Brilaroxazine

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.

REVIVA PHARMACEUTICALS HOLDINGS, INC. RVPH · Schizophrenia

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    1

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 24 Jan 20221 linked trial
  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 Brilaroxazine. Editors add each one with its source.

Filed application

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

FDA advisory committees

No FDA advisory committee meetings are on record for Brilaroxazine.

Clinical trials

Trials linked to Brilaroxazine
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT05184335ClinicalTrials.gov record for NCT05184335 (opens in a new tab)RECOVERSafety and Efficacy of Brilaroxazine (RP5063) in SchizophreniaPhase 3Recruiting690 (estimated)Feb 2025 (estimated) No

Publications listing RECOVER (1), newest first

  1. A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials.

    Biological psychiatry · 2026 Jul 15

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

Loading trial quality…

FDA actions

No FDA approvals on record for this drug.

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)

EMA's medicines data lists no human medicine with the same active substance as Brilaroxazine.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

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