BioNxt completes IMPD for sublingual cladribine MS candidate ahead of first human study

• BioNxt completed the IMPD for BNT23001, its sublingual cladribine oral dissolvable film for relapsing multiple sclerosis.
• The dossier moves the program toward a first-in-human bioequivalence study, pending final review and a European CTA submission.
• Planned trial: randomized, open-label crossover in healthy volunteers versus Mavenclad, targeting pharmacokinetic bioequivalence plus safety and tolerability.
• Development package includes GMP clinical-batch manufacturing, preclinical comparative pharmacokinetics, local tolerability data, and a finalized clinical protocol.
• Patent protection secured in Europe and the Eurasian region for the sublingual cladribine technology.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioNxt Solutions Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 202608260305ACCESSWRNAPR_____1212054) on August 26, 2026, and is solely responsible for the information contained therein.