Reviva Pharmaceuticals' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Reviva Pharmaceuticals (RVPH).
Over the past two years, Reviva Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Brilaroxazine. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Brilaroxazine FDA Regulatory Timeline and Events
Brilaroxazine is a drug developed by Reviva Pharmaceuticals for the following indication: Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Brilaroxazine
- Announced Date:
- June 2, 2025
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals Holdings, Inc. announced a positive full dataset and successful completion of the Company's Phase 3 RECOVER open-label extension (OLE) 1-year study evaluating the long-term safety, tolerability and efficacy of brilaroxazine in patients with schizophrenia.
AI Summary
Reviva Pharmaceuticals announced positive full dataset results and the successful completion of its Phase 3 RECOVER open-label extension (OLE) one-year study evaluating brilaroxazine in patients with schizophrenia. The study demonstrated that once-daily brilaroxazine provided robust, broad-spectrum efficacy across all major symptom domains, including improvements in negative symptoms. Its sustained efficacy over one year was complemented by a favorable safety profile, with a relatively low 35% discontinuation rate. Additionally, the trial reported significant improvements in multiple neuroinflammatory biomarkers, which may help enhance the drug’s overall effectiveness and mitigate side effects. The positive data from the long-term study reinforce the potential of brilaroxazine as a promising treatment option, supporting further development and progress toward regulatory submission for schizophrenia. This milestone underscores Reviva’s commitment to addressing unmet clinical needs in the central nervous system.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- December 16, 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced positive preliminary topline data for the open-label extension (OLE) portion of the Company's ongoing Phase 3 RECOVER study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia.
AI Summary
Reviva Pharmaceuticals announced positive preliminary topline data from the open-label extension (OLE) portion of its ongoing Phase 3 RECOVER study. The study evaluates the long-term safety and tolerability of brilaroxazine, a once-daily treatment for schizophrenia. Patients treated with brilaroxazine showed robust, broad-spectrum efficacy sustained over one year. The data revealed that the treatment was generally well tolerated, with low rates of adverse events (none over 5%) and an overall discontinuation rate of 35%. All tested doses—15 mg, 30 mg, and 50 mg—were effective in improving all major symptom areas of schizophrenia. The company highlighted the potential of brilaroxazine to overcome major barriers in long-term schizophrenia treatment. Full clinical data, including long-term safety, tolerability, and additional efficacy measures, is expected to be released in the first quarter of 2025.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- September 9, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announces Additional vocal biomarker data from ongoing open label extension study evaluating brilaroxazine in schizophrenia expected Q4 2024 –
AI Summary
Reviva Pharmaceuticals announced that additional vocal biomarker data is expected in the fourth quarter of 2024 from an ongoing open-label extension study evaluating brilaroxazine in schizophrenia. The study uses speech latency—a measurable vocal biomarker—to objectively support the efficacy already seen in prior assessments. Statistically significant improvements in vocal speech latency align with strong effects on negative symptoms and other key areas like total and positive symptoms, disorganization, and social functioning. This data is crucial because it validates the scale-based assessments previously done by human raters in the Phase 3 RECOVER trial. Reviva views these findings as a promising step forward in providing a more objective measure of treatment benefits, helping to further demonstrate brilaroxazine’s potential in addressing critical unmet needs in the treatment of schizophrenia.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- September 9, 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announces new vocal biomarker data from Phase 3 RECOVER trial of brilaroxazine in schizophrenia was presented during a virtual key opinion leader event hosted by the Company on September 4, 2024 featuring Brian Kirkpatrick, MD, MSPH (Professor, Psychiatric Research Institute, University of Arkansas for Medical Sciences, Arkansas) and Mark Opler, PhD, MPH (Chief Research Officer at WCG Inc., Executive Director of the PANSS Institute, New York).
