Reviva Pharmaceuticals Holdings, Inc. is a clinical-stage biopharmaceutical company, which engages in the discovery and development of therapeutics for the central nervous system, respiratory, and metabolic diseases. It uses chemical genomics driven technology platform and proprietary chemistry to develop new medicines. It focuses on the RP5063 (Brilaroxazine) and RP1208 pipelines. The company was founded by Laxminarayan Bhat on December 11, 2020 and is headquartered in Cupertino, CA.
Clinical Trials
4
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2006
Completed
1
25.0%
Recruiting
3
75.0%
No approval data available
- The FDA has recommended that Reviva Pharmaceuticals conduct a second Phase 3 trial for brilaroxazine in schizophrenia patients to generate additional efficacy data and expand the safety dataset before NDA submission. - Reviva plans to initiate the RECOVER-2 registrational trial in the first half of 2026, subject to sufficient financing, following the design of the completed RECOVER Phase 3 trial. - Brilaroxazine has demonstrated broad-spectrum efficacy across major symptom domains of schizophrenia, including negative symptoms, in 790 subjects from Phase 2 and Phase 3 trials. - The novel serotonin-dopamine and neuroinflammatory signaling modulator has shown a generally well-tolerated safety profile in over 900 subjects treated to date with once-daily oral administration.
- Reviva Pharmaceuticals will present topline data from the 52-week open-label extension portion of their Phase 3 RECOVER study evaluating brilaroxazine in schizophrenia at the 2025 SIRS Congress in Chicago. - The presentation, scheduled for March 30th, will focus on the long-term efficacy and safety profile of brilaroxazine in stable schizophrenia patients over a 12-month period. - Brilaroxazine (RP5063) is a novel chemical entity discovered in-house by Reviva, which is developing therapies for central nervous system, inflammatory, and cardiometabolic diseases.
- Roth MKM initiated coverage of Reviva Pharmaceuticals with a Buy rating, citing positive Phase 3 data for brilaroxazine in treating schizophrenia. - Brilaroxazine demonstrated significant impact on positive, negative, and cognitive symptoms of schizophrenia, with an effect size exceeding many existing antipsychotics. - Analyst projects potential worldwide sales of brilaroxazine reaching $1.9 billion by 2035, supporting an optimistic valuation and a $7 price target. - Reviva plans to file a New Drug Application (NDA) for brilaroxazine in mid-2026, marking a crucial step toward potential market entry.
• Xanomeline/trospium chloride (Cobenfy) improved cognition in schizophrenia patients with baseline cognitive impairment, according to an exploratory analysis of two phase III trials. • MindMed initiated a phase III trial of lysergide D-tartrate (LSD) for generalized anxiety disorder, marking the first phase III trial for LSD. • Reviva Pharmaceuticals reported that brilaroxazine significantly reduced PANSS total score in schizophrenia patients after 52 weeks in a long-term extension study. • A recall of over 230,000 bottles of duloxetine (Cymbalta) was initiated due to the potential presence of a carcinogen.
- Reviva Pharmaceuticals' brilaroxazine demonstrated sustained efficacy and a favorable safety profile over one year in patients with schizophrenia in the Phase 3 RECOVER study's open-label extension (OLE). - The OLE study, involving 435 patients, showed that once-daily brilaroxazine at doses of 15mg, 30mg, and 50mg led to significant improvements in PANSS total scores and positive/negative symptoms. - Discontinuation rates in the OLE were notably lower (35%) compared to other antipsychotics, and the drug was well-tolerated, with most treatment-related adverse events being mild or moderate. - Reviva plans to initiate the confirmatory Phase 3 RECOVER-2 trial in Q1 2025 and expects to submit the complete OLE data, including biomarker data, in the same quarter.
• AbbVie's emraclidine failed to demonstrate statistically significant improvement in schizophrenia symptoms in Phase II trials, a setback for the muscarinic pathway approach. • Bristol Myers Squibb's Cobenfy (KarXT), a muscarinic agonist, now stands as the frontrunner in schizophrenia treatment after AbbVie's trial failures. • Neurocrine Biosciences is advancing NBI-1117568, an oral muscarinic M4 selective agonist, with Phase III trials planned for early 2025, showing a potential path forward. • Other companies like Neumora Therapeutics and Reviva Pharmaceuticals are also exploring novel mechanisms for schizophrenia treatment, indicating a dynamic therapeutic landscape.
- Reviva Pharmaceuticals announced positive speech latency data for brilaroxazine in schizophrenia from the Phase 3 RECOVER trial. - The data will be presented as a poster at the CNS Summit 2024 in Boston, Massachusetts, on November 12th. - The presentation will highlight how enrichment based on speech latency enhances treatment effects with brilaroxazine. - Brilaroxazine is a new chemical entity being developed by Reviva for central nervous system disorders.
- Reviva Pharmaceuticals announced positive speech latency data for brilaroxazine in schizophrenia from the Phase 3 RECOVER trial. - The data will be presented as a poster at the CNS Summit 2024 in Boston, highlighting the drug's potential in improving speech-related challenges. - The presentation will feature insights into how enrichment based on speech latency enhances the treatment effects of brilaroxazine. - Brilaroxazine, a new chemical entity, is part of Reviva's pipeline focusing on CNS, inflammatory, and cardiometabolic diseases.
- Reviva Pharmaceuticals will present positive speech latency data for brilaroxazine in schizophrenia from the Phase 3 RECOVER trial at the CNS Summit 2024. - The study, titled 'Enrichment Based on Speech Latency Enhances Treatment Effects in a Phase III Study of Brilaroxazine', highlights enhanced treatment effects. - The poster presentation by Dr. Jan Sedway from WCG Clinical will take place on November 12th in Boston, Massachusetts. - Brilaroxazine is being developed to address unmet medical needs in central nervous system disorders.
- Over 22 pharmaceutical and biotech companies are actively developing more than 22 pipeline drugs for bipolar disorder, addressing a significant unmet need. - These therapies span various stages of clinical development, from early-stage to Phase III trials, indicating a robust and diverse pipeline. - Key companies like Vanda Pharmaceuticals, Reviva Pharmaceuticals, and SK Biopharmaceuticals are leading the charge with innovative approaches. - The pipeline includes diverse routes of administration and molecule types, offering potential for personalized treatment strategies.
