SRT2104 (GSK2245840) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 477

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials, primarily sponsored by GlaxoSmithKline and Sirtris, have evaluated SRT2104 in healthy volunteers and across conditions including type 2 diabetes mellitus, ulcerative colitis, psoriasis, muscular atrophy, chronic obstructive pulmonary disease, and sepsis. These studies assessed parameters such as safety, pharmacokinetics, and clinical activity, with several trials completed and others withdrawn prior to evaluation. Overall, these investigations highlight a broad exploratory assessment of SRT2104 in metabolic, inflammatory, and muscle-wasting disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01453491	COMPLETED	Colitis, Ulcerative	Sirtris, a GSK Company	2012-02-13	PHASE1
NCT01702493	COMPLETED	Psoriasis	Sirtris, a GSK Company	2012-10-30	PHASE1
NCT01453491	Completed	Colitis Ulcerative	Sirtris a GSK Company\|GlaxoSmithKline	2012-02-13	Phase 1
NCT01154101	COMPLETED	Psoriasis	Sirtris, a GSK Company	2010-06-07	PHASE2
NCT01031108	COMPLETED	Diabetes Mellitus, Type 2	Sirtris, a GSK Company	2010-05-28	PHASE1
NCT01039909	WITHDRAWN	Healthy Volunteer; Atrophy, Muscular	GlaxoSmithKline	2011-01	PHASE1
NCT01039909	Withdrawn	Healthy Volunteer\|Atrophy Muscular	GlaxoSmithKline	2011-01	Phase 1
NCT01018017	COMPLETED	Diabetes Mellitus, Type 2	GlaxoSmithKline	2010-03-03	PHASE2
NCT00937326	COMPLETED	Diabetes Mellitus, Type 2	Sirtris, a GSK Company	2009-08-19	PHASE2
NCT01154101	Completed	Psoriasis	Sirtris a GSK Company\|GlaxoSmithKline	2010-06-07	Phase 2
NCT01014117	COMPLETED	Sepsis	GlaxoSmithKline	2009-12-09	PHASE1
NCT01031108	Completed	Diabetes Mellitus Type 2	Sirtris a GSK Company\|GlaxoSmithKline	2010-05-28	Phase 1
NCT00964340	COMPLETED	Atrophy, Muscular	GlaxoSmithKline	2009-10-01	PHASE1
NCT01018017	Completed	Diabetes Mellitus Type 2	GlaxoSmithKline	2010-03-03	Phase 2
NCT00920660	COMPLETED	Pulmonary Disease, Chronic Obstructive	GlaxoSmithKline	2009-04-06	PHASE1
NCT00933062	COMPLETED	Diabetes Mellitus, Type 2	GlaxoSmithKline	2009-03-23	PHASE1
NCT00938275	COMPLETED	Diabetes Mellitus, Type 2	Sirtris, a GSK Company	2009-01-20	PHASE1
NCT00937872	COMPLETED	Diabetes Mellitus, Type 2	Sirtris, a GSK Company	2008-11-22	PHASE1
NCT00933530	COMPLETED	Diabetes Mellitus, Type 2; Healthy Volunteer	Sirtris, a GSK Company	2008-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2017-06-01)

Check the SRT2104 (GSK2245840) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SRT2104 functions as a selective activator of sirtuin 1 (SIRT1) that binds to the enzyme to enhance the deacetylation of key downstream transcriptional targets involved in cellular metabolism and immune regulation. By promoting SIRT1-mediated signaling, SRT2104 enhances mitochondrial function, improves cellular energy homeostasis, and suppresses NF-κB-driven inflammatory cascades, which underlies its therapeutic relevance in clinical studies targeting type 2 diabetes, ulcerative colitis, and inflammatory skin disorders.

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>).