Almorexant HCl Clinical Trials

Size	Price	Qty
5mg	USD 170
1g	USD 3,990

Clinical Trials

Multiple completed Phase 1 and Phase 3 clinical trials have evaluated Almorexant for primary insomnia and sleep induction, assessing safety, pharmacokinetics, pharmacodynamics, abuse potential, and neurocognitive performance in healthy volunteers and patients. Sponsored by Idorsia Pharmaceuticals Ltd., Midnight Pharma, LLC, and the Northern California Institute of Research and Education, these studies established the drug's overall safety parameters and therapeutic efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01243060	COMPLETED	Healthy Volunteers	Northern California Institute of Research and Education	2011-05
NCT01954589	COMPLETED	Safety; Tolerability; Pharmacodynamics; Pharmacokinetics	Idorsia Pharmaceuticals Ltd.	2011-11	PHASE1
NCT01987739	COMPLETED	Abuse Potential Study	Midnight Pharma, LLC	2009-09	PHASE1
NCT00608985	COMPLETED	Primary Insomnia	Midnight Pharma, LLC	2008-03	PHASE3
NCT00640848	COMPLETED	Insomnia; Primary Insomnia	Midnight Pharma, LLC	2006-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2014-10-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Almorexant acts as a competitive dual antagonist of orexin 1 and orexin 2 receptors, blocking the downstream binding of wake-promoting orexin neuropeptides and inhibiting central nervous system arousal signaling. This reduction in orexinergic signaling promotes physiological sleep patterns by decreasing sleep latency and increasing sleep efficiency, supporting its clinical evaluation for primary insomnia.

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>).