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Octreotide

Generic Name
Octreotide
Brand Names
Bynfezia, Mycapssa, Sandostatin
Drug Type
Biotech
CAS Number
83150-76-9
Unique Ingredient Identifier
RWM8CCW8GP

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

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Title
Posted
Study ID
Phase
Status
Sponsor
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
2016/11/30
N/A
UNKNOWN

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

EMA Drug Approvals

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Authorization Holder
Status
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No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Octreotide Acetate Injection
国药准字H20133091
化学药品
注射剂
9/20/2022
Octreotide Acetate Injection
国药准字HJ20140908
化学药品
注射剂
9/30/2024
Octreotide Acetate Microspheres for Injection
国药准字H20233996
化学药品
注射剂
8/1/2023
Octreotide Acetate Microspheres for Injection
国药准字H20233997
化学药品
注射剂
8/1/2023
Octreotide Acetate Microspheres for Injection
国药准字HJ20171261
化学药品
注射剂
8/18/2022
Octreotide Acetate Microspheres for Injection
国药准字HJ20171262
化学药品
注射剂
8/18/2022

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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