53 and modulating critical cell survival signaling pathways. This cellular inhibition of deacetylase activity alters gene expression and cellular stress responses, demonstrating potential clinical relevance in therapeutic approaches for Huntington's disease and endometrial conditions.

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>).