Recent Updates
Recently added Catalysts

Troriluzole

Phase 3

Obsessive-Compulsive Disorder | Small molecule | Psychiatry |Biohaven Ltd.|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,471
FDA Designations
PRIORITY_REVIEW
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04693351A Study to Evaluate the Efficacy and Safety of Adjunctive Troriluzole in Obsessive-Compulsive DisorderPHASE3 COMPLETED 589Jan 29, 2021Apr 29, 2025May 22, 202689 United States, Canada +5
NCT04641143Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive DisorderPHASE3 COMPLETED 456Dec 22, 2020Oct 27, 2025Jan 7, 202673 United States
NCT03299166Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive DisorderPHASE2 COMPLETED 426Dec 19, 2017Dec 8, 2025Jan 22, 202657 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement)
Baseline and Week 8

Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement.

The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10

Improvement is measured by a lower total score

Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score
Baseline, Week 12

The Y-BOCS is a clinician-administered scale used extensively in research and clinical practice to both rate severity of obsessive compulsive disorder (OCD) and to monitor improvement during treatment. It is designed to rate the severity of obsessions and compulsions as well as the type of symptoms in patients with OCD. The scale consists of 10 items; the first 5 items assess obsessions, and the last 5 items assess compulsions. Subscale scores can be calculated for obsessions and compulsions, each on a scale of 0 to 20. A total score ranging from 0 to 40 can then be correlated to overall severity. The higher the number on the Y-BOCS, the more severe the symptoms.

Secondary Endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
From first dose up to approximately 12 weeks
Change From Baseline in Sheehan Disability Scale (SDS) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8
Baseline and Week 8
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8
Baseline and Week 8
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TroriluzoleEXPERIMENTALParticipants received troriluzole 200 milligrams (mg) (100 mg\*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg\*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase.
PlaceboPLACEBO_COMPARATORParticipants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase.
Interventions
NameTypeDescription
TroriluzoleDRUGCapsules for oral administration.
PlaceboDRUGDrug- matching capsules for oral administration.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites89

Key Inclusion Criteria: 1. Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening; the duration of the participants illness must be ≥ 1year 2. An inadequate response t...

Countries:United StatesCanadaChinaItalyNetherlandsSpainUnited Kingdom
Unlock Eligibility Criteria