Troriluzole
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
- Sponsor
- Biohaven Ltd. BHVN Source: Company record for Biohaven Ltd. (opens in a new tab)
- 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)
- Application
- NDA 210862 Source: openFDA complete response letters (opens in a new tab) · Action letter for NDA 210862 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 15 Dec 20162 linked trials
- Phase 3 Current stageFirst trial start 15 Dec 20165 linked trials
- Filed Not yet
- 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
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results 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 Disorder | Phase 3 | Completed | 589 (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
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 Disorder | Phase 3 | Completed | 456 (actual) | 27 Oct 2025 (actual) | No |
| NCT03701399ClinicalTrials.gov record for NCT03701399 (opens in a new tab) | Troriluzole in Adult Participants With Spinocerebellar Ataxia | Phase 3 | Active, not recruiting | 299 (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
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
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 Disorder | Phase 2/3 | Completed | 426 (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
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 2/3 | Completed | 141 (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
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
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-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA210862Action letter for NDA210862 (opens in a new tab) | Original 20251104 Complete Response letter | Complete response letter | Not given | openFDA 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.
Papers and preprints load here.
Community discussion loads here.
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.
EMA page for Dazluma (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
Sources
- ClinicalTrials.gov NCT04641143 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04693351 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT03701399 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT03299166 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT02960893 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- openFDA complete response letters NDA210862 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.