Adalvo is on target to launch Teduglutide in Europe in Q1 2026, following the anticipated closure of the DCP towards the end of 2025. In parallel with the EU filing, regulatory approval efforts are also underway in Israel, across Latin America, and in CIS countries where the condition is highly prevalent.
Teduglutide is indicated for the treatment of short bowel syndrome (SBS), a rare and serious condition that impairs the small intestine’s ability to absorb nutrients and fluids. With limited treatment alternatives and high associated healthcare costs, particularly due to lifelong reliance on parenteral support, Teduglutide provides a crucial therapeutic option.
Adalvo aims to address this unmet need by delivering a more affordable alternative to existing treatments, improving both access and outcomes for patients worldwide.
As a complex peptide, Teduglutide demands advanced development capabilities. This program highlights Adalvo’s strong technical expertise in peptide formulation, strategic IP navigation, and regulatory precision, demonstrating its proven ability to execute on high-barrier assets.
According to IQVIA, Teduglutide generated global sales of approximately $167 million in 2024, underlining its clinical value and commercial potential across global markets.
With commercial infrastructure in place and launch readiness aligned to regulatory closure, Adalvo is well-positioned to bring Teduglutide to market swiftly and responsibly.
To explore licensing or commercial opportunities within Adalvo’s gastroenterology portfolio, contact the team today.