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Theravance’s Investigational Drug Ampreloxetine Fails Second Phase 3 Trial

Theravance’s Investigational Drug Ampreloxetine Fails Second Phase 3 Trial

Theravance Biopharma said that its investigational drug ampreloxetine failed its second phase 3 study in patients with symptomatic neurogenic orthostatic hypotension, a condition that frequently involves symptoms such as dizziness when standing up or changing position.

The clinical trial enrolled 128 participants with Parkinson’s disease, pure autonomic failure and multiple system atrophy. The study failed to achieve its primary endpoint of improvement in hypotension symptoms. An earlier phase 3 study had also failed to show a significant improvement in symptoms.

Despite the disappointing results, Theravance is still investigating the drug as a potential treatment for patients with multiple system atrophy, who showed the most benefit from the drug in the second phase 3 trial.

About Ampreloxetine 

Ampreloxetine (TD-9855) is an investigational, Theravance Biopharma-discovered, potent, long-acting, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH).

About Theravance Biopharma 

Theravance Biopharma, Inc. is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Its purpose is to pioneer a new generation of small molecule drugs designed to better meet patient needs. Its research is focused in the areas of inflammation and immunology.

April 7, 2022

https://www.fdanews.com/


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