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:
- April 15, 2026
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals Holdings, Inc. issued a letter to shareholders announcing certain business updates, including in connection with the Company's program for the development of brilaroxazine for the treatment of schizophrenia and regarding the Company's intellectual property strategy.
AI Summary
Reviva Pharmaceuticals sent a letter to shareholders describing recent business updates. The company said it made difficult but necessary decisions to strengthen its capital position and preserve strategic flexibility. Leadership emphasized concentrating resources on what they view as the main driver of long‑term value: brilaroxazine.
The letter highlighted updates tied to the development program for brilaroxazine as a treatment for schizophrenia and noted actions related to the company’s intellectual property strategy. Reviva said it remains focused on realizing brilaroxazine’s potential across schizophrenia and possibly other neuropsychiatric indications, and is aligning its plans and resources to support that goal.
The note was signed by Founder and CEO Laxminarayan Bhat, Ph.D., and included standard forward‑looking cautionary language. Contact and investor relations details were provided for follow‑up.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- January 8, 2026
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced the publication, in the peer-reviewed journal Biological Psychiatry, of an article entitled A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials that highlights clinical vocal biomarker data from the RECOVER Phase 3 clinical trial and the therapeutic potential of brilaroxazine for the treatment of schizophrenia.
AI Summary
Reviva Pharmaceuticals announced publication in the peer‑reviewed journal Biological Psychiatry of "A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials," reporting vocal biomarker data from the RECOVER Phase 3 trial and the therapeutic potential of brilaroxazine for schizophrenia. The study found that speech latency — the time it takes a patient to begin speaking — reliably classified patients with moderate-to-severe negative symptoms (VBM‑positive) versus low negative symptoms (VBM‑negative). VBM‑positive patients showed faster and stronger clinician‑assessed responses to brilaroxazine across negative symptoms and other core domains of schizophrenia.
The authors highlight speech latency as a scalable, objective enrichment tool that works across languages and settings. Using this vocal biomarker could improve patient selection, reduce sample sizes, lower trial costs, and lessen placebo effects, thereby strengthening clinical trial outcomes and supporting the measured efficacy of brilaroxazine. The publication underscores the biomarker’s potential to complement traditional clinician assessments.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- December 23, 2025
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced a regulatory update following a pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding brilaroxazine, a novel serotonin-dopamine and neuroinflammatory signaling modulator, in late-stage development for the treatment of schizophrenia.
AI Summary
Reviva Pharmaceuticals reported the results of a pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration about brilaroxazine, a novel serotonin–dopamine and neuroinflammatory signaling modulator being developed for schizophrenia. In written feedback, the FDA recommended conducting a second Phase 3 trial to provide additional efficacy and expand the safety dataset. The agency also gave guidance on data analysis and presentation and on specific study requirements, including animal pharmacokinetics, human abuse potential, and renal and hepatic impairment assessments. Subject to sufficient financing, Reviva plans to initiate the RECOVER-2 registrational Phase 3 trial in the first half of 2026, with a design similar to the prior RECOVER study.
Reviva noted its current clinical package highlights broad-spectrum activity across major schizophrenia symptoms, a generally favorable long-term safety profile, and good adherence with once-daily dosing observed up to one year. The company said it will work with the FDA to generate the additional data needed to support a potential NDA.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- December 23, 2025
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced a regulatory update following a pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding brilaroxazine, a novel serotonin-dopamine and neuroinflammatory signaling modulator, in late-stage development for the treatment of schizophrenia.
AI Summary
Reviva Pharmaceuticals said the FDA’s written feedback after a pre-NDA meeting recommends a second Phase 3 trial of brilaroxazine, their late-stage serotonin‑dopamine and neuroinflammatory signaling modulator for schizophrenia. The FDA asked for more efficacy and safety data before a New Drug Application. Reviva plans to start the RECOVER‑2 registrational trial in the first half of 2026, if it can secure sufficient financing; the trial will be similar in design to its prior registrational study.
The FDA also gave guidance on data analysis and presentation and on studies for animal pharmacokinetics, human abuse potential, and renal and hepatic impairment. Reviva noted its existing data show broad clinical activity across symptom domains, a generally favorable long‑term safety profile, and good adherence with once‑daily dosing observed in studies up to one year. The company said it will work with the agency to generate the additional data needed to support a potential NDA.
Read Announcement- Drug:
- Brilaroxazine
- Announced Date:
- October 28, 2025
- Indication:
- Potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms.
Announcement
Reviva Pharmaceuticals announced that negative symptom data for brilaroxazine from the Phase 3 RECOVER double-blind trial in patients with acute exacerbation of schizophrenia, and from the long-term open-label extension trial in clinically stable schizophrenia patients will be presented as a poster presentation at the CNS Summit 2025, taking place November 2-5, in Boston, Massachusetts.
AI Summary
Reviva Pharmaceuticals announced that it will present new negative symptom data for brilaroxazine at the upcoming CNS Summit 2025 in Boston, Massachusetts. The data come from the Phase 3 RECOVER double-blind trial in patients experiencing an acute exacerbation of schizophrenia, as well as from a one-year, long-term open-label extension study in clinically stable schizophrenia patients. Negative symptoms such as social withdrawal and lack of motivation are challenging to treat and can greatly impact patient quality of life.
The poster presentation, titled “Brilaroxazine Treatment Effect on Negative Symptoms in Schizophrenia: RECOVER Trial in Acute and Stable Patients Over 1 Year,” is poster number 32. It will be available on Monday, November 3, and Tuesday, November 4, from 5:00 to 7:00 PM ET. Attendees can find abstracts and more details on the CNS Summit 2025 website. Reviva believes the findings will help guide clinicians and researchers.
Read Announcement- 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
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 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
- Target Action Date:
- September 4, 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
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 April 15, 2026, involving Brilaroxazine. The update was categorized as "Provided Update," with the company reporting: "Reviva Pharmaceuticals Holdings, Inc. issued a letter to shareholders announcing certain business updates, including in connection with the Company's program for the development of brilaroxazine for the treatment of schizophrenia and regarding the Company's intellectual property strategy."
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..
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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
FDA progress for NASDAQ:RVPH last updated on 4/15/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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