VANCOUVER, BC — January 21, 2026 — Leads & Copy — BioNxt Solutions Inc. has announced positive final results from a preclinical pig study, demonstrating that its needle-free, swallow-free sublingual oral dissolvable film (ODF) cladribine formulation for Multiple Sclerosis (MS) achieved significantly higher systemic drug delivery compared to conventional oral tablet formulations.
The company’s announcement highlights that the study compared two fundamentally different routes of administration under controlled conditions to de-risk the clinical development and commercialization pathway and supports the rationale for advancing the sublingual ODF formulation into human pharmacokinetic studies.
According to the study, BioNxt’s cladribine sublingual oral dissolvable film achieved meaningfully higher systemic drug availability than the conventional oral tablet formulation. Systemic exposure was assessed over a 48-hour period using AUC (0-48 h). The mean AUC (0-48 h) for the sublingual ODF was 39.46 ng·h/mL, compared with 28.11 ng·h/mL for the oral tablet formulation, representing approximately 40% higher cladribine exposure.
BioNxt reported that the preclinical pig study involved adult miniature pigs (40-50kg), a large-mass non-rodent model, to compare its sublingual ODF formulation with an approved generic cladribine tablet equivalent to the established name-brand reference product. To ensure accurate assessment of sublingual absorption, animals were physically restrained during dosing to prevent swallowing and to isolate the transmucosal route of administration.
Hugh Rogers, Chief Executive Officer of BioNxt, said that the study results validate the efficiency of their sublingual delivery approach and provide quantitative confirmation that the ODF delivers cladribine more efficiently than conventional oral tablets. The company intends to proceed toward human pharmacokinetic and bioequivalence evaluations while continuing GMP manufacturing and regulatory preparation. According to BioNxt, improved systemic drug delivery through sublingual administration may support more efficient dosing, reduce variability associated with oral absorption, and offer a swallow-free, needle-free, patient-friendly alternative for individuals living with neurological or neuromuscular conditions.
BioNxt views its sublingual oral dissolvable film (ODF) technology as a scalable delivery platform with potential applications across a broader range of neuro‑immunological and neurological diseases. The company believes its cladribine ODF approach may also be applicable to indications such as Myasthenia Gravis (MG).
BioNxt Solutions Inc. is focused on next-generation drug delivery platforms, diagnostic screening systems, and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects.
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 780-818-6422
Source: BioNxt Solutions Inc.
