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Adalvo Announces Successful Pivotal BE Study of Ambrisentan/Tadalafil Film- Coated Tablets

06 June 2024

Adalvo announces the successful completion of the Pivotal BE study of Ambrisentan/Tadalafil Film-Coated Tablets 5mg/20mg under Fed and 10mg/40mg under Fasting conditions.  

With the successful completion of our initial studies, we are now preparing to commence further studies of Ambrisentan/Tadalafil Film-Coated Tablets 5mg/20mg under Fasting conditions and 10mg/40mg under Fed conditions. 

Ambrisentan + Tadalafil Film-Coated Tablets is a differentiated treatment addressing the urgent unmet needs of patients with Pulmonary Arterial Hypertension (PAH). The combination of these two active substances has delivered superior efficacy compared to their respective monotherapies, as demonstrated in the AMBITION study(1) conducted by GlaxoSmithKline and Gilead Sciences.  

In 2023, the combined global MAT sales of Ambrisentan and Tadalafil reached approximately $1 billion, according to IQVIA.  

There are no half-measures at Adalvo – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward.  

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1: AMBITION study sponsored by GlaxoSmithKline in collaboration with Gilead Sciences: