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
Countries in Clinic: Austria, France, Germany, Turkey, United States
Active Clinical Trial Count: 8
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 |
|
| VP-VEC-162-3502 | P3 |
Unknown Status |
Unknown |
2026-04-30 |
|
| DSWPD | P3 |
Recruiting |
Sleep Disorders, Circadian Rhythm |
2025-12-01 |
|
| 2021-005475-40 | P3 |
Active, not recruiting |
Unknown |
2025-10-08 |