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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: 09 Jul 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

  • 01 Jul 2025 According to a Camurus media release, company announced that the European Commission (EC) has granted Oczyesa, octreotide subcutaneous depot, marketing authorization* for the maintenance treatment in adult patients with acromegaly based on results from seven clinical studies, including two Phase 3 studies ACROINNOVA 1 and ACROINNOVA 2.
  • 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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