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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: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2025

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At a glance

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

Most Recent Events

  • 11 Jun 2025 Status changed from active, no longer recruiting to completed.
  • 25 Apr 2025 According to a Camurus media release, company announced that the European Medicines Agency CHMP has adopted a positive opinion for market authorization of octreotide subcutaneous depot (CAM2029), for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues. A final decision on the marketing authorization of Oczyesa based on the CHMP recommendation is anticipated from the European Commission in mid-2025.
  • 15 Jul 2024 According to a Camurus media release, regulatory reviews are ongoing in both the US and EU with a first approval decision expected from the US FDA by the PDUFA action date 21 October 2024.

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