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Reviva Announces Grant of European Patent Covering Use of Brilaroxazine for the Treatment of Pulmonary Fibrosis

  • Reviva Pharmaceuticals Holdings, Inc. received European Patent 3749324 covering brilaroxazine for treating pulmonary fibrosis & idiopathic pulmonary fibrosis (IPF).
  • Similar patents have been granted in key global markets including the United States, China, & Japan.
  • Brilaroxazine utilizes a novel mechanism of action targeting serotonin signaling disruptions implicated in pulmonary fibrosis pathogenesis.
  • The U.S. FDA granted Orphan Drug Designation to brilaroxazine for treating IPF.
  • Phase 3 RECOVER trial data demonstrated brilaroxazine met all primary & secondary endpoints for schizophrenia with a well-tolerated side effect profile.
  • Clinical drug-drug interaction studies indicated no significant interaction when brilaroxazine is combined with CYP3A4 inhibitors.
  • Nonclinical studies showed brilaroxazine mitigates fibrosis & inflammation in animal models for psoriasis, pulmonary arterial hypertension (PAH), & IPF.
  • The FDA also granted Orphan Drug Designation for brilaroxazine to treat PAH.
  • Reviva plans to develop brilaroxazine for additional neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD), & ADHD.
  • Reviva is a late-stage biopharmaceutical company focusing on CNS, inflammatory, & cardiometabolic diseases with a pipeline containing brilaroxazine (RP5063) & RP1208.