Clinical Trials

Lanreotide acetate has been evaluated in numerous clinical trials investigating its therapeutic potential across a broad range of endocrine, oncological, and gastrointestinal disorders. These investigations, spanning Early Phase 1 through Phase 4 trials, focus on conditions such as acromegaly, gastroenteropancreatic neuroendocrine tumors, Merkel cell carcinoma, and polycystic liver disease. Key studies, including NCT00444873 assessing long-term efficacy and NCT02351128 evaluating advanced skin neoplasms, feature recruitment statuses ranging from active and recruiting to completed or withdrawn. Supported by commercial pharmaceutical sponsors such as Ipsen alongside academic medical centers like University Hospital, Grenoble, these studies aim to characterize the safety and therapeutic utility of somatostatin analog therapy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06878664 RECRUITING
Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs)
Grupo Espanol de Tumores Neuroendocrinos
 2025-06-12 PHASE3
NCT06807437 RECRUITING
Pancreatic Carcinoma; Pancreatic Neoplasm
SWOG Cancer Research Network
 2025-05-09 PHASE3
NCT05048901 RECRUITING
Neuroendocrine Tumors,Gastroenteropancreatic
National Health Research Institutes, Taiwan
 2021-09-17 PHASE1; PHASE2
NCT03946527 ACTIVE_NOT_RECRUITING
Paraganglioma; Pheochromocytoma
Antonio Fojo
 2019-06-17 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
NCT05050942 ACTIVE_NOT_RECRUITING
Gastro-enteropancreatic Neuroendocrine Tumor
Camurus AB
 2021-10-22 PHASE3
NCT04427787 UNKNOWN
Metastatic Well Differentiated Neuroendocrine Neoplasm; Neuroendocrine Tumors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
 2020-06-20 PHASE2
NCT04065165 WITHDRAWN
Small Intestinal NET; Carcinoid Heart Disease
European Organisation for Research and Treatment of Cancer - EORTC
 2020-04 PHASE3
NCT03289741 COMPLETED
Neuroendocrine Tumors
Memorial Sloan Kettering Cancer Center
 2017-09-19 PHASE4
NCT03439709 UNKNOWN
Acromegaly Due to Pituitary Adenoma
Samsung Medical Center
 2018-03-01 PHASE3
NCT04852679 COMPLETED
Gastroenteropancreatic Neuroendocrine Tumor
Ipsen
 2021-05-24 PHASE3
NCT02859064 TERMINATED
Neuroendocrine Tumors; Gastrointestinal Neoplasms; Carcinoid Tumors
SCRI Development Innovations, LLC
 2017-07-28 PHASE2
NCT01538966 TERMINATED
Acromegaly
Cedars-Sinai Medical Center
 2012-03-29
NCT02823691 UNKNOWN
Neuroendocrine Tumors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
 2016-04 EARLY_PHASE1
NCT03043664 COMPLETED
Gastroenteropancreatic Neuroendocrine Tumors
Duke University
 2017-07-01 PHASE1; PHASE2
NCT03174353 COMPLETED
Pancreatic Leak; Pancreatic Fistula; Pancreaticoduodenal; Fistula; Pancreatectomy; Hyperglycemia
University of Washington
 2018-02-20 PHASE2
NCT03792555 COMPLETED
Acromegaly
Crinetics Pharmaceuticals Inc.
