Reviva Announces Grant of European Patent Covering Use of Brilaroxazine for the Treatment of Pulmonary Fibrosis
Reviva Pharmaceuticals (NASDAQ: RVPH) announced that European Patent 3749324 was granted by the EPO on Nov 10, 2025, covering use of brilaroxazine to treat pulmonary fibrosis, including idiopathic pulmonary fibrosis (IPF).
The patent adds to existing protection in key markets including the United States, China, and Japan. Brilaroxazine is described as having a novel mechanism that targets disrupted serotonin signaling implicated in pulmonary fibrosis. The drug has received Orphan Drug Designation from the U.S. FDA for IPF. Management said the asset is late-stage and has been well-tolerated across large patient populations, supporting plans to expand clinical development from schizophrenia into additional indications.
Reviva Pharmaceuticals (NASDAQ: RVPH) ha annunciato che la Brevetto Europeo 3749324 è stato concesso dall'EPO il 10 novembre 2025, coprendo l'uso di brilaroxazina per trattare la fibrosi polmonare, inclusa la fibrosi polmonare idiopatica (IPF).
Il brevetto si aggiunge alle protezioni esistenti nei mercati chiave, inclusi gli Stati Uniti, la Cina e il Giappone. Brilaroxazina è descritta come avente un meccanismo innovativo che prende di mira la segnalazione della serotonina alterata implicata nella fibrosi polmonare. Il farmaco ha ricevuto una designazione di farmaco orfano dalla FDA statunitense per IPF. La direzione ha detto che l'asset è in fase avanzata e che è stato ben tollerato in popolazioni ampie di pazienti, supportando piani per espandere lo sviluppo clinico dallo schizophrenia ad altre indicazioni.
Reviva Pharmaceuticals (NASDAQ: RVPH) anunció que la patente europea 3749324 fue concedida por la EPO el 10 de noviembre de 2025, cubriendo el uso de brilaroxazina para tratar la fibrosis pulmonar, incluida la fibrosis pulmonar idiopática (IPF).
La patente se añade a la protección existente en mercados clave como Estados Unidos, China y Japón. Se describe a brilaroxazina como que posee un mecanismo novedoso que apunta a la disfunción de la señalización de la serotonina implicada en la fibrosis pulmonar. El fármaco ha recibido la Designación de fármaco huérfano de la FDA de EE. UU. para IPF. La dirección dijo que el activo está en fase avanzada y ha sido bien tolerado en grandes poblaciones de pacientes, respaldando planes para ampliar el desarrollo clínico desde la esquizofrenia a indicaciones adicionales.
Reviva Pharmaceuticals (NASDAQ: RVPH)는 2025년 11월 10일 EPO가 유럽 특허 3749324호를 부여했다고 발표했으며, 이는 IPF를 포함한 원발성 폐섬유증의 치료에 브릴라록사진(brilaroxazine)의 사용을 다룹니다.
이 특허는 미국, 중국, 일본을 포함한 핵심 시장에서 기존 보호에 추가로 간주됩니다. 브릴라록사진은 폐섬유증에 관련된 망가진 세로토닌 신호전달을 표적으로 하는 새로운 기전으로 설명됩니다. 이 약물은 IPF에 대해 미국 FDA의 고아약물 지정을 받았습니다. 경영진은 자산이 후기 단계이며 광범위한 환자 집단에서 안전하게 견뎌졌다고 말했고, 이를 바탕으로 조현병에서 추가 적응증으로 임상 개발을 확장하려는 계획을 지원합니다.
Reviva Pharmaceuticals (NASDAQ: RVPH) a annoncé que le Brevet européen 3749324 a été accordé par l'OEB le 10 novembre 2025, couvrant l'utilisation de brilaroxazine pour traiter la fibrose pulmonaire, y compris la fibrose pulmonaire idiopathique (IPF).
Le brevet renforce la protection existante sur les marchés clés, notamment les États-Unis, la Chine et le Japon. Brilaroxazine est décrit comme ayant un mécanisme novateur qui cible une signalisation de la sérotonine perturbée impliquée dans la fibrose pulmonaire. Le médicament a reçu une Désignation de médicament orphelin de la FDA américaine pour l'IPF. La direction a déclaré que l'actif est en phase tardive et a été bien toléré dans de grandes populations de patients, soutenant des plans d'étendre le développement clinique de la schizophrénie à d'autres indications.
Reviva Pharmaceuticals (NASDAQ: RVPH) gab bekannt, dass Europäisches Patent 3749324 vom EPO am 10. November 2025 erteilt wurde und die Verwendung von Brilaroxazin zur Behandlung der Lungenfibrose abdeckt, einschließlich der idiopathischen Lungenfibrose (IPF).
