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Showing 1–20 of 20 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Tasimelteon Clear all
Active, not recruiting Phase 3 Interventional

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

NCT04652882
View directory record Official record
Conditions
Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders
Interventions
Tasimelteon, Placebo
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
11
States / cities
Los Angeles, California • Redwood City, California • Aurora, Colorado + 8 more
Source: ClinicalTrials.gov public record
Updated Jul 26, 2026 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01402076
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Tasimelteon, Rosiglitazone, Midazolam
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011
U.S. locations
1
States / cities
Springfield, Missouri
Source: ClinicalTrials.gov public record
Updated Feb 16, 2014 · Synced Sep 2, 2026, 4:01 PM EDT
Recruiting Phase 3 Interventional

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

NCT06953869
View directory record Official record
Conditions
Insomnia Disorder
Interventions
Tasimelteon Oral Suspension, Placebo
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
2 Years to 17 Years
Enrollment
420 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
21
States / cities
Dothan, Alabama • Phoenix, Arizona • Irvine, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 3 Interventional

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

NCT01429116
View directory record Official record
Conditions
Non-24-Hour Sleep-Wake Disorder
Interventions
tasimelteon
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
22
States / cities
Phoenix, Arizona • Orange, California • Palo Alto, California + 19 more
Source: ClinicalTrials.gov public record
Updated Apr 20, 2015 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 3 Interventional Results available

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

NCT01430754
View directory record Official record
Conditions
Non-24-Hour Sleep-Wake Disorder
Interventions
tasimelteon, Placebo
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
Not listed
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
22
States / cities
Phoenix, Arizona • Orange, California • Palo Alto, California + 19 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2014 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01637636
View directory record Official record
Conditions
Healthy
Interventions
tasimelteon, Rifampin, Ketoconazole
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
Springfield, Missouri
Source: ClinicalTrials.gov public record
Updated Feb 16, 2014 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01526746
View directory record Official record
Conditions
Renal Impairment
Interventions
Tasimelteon
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 79 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
3
States / cities
Miami, Florida • Orlando, Florida • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Feb 16, 2014 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 3 Interventional Results available

VEC-162 Study in Adult Patients With Primary Insomnia

NCT00548340
View directory record Official record
Conditions
Primary Insomnia
Interventions
VEC-162 20 mg, Placebo, VEC-162 50 mg
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 64 Years
Enrollment
322 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
35
States / cities
Birmingham, Alabama • Hot Springs, Arkansas • Little Rock, Arkansas + 32 more
Source: ClinicalTrials.gov public record
Updated Oct 14, 2014 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01477619
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Tasimelteon
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2012
U.S. locations
1
States / cities
Springfield, Missouri
Source: ClinicalTrials.gov public record
Updated Feb 16, 2014 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 2Phase 3 Interventional

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

NCT02231008
View directory record Official record
Conditions
Smith-Magenis Syndrome, Circadian
Interventions
tasimelteon, placebo
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
3 Years to 65 Years
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2022
U.S. locations
4
States / cities
Santa Monica, California • Baltimore, Maryland • Chevy Chase, Maryland + 1 more
Source: ClinicalTrials.gov public record
Updated Nov 17, 2022 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 1 Interventional

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

NCT02776215
View directory record Official record
Conditions
Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder, Autism Spectrum Disorder, Smith-Magenis Syndrome
Interventions
tasimelteon
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
3 Years to 17 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 20, 2024 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT05572281
View directory record Official record
Conditions
Healthy
Interventions
Tasimelteon Oral Capsule, Tasimelteon Oral Suspension
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Springfield, Missouri
Source: ClinicalTrials.gov public record
Updated Mar 20, 2024 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

NCT01271387
View directory record Official record
Conditions
Hepatic Impairment
Interventions
tasimelteon
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
29 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011
U.S. locations
1
States / cities
Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Feb 16, 2014 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 2Phase 3 Interventional Results available

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

NCT01428661
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
tasimelteon, placebo
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years
Enrollment
507 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
40
States / cities
Garden Grove, California • Irvine, California • Los Alamitos, California + 36 more
Source: ClinicalTrials.gov public record
Updated Jun 18, 2015 · Synced Sep 2, 2026, 4:01 PM EDT
Not listed Phase 3 Interventional

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

NCT05361707
View directory record Official record
Conditions
Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance
Interventions
Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
2 Years to 65 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
5
States / cities
San Jose, California • San Leandro, California • Santa Monica, California + 2 more
Source: ClinicalTrials.gov public record
Updated Mar 20, 2024 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 3 Interventional Results available

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

NCT01163032
View directory record Official record
Conditions
Non-24-Hour Sleep-Wake Disorder
Interventions
tasimelteon, Placebo
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
23
States / cities
Phoenix, Arizona • Orange, California • Palo Alto, California + 20 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2014 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 3 Interventional Accepts healthy volunteers Results available

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

NCT03373201
View directory record Official record
Conditions
Jet Lag Type Insomnia
Interventions
Tasimelteon, Placebo
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
320 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2018
U.S. locations
12
States / cities
Little Rock, Arkansas • Alameda, California • San Diego, California + 9 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2023 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

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

NCT03291041
View directory record Official record
Conditions
Jet Lag Disorder
Interventions
Tasimelteon, Placebo
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
25 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2017
U.S. locations
3
States / cities
Alameda, California • Santa Monica, California • Chevy Chase, Maryland
Source: ClinicalTrials.gov public record
Updated Nov 2, 2021 · Synced Sep 2, 2026, 4:01 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT01540500
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Tasimelteon, Fluvoxamine
Drug
Lead sponsor
Vanda Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
Springfield, Missouri
Source: ClinicalTrials.gov public record
Updated Feb 16, 2014 · Synced Sep 2, 2026, 4:01 PM EDT
Terminated Early Phase 1 Interventional

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

NCT05922995
View directory record Official record
Conditions
REM Behavior Disorder
Interventions
Tasimelteon
Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years to 85 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 8, 2025 · Synced Sep 2, 2026, 4:01 PM EDT