Camurus' Oclaiz™ NDA Resubmission Accepted by FDA: A Huge Leap for Acromegaly Treatment
On January 9, 2026, Camurus, the Swedish biopharmaceutical company listed on NASDAQ Stockholm, announced a significant milestone in the development of Oclaiz™ (CAM2029), an extended-release octreotide injection aimed at treating acromegaly. The U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of the New Drug Application (NDA) for this innovative therapy, with a target action date set for June 10, 2026, following the Prescription Drug User Fee Act (PDUFA) guidelines.
This development comes after a comprehensive review process initiated when Camurus submitted the updated NDA in December 2025. The submission was prompted by a previous Complete Response Letter (CRL) issued by the FDA, which pointed to certain observations from a cGMP inspection conducted at a third-party manufacturing facility. Despite these setbacks, Camurus remains optimistic about the collaboration with the FDA and is eager to make Oclaiz™ available to patients suffering from acromegaly in the U.S. as soon as possible.
"Our team believes that with the continued support from the FDA, we can expedite access to this life-changing treatment for patients in need, all while maintaining the highest regulatory standards," commented Fredrik Tiberg, the President and CEO of Camurus.
Oclaiz™ is designed as a long-acting subcutaneous solution for the optimized management of acromegaly, a rare and progressive illness usually caused by a benign tumor on the pituitary gland, resulting in excessive production of growth hormone. This condition leads to a myriad of complications, including abnormal growth of tissues and organs, joint pain, headaches, and an overall decrease in quality of life.
The innovative aspect of Oclaiz™ lies in its formulation using Camurus' proprietary FluidCrystal® technology, which allows for self-administration via a pre-filled autoinjector pen on a once-monthly basis. This convenient method aims to enhance patient adherence and significantly improve therapeutic outcomes compared to traditional treatments.
The clinical efficacy of Oclaiz™ has been validated through a robust program consisting of seven clinical trials, notably two pivotal Phase 3 studies conducted under the ACROINNOVA program. Findings from these trials demonstrate that CAM2029 offers superior pharmacokinetics, with about five times the bioavailability when compared to existing long-acting intramuscular octreotide formulations.
The data illustrates that patients treated with CAM2029 largely achieved normalized insulin growth factor-1 (IGF-1) levels—a critical biomarker for evaluating acromegaly control—significantly more often than those receiving a placebo. Over a duration of 52 weeks, participants experienced substantial symptomatic relief and improvements in their quality of life metrics, reinforcing the drug's therapeutic potential.
It's also worth noting that Oclaiz™ received marketing authorization in the EU and UK last year, where it is known as Oczyesa®. Following its launch, the drug has started making an impact, providing much-needed relief to patients across Europe. Additionally, Camurus is pursuing further indications for CAM2029, including gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD), showcasing their commitment to tackling complex chronic diseases.
Camurus operates with a clear mission to develop and commercialize innovative long-acting medications that improve patients' quality of life. The company's strategic focus on utilizing its FluidCrystal® technology continues to pave the way for new therapeutic options within the biopharmaceutical landscape. For further developments, stakeholders can stay informed by visiting Camurus' official website and following their updates on LinkedIn.
This development comes after a comprehensive review process initiated when Camurus submitted the updated NDA in December 2025. The submission was prompted by a previous Complete Response Letter (CRL) issued by the FDA, which pointed to certain observations from a cGMP inspection conducted at a third-party manufacturing facility. Despite these setbacks, Camurus remains optimistic about the collaboration with the FDA and is eager to make Oclaiz™ available to patients suffering from acromegaly in the U.S. as soon as possible.
"Our team believes that with the continued support from the FDA, we can expedite access to this life-changing treatment for patients in need, all while maintaining the highest regulatory standards," commented Fredrik Tiberg, the President and CEO of Camurus.
Oclaiz™ is designed as a long-acting subcutaneous solution for the optimized management of acromegaly, a rare and progressive illness usually caused by a benign tumor on the pituitary gland, resulting in excessive production of growth hormone. This condition leads to a myriad of complications, including abnormal growth of tissues and organs, joint pain, headaches, and an overall decrease in quality of life.
The innovative aspect of Oclaiz™ lies in its formulation using Camurus' proprietary FluidCrystal® technology, which allows for self-administration via a pre-filled autoinjector pen on a once-monthly basis. This convenient method aims to enhance patient adherence and significantly improve therapeutic outcomes compared to traditional treatments.
The clinical efficacy of Oclaiz™ has been validated through a robust program consisting of seven clinical trials, notably two pivotal Phase 3 studies conducted under the ACROINNOVA program. Findings from these trials demonstrate that CAM2029 offers superior pharmacokinetics, with about five times the bioavailability when compared to existing long-acting intramuscular octreotide formulations.
The data illustrates that patients treated with CAM2029 largely achieved normalized insulin growth factor-1 (IGF-1) levels—a critical biomarker for evaluating acromegaly control—significantly more often than those receiving a placebo. Over a duration of 52 weeks, participants experienced substantial symptomatic relief and improvements in their quality of life metrics, reinforcing the drug's therapeutic potential.
It's also worth noting that Oclaiz™ received marketing authorization in the EU and UK last year, where it is known as Oczyesa®. Following its launch, the drug has started making an impact, providing much-needed relief to patients across Europe. Additionally, Camurus is pursuing further indications for CAM2029, including gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD), showcasing their commitment to tackling complex chronic diseases.
Camurus operates with a clear mission to develop and commercialize innovative long-acting medications that improve patients' quality of life. The company's strategic focus on utilizing its FluidCrystal® technology continues to pave the way for new therapeutic options within the biopharmaceutical landscape. For further developments, stakeholders can stay informed by visiting Camurus' official website and following their updates on LinkedIn.
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