GSK-2881078 Clinical Trials

Size	Price	Qty
5mg	USD 117
25mg	USD 397

Clinical Trials

GSK-2881078, a selective androgen receptor modulator, has been evaluated in several completed clinical trials for the treatment of cachexia and disease-associated muscle wasting. This research encompasses a GlaxoSmithKline-sponsored Phase 1 study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects, alongside a Phase 2 study conducted in collaboration with Parexel assessing 13-week safety and efficacy in affected patients. All associated trials have reached completed recruitment status without further active enrollment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03359473	Completed	Cachexia	GlaxoSmithKline\|Parexel	2018-02-28	Phase 2
NCT02567773	Completed	Cachexia	GlaxoSmithKline	2015-09	Phase 1

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

Check the GSK-2881078 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK-2881078 selectively binds to and modulates the androgen receptor, driving transcriptional activation of anabolic gene pathways while minimizing unwanted systemic androgenic signaling. This tissue-selective activation enhances muscle protein synthesis and cell retention, which is clinically relevant for counteracting progressive muscle loss and muscle wasting in patients with cachexia.

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>).