Setipiprant (ACT-129968) Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple Phase 2 clinical trials sponsored by Idorsia Pharmaceuticals Ltd. have reached completed status to evaluate the therapeutic application of setipiprant (ACT-129968). These multicenter, randomized, double-blind, placebo-controlled studies investigated the safety, dose-dependent efficacy, and proof-of-concept of setipiprant in adult patients with respiratory and allergic conditions, specifically seasonal allergic rhinitis and asthma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01241214	Completed	Seasonal Allergic Rhinitis	Idorsia Pharmaceuticals Ltd.	2010-11	Phase 2
NCT01225315	Completed	Asthma	Idorsia Pharmaceuticals Ltd.	2010-11-01	Phase 2

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

Check the Setipiprant (ACT-129968) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Setipiprant functions as a selective antagonist of the prostaglandin D2 receptor 2 (DP2/CRTH2), blocking prostaglandin D2-mediated activation of downstream intracellular signaling cascades and halting the recruitment and activation of pro-inflammatory immune cells such as eosinophils, basophils, and Th2 lymphocytes. By inhibiting DP2-driven cellular infiltration and inflammatory mediator release, setipiprant reduces mucosal and respiratory tissue inflammation, demonstrating clinical relevance for managing allergic diseases such as seasonal allergic rhinitis and asthma.

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>).