Adalvo is ready to submit the DCP application for Dimethyl Fumarate gastro-resistant tablets (30mg and 120mg), targeting the treatment of moderate to severe plaque psoriasis in adult patients.
With the submission planned for the end of June 2025, Dimethyl Fumarate is an oral therapy for moderate to severe plaque psoriasis, a chronic skin condition requiring long-term treatment. Based on the reference brand Skilarence, the product generated global sales of around $30 million in 2024, according to IQVIA.
Adalvo is currently not seeing any competitor activity in this space, highlighting a strong early-mover opportunity.
The DCP filing follows a successful pivotal bioequivalence study under fed conditions, supporting regulatory readiness and a clear development path across multiple markets.
Adalvo remains focused on delivering clinically relevant, commercially viable treatments with regulatory clarity and execution strength across high-barrier therapeutic areas.
To explore licensing or partnership opportunities, contact the Adalvo team.