FDA Accepts Camurus NDA Resubmission for Oclaiz in Acromegaly, Sets December 2026 PDUFA Date
The FDA accepted Camurus' NDA resubmission for Oclaiz in acromegaly, setting a December 2026 PDUFA date. The filing follows a June 2026 Complete Response Letter related to third-party manufacturing, with no safety or efficacy issues. Oclaiz is a once-monthly subcutaneous octreotide already approved in the EU as Oczyesa.
The U.S. Food and Drug Administration (FDA) has accepted for review Camurus' resubmission of the New Drug Application (NDA) for Oclaiz (CAM2029), an 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 December 18, 2026. The resubmission follows a Complete Response Letter (CRL) issued by the FDA on June 10, 2026, which related to observations from a cGMP inspection at a third-party manufacturer and did not raise any concerns regarding clinical efficacy or safety. The contract manufacturer has implemented all remediation actions and confirmed inspection readiness. “We look forward to continuing the collaboration with the FDA to make CAM2029 available to patients with acromegaly in the United States,” the President & CEO stated.
The earlier NDA resubmission had been accepted in January 2026 with a PDUFA target action date of June 10, 2026. That submission, dated December 10, 2025, followed an initial CRL solely related to manufacturing facility observations.
Oclaiz is a subcutaneous long-acting octreotide depot based on FluidCrystal® technology, designed for once-monthly self-administration using a prefilled autoinjector pen. The application is supported by data from seven clinical studies, including two Phase 3 studies in the ACROINNOVA program. CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to currently approved long-acting intramuscular octreotide. In the Phase 3 ACROINNOVA 1 study, treatment with CAM2029 resulted in a significantly higher proportion of patients achieving normalized insulin-like growth factor-1 (IGF-1) levels compared to placebo. The 52-week ACROINNOVA 2 study confirmed persistent IGF-1 control and showed reduced disease symptoms, improved quality of life, and treatment satisfaction compared to standard of care at baseline. The most common side effects included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.
CAM2029 received marketing authorization in the European Union and the United Kingdom in 2025 under the brand name Oczyesa®, and launch has initiated in the EU. Marketing authorization applications are also under review in two additional countries. The product is also being developed for gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).