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Could a new pill fix your body clock? phase 3 trial underway

NCT ID NCT04652882

Symptom relief Sponsor: Vanda Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether the drug tasimelteon can help people with Delayed Sleep-Wake Phase Disorder (DSWPD) fall asleep earlier and sleep better. 70 adults with DSWPD will receive either tasimelteon or a placebo daily. The study measures sleep onset and quality using sleep diaries and activity monitors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tasimelteon
What this could lead to
If it works, this could provide a new treatment option to help people with DSWPD fall asleep earlier and improve their sleep quality.
What could go wrong
This is a Phase 3 trial, but it's small (70 participants) and results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.
Why investors are watching

Vanda Pharmaceuticals is running a Phase 3 trial of tasimelteon, a daily pill, against placebo in 70 people with delayed sleep-wake phase disorder, a condition where the body's sleep clock runs late. For a small company, this readout matters because tasimelteon is a key product in its pipeline, and a positive result could support a new approval and broaden its revenue base beyond its existing drugs.

If it works: If the trial shows tasimelteon helps people fall asleep and wake at more normal times, Vanda could seek regulatory approval for this new use, adding a second market for the drug. That would give the company a larger commercial opportunity and reduce its reliance on a single product.

If it fails: Phase 3 trials often fail, and if tasimelteon does not beat placebo, Vanda would have to abandon this indication, losing the time and money spent on the study. A negative result could also raise doubts about the drug's broader potential and pressure the company's outlook.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability and acceptance to provide written informed consent. * A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD). * Men or women between 18 - 75 years, inclusive. * Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m\^2. Exclusion Criteria: * Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 months. * Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days. * Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding. * A positive test for substances of abuse. * Current tobacco user.

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Conditions

The condition(s) this trial relates to.

Chronobiology Disorders circadian rhythm sleep disorder circadian rhythm sleep disorder, delayed sleep phase type sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronobiology disorders Sleep disorders, circadian rhythm Sleep wake disorders

Contacts and locations

Locations

  • Vanda Investigational Site

    Los Angeles, California, 90025, United States

  • Vanda Investigational Site

    Redwood City, California, 94063, United States

  • Vanda Investigational Site

    Aurora, Colorado, 80045, United States

  • Vanda Investigational Site

    Boston, Massachusetts, 02115, United States

  • Vanda Investigational Site

    St Louis, Missouri, 63123, United States

  • Vanda Investigational Site

    New Hyde Park, New York, 11042, United States

  • Vanda Investigational Site

    Cincinnati, Ohio, 45212, United States

  • Vanda Investigational Site

    Cleveland, Ohio, 44195, United States

  • Vanda Investigational Site

    Columbia, South Carolina, 29201, United States

  • Vanda Investigational Site

    San Antonio, Texas, 78229, United States

  • Vanda Investigational Site

    Sherman, Texas, 75092, United States

  • Vanda Investigational Site

    Innsbruck, 6020, Austria

  • Vanda Investigational Site

    Vienna, 1090, Austria

  • Vanda Investigational Site

    Berlin, 10117, Germany

  • Vanda Investigational Site

    Hamburg, 20253, Germany

  • Vanda Investigational Site

    Marburg, 35043, Germany

  • Vanda Investigational Site

    Schwerin, 19053, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.