Pitolisant hydrochloride Clinical Trials

Size	Price	Qty
25mg	USD 190
1g	USD 1,670

Clinical Trials

Multiple clinical trials sponsored by organizations such as Bioprojet and Harmony Biosciences LLC evaluate the therapeutic profile and pharmacokinetics of pitolisant across Phase I and Phase III studies. These trials investigate key sleep-wake conditions—including narcolepsy with or without cataplexy, idiopathic hypersomnia, and excessive daytime sleepiness—by evaluating safety, efficacy, and metabolic parameters in healthy, pediatric, and adult populations. Currently, recruitment statuses across these studies encompass both completed trials and active, non-recruiting cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05458128	Active not recruiting	Idiopathic Hypersomnia\|Excessive Daytime Sleepiness	Harmony Biosciences LLC	2022-08-19	Phase 3
NCT02929342	Completed	Healthy Volunteers	Bioprojet	2016-07	Phase 1
NCT02611687	Active not recruiting	Narcolepsy With Cataplexy\|Narcolepsy Without Cataplexy	Bioprojet	2016-06-06	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pitolisant selectively binds as a high-affinity competitive antagonist and inverse agonist at the human histamine H3 receptor subtype, thereby suppressing autoreceptor activation and enhancing endogenous histamine release in the central nervous system. This elevation in central histaminergic tone promotes cortical arousal and wakefulness, underlying its clinical utility in treating excessive daytime sleepiness, idiopathic hypersomnia, and narcolepsy.

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>).