Bioequivalence studies for generic Avatrombopag are now underway, marking a significant development milestone in Adalvo's programme. The company expects to have a global regulatory dossier ready to file in 2026, covering the US, EU, and Rest of World markets.
Avatrombopag is indicated for adults diagnosed with primary chronic immune thrombocytopenia (ITP) and Thrombocytopenia in adults with chronic liver disease (CLD) who need to undergo a medical procedure.
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As part of a second-generation class of thrombopoietin (TPO) receptor agonists, Avatrombopag has been shown to stimulate platelet production – up to 50,000 per microliter, and in as little as eight days.
For patients, Avatrombopag improves both adherence and safety. As it doesn’t interact with mineral supplements it can be taken with food, removing the need for a strict schedule and diet.
It also has a well-established safety profile and does not require routine liver enzyme monitoring, supporting its use in patients with existing liver impairment or abnormal liver function.
A rapidly growing global market
Since its launch, Avatrombopag has shown exceptional growth. In the two years to the end of Q2, 2025 US and EU markets grew by just over 202%, with sales figures exceeding $514M by Q2, 2025.
Our bioequivalence study is a key step in bringing generic Avatrombopag to both the EU and US. It reinforces our expertise in complex small molecules and is supported by a clearly defined IP pathway, with the aim of enabling Day-1 launches in major global markets.
To add Avatrombopag to your portfolio, or to see our complete haematology range, contact the team today.