Skip to main content

hetlioz

Generic: tasimelteon

hetlioz: sourced relationships with 1 company · 1 FDA decision.

hetlioz evidence translation

What we can confirm

What it means

Source-backed records connect hetlioz to VNDA; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could hetlioz → VNDA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Non-24-Hour Sleep-Wake Disorder (Non-24)

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
Vanda Pharmaceuticals Inc. (VNDA)
Reported 2014-01-31 · Current development: unknownSource
Non-24-Hour Sleep-Wake Disorder (Non-24)
Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 ) Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older ( 1 ) HETLIOZ LQ oral suspension is indicated for the treatment of: Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age ( 1 ) 1.1 Non-24-Hour Sleep-Wake Disorder (Non-24) HETLIOZ capsules are indicated for the treatment of Non-24 in adults. 1.2 Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS) HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older. HETLIOZ LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.(VNDA)FDA ↗
NDA205677Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule

Frequently asked questions

Which companies have sourced relationships with hetlioz?

hetlioz has dated SEC/FDA relationship records for Vanda Pharmaceuticals Inc..

What is hetlioz's latest FDA decision?

The most recent tracked FDA decision for hetlioz is Approval for 1 INDICATIONS AND USAGE HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 ) Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older ( 1 ) HETLIOZ LQ oral suspension is indicated for the treatment of: Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age ( 1 ) 1.1 Non-24-Hour Sleep-Wake Disorder (Non-24) HETLIOZ capsules are indicated for the treatment of Non-24 in adults. 1.2 Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS) HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older. HETLIOZ LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age., dated January 31, 2014.