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 19h ago · AI intelligence enriched 21h 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 individuals who cannot synchronize their internal clock to the 24-hour day. The drug works by binding to melatonin MT1 and MT2 receptors to reset circadian rhythm and promote sleep at appropriate times. It addresses a rare, orphan indication with limited competing options.
$0.096BPart D
Peak14.4 years to LOEProduct is in peak lifecycle with stable $96M annual spending but limited growth headroom; commercial team is likely optimized for maintenance rather than expansion.
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.