BioNxt Solutions Reports Promising Preclinical Data for New Drug Delivery Method

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BioNxt Solutions has released preliminary data from a preclinical study, indicating its sublingual formulation of the drug cladribine may achieve significantly improved absorption. The findings, announced on Sunday, represent a potential step toward human clinical trials and a future alternative in the multi-billion dollar multiple sclerosis treatment market.

The study, conducted between November and December 2025, compared BioNxt's oral dissolving film (ODF) containing 10 mg of cladribine against a conventional tablet. Both were administered at a dose of 5 mg per animal to adult pigs, a species chosen for its metabolic similarity to humans.

Preliminary results suggest that delivering the drug sublingually—under the tongue—leads to a higher bioavailability than traditional oral ingestion. Researchers collected blood samples over a 24-hour period to measure peak concentration, total exposure, and the duration the drug remained in the system.

"We are encouraged that these results support the premise that sublingual administration can substantially improve the efficiency of cladribine delivery," stated Hugh Rogers, CEO of BioNxt Solutions.

Targeting a Substantial Market Opportunity

The company's approach aims to enable lower doses with equivalent efficacy through enhanced absorption, which could improve patient tolerability and reduce side effects. This strategy targets a significant market: the reference product, Merck's Mavenclad®, generates global annual revenues exceeding one billion U.S. dollars.

The broader multiple sclerosis market is projected to grow to over $41 billion by 2033, with approximately 2.3 million people living with the condition worldwide.

BioNxt has secured patent protection for its proprietary formulation, with additional national patents nearing issuance. This intellectual property position is expected to be a relevant factor in potential future licensing discussions.

Path Forward and Broader Applications

The company is currently finalizing its comprehensive data analysis. Detailed pharmacokinetic calculations are forthcoming and will be used to determine the dosing for a planned human bioequivalence study.

Beyond multiple sclerosis, BioNxt also identifies potential for its cladribine formulation in treating other neurodegenerative conditions, such as myasthenia gravis.