NDAORALCAPSULEPriority Review
Approved
Jan 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
Melatonin Receptor Agonists
Pharmacologic Class:
Melatonin Receptor Agonist
Clinical Trials (5)
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
Loss of Exclusivity
LOE Date
Feb 21, 2041
182 months away
Patent Expiry
Feb 21, 2041
Exclusivity Expiry
Dec 1, 2027