Theravance Biopharma completes enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study for symptomatic neurogenic orthostatic hypotension (nOH) due to MSA.
Ampreloxetine could potentially provide a durable benefit for the 40,000 patients in the U.S. with symptomatic nOH in patients with multiple system atrophy (MSA).
The therapy, with Orphan Drug Designation in the U.S., addresses the unmet need in symptomatic nOH due to MSA.
Topline Results Expected in Q1 2026
Theravance Biopharma anticipates top-line results from the Phase 3 CYPRESS trial in the first quarter of 2026.
Expedited NDA Submission Planning
If successful, the company plans to submit an expedited New Drug Application (NDA) for ampreloxetine.
Addressing Unmet Need
Ampreloxetine could be the first therapy to provide lasting benefit for nOH in MSA patients, a critical need for this patient population.
- The completion of enrollment in the CYPRESS study is a significant milestone for Theravance Biopharma in advancing a potential therapy for a rare and progressive condition.
- Ampreloxetine's potential as a selective norepinephrine reuptake inhibitor could have a transformative impact on treating nOH in MSA patients.
The progress in the Phase 3 study and the anticipation of topline results in Q1 2026 highlight Theravance Biopharma's commitment to addressing the unmet medical needs in patients with symptomatic nOH due to MSA.