Oclaiz FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 15, 2024.
FDA Approved: No
Brand name: Oclaiz
Generic name: octreotide
Company: Camurus
Treatment for: Acromegaly
Oclaiz (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.
- Oclaiz 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).
- Oclaiz is an investigational depot formulation of octreotide that can be self-administered by subcutaneous injection once-monthly with a prefilled injection pen or syringe.
- Oclaiz is also under development for the treatment of gastroentero-pancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).
Development timeline for Oclaiz
| Date | Article |
|---|---|
| Dec 21, 2023 | Camurus Submits New Drug Application to the US FDA for Oclaiz for Treatment of Acromegaly |
Further information
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