Tasimelteon Clinical Trials

Size	Price	Qty
10mg	USD 97

Clinical Trials

Multiple clinical trials sponsored by Vanda Pharmaceuticals evaluate the efficacy, safety, and pharmacokinetics of tasimelteon across Phase 1 through Phase 4, encompassing both completed and actively recruiting protocols. Research primarily targets circadian rhythm sleep disorders, particularly non-24-hour sleep-wake disorder and delayed sleep-wake phase disturbances. Additionally, these trials assess the drug's therapeutic potential for sleep disturbances secondary to neurological and genetic conditions, including autism spectrum disorder and Smith-Magenis syndrome.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05361707	Recruiting	Autism Spectrum Disorder\|Sleep Disorder\|Neurological Disorder\|Sleep Disturbance	Vanda Pharmaceuticals	2021-07-28	Phase 3
NCT04652882	Recruiting	Sleep Wake Disorders\|Sleep Disorders Circadian Rhythm\|Chronobiology Disorders	Vanda Pharmaceuticals	2020-12-09	Phase 3
NCT02776215	Completed	Circadian Rhythm Sleep Disorders\|Non-24 Hour Sleep-Wake Disorder\|Autism Spectrum Disorder\|Smith-Magenis Syndrome	Vanda Pharmaceuticals	2016-10-04	Phase 1
NCT02231008	Completed	Smith-Magenis Syndrome\|Circadian	Vanda Pharmaceuticals	2015-09	Phase 2\|Phase 3
NCT02130999	Completed	Non-24-Hour-Sleep-Wake Disorder	Vanda Pharmaceuticals	2014-05	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tasimelteon functions as a selective dual melatonin receptor agonist, displaying preferential binding affinity for MT2 over MT1 receptors to activate downstream melatonin receptor-mediated signaling cascades in central pacemaker neurons. By modulating suprachiasmatic nucleus activity, this receptor activation entrains endogenous biological rhythms to reset sleep-wake cycles, offering therapeutic efficacy for circadian rhythm sleep disorders, non-24-hour sleep-wake disorder, and sleep disturbances associated with autism spectrum disorder or Smith-Magenis syndrome.

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>).