AI Summary
Reviva Pharmaceuticals recently presented new vocal biomarker data from its Phase 3 RECOVER trial of brilaroxazine in schizophrenia. The data, highlighted during a virtual key opinion leader event on September 4, 2024, show statistically significant speech latency results. This emerging vocal biomarker supports the drug’s strong efficacy, particularly regarding negative symptoms as well as overall and positive symptoms, disorganization, and social functioning in patients with schizophrenia.
The event featured insights from Brian Kirkpatrick, MD, MSPH, a professor at the University of Arkansas for Medical Sciences, and Mark Opler, PhD, MPH, Chief Research Officer at WCG Inc. Their discussion underlined how these objective vocal biomarkers could validate clinical improvements observed in the trial. Reviva expects more vocal biomarker data from its ongoing open label extension study, with topline results anticipated by the fourth quarter of 2024.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- August 27, 2024
- Estimated Event Date Range:
- September 4, 2024 - September 4, 2024
- Target Action Date:
- September 04, 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced it will host a virtual key opinion leader (KOL) event on Wednesday, September 4, 2024 at 2:00 PM ET. To register for the event, click here.
AI Summary
Reviva Pharmaceuticals will host a virtual key opinion leader (KOL) event on September 4, 2024, at 2:00 PM ET. This online session will feature expert speakers, including Brian Kirkpatrick, MD, and Mark Opler, PhD, MPH, who will discuss emerging treatment approaches for schizophrenia. The speakers plan to examine the unmet medical needs associated with negative symptoms and delve into the current treatment landscape. They will also highlight innovative research on speech latency as an objective vocal biomarker and review important findings from the Phase 3 RECOVER-1 trial, which assessed key endpoints related to social functioning, cognition, and overall symptom improvement. Attendees will have the opportunity to participate in a live question and answer session following the presentations. Interested individuals can register for the event through the provided online link.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- July 9, 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced European Patent EP3244896 has been granted by the European Patent Office (EPO) covering use of brilaroxazine for the treatment of PH, adding to its existing patent protection in key markets around the world including the United States, China and Japan.
AI Summary
Reviva Pharmaceuticals Holdings announced that the European Patent EP3244896 has been granted by the European Patent Office (EPO). This patent covers the use of brilaroxazine for treating pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH), including treatment in patients with chronic obstructive pulmonary disease (COPD) or sickle cell disease (SCD).
The new European patent adds to the company’s existing intellectual property portfolio, which already includes protection in key global markets such as the United States, China, and Japan. Brilaroxazine works by addressing disruptions in serotonin signaling, a key factor in the development of PH and PAH. Reviva highlighted that the drug has shown a favorable safety profile in clinical trials and demonstrated benefits in reducing inflammation. The company plans to continue its clinical development and explore further opportunities for brilaroxazine in treating these conditions.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- May 15, 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced an enrollment update to the ongoing 1-year open-label extension (OLE) study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia.
AI Summary
Reviva Pharmaceuticals has provided an enrollment update for its ongoing 1-year open-label extension (OLE) study, which is assessing the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. This study is designed to monitor the drug’s safety profile over an extended period, offering critical insights into how patients respond to the treatment in real-world conditions. The update indicates that healthy progress is being made in gathering essential safety data needed to better understand the potential risks and benefits of brilaroxazine, a medication under investigation for managing schizophrenia symptoms. By continuing to enroll patients and collect data, the study aims to ensure that any long-term effects are properly evaluated, reflecting Reviva Pharmaceuticals’ commitment to improving treatment options while maintaining a strong focus on patient safety.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- May 15, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced that Topline data from 1-year open-label extension (OLE) trial expected in Q4 2024 –
AI Summary
Reviva Pharmaceuticals has announced that topline data from its one-year open-label extension (OLE) trial is expected in the fourth quarter of 2024. This extension study is a key part of the company’s effort to further evaluate the long-term outcomes of its treatment. The upcoming data will provide additional insights into the therapy's safety and effectiveness.
