Adalvo announces a positive outcome from the pilot bioequivalence (BE) study for its Lenvatinib 2mg/ml Oral Solution (OS), a patient-friendly formulation designed to expand access to Lenvatinib therapy.
This result marks significant progress toward the full execution of the pivotal clinical program and the regulatory submission of a novel dosage form not currently available globally, with dossier readiness anticipated as early as Q4 2025.
Developed as a 505(b)(2) application in the U.S. and a hybrid application in the EU, Lenvatinib OS offers a value-added alternative to the capsule formulation of Lenvatinib, based on the reference brand, LENVIMA.
Lenvatinib OS is indicated for the treatment of Differentiated Thyroid Carcinoma (DTC), Hepatocellular Carcinoma (HCC), and Endometrial Carcinoma (EC). As a liquid oral formulation, it is specifically developed to meet the needs of patients who cannot swallow capsules or require precision dosing.
In 2024, LENVIMA achieved approximately $1.99 billion in global sales, with a 3Y CAGR of 13%, according to IQVIA.
With a clearly defined regulatory and IP strategy, Adalvo is targeting a Day-1 launch across all major markets, highlighting our position in the development of complex, patient-centered generics and differentiated dosage forms.
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