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: *
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: None
Known Adverse Events: None
Company: Cycle
Company Location: Western America
Company Founding Year: 2012
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, France, Germany, Turkey, United States
Active Clinical Trial Count: 7
Recent & Upcoming Milestones
- FDA will expedite re-reviews for Tradipitant and Hetlioz with PDUFA target dates on Dec 30, 2025, and Jan 7, 2026.
- Clinical Outcomes Reported - Vanda presented P3 Insomnia results on 2025-09-25 for Tasimelteon
- FDA issued a Complete Response Letter on March 4, 2024 for Vanda's Hetlioz SNDA targeting insomnia treatment.
Highest Development Phases
Phase 3: Autism Spectrum Disorder|Dyssomnias|Insomnia|Parasomnias|Sleep Disorders, Circadian Rhythm
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06953869 |
VP-VEC-162-3108 | P3 |
Recruiting |
Insomnia |
2027-11-01 |
56% |
2025-05-03 |
|
NCT04652882 |
DSWPD | P3 |
Recruiting |
Sleep Disorders, Circadian Rhythm |
2026-06-01 |
27% |
2025-12-03 |
|
NCT05361707 |
VP-VEC-162-3601 | P3 |
Recruiting |
Autism Spectrum Disorder|Parasomnias|Dyssomnias |
2025-07-01 |
30% |
2024-03-22 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2024-516411-24-00 |
VP-VEC-162-3108 | P3 |
Not yet recruiting |
Insomnia |
2028-01-31 |
|||
2024-516962-13-00 |
VP-VEC-162-3502 | P3 |
Recruiting |
Unknown |
2026-04-30 |
2025-05-02 |
Treatments |
|
NCT06701396 |
VP-VEC-162-3501 | P3 |
Recruiting |
Sleep Disorders, Circadian Rhythm |
2025-06-30 |
29% |
2024-11-23 |
Primary Endpoints|Treatments |
2024-516721-31-00 |
VP-VEC-162-3202 | P3 |
Not yet recruiting |
Unknown |
2024-12-31 |
2025-05-02 |
Treatments |