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Hetlioz

(tasimelteon)

ApprovedSmall molecule

VVanda Pharmaceuticals

Tasimelteon is used to treat non-24-hour sleep-wake disorder, a condition where a person's internal sleep clock doesn't match the 24-hour day, causing them to have irregular sleep patterns.[2] Hetlioz is currently approved and in use across 10 indications[4].[1]

Hetlioz is one of 180 small molecule programs targeting Insomnia. It is currently in Approved.

10

Indications

24

Total Trials

5

Active Trials

179

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

33

Patents

Pipeline

Status by Indication[4][1]

Indication

InsomniaCompleted

Chromosomal AnomalyActive, not recruiting

Circadian Rhythm Sleep DisorderActive, not recruiting

Smith-Magenis SyndromeApproved

Liver DiseaseApproved

Kidney DiseaseApproved

REM Sleep Behavior DisorderApproved

Sleep-Wake DisorderCompleted

Autism Spectrum DisorderRecruiting

SleepRecruiting

InsomniaPhase 3

Completed

Chromosomal AnomalyApproved

Active, not recruiting

Circadian Rhythm Sleep DisorderApproved

Active, not recruiting

Smith-Magenis SyndromeApproved

Approved

Liver DiseaseApproved

Approved

Kidney DiseaseApproved

Approved

REM Sleep Behavior DisorderApproved

Approved

Sleep-Wake DisorderPhase 3

Completed

Autism Spectrum DisorderPhase 3

Recruiting

SleepPhase 3

Recruiting

Competition

Competitive Landscape

105 competitors in Kidney Disease

#DrugCompanyPhaseTrials

Hetlioz

VVanda Pharmaceuticals

Veozah

Fosrenol

Dayvigo

Scemblix

Cibinqo

Vistide

Uloric

Leqvio

Lorbrena

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 3Recruiting

Insomnia

NCT06953869

Clinical

Trials by Indication[1]

Sleep-Wake Disorder4 trials

Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception

Active, not recruiting·VVanda Pharmaceuticals·Phase 3·NCT01218789·140 enrolled

Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception

Completed·VVanda Pharmaceuticals·Phase 3·NCT01429116·200 enrolled

Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder

Completed·VVanda Pharmaceuticals·Phase 3·NCT01163032·136 enrolled

Show 1 more trial

Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder

Completed·VVanda Pharmaceuticals·Phase 3·NCT01430754·20 enrolled

Insomnia2 trials

Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Recruiting·VVanda Pharmaceuticals·Phase 3·NCT06953869·420 enrolled

Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

Completed·VVanda Pharmaceuticals·Phase 3·NCT03373201·320 enrolled

ESS2 trials

Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™)

Completed·VVanda Pharmaceuticals·Phase 4·NCT02130999·14 enrolled

A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects

Completed·VVanda Pharmaceuticals·Phase 1·NCT01402076·24 enrolled

Tics2 trials

Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine

Completed·VVanda Pharmaceuticals·Phase 1·NCT01540500·24 enrolled

Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.

Completed·VVanda Pharmaceuticals·Phase 1·NCT01637636·48 enrolled

Sleep2 trials

Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

Recruiting·VVanda Pharmaceuticals·Phase 3·NCT06701396·60 enrolled

A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)

Active, not recruiting·VVanda Pharmaceuticals·Phase 3·NCT04652882·70 enrolled

11 more indications

Sleep Disturbance1 trial

Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS

Completed·VVanda Pharmaceuticals·Phase 2/3·NCT02231008·49 enrolled

Adolescent1 trial

Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Completed·VVanda Pharmaceuticals·Phase 1·NCT02776215·24 enrolled

Autism Spectrum Disorder1 trial

Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances

Recruiting·VVanda Pharmaceuticals·Phase 3·NCT05361707·100 enrolled

MPA1 trial

Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects

Completed·VVanda Pharmaceuticals·Phase 1·NCT06323655·48 enrolled

Major Depressive Disorder1 trial

Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder

Completed·VVanda Pharmaceuticals·Phase 2/3·NCT01428661·507 enrolled

ART1 trial

The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

Terminated·—·Phase 1·NCT05922995·20 enrolled

Renal Impairment1 trial

Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function

Completed·VVanda Pharmaceuticals·Phase 1·NCT01526746·32 enrolled

Moderate Hepatic Impairment1 trial

Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

Completed·VVanda Pharmaceuticals·Phase 1·NCT01271387·29 enrolled

Smoking1 trial

Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects

Completed·VVanda Pharmaceuticals·Phase 1·NCT01477619·60 enrolled

Interaction1 trial

Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol

Completed·VVanda Pharmaceuticals·Phase 1·NCT01578057·28 enrolled

Unspecified2 trials

A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

Completed·VVanda Pharmaceuticals·Phase 2·NCT03291041·25 enrolled

Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers

Completed·VVanda Pharmaceuticals·Phase 1·NCT05572281·36 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 31, 2014

HETLIOZ

NDA NDA205677

Dec 1, 2020

HETLIOZ LQ

NDA NDA214517

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for tasimelteon. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Hetlioz drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — tasimelteon compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for tasimelteon. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214517). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Hetlioz. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Vanda Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Melatonin Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VVanda Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Jan 25, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11850229Jan 25, 2033

11826339Jan 25, 2033

RE46604Jan 25, 2033

10149829Jan 25, 2033

11918557Jan 25, 2033

28 more patents

9855241Jan 25, 2033

12201604Jan 25, 2033

9539234Jan 25, 2033

11833130Jan 25, 2033

9060995Jan 25, 2033

10449176Jan 25, 2033

9549913Jan 25, 2033

10980770Jan 25, 2033

10945988Jan 25, 2033

11285129Jan 25, 2033

11633377Jan 25, 2033

10610510Jan 25, 2033

11918556Apr 7, 2033

9730910May 17, 2034

10610511Oct 10, 2034

11786502Oct 10, 2034

11141400Oct 10, 2034

10829465Feb 12, 2035

11760740Feb 12, 2035

11566011Feb 12, 2035

12049457Feb 12, 2035

10071977Feb 12, 2035

10376487Jul 27, 2035

10179119Aug 29, 2035

11266622Aug 29, 2035

11202770Dec 11, 2040

12447141Dec 11, 2040

11759446Feb 21, 2041

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