Epinastine HCl Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Boehringer Ingelheim has sponsored multiple completed clinical trials evaluating Epinastine HCl. These include a Phase 1 study assessing single increasing dose tolerance following intranasal application in healthy volunteers, as well as a Phase 3 open-label study examining a dry syrup formulation in pediatric patients with atopic dermatitis. Together, these Phase 1 and Phase 3 evaluations established the safety, tolerability, and therapeutic efficacy of Epinastine HCl across healthy populations and pediatric dermatological conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02260037	Completed	Healthy	Boehringer Ingelheim	2001-08	Phase 1
NCT02182570	Completed	Dermatitis Atopic	Boehringer Ingelheim	2001-06	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Epinastine HCl functions as a direct histamine H1 receptor antagonist and mast cell stabilizer, binding selectively to the receptor to inhibit histamine-driven downstream intracellular signaling and suppress mast cell degranulation. By blocking the release of pro-inflammatory mediators and reducing allergic cellular activation, Epinastine attenuates tissue inflammation and pruritus, providing clinical relevance in the management of allergic conditions such as atopic dermatitis.

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>).