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NCT06029426 (Navacaprant in Major Depressive Disorder): BVCT ex-ante prediction vs. reported outcome

On 14 Aug 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 2 Jan 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06029426
Acronym
KOASTAL-1
Drug Name
Navacaprant (NMRA-335140)
Drug MoA
KOR antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
Major Depressive Disorder
Human Patients
332
Sponsor
Neumora Therapeutics
Phase
Phase 3

Prediction of , index 1576

Prospective Prediction
Prediction Index
1576
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit non-superior non-inferior to aticaprant; yet inferior to lumateperone)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
141 days in advance
Readout Data Interpretation
navacaprant failed to meet the primary efficacy endpoint MADRS total score compared to placebo; non-superior to aticaprant that achieved borderline statistical significance in MADRS total score in phase 2 trial (p=0.044)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder
Phase
Phase 3
Status
Completed
Enrollment
383
Lead sponsor
Neumora Therapeutics, Inc.
Conditions
Major Depressive Disorder
Interventions
DRUG: NMRA-335140; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-09-20
Primary completion
2024-12-03
Completion
2025-01-15
Primary outcomes
  • Change from Baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score (Baseline and up to Week 6)

NCT06029426 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials