Clinical Trials

Octreotide acetate has been evaluated in numerous clinical trials investigating a broad spectrum of medical conditions, ranging from neuroendocrine tumors and carcinoid syndrome to metabolic disorders such as non-alcoholic fatty liver disease and carotid artery plaque. These evaluations span Phase 1 through Phase 4 studies and include trials addressing conditions like prostate cancer (NCT00166725) and gastroenteropancreatic neuroendocrine tumors (NCT05884255). Research sponsors encompass pharmaceutical leaders such as Novartis and Jiangsu HengRui Medicine alongside academic and university medical centers like M.D. Anderson Cancer Center and Columbia University. Across these initiatives, recruitment statuses vary significantly, including completed, recruiting, active not recruiting, terminated (NCT04140409), and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02019706 RECRUITING
ACTH; Cushing's Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2014-02-12 PHASE2
NCT06974344 NOT_YET_RECRUITING
Small-for-Size Syndrome
King Faisal Specialist Hospital & Research Center
 2025-06-01 PHASE4
NCT00262470 ACTIVE_NOT_RECRUITING
Tachycardia; Chronic Orthostatic Intolerance
Satish R. Raj
 1997-04 PHASE1; PHASE2
NCT07623824 NOT_YET_RECRUITING
Diagnosed With Acromegaly, Currently in the Active Stage of the Disease
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2026-05-31 PHASE3
NCT06878664 RECRUITING
Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs)
Grupo Espanol de Tumores Neuroendocrinos
 2025-06-12 PHASE3
NCT06558422 NOT_YET_RECRUITING
Insulin Resistance; Hyperinsulinemia; Metabolic Dysfunction Associated Steatotic Liver Disease; Non-Alcoholic Fatty Liver Disease; Prediabetic State; Obesity
Columbia University
 2027-01-01 PHASE1
NCT05749289 RECRUITING
SSTR Positive Tumors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2022-12-20 PHASE2; PHASE3
NCT06784752 RECRUITING
Somatostatin Receptor Positive (SSTR+); Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
Novartis Pharmaceuticals
 2025-05-30 PHASE3
NCT07165886 RECRUITING
Gastroenteropancreatic Neuroendocrine Tumors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2025-08-29 PHASE2; PHASE3
NCT06930625 RECRUITING
Acromegaly
Debiopharm International SA
 2025-11-26 PHASE3
NCT07479784 NOT_YET_RECRUITING
Pancreatic Fistula
Shanghai Zhongshan Hospital
 2026-04-01 PHASE3
NCT06881888 NOT_YET_RECRUITING
Diabetic Macular Edema
University of Alabama at Birmingham
 2026-08-31 PHASE1
NCT07255248 RECRUITING
Hoffa's Fat Pad Impingement
Boston Children's Hospital
 2026-03-01 PHASE4
NCT07262957 RECRUITING
Pancreas Head Cancer; Pancreas Adenocarcinoma; IPMN, Pancreatic; Cholangio Carcinoma; Ampulla of Vater Adenocarcinoma; PDAC - Pancreatic Ductal Adenocarcinoma; Duodenal Carcinoma; Mucinous Cystic Neoplasm; Neuro Endocrine Tumours; Pancreatitis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2025-09-01 PHASE4
NCT06505395 RECRUITING
Gastrointestinal Neuroendocrine Pancreatic Tumor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2024-07-30 PHASE2
NCT05477576 RECRUITING
GEP-NET; Gastroenteropancreatic Neuroendocrine Tumor; Gastroenteropancreatic Neuroendocrine Tumor Disease; Neuroendocrine Tumors; Carcinoid; Carcinoid Tumor; Pancreatic NET
RayzeBio, Inc.
 2022-03-24 PHASE3
NCT05884255 RECRUITING
Advanced Gastroenteropancreatic Neuroendocrine Tumor
Jiangsu HengRui Medicine Co., Ltd.
 2023-07-06 PHASE3
NCT07057622 RECRUITING
NETS Ga68 Lu177
HTA Co., Ltd.
 2023-12-12 PHASE3
NCT05050942 ACTIVE_NOT_RECRUITING
Gastro-enteropancreatic Neuroendocrine Tumor
Camurus AB
 2021-10-22 PHASE3
NCT07104487 RECRUITING
Stroke (CVA) or TIA; Carotid Artery Plaque; Atherosclerosis Cardiovascular Disease; Carotid Arteriosclerosis
Universitaire Ziekenhuizen KU Leuven
 2025-03-18 PHASE2
NCT06592261 RECRUITING
Insulin Resistance; Hyperinsulinemia; Obesity; Healthy
Columbia University
 2024-09-16 PHASE1
NCT07663318 COMPLETED
Acromegaly
Triastek (Shanghai) Limited
 2026-06-25 PHASE1
NCT03044977 ACTIVE_NOT_RECRUITING
Neuroendocrine Tumor, Malignant; Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting
David Bushnell
 2017-05-07 EARLY_PHASE1
NCT04917484 RECRUITING
Neuroendocrine Neoplasm
Tine Gregersen, MD
 2020-02-01 PHASE2
NCT06126354 WITHDRAWN
Insulin Resistance; Prediabetic State; Non-Alcoholic Fatty Liver Disease; Overweight and Obesity
Columbia University
 2024-07-01 PHASE1
NCT07460908 COMPLETED
Hepatorenal Syndrome
Lahore General Hospital
 2025-05-01
NCT05724134 COMPLETED
Insulin Resistance; Prediabetic State; Hyperinsulinemia; Non-Alcoholic Fatty Liver Disease; Obesity
Columbia University
 2023-08-29 PHASE1
NCT06085976 UNKNOWN
Hepatic Carcinoma; Hepatic Metastasis
Clinica Universidad de Navarra, Universidad de Navarra
 2023-08-14 PHASE2
NCT06865677 TERMINATED
Recurrent Platinum Resistant Epithelial Ovarian Carcinoma; Recurrent Epithelial Endometrial Carcinoma; Recurrent Epithelial Cervical Carcinoma
National Cancer Institute (NCI)
 2025-06-09 PHASE2
NCT04125836 COMPLETED
Acromegaly
Camurus AB
 2019-10-10 PHASE3
NCT06240039 ACTIVE_NOT_RECRUITING
Non-Alcoholic Fatty Liver Disease; Obesity
University of Copenhagen
 2024-02-11
NCT03879694 COMPLETED
Lung Atypical Carcinoid Tumor; Lung Typical Carcinoid Tumor; Metastatic Pancreatic Neuroendocrine Tumor
Roswell Park Cancer Institute
 2019-06-17 PHASE1
NCT05281328 ACTIVE_NOT_RECRUITING
Polycystic Liver Disease
Camurus AB
 2022-06-28 PHASE2; PHASE3
NCT06045260 RECRUITING
Neuroendocrine Tumors; Paraganglioma; Pheochromocytoma
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
 2023-09-13 PHASE2
NCT03624517 TERMINATED
Esophageal Varices; Liver Cirrhoses; Bleeding Esophageal Varices; Upper Gastrointestinal Bleeding
Medical University of South Carolina
 2018-09-19 PHASE4
NCT05364944 TERMINATED
Acromegaly; GEP-NET
Debiopharm International SA
 2022-05-18 PHASE1
NCT06062719 UNKNOWN
Non-variceal Gastrointestinal Bleeding
National Hepatology & Tropical Medicine Research Institute
 2023-08-23 PHASE2; PHASE3
NCT05459844 ACTIVE_NOT_RECRUITING
Neuroendocrine Tumors
Sinotau Pharmaceutical Group
 2022-08-31 PHASE3
NCT01613495 UNKNOWN
Prader Willis Syndrome
Oregon Health and Science University
 2005-08
NCT04871204 COMPLETED
Esophageal Cancer; Gastric Cancer
Fredrik Klevebro
 2021-06-16 PHASE2
NCT04941911 UNKNOWN
Liver Transplantation; Renal Failure
University College, London
 2022-05-27 PHASE2
NCT03972488 ACTIVE_NOT_RECRUITING
Gastro-enteropancreatic Neuroendocrine Tumor
Advanced Accelerator Applications
 2020-01-08 PHASE3
NCT04048707 WITHDRAWN
Hepatorenal Syndrome; Cirrhosis; Kidney Failure, Acute
University of California, Los Angeles
 2021-07-01 PHASE2
NCT05761431 COMPLETED
Acromegaly
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2023-03-02 PHASE1
NCT05199038 UNKNOWN
Esophageal Varices
Tanta University
 2022-06 PHASE4
NCT04076462 COMPLETED
Acromegaly
Camurus AB
 2019-08-19 PHASE3
NCT03891849 WITHDRAWN
Haemorrhagic Shock; Variceal Hemorrhage
Centre Hospitalier Universitaire, Amiens
 2021-09-01
NCT03289741 COMPLETED
Neuroendocrine Tumors
Memorial Sloan Kettering Cancer Center
 2017-09-19 PHASE4
NCT02384122 COMPLETED
Angiodysplasia; Vascular Malformations; Gastrointestinal Hemorrhage; Anemia
Radboud University Medical Center
 2015-09 PHASE3
NCT01538966 TERMINATED
Acromegaly
Cedars-Sinai Medical Center
 2012-03-29
NCT04552847 COMPLETED
Neuroendocrine Tumors
Universitaire Ziekenhuizen KU Leuven
 2020-10-07 PHASE2; PHASE3
NCT04353193 UNKNOWN
Liver Cirrhosis Portal
Juan A. Arnaiz
 2020-06 PHASE4
NCT03541447 COMPLETED
Autosomal Dominant Polycystic Kidney Disease
Mario Negri Institute for Pharmacological Research
 2018-12-12 PHASE2
NCT06254235 COMPLETED
Healthy Volunteers
Qilu Pharmaceutical Co., Ltd.
 2021-06-16 PHASE1
NCT05682209 COMPLETED
Seroma Following Procedure
Ikechukwu Bartholomew Ulasi
 2020-12-18 PHASE4
NCT04027348 TERMINATED
Malignant Bowel Obstruction
Roswell Park Cancer Institute
 2019-06-26 PHASE2
NCT02294006 UNKNOWN
Well Differentiated Pancreatic Endocrine Tumor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
 2014-06 PHASE2
NCT02437825 UNKNOWN
Fistula; Salivary Duct or Gland
Hadassah Medical Organization
 2015-10 PHASE2
NCT03520569 COMPLETED
Vascular Stiffness; Insulin Sensitivity
University of Virginia
 2019-02-04 EARLY_PHASE1
NCT05683444 COMPLETED
Lymphatic Diseases; Chylothorax
Rigshospitalet, Denmark
 2020-07-01 EARLY_PHASE1
NCT03000946 COMPLETED
Pancreatic Surgery
Assistance Publique - Hôpitaux de Paris
 2017-05-15 PHASE3
NCT02685709 COMPLETED
Acromegaly
Chiasma, Inc.
 2016-02 PHASE3
NCT03792555 COMPLETED
Acromegaly
Crinetics Pharmaceuticals Inc.
 2019-03-11 PHASE2
NCT04028323 UNKNOWN
Renal Function Disorder; Acute Variceal Bleeding
Nanfang Hospital, Southern Medical University
 2019-07-16 PHASE4
NCT03273712 COMPLETED
Neuroendocrine Tumors; Meningioma; Neuroblastoma; Medulloblastoma
University of Iowa
 2017-09-29 PHASE2
NCT03455322 COMPLETED
Renal Impairment in Hepatorenal Syndrome
National Hepatology & Tropical Medicine Research Institute
 2018-08-15 PHASE4
NCT06080204 COMPLETED
Pancreatic Neuroendocrine Tumor G2
Changhai Hospital
 2008-03
NCT05340192 COMPLETED
Healthy
Duke University
 2019-09-24 PHASE1
NCT03798912 COMPLETED
Healthy Volunteers
RANI Therapeutics
 2019-07-09 PHASE1
NCT03179995 TERMINATED
Major Liver Resection
Fox Chase Cancer Center
 2017-07-07 PHASE2
NCT04522297 COMPLETED
Hepato-Renal Syndrome
National Hepatology & Tropical Medicine Research Institute
 2018-04-15
NCT03511768 UNKNOWN
Neuroendocrine Neoplasm
Xiangya Hospital of Central South University
 2018-01-02 PHASE1; PHASE2
NCT04129255 COMPLETED
Neuroendocrine Tumors
National Cancer Institute, Naples
 2017-06-28 PHASE2
NCT03057509 WITHDRAWN
Small Bowel Carcinoid Tumor
Massachusetts General Hospital
 2018-11 PHASE1
NCT03883776 COMPLETED
Neuroendocrine Tumors
Universitaire Ziekenhuizen KU Leuven
 2019-04-11 PHASE1
NCT04140409 TERMINATED
Neuroendocrine Tumors; Carcinoid Syndrome
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
 2016-02-02 PHASE4
NCT03252353 UNKNOWN
Acromegaly
Chiasma, Inc.
 2017-09-01 PHASE3
NCT03571594 TERMINATED
Acromegaly
Ono Pharmaceutical Co., Ltd.
 2018-06-07 PHASE1
NCT02333565 COMPLETED
Recurrent Meningiomas; Resistant Meningiomas
Assistance Publique Hopitaux De Marseille
 2015-01-22 PHASE2
NCT03398941 UNKNOWN
Pancreatic Diseases
Chengfeng Wang
 2018-02-01
NCT04296149 COMPLETED
Neuroendocrine Tumors
European Institute of Oncology
 2017-02-16 PHASE2
NCT02427295 UNKNOWN
Acromegaly
Asan Medical Center
 2014-03 PHASE4
NCT02409849 UNKNOWN
Gastro-entero-pancreatic Carcinoma; Esophageal Neuroendocrine Carcinoma
Peking University
 2015-04 PHASE2
NCT03013387 WITHDRAWN
Neuroendrocrine Tumors; Meningioma; Neuroblastoma; Medulloblastoma
Sue O'Dorisio
 2017-01 PHASE2
NCT02457156 COMPLETED
Pancreatic Cancer
University of Liverpool
 2015-04-23 PHASE3
NCT02874326 UNKNOWN
Hereditary Hemorrhagic Telangiectasia; Gastrointestinal Hemorrhage; Anemia
Radboud University Medical Center
 2016-10 PHASE2
NCT02032784 TERMINATED
Adenoma
AdventHealth
 2014-03 PHASE4
NCT02920567 UNKNOWN
Periampullary Tumors
Saint Vincent's Hospital, Korea
 2014-01
NCT02010385 COMPLETED
Roux-en-Y Bariatric Surgery
University College Dublin
 2013-02
NCT02381249 COMPLETED
Esophageal Neoplasms; Stomach Neoplasms; Weight Loss; Malnutrition; Pancreatic Neoplasms; Duodenal Neoplasms
St. James's Hospital, Ireland
 2015-03
NCT02916433 COMPLETED
Octreotide; Sputum
Danbury Hospital
 2016-09 PHASE2
NCT02691078 COMPLETED
Neuroendocrine Tumors
Latin American Cooperative Oncology Group
 2016-07 PHASE2
NCT02385617 COMPLETED
Esophageal Neoplasms; Stomach Neoplasms; Weight Loss; Malnutrition
St. James's Hospital, Ireland
 2014-01
NCT02396953 COMPLETED
Acromegaly
Ipsen
 2015-03 PHASE1; PHASE2
NCT03061604 COMPLETED
Variceal Hemorrhage
Theodor Bilharz Research Institute
 2014-11
NCT02294786 TERMINATED
Cancer
Novartis Pharmaceuticals
 2014-12-17 PHASE2
NCT01377246 COMPLETED
Autosomal Dominant Polycystic Kidney Disease
Mario Negri Institute for Pharmacological Research
 2011-05 PHASE3
NCT01619865 COMPLETED
Neuroendocrine Tumors; Carcinoid Tumors; Neuroblastoma; Medulloblastoma
Sue O'Dorisio
 2012-02-21 PHASE1; PHASE2
NCT01587222 WITHDRAWN
Fibrosis; Renal Failure; Hepatorenal Syndrome
Anna Cruceta
 2016-07 PHASE2
NCT02474914 COMPLETED
Periampullary Carcinoma Resectable
Mansoura University
 2014-05
NCT03031535 COMPLETED
Healthy Volunteer Study
Dauntless Pharmaceuticals
 2017-01 PHASE1
NCT00223691 COMPLETED
Autonomic Failure; Orthostatic Hypotension
Vanderbilt University
 2002-03 PHASE1
NCT02374632 UNKNOWN
Bariatric Surgery (Gastric Bypass); Severe Obesity
Hvidovre University Hospital
 2014-10 PHASE4
NCT01860742 WITHDRAWN
Gastro-intestinal Neuroendocrine Tumors
Jules Bordet Institute
 2014-12 PHASE3
NCT02668588 COMPLETED
Seroma
Chemi S.p.A.
