BioNxt Solutions Inc. is making strides in addressing dysphagia, a common but often underestimated challenge in medicine. Dysphagia, or difficulty swallowing, can reduce treatment adherence, especially for chronic and autoimmune disease patients.
Dysphagia and Medication Adherence
Dysphagia is more than a minor inconvenience. Up to 40% of adults experience difficulty swallowing pills, often leading to skipped doses, delayed medication, or unsafe practices like crushing tablets. This can compromise drug efficacy and increase side effects. For autoimmune and neuromuscular conditions, dysphagia is even more impactful. Around 45% of patients with Multiple Sclerosis (MS) experience swallowing difficulties, while Myasthenia Gravis (MG) patients often find it one of the most disabling symptoms, affecting treatment persistence.
BioNxt’s Swallow-Free Solution
BioNxt’s thin-film technology dissolves under the tongue within seconds, removing the need to swallow tablets or capsules. This melt-in-the-mouth format provides a needle-free and water-free alternative, reducing choking risks and allowing dosing in virtually any setting. It benefits patients with MS, MG, Rheumatoid Arthritis (RA), and Lupus Nephritis (LN), where mobility, fatigue, or gastrointestinal issues complicate traditional oral dosing.
Sublingual absorption also partially bypasses gastrointestinal transit and first-pass liver metabolism, supporting faster absorption and potentially better bioavailability. This feature is critical for chronic autoimmune diseases requiring consistent drug exposure.
Patent Milestone
BioNxt received its first patent for BNT23001, a sublingual cladribine thin film for MS and MG. The reference drug, cladribine tablets (Mavenclad®), has blockbuster sales exceeding $1 billion annually. The Eurasian patent is valid through 2043 across eight member states, covering over 200 million people. Additional patents are in progress in Europe, North America, and the Asia-Pacific, covering major global autoimmune drug markets.
Accelerated Development
BioNxt has completed GMP clinical batch manufacturing for BNT23001 and is preparing a human bioequivalence study in Q1 2026. Since cladribine is already approved as an oral tablet, the company can pursue a bioequivalence-driven regulatory pathway, shortening development timelines, reducing capital needs, and lowering clinical risk.
Scalable Platform
While BNT23001 is the lead programme, BioNxt’s thin-film delivery system is a scalable platform capable of reformulating multiple approved drugs for autoimmune and chronic diseases. These markets are projected to exceed $75–80 billion annually over the next decade. By combining dysphagia-friendly delivery with efficient manufacturing and strong IP protection, BioNxt addresses a major unmet medical need while creating long-term value. Awareness of dysphagia and innovative dosage forms may increasingly influence therapeutic success.
