MedPath

Tasimelteon

Generic Name
Tasimelteon
Brand Names
Hetlioz
Drug Type
Small Molecule
Chemical Formula
C15H19NO2
CAS Number
609799-22-6
Unique Ingredient Identifier
SHS4PU80D9
Background

Tasimelteon is a selective dual melatonin receptor agonist indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD). Occurring commonly in blind individuals without light perception, this condition is often characterized by periods of night-time insomnia and day-time sleepiness. In blind individuals, a lack of light stimulation causes an extension of the 24-hour circadian cycle and can lead to progressively delayed sleep onset. By activating melatonin receptors MT1 and MT2 in the suprachiasmatic nucleus of the brain, tasimelteon has been shown to improve sleep by resynchronizing the circadian rhythm through its "non-photic" mechanism. Tasimelteon is currently the only drug available for the treatment of N24HSWD and was granted orphan drug status by the FDA in 2010.

Indication

Tasimelteon oral capsules are indicated for the treatment of non-24 hour sleep-wake disorder in adult patients and for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome in patients ≥16 years old. Tasimelteon oral suspension is indicated for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome in patients 3 to 15 years of age.

Associated Conditions
Non 24 Hour Sleep Wake Disorder, Sleep Disturbance
Associated Therapies
-

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

Phase 3
Recruiting
Conditions
Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Gene Mutations and Other Alterations Nec
Interventions
Drug: Placebo
Drug: Tasimelteon
First Posted Date
2024-11-22
Last Posted Date
2024-11-22
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
60
Registration Number
NCT06701396
Locations
🇹🇷

Vanda Investigational Site, Çankaya, Ankara, Turkey

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

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Tasimelteon
Drug: Active Control
Drug: Active Control Placebo
Drug: Tasimelteon Placebo
First Posted Date
2024-03-21
Last Posted Date
2024-03-21
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
48
Registration Number
NCT06323655
Locations
🇨🇦

Vanda Investigational Site, Laval, Quebec, Canada

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

Early Phase 1
Not yet recruiting
Conditions
REM Behavior Disorder
Interventions
First Posted Date
2023-06-28
Last Posted Date
2023-06-29
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
20
Registration Number
NCT05922995
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

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

Phase 3
Recruiting
Conditions
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Sleep Wake Disorders
Interventions
Drug: Tasimelteon
Drug: Placebo
First Posted Date
2020-12-03
Last Posted Date
2024-11-19
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
70
Registration Number
NCT04652882
Locations
🇩🇪

Vanda Investigational Site, Schwerin, Germany

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

Phase 3
Completed
Conditions
Jet Lag Type Insomnia
Interventions
Drug: Placebo
Drug: Tasimelteon
First Posted Date
2017-12-14
Last Posted Date
2023-09-15
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
320
Registration Number
NCT03373201
Locations
🇺🇸

Vanda Investigational Site, Houston, Texas, United States

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

Phase 2
Completed
Conditions
Jet Lag Disorder
Interventions
Drug: Placebo
Drug: Tasimelteon
First Posted Date
2017-09-25
Last Posted Date
2021-11-03
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
25
Registration Number
NCT03291041
Locations
🇺🇸

Vanda Investigational Site, Chevy Chase, Maryland, United States

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

Phase 1
Completed
Conditions
Circadian Rhythm Sleep Disorders
Non-24 Hour Sleep-Wake Disorder
Autism Spectrum Disorder
Smith-Magenis Syndrome
Interventions
First Posted Date
2016-05-18
Last Posted Date
2024-03-21
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT02776215
Locations
🇺🇸

Parexel Early Phase Clinical Unit, Baltimore, Maryland, United States

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

Phase 2
Completed
Conditions
Smith-Magenis Syndrome
Circadian
Interventions
Drug: tasimelteon
Drug: placebo
First Posted Date
2014-09-03
Last Posted Date
2022-11-18
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
49
Registration Number
NCT02231008

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

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2012-07-11
Last Posted Date
2014-02-17
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
48
Registration Number
NCT01637636
Locations
🇺🇸

QPS Bio-Kinetic Clinical Applications, Springfield, Missouri, United States

Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol

Phase 1
Completed
Conditions
Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol
Interventions
First Posted Date
2012-04-16
Last Posted Date
2014-02-17
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
28
Registration Number
NCT01578057
Locations
🇨🇦

INC Research Toronto, Inc., Toronto, Ontario, Canada

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