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Brilaroxazine - Reviva Pharmaceuticals

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Drug Profile

Brilaroxazine - Reviva Pharmaceuticals

Alternative Names: brilaroxazine lipogel; RP 5000; RP-5063

Latest Information Update: 19 Dec 2024

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At a glance

  • Originator Reviva Pharmaceuticals
  • Class Antidepressants; Antifibrotics; Antipsoriatics; Antipsychotics; Behavioural disorder therapies; Benzoxazines; Chlorobenzenes; Ethers; Ketones; Mood stabilisers; Piperazines; Small molecules
  • Mechanism of Action Dopamine D2 receptor partial agonists; Dopamine D3 receptor partial agonists; Dopamine D4 receptor partial agonists; Serotonin 1A receptor partial agonists; Serotonin 2A receptor partial agonists; Serotonin 6 receptor antagonists; Serotonin 7 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pulmonary arterial hypertension; Idiopathic pulmonary fibrosis
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Schizophrenia
  • Phase II Schizoaffective disorder
  • Phase I Attention-deficit hyperactivity disorder; Bipolar disorders; Idiopathic pulmonary fibrosis; Major depressive disorder; Pulmonary arterial hypertension
  • Preclinical Psoriasis
  • Discontinued Autistic disorder; Gilles de la Tourette's syndrome

Most Recent Events

  • 16 Dec 2024 Updated long term efficacy and adverse event data from the phase III RECOVER trial in Schizophrenia released by Reviva Pharmaceuticals
  • 14 Nov 2024 Reviva Pharmaceuticals plans a Phase III RECOVER-2 trial for Schizophrenia (PO) in the 1st quarter of 2025
  • 14 Nov 2024 Reviva Pharmaceuticals announces intention to submit NDA to US FDA for Schizophrenia (PO) in the second quarter of 2026

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