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Tasimelteon · Hetlioz, BMS-214778

Small molecule · Agonist of melatonin receptor MT1 (MTNR1A) and melatonin receptor MT2 (MTNR1B) · developed by Vanda Pharms

Approved FDA, Jan 2014

VNDA Developer

4 Registered trials

What is Tasimelteon?

Tasimelteon is a melatonin receptor agonist that binds MT1 and MT2 receptors involved in circadian rhythm control.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Hetlioz, BMS-214778, VEC-162
Drug type: Small molecule
Targets: melatonin receptor MT1 (MTNR1A), melatonin receptor MT2 (MTNR1B)
Mechanism: Agonist of melatonin receptor MT1 (MTNR1A) and melatonin receptor MT2 (MTNR1B)
Pathways: circadian rhythm regulation
Therapy area: Neurology
Developer: Vanda Pharms Inc (VNDA)
FDA status: Approved as Hetlioz (January 31, 2014), NDA205677 · FDA label
UNII: SHS4PU80D9

✅ FDA-approved uses

Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older
Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in pediatric patients 3 to 15 years of age

From the indications section of the FDA label (version of Aug 4, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06953869	Phase 3	Insomnia Disorder	Recruiting	VNDA
NCT06701396	Phase 3	Sleep Wake Disorders	Recruiting	VNDA
NCT05361707	Phase 3	Autism Spectrum Disorder	Unknown	VNDA
NCT05572281	Phase 1	Healthy	Completed	VNDA

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Chronobiology DisordersGene Mutations and Other Alterations NecInsomnia DisorderSleep Disorders, Circadian RhythmSleep Wake DisordersAutism Spectrum DisorderHealthyNeurological DisorderSleep DisorderSleep Disturbance

More from Vanda Pharms

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Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the VNDA page.

Follow VNDA, the company behind Tasimelteon

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z