Product Description
Ampreloxetine (TD-9855) is an investigational,ÊTheravance Biopharma-discovered, potent, long-acting, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH). (Sourced from: https://investor.theravance.com/news-releases/news-release-details/theravance-biopharma-inc-announces-top-line-results-phase-3)
Mechanisms of Action: NRI Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Hypotension|Hypotension, Orthostatic|Multiple System Atrophy *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Theravance Biopharma
Company Location: GEORGE TOWN, GRAND CAYMAN E9 KY1-1104
Company CEO: Rick E Winningham
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Belgium, Denmark, Estonia, France, Germany, Hungary, Italy, Poland, Portugal, Spain, United States
Active Clinical Trial Count: 3
Highest Development Phases
Phase 3: Hypotension, Orthostatic|Multiple System Atrophy|Shy-Drager Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 0197 | P3 |
Unknown Status |
Hypotension, Orthostatic |
2027-01-29 |
|
| 0171 - Phase 3 Extension Study of TD-9855 for Treating snOH in Subjects with Primary Autonomic Failu | P3 |
Unknown status |
Hypotension, Orthostatic |
2025-03-17 |
|
| CYPRESS | P3 |
Recruiting |
Shy-Drager Syndrome|Multiple System Atrophy|Hypotension, Orthostatic |
2024-12-01 |