Ropanicant for Depression

Recruiting at 26 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Suven Life Sciences Limited

Disqualifiers: Treatment-resistant depression, Pregnancy, Heart rate issues, others

Prior Safety Data This treatment has passed at least one previous human trial

2 Power Preferred Clinics 2 of this trial's clinics are considered top 20 on Power

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

195 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Ropanicant to determine if it helps people with Major Depressive Disorder (MDD) feel better. Researchers aim to compare two different doses of Ropanicant to a placebo (a pill with no active drug) to identify which dose best reduces symptoms of depression. Suitable candidates for this trial are those who have experienced a major depressive episode for at least four weeks but not longer than a year and have not found relief with other treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Ropanicant is likely to be safe for humans?

Research has shown that Ropanicant is safe and well-tolerated. For example, tests with healthy individuals did not reveal serious side effects, even with multiple doses. Another study involving people with moderate to severe depression also demonstrated good safety results. Participants generally handled the treatment well without major issues. These findings suggest that Ropanicant could be a safe option for those considering joining a clinical trial for depression treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Ropanicant is unique because it may offer a new way to tackle depression by targeting different brain pathways than traditional antidepressants, such as SSRIs and SNRIs. Unlike these standard treatments, which primarily increase serotonin or norepinephrine levels, Ropanicant works on the nicotinic acetylcholine receptors. Researchers are excited because this novel mechanism could help patients who don’t respond well to existing medications, potentially offering faster relief and fewer side effects.

What evidence suggests that Ropanicant might be an effective treatment for depression?

Studies have shown that Ropanicant can help alleviate depression symptoms. Research indicates that Ropanicant improved depression scores by 5.9 to 13.4 points within just one week, meaning many patients felt better quickly. Ropanicant blocks certain brain receptors, which might help improve mood. Previous patients found it safe and well-tolerated. Overall, evidence suggests Ropanicant could be a promising option for treating major depressive disorder. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Major Depressive Disorder (MDD) as defined by DSM-5-TR, experiencing a depressive episode lasting between 4 weeks and 12 months. Participants must have moderate to severe depression intensity and anhedonia. They need adequate vision and hearing for tests.

Inclusion Criteria

Have you felt consistently depressed for over a month?

Exclusion Criteria

Have you tried 2 or more antidepressants during your current depressive episode that haven't worked for you?

Have you felt consistently depressed (with no weeks where you felt happy) for over a year?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive Ropanicant or placebo for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ropanicant

Trial Overview The study aims to test the effectiveness of Ropanicant at two different doses versus a placebo in treating MDD. Patients will be randomly assigned to receive either the medication or placebo to compare outcomes.

How Is the Trial Designed?

Group I: Ropanicant Dose Level 2 Experimental Treatment 1 Intervention

Group II: Ropanicant Dose Level 1 Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Suven Life Sciences Limited

Lead Sponsor

Trials

14

Recruited

1,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06126497

Study Evaluating Safety and Efficacy of Ropanicant in MDD ... This is an open-label, parallel-group study to evaluate the safety and efficacy of ropanicant in participants with moderate to severe Major Depressive Disorder ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35963959/

Safety, Tolerability, and Pharmacokinetics of Ropanicant ... Conclusions: Ropanicant was found to be safe and well tolerated following single and multiple oral administrations in healthy subjects.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06836063

NCT06836063 | Study to Evaluate Efficacy and Safety of ... The primary objective is to evaluate the efficacy of Ropanicant at two different dosage levels compared to placebo in patients with Major Depressive Disorder ( ...

4. suven.com suven.com/pdf/SUVENNewsRelease18092024.pdf

CSD/BSE&NSE/PR/2024-2025 Treatment with Ropanicant resulted in mean improvement from the baseline in MADRS total score of 5.9 to 13.4 points at Day 7, and 10.4 to 12.7 ...

5. trial.medpath.com trial.medpath.com/news/a70b0425985765df/suven-life-sciences-to-present-positive-results-from-phase-2a-proof-of-concept-study-of-ropanicant

Suven Life Sciences' Ropanicant Shows Positive Phase 2a ... Ropanicant, an α4β2 nicotinic acetylcholine receptor (nAChR) antagonist, demonstrated promising safety and efficacy outcomes in the open-label Phase 2a study.

6. suven.com suven.com/pdf/EventUpdates-Oct27-2025.pdf

Suven Life Sciences Limited In. Phase-1 trials, Ropanicant was safe and well tolerated at the highest doses, with no significant effects from food or age. The Phase-2a ...