Developer · RVPH · United States
Reviva Pharmaceuticals Holdings, Inc.
Reviva Pharmaceuticals Holdings is a clinical-stage pharmaceutical company developing next-generation therapeutics for central nervous system, cardiovascular, metabolic, respiratory, and inflammatory diseases. Its lead candidate is brilaroxazine (RP5063), a serotonin-dopamine signaling modulator in late-stage development for schizophrenia and other neuropsychiatric indications.
Pipeline (1)
- SchizophreniaPhase 3Active
Catalysts · 1 upcoming · 3 reported
- 1H 2026 start (topline thereafter)Anticipated
Brilaroxazine (RP5063)forSchizophreniaTopline data
RECOVER-2 confirmatory Phase 3 planned to initiate in 1H 2026.
Recently reported
- 2025-12-23pending
Brilaroxazine (RP5063)forSchizophreniaRegulatory
FDA recommends a confirmatory second Phase 3 (RECOVER-2) before a brilaroxazine schizophrenia NDA.
- 2025-06-02met
Brilaroxazine (RP5063)forSchizophreniaFull results
Full 1-year RECOVER open-label extension positive: durable, dose-related efficacy with favorable long-term safety.
- 2023-10-30met
Brilaroxazine (RP5063)forSchizophreniaTopline data
Phase 3 RECOVER met its primary endpoint: brilaroxazine 50 mg cut PANSS total by 10.1 points vs placebo at Week 4 (p<0.001).
Recent activity
- Dec 23, 2025ReadoutBrilaroxazine (RP5063)·SchizophreniapendingFDA recommends a confirmatory second Phase 3 (RECOVER-2) before a brilaroxazine schizophrenia NDA.source ↗
- Jun 2, 2025ReadoutBrilaroxazine (RP5063)·SchizophreniametFull 1-year RECOVER open-label extension positive: durable, dose-related efficacy with favorable long-term safety.source ↗
- Apr 15, 2024Phase changeBrilaroxazine (RP5063)·SchizophreniaPhase 3Reviva reported FDA alignment on the brilaroxazine schizophrenia NDA path: two positive Phase 3 efficacy studies at Week 4 plus >=12 months of long-term safety data could support an NDA for acute treatment of schizophrenia.source ↗
- Oct 30, 2023ReadoutBrilaroxazine (RP5063)·SchizophreniametPhase 3 RECOVER met its primary endpoint: brilaroxazine 50 mg cut PANSS total by 10.1 points vs placebo at Week 4 (p<0.001).source ↗
- Jan 24, 2022Phase changeBrilaroxazine (RP5063)·SchizophreniaPhase 3Pivotal Phase 3 RECOVER trial (NCT05184335) started: 28-day randomized, double-blind, placebo-controlled study of brilaroxazine 15 mg and 50 mg vs placebo in acute schizophrenia, followed by a 52-week open-label extension.source ↗
Competitive landscape
Other companies developing against Reviva Pharmaceuticals Holdings, Inc.'s targets or indications.
- Alkermes plc1 compoundD2Schizophrenia
- LB Pharmaceuticals Inc.1 compoundD2Schizophrenia
- Teva Pharmaceutical Industries Ltd.1 compoundD2Schizophrenia
- Alto Neuroscience, Inc.1 compoundSchizophrenia
- BioXcel Therapeutics, Inc.1 compoundSchizophrenia
- Boehringer Ingelheim International GmbH1 compoundSchizophrenia
- Cerevel Therapeutics Holdings, Inc.1 compoundSchizophrenia
- Engrail Therapeutics, Inc.1 compoundD2
- Intra-Cellular Therapies, Inc.1 compoundSchizophrenia
- MapLight Therapeutics, Inc.1 compoundSchizophrenia
- Merck & Co., Inc.1 compoundSchizophrenia
- Minerva Neurosciences, Inc.1 compoundSchizophrenia