Tasimelteon

Generic Name: Tasimelteon

Brand Names: Hetlioz

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₉NO_₂

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 exte...

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...

Associated Conditions: Non 24 Hour Sleep Wake Disorder, Sleep Disturbance

Associated Therapies: -

Clinical Trials

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: Drug: Tasimelteon

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: Drug: tasimelteon

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: Drug: tasimelteon
Drug: Rifampin
Drug: Ketoconazole

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: Drug: tasimelteon
Drug: Placebo ethanol
Other: Placebo tasimelteon
Drug: Ethanol

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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