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The animal study is scheduled to commence within the next 2–3 weeks and will span 15 days. Completion is anticipated in November 2025, with results expected by December 2025. Preliminary data from a previous small-mass (40 kg) animal study reportedly affirmed dosage bioequivalence, providing valuable insights for dosage direction.
BNT23001 is designed to offer improved bioavailability, a faster onset of action, and simplified dosing for patients suffering from dysphagia. BioNxt is actively pursuing patent nationalization in key global markets. To date, the European Patent Office and the Eurasian Patent Office have issued notices of intentions to grant, and a Track One priority filing is currently active in the United States. This multifaceted approach to intellectual property protection underscores the company’s commitment to securing its market position.
Lo studio sugli animali inizierà nelle prossime 2–3 settimane, durerà 15 giorni, dovrebbe essere completato entro novembre 2025 e i risultati sono previsti per dicembre 2025. Uno studio animale precedente su piccola massa (40 kg) avrebbe confermato la bioequivalenza della posologia e guidato l’assetto del dosaggio.
BNT23001 punta a una migliore biodisponibilità, a un onset più rapido e a un dosaggio più semplice per i pazienti con disfagia. L’azienda sta perseguendo la nazionalizzazione dei brevetti nei mercati chiave; l’Ufficio europeo dei brevetti e l’Ufficio brevetti eurasiatico hanno emesso avvisi di intenzione di concessione, e una domanda con priorità Track One è attiva negli Stati Uniti.
El estudio en animales comenzará en las próximas 2–3 semanas, tendrá una duración de 15 días, se espera que se complete en noviembre de 2025, y se esperan resultados en diciembre de 2025. Un estudio anterior en animales de masa pequeña (40 kg) habría confirmado la bioequivalencia de la dosis y guiado la dirección de la dosificación.
El BNT23001 apunta a una mayor biodisponibilidad, un inicio más rápido y una dosificación más fácil para pacientes con disfagia. La empresa está buscando la nacionalización de patentes en mercados clave; la Oficina Europea de Patentes y la Oficina de Patentes Eurasiática emitieron avisos de intención de conceder, y una presentación de prioridad Track One está activa en los Estados Unidos.
동물 연구는 향후 2–3주 내에 시작되고, 15일간 진행되며, 2025년 11월에 완료될 것으로 예상되며, 결과는 2025년 12월에 발표될 예정입니다. 소대(40 kg) 동물 연구는 이미 약물 용량의 생물학적 등가성을 확인하고 용량 방향을 안내한 것으로 전해집니다.
BNT23001은 생체이용률 증가, 더 빠른 시작 및 삼킴장애 환자용 더 쉬운 용량 조절을 목표로 합니다. 이 회사는 주요 시장에서 특허 국유화를 추진 중이며, 유럽 특허청과 유라시아 특허청이 부여 의도 통지를 발행했고 미국에서 Track One 우선 특허 출원이 활성화되어 있습니다.
L’étude animale débutera dans les 2–3 semaines à venir, durera 15 jours, devrait être achevée en novembre 2025, et les résultats sont attendus en décembre 2025. Une étude animale précédente à masse réduite (40 kg) aurait confirmé l’équivalence de dosage et guidé l’orientation du dosage.
Le BNT23001 vise une meilleure biodisponibilité, un début plus rapide et un dosage plus facile pour les patients souffrant de dysphagie. L’entreprise poursuit la nationalisation des brevets sur les marchés clés ; l’Office européen des brevets et l’Office européen des brevets eurasiatique ont émis des Avis d’intention d’octroi, et une demande prioritaire Track One est active aux États-Unis.
Die Tierversuchs-Studie wird in den nächsten 2–3 Wochen beginnen, 15 Tage dauern, voraussichtlich im November 2025 abgeschlossen sein und die Ergebnisse werden voraussichtlich im Dezember 2025 vorliegen. Eine frühere Tierversuchs-Studie mit kleiner Masse (40 kg) soll die Dosierungsbioäquivalenz bestätigt und die Dosierungsrichtung geführt haben.
Ziel von BNT23001 ist eine verbesserte Bioverfügbarkeit, ein schnellerer Wirkungseintritt und eine einfachere Dosierung für Patienten mit Dysphagie. Das Unternehmen verfolgt eine Patent-Nationalisierung in Schlüsselmärkte; das Europäische Patentamt und das Eurasian Patent Office haben Benachrichtigungen über Absicht zur Grantierung ausgestellt, und eine Track-One-Prioritätsanmeldung ist in den USA aktiv.
ستبدأ الدراسة الحيوانية في خلال الـ2–3 أسابيع المقبلة، وتستمر 15 يوماً، ومن المتوقع أن تكتمل في نوفمبر 2025، وتُتوقع النتائج في ديسمبر 2025. وذكرت دراسة حيوانية سابقة ذات كتلة صغيرة (40 كغ) أنها أكدت التماثل البيولوجي للجرعة ووجهت اتجاه الجرعة.
