SRT3025 HCl Clinical Trials

Size	Price	Qty
5mg	USD 197

Clinical Trials

The clinical landscape for SRT3025 is defined by a clinical trial evaluating its therapeutic profile in patients with type 2 diabetes mellitus. Sponsored by Sirtris, a GlaxoSmithKline company, this completed Phase 1, randomized, dose-escalation study assessed the safety, tolerability, and pharmacokinetics of the compound following single and repeated administrations. Overall, formal clinical evaluation of SRT3025 remains limited to early-phase investigation within metabolic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01340911	Completed	Diabetes Mellitus Type 2	Sirtris a GSK Company\|GlaxoSmithKline	2011-06-03	Phase 1

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

Check the SRT3025 HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SRT3025 selectively binds to and activates the NAD+-dependent deacetylase SIRT1, leading to increased deacetylation of downstream protein targets involved in metabolic regulation. This enhanced enzymatic activity promotes cellular mitochondrial biogenesis and improves glucose homeostasis, which is directly relevant to mitigating metabolic dysfunction in patients with type 2 diabetes mellitus.

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>).