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Adalvo confirms successful pivotal BE study for Lenvatinib Oral Liquid

Business
19 March 2026

With the pivotal bioequivalence (BE) study successfully completed, Adalvo is set for DCP submission of Lenvatinib Oral Liquid (OL) in April 2026.  

Approximately 60% of patients diagnosed with thyroid cancer struggle to swallow capsules because of tumour location. Lenvatinib OL addresses this significant unmet need: as a convenient, ready-to-use liquid, it improves adherence and simplifies administration. A single strength covers all therapeutic doses, removing the complexity of multi-capsule configurations

To bring Lenvatinib Oral Liquid to patients in your territory and view our full range of 34 oncology therapies, contact a member of the team

Based on the reference brand Lenvima, Lenvatinib OL is indicated for the treatment of Differentiated Thyroid Carcinoma (DTC), Hepatocellular Carcinoma (HCC), and Endometrial Carcinoma (EC). 

Developed as a 505(b)(2) application for the U.S. and a hybrid application in the EU, Lenvatinib OL marks a significant milestone in a technically demanding program.  

The complexity in manufacturing this highly potent cytotoxic liquid has been successfully addressed by Adalvo, and is protected by our own patent application. It allows Adalvo to offer partners a Day-1 opportunity with a unique and highly differentiated oncology asset

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 to explore our full oncology portfolio, contact a member of the team today