The news is significant as it marks an important step in the development process, with detailed results anticipated to shed light on how the treatment performs over an extended period. Patients, healthcare providers, and investors are looking forward to this information, which could influence future decisions and further evaluations by the FDA. More details will be available once the data is released in Q4 2024.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- May 13, 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, will present new efficacy data on brilaroxazine in an animal model of idiopathic pulmonary fibrosis as part of a late-breaking poster presentation at the 2024 American Thoracic Society (ATS) International Conference, to be held in San Diego, CA, May 17-22, 2024.
AI Summary
Reviva Pharmaceuticals recently announced that its Founder, President, and CEO, Laxminarayan Bhat, Ph.D., will present new efficacy data on brilaroxazine at the 2024 American Thoracic Society (ATS) International Conference. This data comes from studies using an animal model of idiopathic pulmonary fibrosis, highlighting brilaroxazine’s potential in addressing this challenging lung disease.
During a late-breaking poster presentation, Dr. Bhat will share insights about the effectiveness of the drug, providing valuable information about its role in managing pulmonary fibrosis. The conference, scheduled in San Diego, CA from May 17-22, 2024, will give researchers and clinicians the chance to explore these findings, emphasizing Reviva’s commitment to advancing respiratory disease treatments.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- May 9, 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals Holdings, announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will present new pharmacology data on brilaroxazine as part of two poster presentations at the ASPET 2024 Annual Meeting, to be held in Arlington, VA May 16-19, 2024.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- April 15, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced that Topline data from 1-year open-label extension (OLE) long-term safety trial expected in Q4 2024
AI Summary
Reviva Pharmaceuticals has announced that it expects topline data from its one-year open-label extension (OLE) long-term safety trial in the fourth quarter of 2024. This data is expected to provide important evidence on the long-term safety and tolerability of brilaroxazine, the company’s drug candidate for treating schizophrenia.
The OLE trial is a key component of Reviva's strategy as it builds on previous positive Phase 3 efficacy results. The FDA has accepted their registrational Phase 3 RECOVER-2 study, which, along with two positive 4‑week studies and a 12‑month long-term safety study, could form the basis of a New Drug Application for acute schizophrenia treatment. The anticipated topline data will play an important role in demonstrating the drug's long-term safety profile, further supporting its potential as an effective treatment option for schizophrenia.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- April 15, 2024
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced it has gained alignment with the U.S. Food and Drug Administration (FDA) on its registrational Phase 3 program for brilaroxazine in schizophrenia.
AI Summary
Reviva Pharmaceuticals announced that it has gained alignment with the U.S. Food and Drug Administration (FDA) on its registrational Phase 3 program for brilaroxazine in the treatment of schizophrenia. The FDA has accepted the 4‐week RECOVER-2 study, part of a global effort to evaluate the drug’s safety and efficacy in approximately 450 patients with acute schizophrenia. FDA feedback indicates that two positive 4-week Phase 3 studies, combined with a 12-month long-term safety study, could support a New Drug Application submission for the acute treatment of schizophrenia. The agency also noted that a long-term randomized withdrawal study post-approval will be needed to support maintenance of effect. Reviva plans to begin the RECOVER-2 trial this quarter, with topline data from the 1-year open-label extension expected in the fourth quarter of 2024.
Read Announcement
Reviva Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Reviva Pharmaceuticals (RVPH) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Reviva Pharmaceuticals (RVPH) has reported FDA regulatory activity for Brilaroxazine.
The most recent FDA-related event for Reviva Pharmaceuticals occurred on June 2, 2025, involving Brilaroxazine. The update was categorized as "Positive Data," with the company reporting: "Reviva Pharmaceuticals Holdings, Inc. announced a positive full dataset and successful completion of the Company's Phase 3 RECOVER open-label extension (OLE) 1-year study evaluating the long-term safety, tolerability and efficacy of brilaroxazine in patients with schizophrenia."
Currently, Reviva Pharmaceuticals has one therapy (Brilaroxazine) targeting the following condition: Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:RVPH) was last updated on 8/24/2025 by MarketBeat.com Staff
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