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New Huntington's drug candidate SAGE-718 enters first human safety tests

NCT ID NCT03787758

Disease control Sponsor: Supernus Pharmaceuticals, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026

Summary

This early-stage trial tested the safety and tolerability of an experimental drug called SAGE-718 in 6 healthy adults and a small group of people with Huntington's disease. Researchers looked for side effects and measured how the drug moves through the body. The goal was to see if the drug is safe enough to study further, not to test if it works.

What this could mean

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

Active substance
SAGE-718
What this could lead to
If this early trial shows the drug is safe, it could pave the way for larger studies testing whether SAGE-718 can help control Huntington's disease symptoms.
What could go wrong
This is a very small, early-stage trial focused on safety, not effectiveness. The drug may not work for Huntington's or could have side effects. Results may not apply to all patients.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Feb 2019

Finished

Oct 2019

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 70 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: 1. Subject is positive for mutant HTT (documented CAG repeats ≥ 40 units). 2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening. Exclusion Criteria: 1. Subject has any clinically significant abnormal finding on the physical exam at screening or admission. 2. Subject has a history or presence of a neurologic disease or condition (other than Huntington's disease), including but not limited to severe chorea, epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure. 3. Subject has a family history of epilepsy. 4. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

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Conditions

The condition(s) this trial relates to.

Huntington disease

As listed by the trial registrant

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

Huntington disease

Contacts and locations

Locations

  • Sage Investigational Site

    Long Beach, California, 90806, United States

  • Sage Investigational Site

    Marlton, New Jersey, 08053, United States

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