Adalvo will submit the DCP application for Cladribine Tablets 10mg in August 2025, following the expiry of data exclusivity in key EU markets.
Cladribine is indicated for the treatment of relapsing forms of multiple sclerosis (MS), a chronic and disabling neurological disease with significant long-term management needs. According to IQVIA, Cladribine reached global sales of $1.4 billion in 2024, with a three-year CAGR of 13%.
This product represents a high-complexity development pathway due to the unique characteristics of the molecule. Cladribine is a highly cytotoxic and humidity-sensitive compound, requiring advanced containment, handling protocols, and specialised manufacturing infrastructure. In addition, the oral formulation involves a cyclodextrin complexation step, a technical complexity that is difficult to replicate.
From a regulatory standpoint, the product’s clinical path is particularly challenging, given its cytotoxic nature. The data exclusivity and IP landscape are also distinctive, as Cladribine was originally used as an injectable oncology treatment before being repurposed as an oral therapy for MS.
With a clearly defined approval pathway and launch readiness aligned to market entry windows, Adalvo continues to strengthen its neurology portfolio with partner-ready solutions designed for execution and scale.
To explore licensing or commercial opportunities within Adalvo’s neurology portfolio, contact the team today.