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New depression pill shows promise in early trial

NCT ID NCT06126497

Symptom relief Sponsor: Suven Life Sciences Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study tested a new drug called ropanicant in 41 adults with moderate to severe major depressive disorder. The main goal was to check safety and side effects, while also measuring how well it improved depression symptoms using a standard rating scale. The trial was open-label, meaning everyone knew they were getting the drug, and it has already been completed.

What this could mean

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

Active substance
ropanicant (also known as SUVN-911)
What this could lead to
If successful, this could point toward a new treatment option for people with moderate to severe depression.
What could go wrong
This was a small, early-phase trial (41 people) with no placebo group, so results may not be reliable or generalizable. Side effects are possible and long-term benefits are unknown.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

41 people

The number who actually took part.

Started

Feb 2024

Finished

Jul 2024

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 65 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: * Participants must meet the DSM-5 criteria for MDD without psychotic features and diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI). * Participants with a current major depressive episode of at least 4 weeks of duration prior to the screening visit. * Participants must have an MADRS score of ≥25 at the screening and the baseline visits. * Participants must have a score of ≥4 on Clinical Global Impression - Severity (CGI-S) Scale at the screening and the baseline visits. Exclusion Criteria: * Participants who meet criteria for treatment-resistant depression during the current major depressive episode, which will be defined as being non-responders (less than 50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire (ATRQ). * Participants taking antidepressant treatment (SSRIs and SNRIs) or any medication that is contraindicated with the use of monoamine oxidase inhibitors (eg, opioids, stimulants) within 2 weeks (or 5 half-lives, whichever is longer) prior to baseline and until the end of study visit. * Participants who do not agree to avoid tyramine rich diet from the start of dosing and until 2 weeks following last study drug administration. * Participants who are habitual smokers or using nicotine products.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

Contacts and locations

Locations

  • Cedar Clinical Research, Inc.

    Murray, Utah, 84107, United States

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030, United States

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405, United States

  • Clinical Innovations, Inc

    Bellflower, California, 90706, United States

  • Collaborative Neuroscience Research, LLC

    Torrance, California, 90504, United States

  • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

    Everett, Washington, 98201, United States

  • Innovative Clinical Research, Inc.

    Miami Lakes, Florida, 33016, United States

  • NRC Research Institute

    Orange, California, 92868, United States

  • Neuro behavioral Clinical Research, Inc

    North Canton, Ohio, 44720, United States

  • Precise Research Centers

    Flowood, Mississippi, 39232, United States

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