CLINICAL TRIALS PROFILE FOR AMPRELOXETINE

Clinical Trials for ampreloxetine

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03750552 ↗	Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure	Completed	Theravance Biopharma	Phase 3	A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.
NCT03829657 ↗	Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure	Active, not recruiting	Theravance Biopharma	Phase 3	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
NCT04095793 ↗	Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure	Active, not recruiting	Theravance Biopharma	Phase 3	A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.
NCT04200573 ↗	Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855	Completed	Theravance Biopharma	Phase 1	An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal hepatic function.
NCT04688632 ↗	Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects	Completed	Theravance Biopharma	Phase 1	A double-blind study to characterize the effect of ampreloxetine on cardiac repolarization in healthy subjects.
NCT05696717 ↗	Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy	Not yet recruiting	Theravance Biopharma	Phase 3	This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

Clinical Trial Conditions for ampreloxetine

Condition Name

Condition Name
Intervention	Trials
Symptomatic Neurogenic Orthostatic Hypotension	4
nOH	2
Symptomatic Neurogenic Orthostatic Hypertension	2
Parkinson's Disease (PD)	1

Condition MeSH

Condition MeSH
Intervention	Trials
Hypotension, Orthostatic	4
Hypotension	4
Pure Autonomic Failure	3
Hypertension	2

Clinical Trial Locations for ampreloxetine

Trials by Country

Trials by Country
Location	Trials
United States	44
Australia	10
United Kingdom	10
Spain	9
Canada	7

Trials by US State

Trials by US State
Location	Trials
Florida	4
Texas	3
Tennessee	3
Oregon	3
Ohio	3

Clinical Trial Progress for ampreloxetine

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	4
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for ampreloxetine

Sponsor Name

Sponsor Name
Sponsor	Trials
Theravance Biopharma	6

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	6