Cladribine

BioNxt (BNXTF) has initiated a large-mass animal study for BNT23001, a sublingual cladribine film for multiple sclerosis, to optimize dosing before human trials planned for early 2026. The study, expected to complete in November 2025 with results in December 2025, aims to improve bioavailability and simplify dosing. Patent nationalization is ongoing, with positive notices from European and Eurasian Patent Offices, and a priority filing in the US. BNT23001 targets improved outcomes for dysphagia patients, offering a non-tablet option.

BioNxt Solutions has secured a pivotal European patent for its sublingual drug delivery platform, enhancing its intellectual property position for treating autoimmune diseases. The technology underpins BNT23001, a fast-dissolving oral film of Cladribine aimed at revolutionizing multiple sclerosis therapy by replacing injections with a needle-free, bioavailable alternative. Global patent filings are advancing in the U.S., Japan, and Eurasia, targeting a $150B+ autoimmune market. Upcoming bioequivalence studies in 2025 could enable accelerated EU approval. The platform also shows potential for lupus and arthritis treatments, with preclinical data suggesting improved delivery of biologic agents, positioning BioNxt as a leader in precision drug reformulation.