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 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
Related News

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

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Tasimelteon
Drug: Fluvoxamine
First Posted Date
2012-02-28
Last Posted Date
2014-02-17
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT01540500
Locations
🇺🇸

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

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

Phase 1
Completed
Conditions
Renal Impairment
Interventions
Drug: Tasimelteon
First Posted Date
2012-02-06
Last Posted Date
2014-02-17
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
32
Registration Number
NCT01526746
Locations
🇺🇸

DaVita Clinical Research, Minneapolis, Minnesota, United States

🇺🇸

Clinical Pharmacology of Miami, Inc., Miami, Florida, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

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

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Tasimelteon
First Posted Date
2011-11-22
Last Posted Date
2014-02-17
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
60
Registration Number
NCT01477619
Locations
🇺🇸

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

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

First Posted Date
2011-09-08
Last Posted Date
2014-10-10
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
20
Registration Number
NCT01430754
Locations
🇺🇸

PAB Clinical Research Inc., Brandon, Florida, United States

🇺🇸

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

🇺🇸

Todd J. Swick, M.D., P.A., Houston, Texas, United States

and more 19 locations

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

Phase 2
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: placebo
Drug: tasimelteon
First Posted Date
2011-09-05
Last Posted Date
2015-06-19
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
507
Registration Number
NCT01428661
Locations
🇺🇸

Vanda Investigational Site, Brown Deer, Wisconsin, United States

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

Phase 3
Completed
Conditions
Non-24-Hour Sleep-Wake Disorder
Interventions
Drug: tasimelteon
First Posted Date
2011-09-05
Last Posted Date
2015-04-21
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
200
Registration Number
NCT01429116
Locations
🇺🇸

SleepMed, Inc. - Columbia, Columbia, South Carolina, United States

🇺🇸

SDS Clinical Trials Inc., Orange, California, United States

🇺🇸

VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area), Palo Alto, California, United States

and more 19 locations

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

First Posted Date
2011-07-26
Last Posted Date
2014-02-17
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT01402076
Locations
🇺🇸

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

Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

Phase 1
Completed
Conditions
Hepatic Impairment
Interventions
Drug: tasimelteon
First Posted Date
2011-01-06
Last Posted Date
2014-02-17
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
29
Registration Number
NCT01271387
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

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

Phase 3
Active, not recruiting
Conditions
Non 24 Hour Sleep Wake Disorder
Interventions
Drug: tasimelteon
First Posted Date
2010-10-11
Last Posted Date
2024-04-03
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
140
Registration Number
NCT01218789

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

First Posted Date
2010-07-15
Last Posted Date
2014-10-16
Lead Sponsor
Vanda Pharmaceuticals
Target Recruit Count
136
Registration Number
NCT01163032
Locations
🇺🇸

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

🇺🇸

SDS Clinical Trials Inc., Orange, California, United States

🇺🇸

St. Johns Sleep Disorder Center - St. Johns Medical Plaza, Santa Monica, California, United States

and more 25 locations
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