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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: 16 Jan 2026

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At a glance

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

Most Recent Events

  • 09 Jan 2026 According to a Camurus media release, company has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companys resubmission of the New Drug Application (NDA) for Oclaiz (CAM2029), octreotide extended-release injection, for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 10 June 2026.
  • 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.
  • 11 Jun 2025 Status changed from active, no longer recruiting to completed.

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