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A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)

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Trial Profile

A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 20 Feb 2025

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At a glance

  • Drugs Afamelanotide (Primary)
  • Indications Erythropoietic protoporphyria
  • Focus Pharmacokinetics; Registrational
  • Sponsors Clinuvel Pharmaceuticals
  • Most Recent Events

    • 13 Feb 2025 Status changed from planning to recruiting.
    • 10 Feb 2025 Status changed from recruiting to completed, According to a CLINUVEL media release.
    • 10 Feb 2025 According to a CLINUVEL media release, Final analyses of data from CUV052 are expected in the second half of 2025, with a further submission to the EMA planned to seek expansion of the SCENESSE label. company is facilitating limited special access to SCENESSE treatment for patients enrolled in the CUV052 study, with all eligible enrolled patients electing to receive further treatment in 2024 or 2025.

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