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A Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly

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Trial Profile

A Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 May 2025

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At a glance

  • Drugs Octreotide (Primary)
  • Indications Acromegaly
  • Focus Registrational; Therapeutic Use
  • Acronyms ACROINNOVA 1
  • Sponsors Camurus

Most Recent Events

  • 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.
  • 23 May 2024 According to a Camurus media release, company announced that the European Medicines Agency (EMA) has accepted for review the company's Market Authorisation Application (MAA) for octreotide subcutaneous (SC) depot (CAM2029) for the treatment of patients with acromegaly. The MAA submission for CAM2029 is supported by data from seven clinical trials, including two Phase 3 studies within the ACROINNOVA program.

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