BioNxt Advances "Melt in Your Mouth" Cladribine Formulation to Improve Treatment for MS Patients with Dysphagia

Executive Summary

• BioNxt Solutions announced the development of a next‑generation “Melt in Your Mouth” oral dissolvable film (ODF) formulation of cladribine (BNT23001) for multiple sclerosis (MS) patients who have difficulty swallowing tablets.
• The ODF is designed to dissolve sublingually within seconds, offering a swallow‑free, needle‑free delivery method intended to improve adherence, safety and quality of life.
• Market context highlights the large global cladribine market (≈ USD 1.2 bn in 2023, projected USD 2.5 bn by 2032) and rapid growth in the oral transmucosal drug‑delivery sector (USD 45.8 bn in 2025 → ≈ USD 96.8 bn by 2033).

Key Details

• Program name: BNT23001 – melt‑in‑your‑mouth cladribine ODF.
• Therapeutic target: Multiple sclerosis (MS) patients with dysphagia or swallowing difficulties.
• Technology: Proprietary oral dissolvable film (ODF) that dissolves in seconds under the tongue, eliminating the need for tablets or injections.
• Clinical rationale: Approximately 45 % of MS patients experience dysphagia; tablet‑based cladribine can cause coughing, choking, missed doses and reduced treatment consistency.
• Market opportunity:
• Global cladribine sales: USD 1.28 bn in 2024; Merck’s Mavenclad generated > USD 950 m in Q1–Q3 2025.
• Projected cladribine market size: USD 2.5 bn by 2032 (8.5 % CAGR).
• Oral transmucosal drug‑delivery market: USD 45.8 bn in 2025 → ≈ USD 96.8 bn by 2033.
• Regulatory focus: Development aimed at European markets; regulatory filings anticipated (specific timelines not disclosed).
• CEO Quote: “Taking a tablet should not be a barrier to treatment… we are addressing a meaningful unmet need by making an important therapy easier, safer, and more accessible.”

Notable Quotes

“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.”