GSK2981278 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 357

Clinical Trials

A completed Phase 1/2 clinical trial sponsored by GlaxoSmithKline evaluated a topical formulation of the small molecule GSK2981278 for the treatment of psoriasis. This early-stage study investigated the drug's safety, tolerability, systemic exposure, and therapeutic efficacy in human subjects. The trial provides foundational clinical data regarding the safety and therapeutic potential of this investigational compound for dermatological conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03004846	Completed	Psoriasis	GlaxoSmithKline	2017-02-13	Phase 1\|Phase 2

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

Check the GSK2981278 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK2981278 acts as a potent and selective inverse agonist that directly binds to retinoic acid receptor-related orphan receptor gamma (RORγ), thereby inhibiting its transcriptional activity and repressing the expression of downstream pro-inflammatory cytokines such as interleukin-17. By suppressing T helper 17 cell-mediated inflammatory signaling and immune cell activation, this targeted inhibition attenuates chronic tissue inflammation relevant to therapeutic intervention in psoriasis.

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>).