 2015-10-22 PHASE2
NCT02119884 COMPLETED
Gastric and Esophageal Varices
Shanghai Zhongshan Hospital
 2014-02 PHASE4
NCT02299089 COMPLETED
Acromegaly; Neuroendocrine Tumors
Camurus AB
 2015-01 PHASE2
NCT00600886 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2008-02-11 PHASE3
NCT01865760 COMPLETED
Obesity; Hypoglycemia; Surgery
University of Aarhus
 2013-06
NCT02111044 COMPLETED
Acromegaly
Italfarmaco
 2014-04 PHASE2
NCT06753630 COMPLETED
Lateral Epicondylitis; Extracorporeal Shockwave Therapy; Muscle Strengthening
Chuncheon Sacred Heart Hospital
 2014-11-20
NCT01673906 COMPLETED
Neuroendocrine Tumours
Azienda USL Reggio Emilia - IRCCS
 2012-08 PHASE2
NCT01578239 COMPLETED
Carcinoid Tumor of the Small Bowel; Neuroendocrine Tumour
Advanced Accelerator Applications
 2012-09-06 PHASE3
NCT02237053 COMPLETED
Hyperglucagonemia; Obesity
AdventHealth Translational Research Institute
 2014-09 PHASE1
NCT00569127 ACTIVE_NOT_RECRUITING
Colorectal Neuroendocrine Tumor G1; Gastric Neuroendocrine Tumor G1; Neuroendocrine Neoplasm; Neuroendocrine Tumor; Neuroendocrine Tumor G2
National Cancer Institute (NCI)
 2007-12-01 PHASE3
NCT00427349 COMPLETED
Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Neoplastic Syndrome
Eastern Cooperative Oncology Group
 2008-11-07 PHASE2
NCT01469338 TERMINATED
Diarrhea; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer
University of Southern California
 2012-07 PHASE2
NCT02195635 COMPLETED
Drug Interactions
Lexicon Pharmaceuticals
 2014-07 PHASE1
NCT01707225 COMPLETED
Gastrointestinal Bleeding
Virginia Commonwealth University
 2013-02 PHASE1
NCT01229943 COMPLETED
Advanced Pancreatic Neuroendocrine Tumor; Locally Advanced Pancreatic Neuroendocrine Tumor; Pancreatic Gastrinoma; Pancreatic Neuroendocrine Tumor G1; Pancreatic Neuroendocrine Tumor G2; Pancreatic Vipoma
National Cancer Institute (NCI)
 2010-10-15 PHASE2
NCT01567488 COMPLETED
Gastrointestinal Neoplasms
Grupo Espanol de Tumores Neuroendocrinos
 2011-06-08 PHASE2
NCT01301222 COMPLETED
Pancreatic Fistula
PVS Memorial Hospital
 2010-09 PHASE4
NCT01886287 TERMINATED
Neuroendocrine Carcinoma
H. Lee Moffitt Cancer Center and Research Institute
 2013-12 PHASE2
NCT01204476 COMPLETED
Gastrin-Producing Neuroendocrine Tumor; Lung Carcinoid Tumor; Metastatic Digestive System Neuroendocrine Tumor G1; Pancreatic Glucagonoma; Pancreatic Insulinoma; Pancreatic Polypeptide Tumor; Paraganglioma; Recurrent Digestive System Neuroendocrine Tumor G1; Recurrent Merkel Cell Carcinoma; Recurrent Pancreatic Neuroendocrine Carcinoma; Regional Digestive System Neuroendocrine Tumor G1; Somatostatin-Producing Neuroendocrine Tumor; Stage III Merkel Cell Carcinoma; Stage IV Merkel Cell Carcinoma; Thyroid Gland Medullary Carcinoma
National Cancer Institute (NCI)
 2010-10 PHASE1
NCT00853047 COMPLETED
Carcinoid Syndrome
Lexicon Pharmaceuticals
 2009-03 PHASE2
NCT01917773 COMPLETED
Colonic Motility Index; Constipation
Indiana University
 2013-08 PHASE4
NCT01412424 COMPLETED
Acromegaly
Chiasma, Inc.
