BioNxt Advances "Melt in Your Mouth" Cladribine Formulation to Improve Treatment for MS Patients with Dysphagia
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Rhea-AI Summary
BioNxt Solutions (OTCQB:BNXTF) is advancing a next‑generation "Melt in Your Mouth" cladribine oral dissolvable film (ODF), BNT23001, designed for rapid sublingual absorption to help multiple sclerosis (MS) patients with dysphagia who struggle to swallow tablets.
The company cites a meta‑analysis finding ~45% of MS patients experience dysphagia and notes cladribine tablets generated ~USD 1.28 billion in 2024. Market data show cladribine sales of >USD 950M through Q3 2025 and a projected cladribine market CAGR of 8.5% to 2032; the oral transmucosal market is forecast to grow from USD 45.8B (2025) to USD 96.8B (2033).
Positive
- Addresses dysphagia affecting ~45% of MS patients
- Targets cladribine market with ~USD 1.28B 2024 sales
- Aligns with oral transmucosal market forecast rising to USD 96.8B by 2033
Negative
- U.S. patent decision could allow generic cladribine entry beginning in 2026
Details
News Market Reaction – BNXTF
On Dec 9, the day this news came out, BNXTF closed 1.64% above the previous close.
Data tracked by StockTitan Argus for the Dec 9 session.
Key Figures
- Cladribine tablet sales
- USD 1.28 billion
- Global cladribine tablet sales in 2024
- Mavenclad sales Q1–Q3 2025
- Over USD 950 million
- Merck KGaA cladribine tablets through first three quarters 2025
- Global cladribine market 2023
- USD 1.2 billion
- Market size from Cladribine Market Research Report 2033
- Projected cladribine market 2032
- USD 2.5 billion
- Forecast market size by 2032
- Cladribine market CAGR
- 8.5%
- Projected CAGR to 2032
- Oral transmucosal market 2025
- USD 45.8 billion
- Global oral transmucosal drug-delivery market in 2025
- Oral transmucosal market 2033
- USD 96.8 billion
- Projected market size by 2033
- MS patients in meta-analysis
- More than 10,800 patients; ~45% with dysphagia
- 2023 Journal of Clinical Neuroscience meta-analysis
Historical Context
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Advanced BNT23001 melt-in-mouth cladribine ODF targeting MS dysphagia.
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Letter to acquire 100% IP and codevelop sublingual oncology formulation.
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Final Eurasian patent grant for sublingual cladribine platform BNT23001.
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EPO Intention to Grant for sublingual cladribine thin-film for MS.
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Eurasian Readiness to Grant for sublingual anticancer drug delivery patent.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
dysphagia medical
meta-analysis technical
sublingual medical
oral dissolvable film technical
oral transmucosal drug-delivery technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
VANCOUVER, BC / ACCESS Newswire / December 9, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is advancing the development of a next-generation "Melt in Your Mouth" cladribine formulation, built on the Company's proprietary oral dissolvable film (ODF) drug-delivery system. The technology is designed for rapid, sublingual (under-the-tongue) absorption of medication and aims to improve treatment access and comfort for people living with multiple sclerosis (MS). BioNxt's lead program, BNT23001, is being developed as a swallow-free alternative to cladribine tablets, which generated USD 1.28 billion in global sales in 2024.
Cladribine (Mavenclad®) is an established therapy for MS; however, many patients struggle with difficulty swallowing tablets, a symptom that is both common and often under-recognized. For these individuals, pill-based medication can lead to coughing, choking, anxiety, and missed doses - all of which reduce treatment consistency and therapeutic effectiveness.
BioNxt's "Melt in Your Mouth" ODF is engineered to dissolve in seconds under the tongue, eliminating the need to swallow and offering a needle-free, patient-friendly method of administration. The approach aims to enhance treatment adherence, safety, and overall quality of life for MS patients who face challenges with tablet-based medication.
Swallowing Difficulties: A Hidden Barrier in Multiple Sclerosis Treatment
Swallowing problems (dysphagia) are common in MS but often overlooked. A recent meta-analysis of more than 10,800 MS patients found that approximately
For these individuals, tablets may feel "stuck," provoke coughing or choking, or require repeated attempts to swallow - turning a simple daily task into a persistent source of stress.
As swallowing becomes more difficult or unsafe, patients may delay doses, avoid medication altogether, or require caregiver assistance. By removing the need to swallow, BioNxt's "Melt in Your Mouth" cladribine ODF is being developed specifically to address this barrier and help maintain consistent, safe access to cladribine therapy.
Significant Market Opportunity for a Patient-Friendly Cladribine Format
The global cladribine market is expanding rapidly. Merck KGaA's cladribine tablets (Mavenclad®) generated over USD 950 million in the first three quarters of 2025, reflecting strong, ongoing demand across the U.S. and Europe. The company reported record quarterly sales in 2025 and continues to expect growth in Europe, although a recent U.S. patent decision could open the door to generic competition beginning in 2026.
According to Cladribine Market Research Report 2033 from Dataintelo, the global cladribine market was valued at USD 1.2 billion in 2023 and is projected to reach USD 2.5 billion by 2032, representing a robust
At the same time, the oral transmucosal drug-delivery market - including sublingual and buccal systems - is expected to grow from USD 45.8 billion in 2025 to nearly USD 96.8 billion by 2033. As a low-dose molecule well suited to BioNxt's Melt in Your Mouth ODF technology, cladribine sits at the intersection of two fast-growing global markets, offering a significant opportunity to modernize and differentiate an established therapy.
"Taking a tablet should not be a barrier to treatment," said Hugh Rogers, CEO of BioNxt Solutions. "Our Melt in Your Mouth cladribine film is designed specifically for MS patients who struggle to swallow pills. We are addressing a meaningful unmet need by making an important therapy easier, safer, and more accessible in everyday life."
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next‐generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin‐Film), Transdermal (Skin Patch), and Oral (Enteric‐Coated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.
With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient‐centric solutions that enhance treatment outcomes worldwide.
BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets:BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.
Investor Relations & Media Contact
Hugh Rogers, Co‐Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 778.598.2698
Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt‐solutions
Instagram: https://www.instagram.com/bionxt
Cautionary Statement Regarding "Forward‐Looking" Information
This news release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Forward-looking information in this news release includes the anticipated filing date of the Annual Filings. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
SOURCE: BioNxt Solutions Inc.
View the original press release on ACCESS Newswire
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