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A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

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Trial Profile

A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 May 2024

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At a glance

  • Drugs Octreotide (Primary)
  • Indications Acromegaly
  • Focus Adverse reactions; Registrational
  • Acronyms ACROINNOVA 2
  • Sponsors Camurus
  • Most Recent Events

    • 21 Dec 2023 According to a Camurus media release, company announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Oclaiz (CAM2029), the companys investigational, once-monthly octreotide subcutaneous (SC) depot for the treatment of patients with acromegaly. The NDA submission follows recent announcements of positive results from the two Phase 3 ACROINNOVA studies and completed pre-NDA meetings with the US FDA.
    • 17 Jul 2023 According to a Camurus media release, data from this study will be presented the upcoming medical meetings and in a scientific publication.
    • 17 Jul 2023 According to a Camurus media release, the interim data from this study will be a part of the regulatory submissions for CAM2029.
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