 2012-03 PHASE3
NCT02217826 COMPLETED
Healthy
Aspireo Pharmaceuticals Limited
 PHASE1
NCT02217800 COMPLETED
Acromegaly
Aspireo Pharmaceuticals Limited
 2013-11 PHASE2
NCT00552071 COMPLETED
Acromegaly
Cedars-Sinai Medical Center
 2007-07 PHASE4
NCT01048086 WITHDRAWN
Neuroblastoma; Neuroendocrine Tumor
University of Iowa
 2009-06 PHASE2
NCT00742339 TERMINATED
Cirrhosis; Hepatorenal Syndrome
University of Padova
 2005-05 PHASE2; PHASE3
NCT00701363 COMPLETED
Acromegaly
Ipsen
 2008-10 PHASE4
NCT01137682 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2010-07-19 PHASE3
NCT02217839 COMPLETED
Healthy
Aspireo Pharmaceuticals Limited
 2012-04 PHASE1
NCT02235987 COMPLETED
Acromegaly
Aspireo Pharmaceuticals Limited
 2012-10 PHASE2
NCT01871844 COMPLETED
Healthy Male Volunteers
Italfarmaco
 2012-01 PHASE1
NCT01480986 COMPLETED
Progression Free Survival of the Treatment
Peking University
 2011-09 PHASE2
NCT01157858 COMPLETED
Polycystic Liver Disease
Radboud University Medical Center
 2010-06 PHASE2
NCT01295060 TERMINATED
Acromegaly
Endo USA Inc., a Keenova Therapeutics Company
 2011-02 PHASE3
NCT00690430 COMPLETED
Symptomatic Refractory Resistant Carcinoid Disease
Novartis Pharmaceuticals
 2008-04 PHASE3
NCT01400100 COMPLETED
Pancreatic Fistula
St. Josef Hospital Bochum
 2011-08
NCT01561066 COMPLETED
Enterocutaneous Fistulas; Intra-abdominal Infection
Jinling Hospital, China
 2008-01 PHASE1
NCT01029275 COMPLETED
Acromegaly
University Hospital, Rouen
 2005-01
NCT00884715 TERMINATED
Carcinoid Syndrome
Endo USA Inc., a Keenova Therapeutics Company
 2009-07 PHASE1; PHASE2
NCT02305069 COMPLETED
Obesity; Sarcopenia
University of Nottingham
 2009-10
NCT00049023 COMPLETED
Brain and Central Nervous System Tumors; Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Neuroblastoma; Pheochromocytoma; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific
O'Dorisio, M S
 2002-01 PHASE1
NCT00781911 COMPLETED
Carcinoma; Neuroendocrine Tumors
Eli Lilly and Company
 2009-02 PHASE2
NCT00765323 TERMINATED
Acromegaly
Endo USA Inc., a Keenova Therapeutics Company
 2008-09 PHASE3
NCT00332969 COMPLETED
Thymoma
Novartis Pharmaceuticals
 2005-09 PHASE2
NCT00582426 COMPLETED
Chemotherapy-induced Diarrhea
Novartis Pharmaceuticals
 2008-04 PHASE3
NCT00108355 COMPLETED
Ascites; Cirrhosis
US Department of Veterans Affairs
 2003-12 PHASE4
NCT01371643 COMPLETED
Pituitary Adenoma
NYU Langone Health
 2004-04 PHASE4
NCT00432068 COMPLETED
Healthy Cholecystectomized
Novartis Pharmaceuticals
 2007-01 PHASE1
NCT01086982 SUSPENDED
Acromegaly
Azidus Brasil
 2010-03 PHASE1
NCT00966355 COMPLETED
Variceal Bleeding, Cirrhosis
Korea University
 2006-09 PHASE4
NCT00412061 COMPLETED
Carcinoid Tumor; Malignant Carcinoid Syndrome
Novartis Pharmaceuticals
 2006-12 PHASE3
NCT00376064 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2006-03 PHASE4
NCT00463983 COMPLETED
Idiopathic Pulmonary Fibrosis
Institut National de la Santé Et de la Recherche Médicale, France
 2006-10 PHASE1; PHASE2
NCT00652379 COMPLETED
Acromegaly; Insulin Resistance; Impaired Glucose Tolerance
University of Aarhus
 2008-06
NCT00182754 COMPLETED
Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Alliance for Clinical Trials in Oncology
 2005-10 PHASE3
NCT00642421 TERMINATED
Acromegaly
Ambrilia Biopharma, Inc.
 2008-02 PHASE3
NCT00113360 COMPLETED
Neuroendocrine Carcinoma; Islet Cell Carcinoma
M.D. Anderson Cancer Center
 2005-01 PHASE2
NCT00635765 COMPLETED
Acromegaly
Ambrilia Biopharma, Inc.
