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: 27 Jan 2026
Price :
$35
*
At a glance
- Drugs Octreotide (Primary)
- Indications Acromegaly
- Focus Registrational; Therapeutic Use
- Acronyms ACROINNOVA 1
- 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.
- 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.