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Adalvo Ready to Submit DCP for Dapagliflozin + Metformin IR Fixed-Dose Combination

Business
18 June 2025

Adalvo is ready to submit the DCP application for Dapagliflozin + Metformin IR fixed-dose combination tablet in August 2025, expanding its metabolic portfolio with a clinically established treatment for type 2 diabetes mellitus in adults requiring dual therapy. 

This fixed-dose combination brings together Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and Metformin, a first-line biguanide, offering complementary mechanisms of action to improve glycemic control when used alongside diet and exercise.

The formulation provides an immediate-release dosing option, administered twice daily, and is film-coated for oral use. 

According to IQVIA, the global market for Dapagliflozin + Metformin IR reached $528 million in 2024, with a 3Y CAGR of 22%, reflecting strong and accelerating demand for effective, accessible oral diabetes therapies. 

This development builds on Adalvo’s growing diabetes portfolio, which includes a DCP-approved Dapagliflozin monotherapy and a ready-to-file Dapagliflozin + Metformin XR formulation, offering partners a complementary suite of differentiated products across treatment stages.

Adalvo’s dossier is backed by a strong development strategy, regulatory clarity, and a focus on timely market access.  

To explore licensing opportunities or access Adalvo’s metabolic portfolio, contact the team today.