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Ampreloxetine - Theravance Biopharma

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Drug Profile

Ampreloxetine - Theravance Biopharma

Alternative Names: Ampreloxetine; Ampreloxetine hydrochloride; TD 9855; TD-9855 HCl

Latest Information Update: 02 Sep 2025

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At a glance

  • Originator Theravance
  • Developer Theravance Biopharma
  • Class Analgesics; Antihypotensives; Behavioural disorder therapies; Piperidines; Small molecules
  • Mechanism of Action Adrenergic uptake inhibitors; Central nervous system stimulants; Serotonin uptake inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Orthostatic hypotension
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Orthostatic hypotension
  • Discontinued Attention-deficit hyperactivity disorder; Fibromyalgia

Most Recent Events

  • 25 Aug 2025 Theravance Biopharma completes enrolment in the phase III CYPRESS trial for neurogenic orthostatic hypotension (nOH) in the US, Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Spain, Taiwan, and United Kingdom (PO) (NCT05696717)
  • 28 Apr 2025 Theravance Biopharma terminates the phase III SEQUOIA trial in Orthostatic hypotension (In adults, In the elderly) in the US, Australia, Austria, Bulgaria, Canada, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Russia, Spain, Ukraine, and the UK due to business decision (PO, Tablet) (NCT03750552) (EudraCT2018-003289-15)
  • 17 Nov 2023 Theravance Biopharma announces intention to submit NDA to US FDA for symptomatic neurogenic orthostatic hypotension

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