CAM2029 FDA Approval Status
Last updated by Judith Stewart, BPharm on Oct 22, 2024.
FDA Approved: No
Brand name: CAM2029
Generic name: octreotide
Previous Name: Oclaiz
Company: Camurus
Treatment for: Acromegaly
CAM2029 (octreotide) is a once-monthly, subcutaneous (SC) depot formulation of the approved somatostatin analogue octreotide in development for the treatment of patients with acromegaly.
- Acromegaly is a condition characterized by abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs. It is typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. Symptoms include fatigue, joint pain, headache, visual field defects, excessive sweating and paresthesia.
- CAM2029 contains octreotide, a somatostatin analogue that that works to treat acromegaly by inhibiting growth hormone, glucagon, and insulin.
- Octreotide was first approved under the brand name Sandostatin in 1988. It has been approved in a number of formulations for the treatment of acromegaly including Sandostatin (injection administered subcutaneously or intravenously three times daily), Sandostatin LAR (depot injection administered intramuscularly every 4 weeks), and Mycapssa (delayed-release capsules administered orally twice daily).
- CAM2029 is an investigational depot formulation of octreotide that can be self-administered by subcutaneous injection once-monthly with a prefilled injection pen or syringe.
- CAM2029 is also under development for the treatment of gastroentero-pancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).
- On October 22, 2024, Camurus announced that the U.S. Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 for the treatment of patients with acromegaly. The CRL was attributed to facility-related deficiencies identified during a Current Good Manufacturing Practices (cGMP) inspection of a third-party manufacturer completed in September 2024. The CRL did not state any other concerns, including the clinical efficacy or safety of CAM2029.
Development timeline for CAM2029
| Date | Article |
|---|---|
| Oct 22, 2024 | Camurus Provides Regulatory Update on the US NDA for CAM2029 in Acromegaly |
| Dec 21, 2023 | Camurus Submits New Drug Application to the US FDA for Oclaiz for Treatment of Acromegaly |
Further information
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