NDAORALCAPSULEPriority Review
Approved
Jan 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
HETLIOZ (tasimelteon) by Vanda Pharmaceuticals is melatonin receptor agonists [moa]. Approved for non-24-hour sleep-wake disorder. First approved in 2014.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HETLIOZ (tasimelteon) is an oral melatonin receptor agonist approved by the FDA on January 31, 2014, for the treatment of non-24-hour sleep-wake disorder. As a selective MT1/MT2 melatonin receptor agonist, it works by resynchronizing circadian rhythm disruptions in patients with this rare condition. HETLIOZ represents a novel pharmacological approach to circadian sleep disorders and occupies a unique niche in sleep medicine with minimal direct competition.
$0.1BPart D
14.8 years to LOEMechanism of Action
Melatonin Receptor Agonists
Pharmacologic Class:
Melatonin Receptor Agonist
Indications (1)
Clinical Trials (20)
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Started Apr 2025
420 enrolled
Insomnia Disorder
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Started Oct 2024
60 enrolled
Sleep Wake DisordersSleep Disorders, Circadian RhythmChronobiology Disorders+1 more
The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)
Started Sep 2023
20 enrolled
REM Behavior Disorder
Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers
Started May 2022
36 enrolled
Healthy
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
Started Jul 2021
100 enrolled
Autism Spectrum DisorderSleep DisorderNeurological Disorder+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.