Rupatadine Fumarate Clinical Trials

Size	Price	Qty
10mg	USD 170

Clinical Trials

Multiple clinical trials have evaluated rupatadine fumarate for dermatological allergic conditions, specifically cold contact urticaria and general urticaria. These Phase 2 and Phase 3 investigations were supported by academic medical centers, such as Charité University Berlin with Hospital del Mar, alongside industry sponsors like J. Uriach and Company. While a Phase 2 trial successfully completed its assessment of safety and efficacy in cold contact urticaria, a Phase 3 study evaluating broader urticaria patient cohorts was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01605487	Completed	Cold Contact Urticaria	Charite University Berlin Germany\|Hospital del Mar	2012-06	Phase 2
NCT00199251	Terminated	Urticaria	J. Uriach and Company	2004-04	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rupatadine Fumarate acts as a dual antagonist targeting the histamine H1 receptor and platelet-activating factor receptor (PAFR) with Ki values of 102 nM and 550 nM, respectively, thereby preventing ligand-induced activation of downstream pro-inflammatory signaling pathways. By suppressing H1 and PAFR-mediated mediator release and cellular activation, the compound reduces vascular permeability and tissue inflammation, providing therapeutic relevance in clinical conditions such as cold contact urticaria and urticaria.

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>).