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Tasimelteon

Alternative Names: tasimelteon, vec-162, hetlioz, hetlioz lq
Latest Update: 2024-09-24
Latest Update Note: News Article

Product Description

Tasimelteon is used to treat non-24-hour sleep-wake disorder (non-24; a condition that occurs mainly in people who are blind in which the body's natural clock is out of sync with the normal day-night cycle and causes a disrupted sleep schedule) in adults. It is also used to treat nighttime sleep problems in adults and children 3 years of age and older with Smith-Magenis Syndrome (SMS; a developmental disorder). Tasimelteon is in a class of medications called melatonin receptor agonists. It works similarly to melatonin, a natural substance in the brain that is needed for sleep. (Sourced from: https://medlineplus.gov/druginfo/meds/a615004.html)

Mechanisms of Action: MT Agonist

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: None *

Approval Status: Approved

Approved Countries: Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | Germany | Hungary | Iceland | Ireland | Italy | Latvia | Lithuania | Netherlands | Poland | Portugal | Slovakia | Sweden | United States

Approved Indications: Smith-Magenis Syndrome

Known Adverse Events: Headache

Company: Vanda
Company Location: WASHINGTON DC 20037
Company CEO: Mihael H. Polymeropoulos
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Tasimelteon

Countries in Clinic: Australia, Germany, United States

Active Clinical Trial Count: 5

Highest Development Phases

Phase 3: Autism Spectrum Disorder|Dyssomnias|Parasomnias|Sleep Disorders, Circadian Rhythm

Phase 1: Healthy Volunteers|REM Sleep Behavior Disorder

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

RBD

P1

Not yet recruiting

REM Sleep Behavior Disorder

2026-09-30

2021-005475-40

P3

Active, not recruiting

Unknown

2025-10-08

VP-VEC-162-3601

P3

Recruiting

Parasomnias|Dyssomnias|Autism Spectrum Disorder

2025-07-01

90%

DSWPD

P3

Recruiting

Sleep Disorders, Circadian Rhythm

2024-12-01

95%

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