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A phase I repeated dose study of CAM2029 for treatment of patients with acromegaly, neuroendocrine tumors (NETs).

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Trial Profile

A phase I repeated dose study of CAM2029 for treatment of patients with acromegaly, neuroendocrine tumors (NETs).

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 May 2025

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At a glance

  • Drugs Octreotide (Primary)
  • Indications Acromegaly; Neuroendocrine tumours
  • Focus Adverse reactions

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.
  • 06 May 2016 New trial record

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