The FDA has accepted Camurus’ NDA resubmission for Oclaiz™ (CAM2029) for the treatment of acromegaly. The application is under Class 2 review and supported by Phase 3 ACROINNOVA clinical data.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
Camurus announced that the U.S. Food and Drug Administration has accepted its resubmission of the New Drug Application (NDA) for Oclaiz™ for the treatment of acromegaly. The acceptance confirms that the application is now under FDA review.
The resubmitted NDA follows Camurus’ response to a previous Complete Response Letter from the FDA. According to the company, the resubmission addresses additional information requested by the agency and does not include new clinical efficacy or safety data. The FDA has classified the filing as a Class 2 resubmission, which is subject to a standard six-month review timeline under the Prescription Drug User Fee Act.
Clinical evidence supporting CAM2029
The clinical evidence for CAM2029 is based on a comprehensive development program in acromegaly that includes seven clinical trials, comprising four Phase 1 studies, one Phase 2 study, and two Phase 3 studies conducted under the ACROINNOVA program. Across these studies, CAM2029 demonstrated approximately five-fold higher bioavailability compared with currently approved long-acting intramuscular octreotide formulations.
In the Phase 3 ACROINNOVA 1 trial, treatment with CAM2029 resulted in a significantly higher proportion of patients achieving normalized insulin-like growth factor-1 (IGF-1) levels compared with placebo. These effects were sustained in the ACROINNOVA 2 study, where persistence of mean IGF-1 control and continued symptom reduction were confirmed over 52 weeks. Patients treated with CAM2029 also reported reduced disease-related symptoms, along with improvements in quality of life and treatment satisfaction scores after one year compared with standard of care at baseline.
The most commonly reported adverse events across the clinical program included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.
About Oclaiz
Oclaiz™ (CAM2029) is a ready-to-use, long-acting subcutaneous octreotide formulation based on Camurus’ FluidCrystal® technology platform. It is being developed for the treatment of acromegaly, a condition caused by excessive growth hormone secretion, most commonly due to a pituitary adenoma. Current standard therapies often require frequent or intramuscular injections, and Oclaiz™ is designed to reduce treatment burden while maintaining disease control.
If approved, Oclaiz™ would be administered once monthly using a ready-to-use injection, with the aim of simplifying long-term disease management for patients with acromegaly. Camurus noted that the NDA is supported by clinical data demonstrating effective growth hormone and IGF-1 control in patients previously treated with standard of care therapies.
The company also stated that it continues to work closely with the U.S. Food and Drug Administration during the review process and will provide updates as the evaluation progresses.
Beyond acromegaly, Camurus is continuing the development of CAM2029 in two additional chronic and severe disease indications, including gastroenteropancreatic neuroendocrine tumors and polycystic liver disease, reflecting a broader strategy to expand the therapeutic potential of the product.
About Acromegaly
Acromegaly is a chronic condition that can lead to serious complications, including cardiovascular disease, diabetes, and joint disorders, if not adequately controlled. Long-acting treatment options that support sustained hormone control are considered important for improving adherence and long-term outcomes.
References
Camurus announces FDA acceptance of NDA resubmission for Oclaiz™ for the treatment of acromegaly, 09 January 2026, https://www.camurus.com/files/Main/13456/4290495/press-release.pdf
Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly, 22 October 2024, https://www.camurus.com/files/Main/13456/4054318/press-release.pdf
Camurus announces positive Phase 3 results from the ACROINNOVA 2 study of octreotide SC depot (CAM2029) in acromegaly patients, 15 July 2024 , https://www.camurus.com/files/Main/13456/4014809/press-release.pdf
Camurus’ octreotide SC depot (CAM2029) achieves superior treatment response compared to placebo in Phase 3 acromegaly trial, 20 June 2023, https://www.camurus.com/files/Main/13456/3790183/press-release.pdf