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New depression pill zelquistinel passes first safety check in humans

NCT ID NCT04981561

Symptom relief Sponsor: Syndeio Biosciences, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested the safety of a single dose of zelquistinel, an experimental drug for major depressive disorder, in 68 healthy adults. Researchers monitored side effects and how the drug moves through the body. Since it was a Phase 1 study, it focused on safety and dosing, not on treating depression.

What this could mean

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

Active substance
zelquistinel
What this could lead to
If successful, this could lead to a new oral medication for major depressive disorder.
What could go wrong
This is a very early Phase 1 safety study in healthy people, not patients. It does not test if the drug works for depression, and many drugs fail at this stage.

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

68 people

The number who actually took part.

Started

Dec 2016

Finished

Dec 2017

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 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Agree to effective method of birth control * If female, negative pregnancy test at screening and Day -1 * Nonsmoking at least 2 years * BMI 18-30 * Supine pulse rate 30-100 Exclusion Criteria: * Known hypersensitivity to NMDA receptor drugs * clinically significant disease in any body system * QTcF \> 430 ms in males, \>450 ms in females * positive test for hepatitis B or C * abnormal liver function tests on Day -1 * History of alcohol or other substance abuse during the previous 5 years * Positive drug screen at screening or Day -1 * Taken any medication within the past 14 days

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

More trials for these conditions

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