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.
Background
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/15 | Phase 4 | Not yet recruiting | |||
2025/03/18 | Phase 1 | Not yet recruiting | |||
2025/01/20 | Phase 3 | Recruiting | |||
2024/09/19 | Phase 1 | Recruiting | |||
2024/08/16 | Phase 1 | Not yet recruiting | |||
2024/07/17 | Phase 2 | Recruiting | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2024/03/08 | N/A | Not yet recruiting | |||
2024/01/05 | N/A | Active, not recruiting | Mario Negri Institute for Pharmacological Research | ||
2023/11/13 | Phase 1 | Withdrawn | |||
2023/10/17 | Phase 2 | Recruiting | Clinica Universidad de Navarra, Universidad de Navarra |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Wockhardt Limited | 55648-632 | INTRAVENOUS, SUBCUTANEOUS | 1000 ug in 1 mL | 9/13/2012 | |
| GLENMARK PHARMACEUTICALS INC., USA | 68462-897 | INTRAVENOUS, SUBCUTANEOUS | 500 ug in 1 mL | 11/29/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6174 | INTRAVENOUS, SUBCUTANEOUS | 50 ug in 1 mL | 7/27/2021 | |
| USV North America Inc. | 76135-011 | INTRAVENOUS, SUBCUTANEOUS | 500 ug in 1 mL | 2/7/2013 | |
| Novartis Pharmaceuticals Corporation | 0078-0182 | INTRAVENOUS, SUBCUTANEOUS | 500 ug in 1 mL | 11/3/2023 | |
| Sagent Pharmaceuticals | 25021-467 | SUBCUTANEOUS, INTRAVENOUS | 1000 ug in 1 mL | 3/7/2023 | |
| Gland Pharma Limited | 68083-560 | INTRAVENOUS, SUBCUTANEOUS | 500 ug in 1 mL | 11/22/2023 | |
| Mylan Institutional LLC | 67457-246 | SUBCUTANEOUS, INTRAVENOUS | 500 ug in 1 mL | 11/9/2022 | |
| Fresenius Kabi USA, LLC | 63323-377 | SUBCUTANEOUS, INTRAVENOUS | 500 ug in 1 mL | 5/11/2021 | |
| USV North America Inc. | 76135-006 | INTRAVENOUS | 1000 ug in 1 mL | 12/26/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Withdrawn | 12/2/2022 | ||
Withdrawn | 12/2/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SANDOSTATIN INJECTION 0.1 mg/ml | SIN03808P | INJECTION | 0.1 mg/ml | 2/1/1990 | |
| SANDOSTATIN LAR FOR INJECTION 20 mg | SIN11637P | INJECTION | 20 mg/vial | 8/20/2001 | |
| SANDOSTATIN LAR FOR INJECTION 30 mg | SIN11638P | INJECTION | 30 mg/vial | 8/20/2001 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Octreotide Acetate for Injection | 国药准字H20100099 | 化学药品 | 注射剂 | 9/5/2024 | |
| Octreotide Acetate for Injection | 国药准字H20040639 | 化学药品 | 注射剂(注射用无菌粉末) | 10/23/2020 | |
| Octreotide Acetate for Injection | 国药准字H20052374 | 化学药品 | 注射剂 | 9/2/2020 | |
| Octreotide Acetate for Injection | 国药准字H20041533 | 化学药品 | 注射剂 | 8/10/2020 | |
| Octreotide Acetate for Injection | 国药准字H20090291 | 化学药品 | 注射剂 | 6/25/2019 | |
| Octreotide Acetate for Injection | 国药准字H20051860 | 化学药品 | 注射剂 | 8/10/2020 | |
| Octreotide Acetate for Injection | 国药准字H20100100 | 化学药品 | 注射剂 | 9/5/2024 | |
| Octreotide Acetate for Injection | 国药准字H20060171 | 化学药品 | 注射剂(冻干) | 8/31/2020 | |
| Octreotide Acetate for Injection | 国药准字H20184044 | 化学药品 | 注射剂 | 9/2/2020 | |
| Octreotide Acetate Injection | 国药准字H20103209 | 化学药品 | 注射剂 | 3/16/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SANDOSTATIN SOLUTION FOR INJECTION OR INFUSION 0.1MG/1ML | N/A | N/A | N/A | 9/4/2024 | |
| OCTREOTIDE SOLUTION FOR INJECTION OR INFUSION 0.5MG/1ML | N/A | N/A | N/A | 11/13/2024 | |
| OCTREOTIDE SOLUTION FOR INJECTION OR INFUSION 0.1MG/1ML | N/A | N/A | N/A | 11/13/2024 | |
| OCTREOTIDE SOLUTION FOR INJECTION OR INFUSION 0.05MG/1ML | N/A | N/A | N/A | 11/13/2024 | |
| SANDOSTATIN INJ 0.05MG/ML | N/A | N/A | N/A | 10/25/1989 | |
| SANDOSTATIN SOLUTION FOR INJECTION OR INFUSION 0.05MG/1ML | N/A | N/A | N/A | 5/29/2024 | |
| SANDOSTATIN INJ 0.1MG/ML | N/A | N/A | N/A | 10/25/1989 |