Camurus' Acromegaly Drug Oclaiz Gets Second Shot at FDA Approval

LUND, Sweden – January 09, 2026 – Swedish biopharmaceutical firm Camurus has cleared a significant regulatory hurdle in its quest to bring a new treatment for the rare disease acromegaly to the United States. The company announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for Oclaiz™ (CAM2029), a long-acting, self-administered injection.

The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026, marking a critical milestone and setting a clear timeline for a potential approval decision. The acceptance signals a major comeback for the drug, which previously received a Complete Response Letter (CRL) from the FDA due to manufacturing-related issues, and positions Camurus to potentially enter the lucrative U.S. acromegaly market.

"We look forward to the continued collaboration with the FDA to make Oclaiz available to patients with acromegaly in the US as soon as possible," said Fredrik Tiberg, President & CEO of Camurus, in the company's official statement.

A Second Chance Following a Manufacturing Setback

The FDA's acceptance of the resubmission is particularly significant because it suggests Camurus has successfully addressed the deficiencies that previously stalled the drug's path to the U.S. market. The initial CRL, issued in 2025, was not related to the clinical safety or efficacy of Oclaiz™ itself. Instead, the rejection stemmed exclusively from observations made during a current Good Manufacturing Practice (cGMP) inspection at a third-party manufacturing facility responsible for producing the drug.

Such manufacturing-related setbacks, while frustrating for drug developers, are not uncommon in the highly regulated pharmaceutical industry. The successful resubmission indicates that Camurus and its manufacturing partner have implemented corrective actions to the FDA's satisfaction. This resolution effectively de-risks the regulatory path forward, shifting the focus back to the drug's clinical merits and its potential impact on patients.

The journey of Oclaiz™ highlights the immense complexities of drug development, where clinical success must be paired with flawless execution in manufacturing and quality control to meet the FDA's stringent standards. For Camurus, navigating this challenge and securing a new review date represents a crucial demonstration of regulatory and operational resilience.

Redefining Treatment for a Lifelong Condition

For patients, the potential approval of Oclaiz™ represents a significant step forward in managing acromegaly, a rare and slowly progressive disease caused by a benign tumor on the pituitary gland. This tumor leads to an overproduction of growth hormone (GH), causing abnormal growth in bones and tissues, particularly in the hands, feet, and face. The condition, which affects an estimated 60 people per million, can lead to debilitating symptoms like joint pain, fatigue, headaches, and an increased risk of mortality if not adequately controlled.

The current standard of medical care for acromegaly is dominated by a class of drugs called somatostatin analogs (SSAs), which work to suppress excess GH production. While effective, market-leading treatments like Novartis's Sandostatin® LAR and Ipsen's Somatuline® Depot are typically administered as deep intramuscular injections in a clinical setting every four weeks. These injections can be painful and require patients to make regular, time-consuming visits to their healthcare provider.

Oclaiz™ aims to revolutionize this treatment paradigm. Based on Camurus' proprietary FluidCrystal® technology, it is a ready-to-use, long-acting formulation of octreotide—the same well-established active ingredient in Sandostatin. However, its key innovation lies in its delivery. Oclaiz™ is designed for a once-monthly subcutaneous injection using a pre-filled autoinjector pen with a thin, hidden needle, allowing patients to administer the treatment themselves at home.

This shift from clinician-administered intramuscular injections to patient-administered subcutaneous ones promises to dramatically improve convenience, reduce treatment burden, and grant patients greater independence in managing their chronic illness. Clinical data from the ACROINNOVA Phase 3 program, which supports the NDA, has demonstrated that treatment with Oclaiz™ leads to a significantly higher proportion of patients achieving normalized hormone levels compared to placebo. Furthermore, long-term data confirmed sustained disease control and showed meaningful improvements in quality of life and treatment satisfaction scores compared to the prior standard of care.

Navigating a Shifting Competitive Landscape

Should it gain approval, Oclaiz™ will enter a dynamic and increasingly competitive U.S. acromegaly market, which was valued at over $570 million in 2024 and is projected to approach $1 billion by 2033. While SSAs remain the cornerstone of medical therapy, the market is evolving towards more patient-centric options.

Oclaiz™ will compete directly with the established injectable SSAs from Novartis and Ipsen, where its self-administration offers a powerful differentiating factor. It will also contend with newer therapies, such as Mycapssa® from Chiesi Group, the first and only oral SSA, which eliminates injections but requires a strict dosing regimen around meals. Furthermore, the pipeline includes promising oral candidates like paltusotine from Crinetics Pharmaceuticals, which could further disrupt the treatment landscape.

In this environment, Oclaiz™ is positioned as a compelling alternative that blends the proven efficacy of the octreotide molecule with a delivery system that addresses the long-standing patient desire for convenience and autonomy. Its profile could appeal to both patients currently on injectable SSAs who seek a less burdensome option and those for whom an oral therapy may not be suitable.

A Global Strategy and a Platform for Growth

The FDA's decision is a linchpin in Camurus' broader global strategy. The drug, marketed as Oczyesa®, has already received approval in the European Union and the United Kingdom, with commercial launches recently initiated. Securing access to the U.S.—the world's largest pharmaceutical market—would be a transformative commercial achievement, unlocking a significant new revenue stream and solidifying the product's blockbuster potential.

Beyond Oclaiz™, a U.S. approval would serve as a powerful validation of Camurus' underlying FluidCrystal® drug delivery technology. This proprietary platform is the engine behind the company's pipeline, which includes long-acting treatments for dependence, pain, and cancer. A high-profile success with the FDA would bolster confidence in the platform, potentially accelerating the development of other candidates and enhancing Camurus' attractiveness as a partner for other pharmaceutical companies.

With the regulatory path now clarified and a decision date on the horizon, the focus for Camurus shifts to preparing for a potential U.S. launch in 2026. A favorable FDA decision in June would not only be a victory for the company but would also mark the arrival of a meaningful new treatment option for thousands of Americans living with the lifelong challenges of acromegaly.