Solcitinib Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple Phase I clinical trials evaluated solcitinib to assess its safety, tolerability, and pharmacokinetics in healthy volunteers and patients with moderate to severe ulcerative colitis. Sponsored by GlaxoSmithKline, Galapagos NV, and academic researchers at AMC Amsterdam, these early-development studies included a completed dose-ranging trial in healthy subjects and a terminated clinical trial in patients with ulcerative colitis. Together, these efforts represent the preliminary clinical assessment of solcitinib for treating inflammatory disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02000453	Terminated	Colitis Ulcerative	GlaxoSmithKline\|Prof Geert D''Haens AMC Amsterdam	2013-12-20	Phase 1
NCT01336244	Completed	Healthy	Galapagos NV	2011-04	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Solcitinib potently and selectively binds to Janus kinase 1 (JAK1), preventing its activation and halting downstream phosphorylation of STAT transcription factors within inflammatory cytokine pathways. This blockade suppresses key intracellular signals and immune cell responses, thereby reducing pathological tissue inflammation and offering clinical relevance for treating inflammatory bowel disorders such as ulcerative colitis.

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>).