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
Latest Information Update: 09 Jul 2025
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.