يهدف BNT23001 إلى تحسين التوافر الحيوي، وبدء أسرع، وتسهيل الجرعة للمرضى المصابين باضطراب البلع. تسعى الشركة إلى توطين براءات الاختراع في الأسواق الرئيسية؛ وقد أصدرت مكتب براءات الاختراع الأوروبي ومكتب براءات الاختراع الأوروآسيا إشعارات بنوايا منح، وهناك تسجيل أولوية Track One نشط في الولايات المتحدة.
动物研究将在接下来的 2–3 周内开始，持续 15 天，预计在 2025 年 11 月完成，结果预计在 2025 年 12 月公布。此前的一项小质量（40 kg）动物研究据称已证实药物剂量的生物等效性并指导了给药方向。
BNT23001 旨在提高生物利用度、加快起效时间以及为吞咽困难患者提供更易用的给药方式。公司正在关键市场推进专利国家化；欧洲专利局和欧亚专利局发出了授予意向通知，美国也有 Track One 优先权申请在案。
Positive
- 15-day large-mass animal study initiated to refine human dosing
- Human comparative bioequivalence study planned for early 2026
- Preclinical studies reported high absorption and no toxicity
- EPO and Eurasian offices issued notices of intentions to grant patents
Negative
- No human comparative bioequivalence results yet; study planned for early 2026
- Patent nationalization ongoing; favorable communications are not final grants
10/21/2025 – 03:05 AM
VANCOUVER, BC – BioNxt Solutions Inc. (OTCQB:BNXTF) is advancing its lead drug candidate, BNT23001, a sublingual cladribine film for multiple sclerosis, with the initiation of a large-mass animal bioequivalence study. This move is designed to fine-tune dosing strategies before the company embarks on human trials in early 2026, a critical step in bringing this novel formulation to market.
The 15-day animal study, set to commence within weeks, is crucial for optimizing the drug load and understanding the absorption characteristics of BNT23001. According to BioNxt CEO Hugh Rogers, the study will enhance the precision of the forthcoming human trials by generating comparative drug absorption data against existing tablet formulations. “Optimization of drug load per dose and potential super bioavailability are key pieces of information that will guide the final clinical planning for our upcoming comparative human bioequivalence study,” Rogers stated.
The rationale behind BNT23001 is clear: improve bioavailability, speed up onset, and simplify dosing, particularly for patients with dysphagia. The sublingual delivery method bypasses the digestive system, potentially leading to more consistent drug levels and reduced side effects. Cladribine, the active ingredient, is a well-established immunomodulatory compound for MS, but its traditional oral formulations can present challenges for some patients.
Beyond the clinical advantages, BioNxt is also focused on securing its intellectual property position. Patent nationalization efforts are underway in key markets, with positive signals from both the European and Eurasian Patent Offices. A Track One priority filing is also active in the United States, demonstrating a proactive approach to protecting their innovation. Securing these patents will be crucial for BioNxt as it seeks partnerships and eventual commercialization, especially considering the competitive landscape of MS treatments which includes established pharmaceutical giants.
Analysts are watching closely as BioNxt progresses through these stages. The successful completion of the animal study and the subsequent commencement of human trials will be key milestones for the company. While the company has reported positive preclinical data showing high absorption and no signs of toxicity, the ultimate validation will come from human studies demonstrating improved patient outcomes.
BioNxt is listed on the Canadian Securities Exchange (BNXT) and the OTC Markets (BNXTF), reflecting growing investor interest in innovative drug delivery systems. The bioscience company specializes in next-generation drug delivery platforms designed to improve patient outcomes. BNT23001 represents a significant opportunity for BioNxt to carve out a niche in the MS treatment landscape.
FAQ
What is BioNxt announcing for BNT23001 (OTCQB:BNXTF) on October 21, 2025?
BioNxt launched a 15-day large-mass animal crossover bioequivalence study to optimize sublingual cladribine dosing ahead of a human study planned for early 2026.
When will the large-mass animal bioequivalence study for BNXTF start and finish?
The study is set to begin in the next 2–3 weeks, runs for 15 days, is expected to complete in November 2025, with results due in December 2025.
What did preclinical work show for BioNxt’s BNT23001 sublingual cladribine?
Preclinical studies reportedly demonstrated high absorption rates, bioequivalence to oral therapies, and no indications of toxicity.
How does BNT23001 aim to benefit multiple sclerosis patients?
BNT23001 is an orally dissolvable thin-film designed for improved bioavailability, faster onset, and easier dosing for patients with dysphagia or who prefer non-tablet options.
What is the timeline for BioNxt’s human comparative bioequivalence study (BNXTF)?
The company plans to conduct the human comparative bioequivalence study in early 2026, following completion of the large-mass animal study and analysis.
What is the status of patent protection for BNT23001?
Patent nationalization is underway across key markets; the EPO and Eurasian offices issued notices of intentions to grant, and a Track One priority filing is active in the United States.
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