BioNxt Initiates Sublingual Cladribine Study for MS Treatment Optimization

BioNxt Solutions Inc., a leader in drug delivery innovations, has launched a large-mass animal bioequivalence study for its BNT23001 product. This product is a sublingual cladribine formulation designed for multiple sclerosis treatment. The study aims to finalize dosing parameters ahead of a human bioequivalence study scheduled for early 2026.

Having confirmed bioequivalence in smaller animals, this new study will explore dosage for larger animals, providing crucial data for human trials. The study will take place over 15 days, with completion expected in November and results in December.

BNT23001, a dissolvable thin-film of cladribine, promises improved bioavailability and patient compliance, addressing needs for a non-invasive alternative. BioNxt is progressing patent nationalization in major markets, with positive feedback from European and Eurasian patent offices.