In January 2026, Camurus announced an important regulatory milestone for patients living with acromegaly. The United States Food and Drug Administration accepted the resubmission of the New Drug Application for Oclaiz, an extended release formulation of octreotide developed for the treatment of acromegaly. The FDA also assigned a target action date of June 10, 2026 under the Prescription Drug User Fee Act. This decision places Oclaiz one step closer to potential approval in the United States and signals renewed momentum after a previous regulatory delay.
Acromegaly is a rare and often underdiagnosed endocrine disorder that can lead to serious long term complications if not adequately controlled. Advances in drug delivery and formulation are especially meaningful for this patient population, where treatment burden and disease control remain ongoing challenges. The FDA acceptance of the resubmitted application reflects progress not only for Camurus as a company but also for innovation in how acromegaly may be managed in the future.
Acromegaly is typically caused by a benign tumor of the pituitary gland that produces excess growth hormone. This overproduction stimulates elevated levels of insulin like growth factor one, which leads to abnormal growth of bones and soft tissues. The disease usually progresses slowly, meaning symptoms can develop over many years before a diagnosis is made.
Common physical changes include enlargement of the hands and feet, changes in facial features, and enlargement of internal organs. Patients may also experience joint pain, fatigue, headaches, excessive sweating, visual disturbances, and numbness or tingling in the extremities. Beyond physical symptoms, acromegaly can significantly reduce quality of life and is associated with increased risk of cardiovascular disease, diabetes, and premature mortality when inadequately treated.
The estimated prevalence of acromegaly is about sixty cases per million people worldwide. Although rare, the disease carries a substantial personal and healthcare burden, making effective and convenient long term treatment options essential.
The management of acromegaly often involves a combination of surgery, radiation therapy, and medical treatment. When surgery does not fully control hormone levels or is not an option, pharmacologic therapy becomes central to disease management.
Somatostatin analogs such as octreotide have been a cornerstone of medical treatment for decades. These drugs suppress growth hormone secretion and help normalize insulin like growth factor one levels. Traditionally, long acting octreotide formulations are administered via intramuscular injection, typically once every four weeks. While effective for many patients, intramuscular injections can be painful, require healthcare professional administration, and may lead to variable drug absorption.
As a result, there has been ongoing interest in developing alternative formulations that improve convenience, consistency, and patient satisfaction without compromising efficacy.
Oclaiz, also known as CAM2029, is a ready to use octreotide formulation designed for monthly subcutaneous administration. It is based on Camurus proprietary FluidCrystal technology, which enables sustained release of the drug after injection. Oclaiz is delivered using a prefilled autoinjector pen with a hidden thin needle, allowing for potential self administration.
This design aims to address several limitations of existing long acting octreotide therapies. Subcutaneous administration is generally considered less invasive than intramuscular injection and may reduce discomfort and logistical barriers associated with clinic based dosing. The autoinjector format is also intended to simplify handling and improve adherence.
The New Drug Application for Oclaiz is supported by data from seven clinical studies, including two pivotal Phase Three trials conducted as part of the ACROINNOVA clinical program. These studies evaluated the safety, efficacy, and patient reported outcomes associated with CAM2029 in adults with acromegaly.
One of the most notable findings from the clinical program is the approximately five fold higher bioavailability of CAM2029 compared to currently approved long acting intramuscular octreotide. Higher bioavailability suggests that more of the drug reaches systemic circulation, which may translate into more consistent hormone suppression.
The ACROINNOVA One study demonstrated that a significantly higher proportion of patients treated with CAM2029 achieved normalized insulin like growth factor one levels compared to placebo. The follow up ACROINNOVA Two study confirmed sustained biochemical control over fifty two weeks, along with improvements in symptoms, quality of life, and treatment satisfaction scores compared to standard of care at baseline.
Reported side effects were consistent with the known safety profile of octreotide. The most common adverse events included gastrointestinal symptoms, nervous system disorders, hepatobiliary effects, metabolic changes, and injection site reactions. Overall, the safety findings did not reveal unexpected concerns.
Camurus initially submitted the New Drug Application for Oclaiz to the FDA in December 2023. In response, the agency issued a Complete Response Letter that prevented approval at that time. Importantly, the issues raised in the letter were not related to clinical efficacy or safety but were instead tied to observations made during a current Good Manufacturing Practice inspection at a third party manufacturing facility.
According to Camurus, the updated NDA was resubmitted on December 10, 2025 after addressing the inspection related concerns. The FDA acceptance of the resubmission in January 2026 indicates that the agency found the application sufficiently complete for review. The assigned PDUFA target date of June 10, 2026 establishes a clear regulatory timeline for a potential approval decision.
This sequence highlights a common reality in drug development, where manufacturing and quality controls play a critical role in regulatory outcomes even when clinical data are strong.
While Oclaiz is still under FDA review in the United States, the product has already achieved regulatory success in other regions. In 2025, it received marketing authorization in the European Union and the United Kingdom under the brand name Oczyesa. Commercial launch in parts of Europe has already begun.
International approval provides real world experience with the product and may offer additional reassurance to clinicians and regulators regarding its use. However, regulatory standards and review processes differ between regions, and approval in one market does not guarantee approval in another.
If approved in the United States, Oclaiz could represent a meaningful shift in how acromegaly is treated. Monthly subcutaneous self administration has the potential to reduce clinic visits, improve patient autonomy, and lessen the physical discomfort associated with intramuscular injections.
Improved treatment satisfaction and quality of life outcomes observed in clinical trials are particularly relevant for a chronic condition that requires long term therapy. For patients who struggle with current injection regimens or experience inconsistent disease control, Oclaiz may offer an alternative worth considering.
From a healthcare system perspective, easier administration could also reduce resource utilization and support more flexible models of care.
With a PDUFA target date set for June 2026, attention will now turn to the FDA review process and any additional information requests that may arise. Investors, clinicians, and patient advocacy groups will be closely watching the outcome, as it may influence treatment guidelines and market dynamics in the acromegaly space.
Camurus has also indicated that CAM2029 is being developed for other indications, including gastroenteropancreatic neuroendocrine tumors and polycystic liver disease. Success in acromegaly could therefore have broader implications for the company’s long acting drug delivery platform.
For patients living with acromegaly, regulatory progress like this offers cautious optimism. While approval is not guaranteed, the acceptance of the NDA resubmission represents an important step toward expanding therapeutic options in a field where innovation is deeply needed.
This article is intended for informational and educational purposes only. It does not constitute medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare professional regarding any medical condition or treatment decisions. Regulatory status and clinical data may change over time.
