Camurus CAM2029 NDA Accepted by FDA for Acromegaly

Camurus announced that the US Food and Drug Administration has accepted the resubmission of its NDA for CAM2029, an investigational once-monthly subcutaneous octreotide depot designed for self-administration using a prefilled autoinjector pen for the treatment of adults with acromegaly. The application has been assigned a PDUFA target action date of December 18, 2026, marking the next regulatory milestone for the therapy in the United States.

The resubmission follows a Complete Response Letter (CRL) issued by the FDA on June 10, 2026, after observations made during a current Good Manufacturing Practice (cGMP) inspection at a third-party manufacturing facility. According to the company, the CRL did not identify any concerns related to CAM2029’s clinical efficacy or safety. Following corrective actions by the contract manufacturer and confirmation of inspection readiness, the FDA accepted the NDA for review.

Commenting on the milestone, Fredrik Tiberg, President and CEO of Camurus, said the company looks forward to continuing its collaboration with the FDA to make CAM2029 available to patients with acromegaly in the United States.

Phase 3 ACROINNOVA program supported the NDA

The NDA is supported by data from seven clinical studies, including four Phase 1 studies, one Phase 2 study, and two pivotal Phase 3 studies from the ACROINNOVA clinical development program.

The pivotal ACROINNOVA 1 study (NCT04076462) was a randomized, double-blind, placebo-controlled Phase 3 trial evaluating CAM2029 in adults with acromegaly whose disease had previously been controlled with first-generation somatostatin receptor ligands (SRLs), including octreotide LAR and lanreotide. The trial met its primary endpoint, demonstrating superior biochemical control compared with placebo. Patients receiving CAM2029 also showed improvements in acromegaly symptoms, treatment satisfaction, and health-related quality of life compared with baseline standard-of-care therapy.

Long-term efficacy and safety were further evaluated in the open-label ACROINNOVA 2 extension study (NCT04125836), which enrolled patients completing ACROINNOVA 1 as well as newly recruited participants. The extension study assessed the long-term efficacy and safety of CAM2029 over 52 weeks of treatment. During this period, CAM2029 maintained biochemical disease control, sustained insulin-like growth factor-1 (IGF-1) normalization, and demonstrated continued improvements in symptom burden, quality of life, and treatment satisfaction. The safety profile remained consistent with currently available first-generation SRLs, with no new safety signals identified.

CAM2029 is designed as a ready-to-use, once-monthly subcutaneous depot that may offer a more convenient alternative to existing long-acting intramuscular octreotide formulations while maintaining effective disease control.

CAM2029 aims to simplify long-term acromegaly management

CAM2029 is a ready-to-use, once-monthly subcutaneous depot formulation of octreotide developed using Camurus’ proprietary FluidCrystal® technology. Unlike conventional long-acting octreotide formulations that require reconstitution and intramuscular administration by healthcare professionals, CAM2029 is designed for administration using a prefilled autoinjector pen, enabling convenient once-monthly self-administration by patients.

The formulation has demonstrated approximately five-fold higher bioavailability than currently available long-acting intramuscular octreotide, potentially enabling improved drug exposure while simplifying treatment administration. By offering a convenient subcutaneous, ready-to-use option, CAM2029 has the potential to reduce treatment burden, improve patient adherence, and enhance overall treatment satisfaction.

In addition to acromegaly, the product is also being investigated for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and polycystic liver disease (PLD).

 Approved in Europe as Oczyesa®

Outside the United States, CAM2029 has already received marketing authorization in the European Union and the United Kingdom under the brand name Oczyesa® for the treatment of acromegaly. Marketing authorization applications are also under review in two additional countries.

If approved by the FDA, CAM2029 could become the first once-monthly, ready-to-use, self-administered subcutaneous octreotide depot available in the United States, offering patients a convenient alternative to currently available long-acting intramuscular octreotide formulations while expanding treatment options for adults living with acromegaly.

References

CAM2029 NDA resubmission for acromegaly accepted for review by the US FDA. Press release. July 17, 2026.