TBPH

AMPRELOXETINE (TD-9855)

Neurogenic orthostatic hypotension (nOH)

Phase 3

Exp Date

Q3 2021

Amp Volatility Score

N/A

Catalyst Info & Data Links

TITLE: TD-9855 for Neurogenic orthostatic hypotension - Phase 3 Top-line Data

  • ClinicalTrial.gov (NCT03750552): Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (SEQUOIA)

  • ClinicalTrial.gov (NCT03829657): Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (Redwood)

  • ClinicalTrial.gov (NCT04095793): Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (OAK)


WHAT IS THE CATALYST EVENT?

  • Phase 3 Top-line Data


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA/EVENTS

PRESS RELEASE

MECHANISM OF ACTION

  • Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor (NRI) being developed for the treatment of patients with symptomatic neurogenic orthostatic hypotension (nOH). The compound has high affinity for binding to norepinephrine transporters. By blocking the action of these transporters, ampreloxetine causes an increase in extracellular concentrations of norepinephrine.

MARKET

  • Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a sustained orthostatic fall in systolic blood pressure (SBP) of ≥ 20 mm Hg or diastolic blood pressure (DBP) of ≥ 10 mm Hg within three minutes of standing. Severely affected patients are unable to stand for extended periods of time because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating and head and neck pain. nOH is caused by autonomic nervous system (ANS) malfunction and is associated with several underlying medical conditions including multiple system atrophy (MSA), pure autonomic failure (PAF) and Parkinson's disease (PD).

Updated by HC

TBPH, Neurogenic orthostatic hypotension (nOH), AMPRELOXETINE (TD-9855), autonomic nervous system, blood pressure, rare diseases

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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