MedPath

Octreotide

Generic Name
Octreotide
Brand Names
Bynfezia, Mycapssa, Sandostatin
Drug Type
Biotech
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

Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial)

Phase 4
Not yet recruiting
Conditions
Small-for-Size Syndrome
Interventions
Procedure: Splenic Artery Ligation (SAL)
First Posted Date
2025-05-15
Last Posted Date
2025-05-15
Lead Sponsor
King Faisal Specialist Hospital & Research Center
Target Recruit Count
80
Registration Number
NCT06974344
Locations
🇸🇦

Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

Phase 1
Not yet recruiting
Conditions
Diabetic Macular Edema
Interventions
First Posted Date
2025-03-18
Last Posted Date
2025-03-18
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
60
Registration Number
NCT06881888
Locations
🇺🇸

The University of Alabama at Birmingham, Birmingham, Alabama, United States

Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET

Phase 3
Not yet recruiting
Conditions
Somatostatin Receptor Positive (SSTR+)
Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
Interventions
Radiation: [177Lu]Lu-DOTA-TATE
First Posted Date
2025-01-20
Last Posted Date
2025-04-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
240
Registration Number
NCT06784752

Graded Insulin Suppression Test P&F

Phase 1
Recruiting
Conditions
Insulin Resistance
Hyperinsulinemia
Obesity
Healthy
Interventions
Drug: Insulin regular, 2.0-3.2 mU/m2/min (euinsulinemia)
Drug: Insulin regular, 32 mU/m2/min (hyperinsulinemia)
Drug: Dextrose 20 % in Water
Drug: Glucagon, 0-0.5 ng/kg/min
First Posted Date
2024-09-19
Last Posted Date
2025-01-16
Lead Sponsor
Columbia University
Target Recruit Count
15
Registration Number
NCT06592261
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

Human Models of Selective Insulin Resistance: Pancreatic Clamp

Phase 1
Not yet recruiting
Conditions
Insulin Resistance
Hyperinsulinemia
Metabolic Dysfunction Associated Steatotic Liver Disease
Non-Alcoholic Fatty Liver Disease
Prediabetic State
Obesity
Interventions
Drug: Growth Hormone, Human
Diagnostic Test: [6,6-2H2] D-glucose
Diagnostic Test: [1-13C1] sodium acetate
Dietary Supplement: Nestle BOOST Plus
Dietary Supplement: KIND Bar
Device: Harvard Apparatus PHD ULTRA CP syringe pump
Device: Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer
First Posted Date
2024-08-16
Last Posted Date
2025-01-08
Lead Sponsor
Columbia University
Target Recruit Count
36
Registration Number
NCT06558422
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)

Phase 2
Recruiting
Conditions
Gastrointestinal Neuroendocrine Pancreatic Tumor
Interventions
Drug: SYHX2008 injection
First Posted Date
2024-07-17
Last Posted Date
2024-08-26
Lead Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Target Recruit Count
90
Registration Number
NCT06505395
Locations
🇨🇳

Chinese PLA General Hosptial, Beijing, Beijing, China

A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors

Not yet recruiting
Conditions
Neuroendocrine Tumors
Interventions
First Posted Date
2024-03-08
Last Posted Date
2024-03-08
Lead Sponsor
Qilu Hospital of Shandong University
Target Recruit Count
500
Registration Number
NCT06300216
Locations
🇨🇳

Qilu hospital of Shandong University, Jinan, Shandong, China

Outcome of ADPKD With Octreotide LAR

Active, not recruiting
Conditions
Autosomal Dominant Polycystic Kidney
First Posted Date
2024-01-05
Last Posted Date
2025-05-07
Lead Sponsor
Mario Negri Institute for Pharmacological Research
Target Recruit Count
70
Registration Number
NCT06193616
Locations
🇮🇹

ASST HPG23 - Unità di Nefrologia, Bergamo, BG, Italy

Dexamethasone/Pancreatic Clamp P&F

Phase 1
Withdrawn
Conditions
Insulin Resistance
Non-Alcoholic Fatty Liver Disease
Prediabetic State
Overweight and Obesity
Interventions
Other: [6,6-2H2] D-glucose
Dietary Supplement: BOOST Plus
Device: Harvard Apparatus PHD ULTRA CP syringe pump
Device: Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer
Other: Normal saline
Other: Human albumin
First Posted Date
2023-11-13
Last Posted Date
2024-07-10
Lead Sponsor
Columbia University
Registration Number
NCT06126354
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.

Phase 2
Recruiting
Conditions
Hepatic Metastasis
Hepatic Carcinoma
Interventions
Other: Placebo
First Posted Date
2023-10-17
Last Posted Date
2023-10-17
Lead Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Target Recruit Count
62
Registration Number
NCT06085976
Locations
🇪🇸

Clinica Universidad de Navarra, Pamplona, Spain

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