BioinvestGPT ApS · Research use only

NCT06419608 (BHV-7000 in Major Depressive Disorder): BVCT ex-ante prediction vs. reported outcome

On 28 Jul 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 24 Dec 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

Drug Name
BHV-7000
Drug MoA
KCNQ2/KCNQ3 activator
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
Major Depressive Disorder
Human Patients
336
Sponsor
Biohaven
Phase
Phase 2

Prediction of , index 2037

Prospective Prediction
Prediction Index
2037
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in MADRS slightly-to-moderately inferior to lumateperone and moderately-to-strongly inferior to deuterated psilocin)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in MADRS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
149 days in advance
Readout Data Interpretation
BHV-7000 failed to meet the primary endpoint of MADRS over six weeks compared with placebo; results do not support advancing BHV-7000 in MDD
Press Release
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 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder
Phase
Phase 2
Status
Completed
Enrollment
336
Lead sponsor
Biohaven Therapeutics Ltd.
Conditions
Major Depressive Disorder
Interventions
DRUG: BHV-7000; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-05-28
Primary completion
2025-11-07
Completion
2025-11-07
Primary outcomes
  • Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6 (Baseline to Week 6)

NCT06419608 on ClinicalTrials.gov

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