Overview
Acromegaly is a disorder caused by excess growth hormone (GH), increasing the growth of body tissues and causing metabolic dysfunction. In most cases, it results from an anterior pituitary growth hormone-releasing tumor. Typically, the feet, hands, and face grow abnormally large; organomegaly and insulin resistance may also occur. Acromegaly is a life-threatening disease requiring life-long management. Octreotide is a long-acting drug with pharmacologic activities that mimic those of the natural hormone, somatostatin, which inhibits the secretion of growth hormone. Additionally, it is used for the treatment of acromegaly and symptoms arising from various tumors, including carcinoid tumors and vasoactive intestinal tumors (VIPomas). In the past, octreotide has been administered solely by injection. On June 26, 2020, the first approved delayed-release oral somatostatin analog, Mycapssa, received FDA approval for the long term maintenance treatment of acromegaly. This drug was developed by Chiasma Inc.
Indication
Octreotide by injection is used for the treatment of acromegaly and the reduction of flushing and diarrhea symptoms related to carcinoid tumors and/or vasoactive intestinal peptide (VIPoma) tumors. The delayed-release oral formulation is used for the long-term treatment of acromegaly in patients who tolerate and respond adequately to injectable octreotide and lanreotide.
Associated Conditions
- Acromegaly
- Diarrhea
- Metastatic Carcinoid Tumors
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/06/27 | Phase 1 | Terminated | |||
2018/05/30 | Phase 2 | Completed | Mario Negri Institute for Pharmacological Research | ||
2018/05/09 | Early Phase 1 | Completed | |||
2017/09/21 | Phase 4 | Completed | |||
2017/08/17 | Phase 3 | UNKNOWN | |||
2017/06/07 | Phase 2 | Terminated | |||
2017/05/17 | N/A | Recruiting | Ginkgo Leaf Center for Rare Disorders | ||
2017/02/23 | Not Applicable | Completed | |||
2017/01/25 | Phase 1 | Completed | Dauntless Pharmaceuticals | ||
2016/12/22 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-689 | INTRAVENOUS, SUBCUTANEOUS | 500 ug in 1 mL | 1/10/2024 | |
| Amryt Pharmaceuticals Designated Activity Company | 69880-120 | ORAL | 20 mg in 1 1 | 9/15/2023 | |
| Gland Pharma Limited | 68083-516 | SUBCUTANEOUS, INTRAVENOUS | 1000 ug in 1 mL | 12/20/2023 | |
| USV North America Inc. | 76135-009 | INTRAVENOUS, SUBCUTANEOUS | 50 ug in 1 mL | 2/7/2013 |
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| No EMA approvals found for this drug. | |||
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