Trial Outcomes & Findings for Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients (NCT NCT06126497)
NCT ID: NCT06126497
Last Updated: 2026-09-01
Results Overview
Participants with at least one Treatment-emergent adverse events (TEAEs) reported during the duration of the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
From Screening to Day 21
Results posted on
2026-09-01
Participant Flow
Participant milestones
| Measure |
Ropanicant 45 mg, QD
The participant received one tablet/day in the morning (for qd dosing).
Ropanicant: 45 mg Tablet
|
Ropanicant 30 mg, BID
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 30 Tablet
|
Ropanicant 45 mg, BID
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 45 mg Tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients
Baseline characteristics by cohort
| Measure |
Ropanicant 45 mg, QD
n=14 Participants
The participant received 1 tablet/day in the morning (for qd dosing).
Ropanicant: 45 mg Tablet
|
Ropanicant 30 mg, BID
n=13 Participants
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 30 mg Tablet
|
Ropanicant 45 mg, BID
n=13 Participants
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 45 mg Tablet
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=14 Participants
|
13 Participants
n=36 Participants
|
13 Participants
n=324 Participants
|
40 Participants
n=49 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 13.74 • n=14 Participants
|
39.5 years
STANDARD_DEVIATION 13.28 • n=36 Participants
|
52.5 years
STANDARD_DEVIATION 11.28 • n=324 Participants
|
44.9 years
STANDARD_DEVIATION 13.67 • n=49 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=14 Participants
|
9 Participants
n=36 Participants
|
9 Participants
n=324 Participants
|
28 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=14 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
12 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
4 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=14 Participants
|
13 Participants
n=36 Participants
|
11 Participants
n=324 Participants
|
36 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
1 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=14 Participants
|
6 Participants
n=36 Participants
|
8 Participants
n=324 Participants
|
21 Participants
n=49 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=14 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=324 Participants
|
18 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
13 participants
n=36 Participants
|
13 participants
n=324 Participants
|
40 participants
n=49 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
31.7 units on a scale
STANDARD_DEVIATION 3.50 • n=14 Participants
|
33.6 units on a scale
STANDARD_DEVIATION 6.27 • n=36 Participants
|
31.0 units on a scale
STANDARD_DEVIATION 3.42 • n=324 Participants
|
32.1 units on a scale
STANDARD_DEVIATION 4.58 • n=49 Participants
|
PRIMARY outcome
Timeframe: From Screening to Day 21Population: The analysis population considered is Safety Set which included all participants who received any study drug.
Participants with at least one Treatment-emergent adverse events (TEAEs) reported during the duration of the study.
Outcome measures
| Measure |
Ropanicant 45 mg, QD
n=14 Participants
The participant received 1 tablet/day in the morning (for qd dosing).
Ropanicant: 45 mg Tablet
|
Ropanicant 30 mg, BID
n=13 Participants
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 30 mg Tablet
|
Ropanicant 45 mg, BID
n=13 Participants
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 45 mg Tablet
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
6 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 14Population: The analysis population considered is modified Full Analysis Set (mFAS) which included all participants who were randomized, received study drug, and had a baseline and at least 1 post baseline efficacy assessment of MADRS.
Change from the baseline to the MADRS total score. The MADRS is a clinician-rated scale to assess depressive symptoms which consists of 10 items. The time frame for this scale is the past 7 days. Each item is scored on 7-point scale (0 \[absence of symptoms\] to 6 \[severe\]). The total score is the sum of 10 items and can take range from 0 to 60. A higher score represents a higher severity of the level of depression.
Outcome measures
| Measure |
Ropanicant 45 mg, QD
n=13 Participants
The participant received 1 tablet/day in the morning (for qd dosing).
Ropanicant: 45 mg Tablet
|
Ropanicant 30 mg, BID
n=12 Participants
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 30 mg Tablet
|
Ropanicant 45 mg, BID
n=13 Participants
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 45 mg Tablet
|
|---|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale (MADRS) Score
|
-10.5 score on a scale
Standard Deviation 7.47
|
-12.7 score on a scale
Standard Deviation 9.54
|
-10.4 score on a scale
Standard Deviation 6.51
|
Adverse Events
Ropanicant 45 mg, QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Ropanicant 30 mg, BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Ropanicant 45 mg, BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ropanicant 45 mg, QD
n=14 participants at risk
The participant received 1 tablet/day in the morning (for qd dosing)
Ropanicant: 45 mg Tablet
|
Ropanicant 30 mg, BID
n=13 participants at risk
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 30 mg Tablet
|
Ropanicant 45 mg, BID
n=13 participants at risk
The participant received 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant: 45 mg Tablet
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
15.4%
2/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Somnolence
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
15.4%
2/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Sucidal ideation
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
15.4%
2/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Abnormal dreams
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Aggression
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Euphoric mood
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Irritability
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Nervous system disorders
Sedation
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Infections and infestations
Localised infection
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Polydipsia
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
7.7%
1/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
0.00%
0/13 • From Screening to Day 21
The Safety Population included all patients from the Randomized Population who took at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60