HETLIOZ (tasimelteon)
HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder; Smith-Magenis Syndrome.
How HETLIOZ Works
Tasimelteon is an agonist at melatonin MT1 and MT2 receptors. While the precise mechanism by which it exerts its therapeutic effect in patients with Non-24 or SMS is unclear, these receptors are thought to be involved in the control of circadian rhythms and the regulation of the sleep-wake cycle.
Details
- Status
- Prescription
- First Approved
- 2014-01-31
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- CAPSULE
HETLIOZ Approval History
What HETLIOZ Treats
2 indicationsHETLIOZ is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-24-Hour Sleep-Wake Disorder
- Smith-Magenis Syndrome
HETLIOZ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to HETLIOZ
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04652882 | VP-VEC-162-3502 | Ph 3 | recruiting | Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) |
| NCT06701396 | VP-VEC-162-3501 | Ph 3 | recruiting | Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant |
| NCT06323655 | VP-VEC-162-1201 | Ph 1 | completed | Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects |
| NCT02776215 | VP-VEC-162-4201 | Ph 1 | completed | Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents |
| NCT03373201 results posted | VP-VEC-162-3107 | Ph 3 | completed | Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia |
| NCT02231008 | VP-VEC-162-2401 | Ph 2, Ph 3 | completed | Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS |
| NCT03291041 results posted | VP-VEC-162-2102 | Ph 2 | completed | A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder |
| NCT01428661 MAGELLAN results posted | VP-VEC-162-2301 | Ph 2, Ph 3 | completed | Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder |
| NCT01429116 | VP-VEC-162-3204 | Ph 3 | completed | Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception |
| NCT01163032 results posted | VP-VEC-162-3201 | Ph 3 | completed | Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder |
| NCT01430754 results posted | VP-VEC-162-3203 | Ph 3 | completed | Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder |
| NCT01271387 | VP-VEC-162-1105 | Ph 1 | completed | Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment |
| NCT01402076 | VP-VEC-162-1110 | Ph 1 | completed | A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects |
| NCT01526746 | VP-VEC-162-1106 | Ph 1 | completed | Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function |
| NCT01540500 | VP-VEC-162-1111 | Ph 1 | completed | Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine |
| NCT01637636 | VP-VEC-162-1112 | Ph 1 | completed | Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin. |
| NCT01578057 | VP-VEC-162-1108 | Ph 1 | completed | Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol |
| NCT01477619 | VP-VEC-162-1107 | Ph 1 | completed | Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HETLIOZ FDA Label Details
Indications & Usage
FDA Label (PDF)HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder; Smith-Magenis Syndrome.
HETLIOZ Patents & Exclusivity
Patents (31 active)
Exclusivity
Pro Intelligence Preview
Deep insights for HETLIOZ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 48 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.