NDAORALCAPSULEPriority Review
Approved
Jan 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
HETLIOZ (tasimelteon) by Vanda Pharmaceuticals is melatonin receptor agonists [moa]. First approved in 2014.
Drug data last refreshed 1m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HETLIOZ (tasimelteon) is an oral melatonin receptor agonist approved in 2014 for non-24-hour sleep-wake disorder, a circadian rhythm disorder affecting blind individuals and others with disrupted sleep cycles. It works by binding melatonin receptors to help synchronize the body's internal clock to a 24-hour schedule.
$96MPart D
PeakStable
14.7 years to LOEPeak lifecycle product with modest Medicare utilization (3,561 Part D claims in 2023) indicates a stable, niche commercial franchise with lean team structure.
Mechanism of Action
Melatonin Receptor Agonists
Pharmacologic Class:
Melatonin Receptor Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.