 2007-10 PHASE3
NCT01203306 UNKNOWN
Neuroendocrine Carcinomas
University of Turin, Italy
 2006-01 PHASE2
NCT00399893 TERMINATED
Prader-Willi Syndrome
Duke University
 2006-12
NCT00584298 COMPLETED
Irritable Bowel Syndrome (IBS)
Novartis
 2008-01 PHASE1
NCT00426153 COMPLETED
Polycystic Kidney, Autosomal Dominant; Polycystic Liver Disease; Hepatomegaly; Liver Diseases; Kidney, Polycystic; Abdominal Pain
Mayo Clinic
 2007-01 PHASE2; PHASE3
NCT00332696 COMPLETED
Peritoneal Neoplasms; Intestinal Obstruction; Carcinomatosis
Novartis Pharmaceuticals
 2005-09 PHASE2
NCT00171873 COMPLETED
Neuroendocrine Tumors
Carmen Schade-Brittinger
 2001-09 PHASE3
NCT00495846 COMPLETED
Advanced Hepatocellular Carcinoma
Federico II University
 2007-04 PHASE2; PHASE3
NCT00005906 COMPLETED
Lymphangioleiomyomatosis; Lymphangiomyomas; Pleural Effusions; Ascites
National Heart, Lung, and Blood Institute (NHLBI)
 2000-06 PHASE2
NCT00595140 COMPLETED
Acromegaly
Ludwig-Maximilians - University of Munich
 2008-01 PHASE4
NCT00616551 COMPLETED
Acromegaly
Ambrilia Biopharma, Inc.
 2007-04 PHASE3
NCT00363051 COMPLETED
Islet Cell Carcinoma; Neuroendocrine Carcinoma; Neuroendocrine Tumor; Pancreatic Neoplasms
Novartis Pharmaceuticals
 2006-06 PHASE2
NCT00444873 COMPLETED
Acromegaly
Ipsen
 2005-01 PHASE3
NCT00002864 COMPLETED
Breast Cancer
NCIC Clinical Trials Group
 1996-09-24 PHASE3
NCT00990535 COMPLETED
Respiratory Tract Neoplasms; Thymic Neoplasms; Pancreatic Neoplasms; Gastrointestinal Neoplasms; Multiple Endocrine Neoplasia
Federico II University
 2006-01 PHASE2
NCT00372697 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2005-12 PHASE3
NCT00913055 COMPLETED
Acromegaly
Endo USA Inc., a Keenova Therapeutics Company
 2007-02 PHASE2
NCT00257426 COMPLETED
Liver Cancer
UNC Lineberger Comprehensive Cancer Center
 2005-07 PHASE2
NCT00466856 TERMINATED
Head and Neck Cancer; Islet Cell Tumor; Metastatic Cancer; Pheochromocytoma
Vanderbilt-Ingram Cancer Center
 2003-12 PHASE2
NCT00075868 COMPLETED
Anal Cancer; Colorectal Cancer; Drug/Agent Toxicity by Tissue/Organ; Radiation Enteritis
Radiation Therapy Oncology Group
 2003-12 PHASE3
NCT00248131 TERMINATED
Diabetic Retinopathy
Novartis Pharmaceuticals
 2005-11 PHASE3
NCT00033605 COMPLETED
Cervical Cancer; Colorectal Cancer; Diarrhea; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Prostate Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific; Vaginal Cancer; Vulvar Cancer
Alliance for Clinical Trials in Oncology
 2002-04 PHASE3
NCT00216398 COMPLETED
Acromegaly
Ipsen
 2004-06 PHASE4
NCT00171886 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2002-07 PHASE4
NCT00170742 TERMINATED
Proliferative Diabetic Retinopathy
Novartis
 2003-12 PHASE3
NCT00248157 TERMINATED
Diabetic Retinopathy
Novartis Pharmaceuticals
 2005-11 PHASE3
NCT00953394 COMPLETED
Neuroendocrine Tumors
University of Turin, Italy
 2002-02 PHASE2
NCT00250796 COMPLETED
Liver; Cancer
University of New Mexico
 2000-09 PHASE2
NCT00131144 COMPLETED
Diabetic Retinopathy
Novartis
 1999-11 PHASE3
NCT00130845 COMPLETED
Diabetic Retinopathy
Novartis
 2000-02 PHASE3
NCT00241020 COMPLETED
Advanced Hepatocellular Carcinoma
Novartis Pharmaceuticals
 2002-06 PHASE3
NCT00171613 COMPLETED
Hypothalamic Obesity
Novartis
 2005-02 PHASE4
NCT00088582 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2004-03 PHASE2
NCT00242541 TERMINATED
Acromegaly
Novartis Pharmaceuticals
 2003-03 PHASE4
NCT00521300 COMPLETED
