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A Phase II, Open-label, Multicentre, Randomised Study of the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of CAM2029 in Patients With Acromegaly and Neuroendocrine Tumours (NETs) Previously Treated With Sandostatin LAR

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Trial Profile

A Phase II, Open-label, Multicentre, Randomised Study of the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of CAM2029 in Patients With Acromegaly and Neuroendocrine Tumours (NETs) Previously Treated With Sandostatin LAR

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 May 2025

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At a glance

  • Drugs Octreotide (Primary)
  • Indications Acromegaly; Neuroendocrine tumours
  • Focus Pharmacokinetics
  • 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.
  • 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.
  • 04 Apr 2017 Results presented at The 99th Annual Meeting of the Endocrine Society

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