BioNxt Solutions Inc. has reported meaningful progress in addressing dysphagia, a widespread but frequently underestimated challenge in modern medicine.
Dysphagia, or difficulty swallowing, affects a significant proportion of the population and can seriously undermine treatment adherence, particularly in patients with chronic and autoimmune diseases.
By advancing a rapid-dissolving thin-film drug delivery platform and securing its first national-level patent, BioNxt is moving closer to commercialising a solution designed around real patient needs.
Dysphagia and the real-world impact on medication adherence
Dysphagia is far more than a minor inconvenience. Surveys suggest that up to 40% of adults have experienced difficulty swallowing pills, a problem that often leads to delayed dosing, skipped medications, or unsafe practices such as crushing or splitting tablets. These behaviours can compromise drug efficacy and increase the risk of side effects.
In autoimmune and neuromuscular conditions, dysphagia is even more prevalent and clinically significant. Systematic reviews estimate that roughly 45% of patients with Multiple Sclerosis (MS) experience swallowing impairment. In Myasthenia Gravis (MG), dysphagia is widely recognised as one of the most distressing and disabling symptoms, frequently influencing treatment persistence. In these populations, the physical form of a medication can be just as important as its pharmacology.
A swallow-free approach to chronic therapy
BioNxt’s proprietary thin-film technology is designed to dissolve under the tongue within seconds, eliminating the need to swallow tablets or capsules. This melt-in-the-mouth format offers a needle-free and water-free alternative that aligns with the daily realities of patients living with dysphagia.
The thin films are intended to reduce the choking risk associated with conventional solid oral dosage forms and allow dosing in virtually any setting. This flexibility is particularly relevant for individuals with MS, MG, Rheumatoid Arthritis (RA), and Lupus Nephritis (LN), where mobility limitations, fatigue, or gastrointestinal complications can interfere with traditional oral administration.
In addition, sublingual absorption allows a portion of the drug to bypass gastrointestinal transit and first-pass liver metabolism. This mechanism may support faster absorption and improved bioavailability, which is especially relevant in chronic autoimmune diseases requiring consistent and reliable drug exposure.
First patent marks a commercial milestone
A major step forward came with the granting of BioNxt’s first patent covering BNT23001, a proprietary sublingual cladribine thin film being developed for MS and MG. The reference product, cladribine tablets marketed as Mavenclad®, has achieved blockbuster status with annual sales exceeding USD 1 billion, highlighting sustained demand in the MS treatment landscape.
The newly issued Eurasian patent is valid through 2043 and spans eight member states, representing a population of more than 200 million people. This patent serves as the first issued asset within BioNxt’s expanding global intellectual property portfolio. Additional patent applications are progressing across Europe, North America, and Asia-Pacific, regions that together account for the majority of global autoimmune drug spending.
Accelerated development and reduced clinical risk
BioNxt has completed GMP clinical batch manufacturing for BNT23001 and is preparing for a comparative human bioequivalence study scheduled for the first quarter of 2026. Because cladribine is already approved as an oral tablet, the company expects to pursue a bioequivalence-driven regulatory pathway. This approach has the potential to shorten development timelines significantly, lower capital requirements, and reduce clinical risk compared with entirely new drug development.
A scalable platform addressing dysphagia at scale
While BNT23001 is the lead programme, BioNxt’s thin-film delivery system is designed as a scalable platform supported by a growing patent family. This structure enables the reformulation of multiple approved drugs across autoimmune and chronic disease categories. Combined, these markets are projected to exceed $75–80bn annually over the next decade.
By pairing dysphagia-friendly drug delivery with platform efficiency, shared manufacturing infrastructure, and layered intellectual property protection, BioNxt is positioning itself to address an unmet medical need while building long-term value. As awareness of dysphagia grows, dosage form innovation may increasingly become a decisive factor in therapeutic success.