Acromegaly
St. Olavs Hospital
 1999-09 PHASE4
NCT00225979 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2002-11 PHASE3
NCT00128232 COMPLETED
Acromegaly
Novartis
 2002-12 PHASE3
NCT00002947 TERMINATED
Brain and Central Nervous System Tumors; Childhood Langerhans Cell Histiocytosis; Gastrointestinal Carcinoid Tumor; Head and Neck Cancer; Intraocular Melanoma; Islet Cell Tumor; Kidney Cancer; Lung Cancer; Melanoma (Skin); Neoplastic Syndrome; Neuroendocrine Carcinoma of the Skin; Pheochromocytoma
Yale University
 1996-10 PHASE1
NCT00003283 COMPLETED
Thymoma and Thymic Carcinoma
Eastern Cooperative Oncology Group
 1998-10-13 PHASE2
NCT00004895 COMPLETED
Colorectal Cancer; Constipation, Impaction, and Bowel Obstruction; Extrahepatic Bile Duct Cancer; Gastric Cancer; Gastrointestinal Stromal Tumor; Nausea and Vomiting; Ovarian Cancer; Pancreatic Cancer; Peritoneal Cavity Cancer; Small Intestine Cancer
Northwestern University
 1999-10 PHASE2
NCT00008073 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
University of Pittsburgh
 1996-01 PHASE1
NCT01188733 COMPLETED
Cirrhosis; Portal Hypertension; Esophageal Varices
Mayo Clinic
 1998-06 PHASE1; PHASE2
NCT00002779 COMPLETED
Lymphoma
Alliance for Clinical Trials in Oncology
 1998-02 PHASE2
NCT00003057 COMPLETED
Colorectal Cancer; Diarrhea
Eastern Cooperative Oncology Group
 1997-03-26 PHASE3
NCT00006269 TERMINATED
Colorectal Cancer; Diarrhea
Novartis
 1999-12 PHASE3
NCT00145405 COMPLETED
Acromegaly
Odense University Hospital
 2002-09 PHASE4
NCT00002967 COMPLETED
Breast Cancer
NSABP Foundation Inc
 1997-05 PHASE3
NCT00386984 COMPLETED
Carcinoma, Hepatocellular
University Hospital Freiburg
 1999-10 PHASE3
NCT00461149 COMPLETED
Acromegaly
Federico II University
 1995-01 PHASE4
NCT00001228 COMPLETED
Islet Cell Adenoma; Zollinger Ellison Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 1988-10-25 PHASE2
NCT00002253 COMPLETED
Diarrhea; HIV Infections
Sandoz
NCT00002252 COMPLETED
Diarrhea; HIV Infections
Sandoz
NCT00804297 COMPLETED
Hypoglycemia; Diabetes Mellitus
Albert Einstein Healthcare Network
 2005-06 PHASE3
NCT00534677 COMPLETED
Portal Hypertension; Cirrhosis; Hematemesis; Melena
Aga Khan University
 2004-05 PHASE4
NCT00166725 COMPLETED
Prostate Cancer
Novartis
 2004-02 PHASE2
NCT00004327 COMPLETED
Hereditary Hemorrhagic Telangiectasia; Ectasia
National Center for Research Resources (NCRR)
 1995-01 PHASE2
NCT00240045 COMPLETED
Type 2 Hepatorenal Syndrome; Refractory Ascites
University of Alberta
 2005-10 PHASE2; PHASE3
NCT00274170 UNKNOWN
Migraine Headache
C.R.Darnall Army Medical Center
 2006-01 PHASE1; PHASE2
NCT00227773 WITHDRAWN
Gastrointestinal Carcinoid Tumor; Islet Cell Carcinoma
Eastern Cooperative Oncology Group
 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-08)

Check the Octreotide acetate (SMS 201-995) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a long-acting synthetic analog of natural somatostatin, octreotide acetate selectively binds to somatostatin receptors—predominantly SSTR2 and SSTR5—which leads to the inhibition of adenylyl cyclase and a subsequent reduction in intracellular cyclic AMP levels. This signaling suppression blocks the pathological hypersecretion of gastroenteropancreatic hormones and growth factors, thereby inhibiting cellular proliferation and stabilizing disease progression in neuroendocrine tumors and carcinoid syndrome.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.