Das Patent ergänzt bestehenden Schutz in Schlüsselmärkten wie den Vereinigten Staaten, China und Japan. Brilaroxazin wird als neuartiger Mechanismus beschrieben, der die durch eine gestörte Serotonin-Signalisierung beeinträchtigte Rolle bei der Lungenfibrose ins Visier nimmt. Das Medikament hat eine Orphan Drug Designation der US-FDA für IPF erhalten. Das Management sagte, dass der Vermögenswert spätphase sei und in großen Patientengruppen gut toleriert wurde, was Pläne unterstützt, die klinische Entwicklung von Schizophrenie auf zusätzliche Indikationen auszuweiten.
Reviva Pharmaceuticals (NASDAQ: RVPH) أعلنت أن براءة الاختراع الأوروبية 3749324 مُنحت من قبل EPO في 10 نوفمبر 2025، تغطي استخدام بريلاروكسازين لعلاج التليف الرئوي، بما في ذلك التليف الرئوي التأتبي (IPF).
يضيف هذا البراءة إلى حماية موجودة في الأسواق الرئيسية بما فيها الولايات المتحدة والصين واليابان. يوصف بريlaroxazine كأنه يمتلك آلية جديدة تستهدف إشارات السيروتونين المعطلة المرتبطة بالتليف الرئوي. تلقّى الدواء تصنيف دواء يتيم من إدارة الغذاء والدواء الأمريكية IPF. قالت الإدارة أن الأصل متقدم في المراحل المتأخرة وأنه تم تحمله جيداً عبر تجمعات كبيرة من المرضى، داعمين خطط لتوسيع التطوير السريري من الفصام إلى مؤشرات إضافية.
- EPO patent granted on Nov 10, 2025 for brilaroxazine use
- Patent protection in United States, China, and Japan
- FDA Orphan Drug Designation for IPF
- Late-stage asset described as well-tolerated in trials
- None.
Insights
European patent grant and existing global patents strengthen brilaroxazine's IP and support clinical expansion into pulmonary fibrosis.
Reviva secured European Patent 3749324 for use of brilaroxazine in pulmonary fibrosis, adding to patents in the United States, China, and Japan. The release also notes Orphan Drug Designation from the FDA for idiopathic pulmonary fibrosis, and that brilaroxazine is a late-stage asset with tolerability observed in trials.
The business mechanism is straightforward: patent protection plus orphan status can lengthen exclusivity and reduce competition for a new indication. Key dependencies and risks include successful clinical development in pulmonary fibrosis and regulatory approvals; patent coverage and orphan designation do not guarantee clinical or commercial success.
Concrete items to watch are initiation and readouts of pulmonary fibrosis clinical trials, regulatory filing or approval milestones, and any changes to patent scope or challenges; monitor developments over the next clinical cycle, roughly the coming 12–36 months.
- Patent covers brilaroxazine use for treating Pulmonary Fibrosis
-Similar patents have also been granted in key markets around the world including the United States, China, and Japan
-Brilaroxazine has a novel mechanism of action for treating the underlying disruption in serotonin signaling implicated in the pathogenesis of Pulmonary Fibrosis
CUPERTINO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced European Patent 3749324 has been granted by the European Patent Office (EPO) covering use of brilaroxazine for the treatment of pulmonary fibrosis, including idiopathic pulmonary fibrosis (IPF), adding to its existing patent protection in key markets around the world including the United States, China and Japan. Brilaroxazine has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of IPF.
"Securing this latest patent further strengthens our intellectual property portfolio and underscores the broad therapeutic relevance of brilaroxazine’s unique mechanism of action in chronic fibrotic disorders like pulmonary fibrosis or IPF,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO. “With a late-stage asset that in our trials has been well-tolerated across large patient populations, we are poised to further expand clinical development from schizophrenia into additional high-value indications with the potential for multiple paths to value creation for our brilaroxazine program.”
Additional information on the potential of brilaroxazine for the treatment of IPF can be found on the "Publications" section of the Reviva website.
About Brilaroxazine
Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathophysiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF).
Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains including reduction in key proinflammatory cytokines implicated in the pathophysiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine vs. placebo, with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of the CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitors. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD).
Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the FDA for the treatment of PAH and IPF conditions. To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.
About Reviva
Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s plans for its brilaroxazine program including intended steps towards potential approval, the Company’s plans for meeting with FDA and plans for potential NDA submission, the Company’s statements regarding assessment of plans for a potential registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia, if required, statements about potential IND submissions, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans and the timing thereof, including the anticipated timing of the availability of trial data, clinical and regulatory timelines and expenses, planned or intended additional trials or studies and the timing thereof, planned or intended regulatory submissions and the timing thereof, trial results, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Corporate Contact:
Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com
Investor Relations Contact:
LifeSci Advisors, LLC
PJ Kelleher
pkelleher@lifesciadvisors.com
FAQ
What did Reviva (RVPH) announce on Nov 10, 2025 about brilaroxazine?
Does Reviva (RVPH) have patent protection for brilaroxazine outside Europe?
Has brilaroxazine received any regulatory designations for IPF for RVPH shareholders to note?
How does Reviva describe brilaroxazine’s mechanism for treating pulmonary fibrosis?
Will the new EPO patent affect Reviva’s clinical plans for RVPH?
