Adalvo continues to progress its Ambrisentan + Tadalafil film-coated tablets towards MA approval in Q1 2027.
This first-of-its-kind fixed-dose combination (FDC) therapy is indicated to treat Pulmonary Arterial Hypertension (PAH) in adult patients.
To add Ambrisentan + Tadalafil film-coated tablets to your portfolio, contact us today.
Pulmonary Arterial Hypertension (PAH) is a rare, progressive condition that can lead to right heart failure. It most commonly affects women aged 30 to 60, and while there's no cure, current treatments can help manage symptoms, slow disease progression and improve quality of life.
The combination of Ambrisentan (an endothelin receptor antagonist) and Tadalafil (a PDE5 inhibitor) is a potent, dual-action therapy.
The landmark AMBITION study found that the combined therapies delivered superior efficacy, reduced the risk of clinical failure events by 50%, and improved exercise capability.
Reflecting guideline recommendations around upfront combination therapy, Adalvo is developing the FDC in the full range of strengths: 5mg+20mg, 5mg+40mg, 10mg+40mg. This benefits both prescribers and patients; patients remain on a single tablet throughout titration rather than switching to separate tablets during dose adjustment.
And it means prescribers can offer a convenient, proven, and differentiated once-daily oral treatment, helping to improve adherence.
The global PAH treatment market is projected to reach approximately $13.3 billion by 2033, reflecting a CAGR of around 5.9% from 2025. This growth reflects increasing diagnosis rates, improved awareness and an expanding treatment landscape.
According to IQVIA, combined global sales of Ambrisentan and Tadalafil brands exceeded $3 billion in 2025.
To explore partnership opportunities for Ambrisentan + Tadalafil fixed-dose combination tablets, or to discover Adalvo's cardiovascular and rare disease portfolio, contact one of the team today.