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: Western America
Company CEO: Rick E Winningham
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Serbia, Spain, Taiwan, United Kingdom, United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Theravance Biopharma announced they will present P3 Hypotension, Orthostatic results in 1Q26 for Ampreloxetine
- Clinical Outcomes Expected - Theravance Biopharma announced they will present P3 Hypotension, Orthostatic|Multiple System Atrophy results in 1Q26 for Ampreloxetine
- Clinical Outcomes Expected - Theravance Biopharma announced they will present P3 Multiple System Atrophy results in 1H26 for Ampreloxetine
Highest Development Phases
Phase 3: Hypotension, Orthostatic|Multiple System Atrophy
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05696717 |
CYPRESS | P3 |
Active, not recruiting |
Hypotension, Orthostatic|Multiple System Atrophy |
2026-01-01 |
23% |
2025-09-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-504876-12-00 |
0197 | P3 |
Recruiting |
Hypotension, Orthostatic |
2027-01-29 |
2025-05-02 |