Adalvo is progressing dossier development for Ruxolitinib 1.5% cream, targeting first to file/first to market opportunities across Europe.
Based on the reference brand, Opzelura, Ruxolitinib cream is indicated for the treatment of non-segmental vitiligo (NSV), an area of significant unmet clinical need.
Non-segmental vitiligo is a chronic skin disorder, and the most common of four vitiligo subtypes, accounting for 85-90% of cases. It’s influenced by genetic factors and characterized by de-pigmented lesions that develop intermittently throughout life.
Non-segmental vitiligo differs from the rarer segmental form by presenting symmetrically on both sides of the body, including visible areas such as the hands, knees, and face. It can cause stigma, anxiety and depression among patients, making early intervention crucial for managing the condition.
Ruxolitinib is the first and only approved nonsteroidal topical JAK inhibitor to match or exceed corticosteroid efficacy for treating non-segmental vitiligo, including skin re-pigmentation. The originator brand, Opzelura, has also received approval for atopic dermatitis outside the EU, showing the therapy's potential for other dermatological conditions.
IQVIA figures show that the global annual MAT for Opzelura cream reached $660 million in Q2 2025.
Adalvo has also secured one of the few specialized finished dosage form manufacturing facilities capable of handling the complex API, allowing us to launch a high-quality product on Day-1.
Building on Adalvo's proven expertise in complex topical formulations across multiple indications, including acne, rosacea, psoriasis, and atopic dermatitis, Ruxolitinib cream further strengthens our position in high-value dermatology.
To discuss licensing opportunities or to see our full dermatology portfolio, contact one of our team today.