19 completed, 1 recruiting, 1 terminated, 1 unknown. 10 Phase 1, 9 Phase 3, 3 Phase 2, 1 Early Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 10 |
| Phase 3 | 9 | Completed 7, Recruiting 1, Unknown 1 |
| Phase 2 | 3 | Completed 3 |
| Early Phase 1 | 1 | Terminated 1 |
| Phase 4 | 1 | Completed 1 |
Follow tasimelteon: new trials by email Literature Review of tasimelteon trials Research Report on tasimelteon
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant Tasimelteon, Placebo - Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm | Phase 3 | Recruiting | Vanda Pharmaceuticals | 60 | 2024-10-08 | 2024-11-22 |
| The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD) Tasimelteon - REM Behavior Disorder | Early Phase 1 | Terminated | Brigham and Women's Hospital | 20 | 2023-09-30 | 2025-10-09 |
| Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers Tasimelteon Oral Capsule, Tasimelteon Oral Suspension - Healthy | Phase 1 | Completed | Vanda Pharmaceuticals | 36 | 2022-05-18 | 2024-03-21 |
| Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) Tasimelteon, Placebo - Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm | Phase 3 | Completed | Vanda Pharmaceuticals | 43 | 2020-12-09 | 2026-10-09 |
| Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects Tasimelteon, Active Control Placebo, Tasimelteon Placebo - Healthy Volunteers | Phase 1 | Completed | Vanda Pharmaceuticals | 48 | 2018-07-19 | 2024-03-21 |
| Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia Tasimelteon, Placebo - Jet Lag Type Insomnia | Phase 3 | Completed | Vanda Pharmaceuticals | 320 | 2017-10-16 | 2023-09-15 |
| Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents tasimelteon - Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder | Phase 1 | Completed | Vanda Pharmaceuticals | 24 | 2016-10-04 | 2024-03-21 |
| A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder Tasimelteon, Placebo - Jet Lag Disorder | Phase 2 | Completed | Vanda Pharmaceuticals | 25 | 2016-07-01 | 2021-11-03 |
| Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS tasimelteon, placebo - Smith-Magenis Syndrome, Circadian | Phase 2 / Phase 3 | Completed | Vanda Pharmaceuticals | 49 | 2015-09-01 | 2022-11-18 |
| Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™) tasimelteon 20 mg capsule, tasimelteon 2 mg I.V. - Non-24-Hour-Sleep-Wake Disorder | Phase 4 | Completed | Vanda Pharmaceuticals | 14 | 2014-05-01 | 2016-08-22 |
| Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin. tasimelteon, Rifampin, Ketoconazole - Healthy | Phase 1 | Completed | Vanda Pharmaceuticals | 48 | 2012-06-01 | 2014-02-17 |
| Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol tasimelteon, Ethanol, Placebo tasimelteon - Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol | Phase 1 | Completed | Vanda Pharmaceuticals | 28 | 2012-04-01 | 2014-02-17 |
| Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function Tasimelteon - Renal Impairment | Phase 1 | Completed | Vanda Pharmaceuticals | 32 | 2012-02-01 | 2014-02-17 |
| Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine Tasimelteon, Fluvoxamine - Healthy Volunteers | Phase 1 | Completed | Vanda Pharmaceuticals | 24 | 2012-02-01 | 2014-02-17 |
| Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects Tasimelteon - Healthy Volunteers | Phase 1 | Completed | Vanda Pharmaceuticals | 60 | 2011-11-01 | 2014-02-17 |
| Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception tasimelteon - Non-24-Hour Sleep-Wake Disorder | Phase 3 | Completed | Vanda Pharmaceuticals | 200 | 2011-10-01 | 2015-04-21 |
| Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder tasimelteon, placebo - Major Depressive Disorder | Phase 2 / Phase 3 | Completed | Vanda Pharmaceuticals | 507 | 2011-09-01 | 2015-06-19 |
| Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder tasimelteon, Placebo - Non-24-Hour Sleep-Wake Disorder | Phase 3 | Completed | Vanda Pharmaceuticals | 20 | 2011-09-01 | 2014-10-10 |
| A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects Tasimelteon, Rosiglitazone, Midazolam - Healthy Volunteers | Phase 1 | Completed | Vanda Pharmaceuticals | 24 | 2011-08-01 | 2014-02-17 |
| Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment tasimelteon - Hepatic Impairment | Phase 1 | Completed | Vanda Pharmaceuticals | 29 | 2011-01-01 | 2014-02-17 |
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Sleep Disorders, Circadian Rhythm (8) · Chronobiology Disorders (6) · Sleep Wake Disorders (6) · Blindness (4) · Dyssomnias (4) · Eye Diseases (4) · Nervous System Diseases (4) · Smith-Magenis Syndrome (2) · Autism Spectrum Disorder (1) · Depression (1) · Depressive Disorder, Major (1) · Kidney Diseases (1) · Kidney Failure, Chronic (1) · Liver Diseases (1) · REM Sleep Behavior Disorder (1)
Vanda Pharmaceuticals (21) · Brigham and Women's Hospital (1)
United States (17) · Canada (2) · Germany (2) · Austria (1) · France (1) · Turkey (Türkiye) (1)