Octreotide

Generic Name: Octreotide

Brand Names: Bynfezia, Mycapssa, Sandostatin

Drug Type: Biotech

Chemical Formula: -

CAS Number: 83150-76-9

Unique Ingredient Identifier: RWM8CCW8GP

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

Associated Therapies: Long-term maintenance therapy

Clinical Trials

Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

Phase 1

Terminated

Conditions: Carcinoid Syndrome

Interventions: Drug: Octreotide

First Posted Date: 2009-04-21

Last Posted Date: 2013-09-20

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 10

Registration Number: NCT00884715

Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

Phase 3

Completed

Conditions: Symptomatic Refractory Resistant Carcinoid Disease

Interventions: Drug: Pasireotide
Drug: Octreotide

First Posted Date: 2008-06-04

Last Posted Date: 2013-07-30

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 186

Registration Number: NCT00690430

Locations: 🇺🇸
University of Arizona / Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service, Scottsdale, Arizona, United States
🇺🇸
Loma Linda University Dept. of Loma Linda CancerCent, Loma Linda, California, United States

and more 8 locations

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Phase 3

Completed

Conditions: Acromegaly

Interventions: Drug: Pasireotide
Drug: Octreotide

First Posted Date: 2008-01-25

Last Posted Date: 2017-07-02

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 358

Registration Number: NCT00600886

Locations: 🇬🇧
Novartis Investigative Site, Southampton, United Kingdom
🇺🇸
Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv., Baltimore, Maryland, United States
🇺🇸
University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes, Ann Arbor, Michigan, United States

and more 12 locations

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

Phase 3

Active, not recruiting

Conditions: Colorectal Neuroendocrine Tumor G1
Gastric Neuroendocrine Tumor G1
Neuroendocrine Neoplasm
Neuroendocrine Tumor
Neuroendocrine Tumor G2

Interventions: Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Biological: Recombinant Interferon Alfa-2b
Drug: Octreotide Acetate

First Posted Date: 2007-12-06

Last Posted Date: 2025-01-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 427

Registration Number: NCT00569127

Locations: 🇺🇸
Providence Hospital, Mobile, Alabama, United States
🇺🇸
Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
🇺🇸
Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States

and more 491 locations

The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed

Phase 4

Completed

Conditions: Portal Hypertension
Cirrhosis
Hematemesis
Melena

Interventions: Drug: Terlipressin
Drug: Octreotide

First Posted Date: 2007-09-26

Last Posted Date: 2007-12-05

Lead Sponsor: Aga Khan University

Target Recruit Count: 320

Registration Number: NCT00534677

Locations: 🇵🇰
The Aga Khan University Hospital, Karachi, Sindh, Pakistan

Preoperative Octreotide Treatment of Acromegaly

Phase 4

Completed

Conditions: Acromegaly

Interventions: Drug: Octreotide
Procedure: Direct surgery for acromegaly

First Posted Date: 2007-08-27

Last Posted Date: 2014-06-02

Lead Sponsor: St. Olavs Hospital

Target Recruit Count: 62

Registration Number: NCT00521300

Locations: 🇳🇴
Endocrinology Unit, Department of Medicine, Haukeland University Hospital, Bergen, Norway
🇳🇴
Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway
🇳🇴
Endocrinology Unit, Department of Medicine, University Hospital of North Norway, Tromsø, Norway

and more 2 locations

Sandostatin for Patients With Androgen Independent Prostate Cancer

Phase 2

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Sandostatin

First Posted Date: 2007-08-01

Last Posted Date: 2013-12-11

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 13

Registration Number: NCT00510224

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide

Phase 1

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: octreotide

First Posted Date: 2007-04-20

Last Posted Date: 2012-09-21

Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Target Recruit Count: 25

Registration Number: NCT00463983

AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors

Phase 2

Completed

Conditions: Islet Cell Tumor
Neoplastic Syndrome
Gastrointestinal Carcinoid Tumor

Interventions: Drug: AMG 706
Drug: octreotide

First Posted Date: 2007-01-29

Last Posted Date: 2023-07-05

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 46

Registration Number: NCT00427349

Locations: 🇺🇸
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
🇺🇸
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
🇺🇸
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States

and more 109 locations

Octreotide in Severe Polycystic Liver Disease

Phase 2

Completed

Conditions: Polycystic Kidney, Autosomal Dominant
Polycystic Liver Disease
Hepatomegaly
Liver Diseases
Kidney, Polycystic
Abdominal Pain

Interventions: Drug: Octreotide
Drug: Placebo

First Posted Date: 2007-01-24

Last Posted Date: 2012-11-21

Lead Sponsor: Mayo Clinic

Target Recruit Count: 42

Registration Number: NCT00426153

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

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