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Adalvo announces dossier readiness for Lenvatinib oral liquid

Business
18 February 2026

With dossier development now complete, Adalvo is preparing European (DCP) and US (NDA) submissions of Lenvatinib oral liquid, targeted for April 2026

Indicated for the treatment of Differentiated Thyroid Carcinoma (DTC), Hepatocellular Carcinoma (HCC), and Endometrial Carcinoma (EC), Lenvatinib oral liquid has been designed for patients who are unable to swallow capsules, or who need precision dosing

To bring Lenvatinib oral liquid to patients in your territory and explore our full range of 34 oncology therapies, contact a member of the team

Up to 60% of patients with thyroid cancer experience difficulty swallowing (dysphagia), and struggle with even small capsules. This can lead to missed doses and reduced treatment adherence.  

Lenvatinib oral liquid, based on the reference brand, Lenvima, removes this friction and gives patients a ready-to-use liquid formulation that allows for easy, flexible, and precise dosing

Developed as a 505(b)(2) application for the U.S. and a hybrid application in the EU, the technical complexity associated with this high-potency cytotoxic liquid formulation has been successfully addressed by Adalvo and is now protected by patent application. 

This offers partners a highly differentiated, patent-pending asset for oncology treatments and a Day-1 launch in major markets

According to IQVIA, Lenvima global sales exceeded $2.2 billion by Q2 2025, representing a two-year CAGR of 14.66%. 

To discuss licensing opportunities, or explore all our oncology therapies, contact a member of the team today