Troriluzole

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Biohaven Ltd. BHVN · Obsessive-Compulsive Disorder; Spinocerebellar Ataxias; Spinocerebellar Ataxia Genotype Type 1; Spinocerebellar Ataxia Genotype Type 10; Spinocerebellar Ataxia Genotype Type 2

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    5

    From ClinicalTrials.gov

  • Latest FDA action

    Complete response letter

    NDA210862,

Recalls, shortages, patents and EU status at a glance

Key information

Indications
Obsessive-Compulsive Disorder; Spinocerebellar Ataxias; Spinocerebellar Ataxia Genotype Type 1; Spinocerebellar Ataxia Genotype Type 10; Spinocerebellar Ataxia Genotype Type 2 Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 CompletedFirst trial start 15 Dec 20162 linked trials
  4. Phase 3 Current stageFirst trial start 15 Dec 20165 linked trials
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Troriluzole. Editors add each one with its source.

Filed application

No filed application is on record for Troriluzole. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Troriluzole.

Clinical trials

Trials linked to Troriluzole
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT04693351ClinicalTrials.gov record for NCT04693351 (opens in a new tab)A Study to Evaluate the Efficacy and Safety of Adjunctive Troriluzole in Obsessive-Compulsive DisorderPhase 3Completed589 (actual)29 Apr 2025 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04693351 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT04693351

  • 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) (score on a scale)
    • Troriluzole vs Placebo: Least squares mean difference 0.97 (95% CI 0.02 to 1.92), p-value 0.041, Mixed Models Analysis, superiority

Serious adverse events (For Adverse Events: From first dose up to approximately 12 weeks For All-cause Mortality: From Day 1 up to approximately 12 weeks): Troriluzole 3 of 292; Placebo 2 of 289

Source: ClinicalTrials.gov results for NCT04693351 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

NCT04641143ClinicalTrials.gov record for NCT04641143 (opens in a new tab)Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive DisorderPhase 3Completed456 (actual)27 Oct 2025 (actual) No
NCT03701399ClinicalTrials.gov record for NCT03701399 (opens in a new tab)Troriluzole in Adult Participants With Spinocerebellar AtaxiaPhase 3Active, not recruiting299 (actual)18 Feb 2022 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03701399 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT03701399

  • Randomization Phase: Change From Baseline in the Modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA) Total Score at Week 48 in SCA Participants (score on a scale)
    • Troriluzole vs Placebo: Least squares mean difference -0.06 (95% CI -0.47 to 0.34), p-value 0.7581, Mixed Models Analysis, superiority
    • Troriluzole vs Placebo: Least square mean difference -0.56 (95% CI -1.11 to -0.01), p-value 0.0450, Mixed Models Analysis, superiority

Serious adverse events (For Adverse events (AEs): From first dose of study drug up to Week 48 plus 30 days (maximum duration: 52 weeks) For All-cause mortality: From randomization up to Week 48 plus 30 days (maximum duration: 52 weeks)): Troriluzole 6 of 108; Placebo 8 of 109

Source: ClinicalTrials.gov results for NCT03701399 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing NCT03701399 (3), newest first

  1. Measurement Properties of the Friedreich Ataxia Rating Scale in Patients with Spinocerebellar Ataxia.

    Neurology and therapy · 2025 Apr

  2. Video-Based Kinematic Analysis of Movement Quality in a Phase 3 Clinical Trial of Troriluzole in Adults with Spinocerebellar Ataxia: A Post Hoc Analysis.

    Neurology and therapy · 2024 Aug

  3. Development and Validation of a Patient-Reported Outcome Measure of Ataxia.

    Movement disorders : official journal of the Movement Disorder Society · 2021 Oct

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT03299166ClinicalTrials.gov record for NCT03299166 (opens in a new tab)Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive DisorderPhase 2/3Completed426 (actual)2 Jun 2020 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03299166 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT03299166

  • Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score (Scores on a scale)
    • Troriluzole - Randomization Phase vs Placebo - Randomization Phase: LS Mean Difference -1.00 (95% CI -2.59 to 0.60), p-value 0.2202, Mixed Models Analysis, superiority

Serious adverse events (Randomization Phase: Maximum duration: 12 weeks): Troriluzole - Randomization Phase 0 of 122; Placebo - Randomization Phase 0 of 122

Source: ClinicalTrials.gov results for NCT03299166 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

NCT02960893ClinicalTrials.gov record for NCT02960893 (opens in a new tab)Trial in Adult Participants With Spinocerebellar Ataxia (SCA)Phase 2/3Completed141 (actual)18 Aug 2017 (actual) Yes First posted Results on ClinicalTrials.gov for NCT02960893 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT02960893

  • Change From Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Randomization Phase Week 8 (score on a scale)
    • Troriluzole - Randomization Phase vs Placebo - Randomization Phase: LS Mean 0.2 (95% CI -0.5 to 0.9), p-value 0.519, Mixed Model with Repeated Measures, superiority

Serious adverse events (From first dose of study drug to 30 days post the last dose in the OLE Phase (Up to 348 weeks after last randomization participant was enrolled)): Troriluzole - Randomization Phase 4 of 71; Placebo - Randomization Phase 1 of 70; Troriluzole/Troriluzole - OLE Phase 11 of 64; Placebo/Troriluzole - OLE Phase 9 of 67

Source: ClinicalTrials.gov results for NCT02960893 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing NCT02960893 (1), newest first

  1. Development and Validation of a Patient-Reported Outcome Measure of Ataxia.

    Movement disorders : official journal of the Movement Disorder Society · 2021 Oct

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Troriluzole, newest first
ApplicationActionDateOutcomeReviewSource
NDA210862Action letter for NDA210862 (opens in a new tab) Original 20251104 Complete Response letterComplete response letterNot givenopenFDA complete response letters (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

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EU status (EMA)

Application withdrawn

Dazluma (EMEA/H/C/006068)

Authorised
Not given
Therapeutic area
Spinocerebellar Ataxias
Marketing authorisation holder
Biohaven Bioscience Ireland Limited
Active substance (INN)
troriluzole
ATC code
N07XX

Matched by active substance: EMA's INN or active substance equals this drug's name.

Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.

Related news

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.