United Therapeutics terminates oral pulmonary arterial hypertension drug following Phase 3 failure

pharmafile | April 9, 2019 | News story | Manufacturing and Production, Research and Development Tyvaso, United Therapeutics, pharma, pulmonary arterial hypertension 

United Therapeutics has revealed in a short announcement that, because its pulmonary arterial hypertension (PAH) therapy failed to meet its primary endpoint at Phase 3, it has decided to discontinue all further development of the product.

The company sought to prove the efficacy of oral esuberaprost tablets when added to its inhaled therapy Tyvaso (treprostinil) compared to Tyvaso alone. However, it was found that esuberaprost failed to delay time until first clinical worsening event such as death or hospitalisation from disease worsening, falling short of the trial’s primary endpoint.

Secondary endpoints included six-minute walking distance, WHO functional class and Borg dyspnoea score.  

United Therapeutics is now disadvantaged in the PAH space, after the launch by Sandoz of the first generic version of the company’s own injectable treprostinil therapy Remodulin in March.

Matt Fellows

Related Content

FDA approves IMIDEX’s AI-powered device VisiRad XR

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …

Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo

On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ …


Novartis acquires Chinook Therapeutics for $3.5bn

Swiss pharmaceutical company Novartis has entered into an agreement and plan of merger with US-based …

Latest content