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A Phase IIa, Open Label, Proof of Concept Study to Evaluate the Safety of Aqueous Afamelanotide Solution in Patients with acute Arterial Ischaemic Stroke (AIS) who are ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)

Trial Profile

A Phase IIa, Open Label, Proof of Concept Study to Evaluate the Safety of Aqueous Afamelanotide Solution in Patients with acute Arterial Ischaemic Stroke (AIS) who are ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs Afamelanotide (Primary)
  • Indications Stroke
  • Focus Adverse reactions; Proof of concept
  • Acronyms CUV803
  • Sponsors Clinuvel Pharmaceuticals

Most Recent Events

  • 26 Mar 2025 Status changed from recruiting to completed.
  • 26 Mar 2025 Results presented in the Clinuvel Pharmaceuticals Media Release.
  • 09 May 2023 Results presented in the Clinuvel Pharmaceuticals Media Release

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