Vidofludimus Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Multiple clinical trials have evaluated vidofludimus for the treatment of gastroenterological and hepatological autoimmune conditions. These completed Phase II studies include an open-label trial in inflammatory bowel disease sponsored by 4SC AG, alongside an evaluation in primary sclerosing cholangitis sponsored by Elizabeth Carey. Designed to assess drug safety, tolerability, and therapeutic efficacy, these trials reflect the mid-stage clinical evaluation of this orally active small molecule.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03722576	COMPLETED	Primary Sclerosing Cholangitis	Elizabeth Carey	2019-06-17	PHASE2
NCT00820365	Completed	Inflammatory Bowel Disease (IBD)	4SC AG	2009-03	Phase 2

(data from https://clinicaltrials.gov, updated on 2022-10-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vidofludimus potently binds to human dihydroorotate dehydrogenase (DHODH) with an IC50 of 134 nM, effectively blocking de novo pyrimidine biosynthesis and inhibiting the proliferation of activated lymphocytes. By suppressing hyperactive immune cell responses through DHODH inhibition, vidofludimus mitigates chronic mucosal and hepatic inflammation relevant to clinical conditions such as inflammatory bowel disease and primary sclerosing cholangitis.

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>).