 2019-03-11 PHASE2
NCT02683941 TERMINATED
Neuroendocrine Tumors in Lung
Ipsen
 2017-03-06 PHASE3
NCT03083210 UNKNOWN
Neuroendocrine Tumors
Samsung Medical Center
 2017-07-05 PHASE4
NCT02288377 TERMINATED
Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours
Federation Francophone de Cancerologie Digestive
 2015-01 PHASE2; PHASE3
NCT02651987 COMPLETED
Pancreatic Tumours; Midgut Neuroendocrine Tumours
Ipsen
 2015-12-15 PHASE2
NCT02127437 COMPLETED
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Assistance Publique - Hôpitaux de Paris
 2014-09-19 PHASE3
NCT02698410 COMPLETED
Neuroendocrine Tumours
Ipsen
 2016-07 PHASE2
NCT03012594 COMPLETED
Gastrointestinal Motility Disorder; Intestinal Disease
Northwell Health
 2017-05-11 PHASE2
NCT02365584 TERMINATED
Intestinal Obstruction
Ipsen
 2015-01 PHASE2
NCT02354768 TERMINATED
High Output Stoma
University Hospital, Strasbourg, France
 2015-10-22 PHASE3
NCT01731925 UNKNOWN
Carcinoid Tumors
GERCOR - Multidisciplinary Oncology Cooperative Group
 2013-01-07 PHASE2
NCT02396953 COMPLETED
Acromegaly
Ipsen
 2015-03 PHASE1; PHASE2
NCT02275338 COMPLETED
Intestinal Obstruction
Ipsen
 2014-11-19 PHASE2
NCT01616927 UNKNOWN
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
University Medical Center Groningen
 2012-06 PHASE3
NCT02075606 COMPLETED
NeuroEndocrine Tumours
Ipsen
 2014-05 PHASE4
NCT02351128 COMPLETED
Carcinoma, Merkel Cell
University Hospital, Grenoble
 2015-04 PHASE2
NCT02231762 COMPLETED
Gastroenteropancreatic Neuroendocrine Tumors
Ipsen
 2014-10 PHASE2
NCT02493517 COMPLETED
Acromegaly
Ipsen
 2014-10 PHASE3
NCT01861717 TERMINATED
Acromegaly
Saint John's Cancer Institute
 2013-05 PHASE4
NCT00842348 COMPLETED
Non Functioning Entero-pancreatic Endocrine Tumour
Ipsen
 2009-02 PHASE3
NCT02054637 UNKNOWN
Acid Reflux Esophagitis; Non-acid Reflux Esophagitis
Universitair Ziekenhuis Brussel
 2014-04 PHASE2
NCT01070758 COMPLETED
Congenital Hyperinsulinism
Sheba Medical Center
 2010-02 PHASE4
NCT01372007 COMPLETED
Rectal Carcinoma
University Hospital, Ghent
 2011-07 PHASE3
NCT01315795 COMPLETED
Polycystic Liver Disease
Universitaire Ziekenhuizen KU Leuven
 2011-03 PHASE2; PHASE3
NCT01923649 COMPLETED
Dumping Syndrome
Universitaire Ziekenhuizen KU Leuven
 2008-04 PHASE2
NCT01076803 COMPLETED
Malignant Intestinal Obstruction
University Hospital, Ghent
 2009-10 PHASE2
NCT01313273 TERMINATED
Prostate Cancer
Ipsen
 2011-06 PHASE3
NCT00774930 COMPLETED
Carcinoid Syndrome
Ipsen
 2009-05 PHASE3
NCT00353496 COMPLETED
Endocrine Tumors
Ipsen
 2006-06 PHASE3
NCT00701363 COMPLETED
Acromegaly
Ipsen
 2008-10 PHASE4
NCT01137682 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2010-07-19 PHASE3
NCT00891371 COMPLETED
Diarrhea
Ipsen
 2009-07 PHASE2; PHASE3
NCT00690898 COMPLETED
Acromegaly
Ipsen
 2008-05 PHASE3
NCT00630695 COMPLETED
Lymphocele
University Hospital, Limoges
 2008-03 PHASE3
NCT00681187 COMPLETED
Neuroendocrine Tumour With Carcinoid Symptoms
Ipsen
 2008-06 PHASE4
NCT00993356 UNKNOWN
Acromegaly
Shanghai Jiao Tong University School of Medicine
 2004-01 PHASE2
NCT00326469 COMPLETED
Neuroendocrine Tumours
Ipsen
 2006-05 PHASE2
NCT00652379 COMPLETED
Acromegaly; Insulin Resistance; Impaired Glucose Tolerance
University of Aarhus
 2008-06
NCT00447499 COMPLETED
Acromegaly
Ipsen
 2007-04 PHASE3
NCT00517491 WITHDRAWN
Acromegaly
Ipsen
 2008-05 PHASE2
NCT00383708 COMPLETED
Acromegaly
Ipsen
 2006-10 PHASE3
NCT00771888 UNKNOWN
Polycystic Liver Disease; Hepatomegaly; Liver Diseases; Polycystic Kidney; Autosomal Dominant
Radboud University Medical Center
 2008-04 PHASE2; PHASE3
NCT00216372 COMPLETED
Intestinal Obstruction; Carcinoma; Peritoneal Neoplasms
Ipsen
 2003-09 PHASE3
NCT00495846 COMPLETED
Advanced Hepatocellular Carcinoma
Federico II University
 2007-04 PHASE2; PHASE3
NCT00444873 COMPLETED
Acromegaly
Ipsen
 2005-01 PHASE3
NCT00627796 COMPLETED
Acromegaly
Federico II University
 2003-01 PHASE4
NCT00288522 TERMINATED
Thyroid-Associated Ophthalmopathy
Ipsen
 2006-01 PHASE2
NCT00216398 COMPLETED
Acromegaly
Ipsen
 2004-06 PHASE4
NCT00149188 COMPLETED
Acromegaly
Ipsen
 2004-02 PHASE4
NCT00729313 COMPLETED
Digestive Fistulae
Ipsen
 2000-04 PHASE3
NCT00234572 COMPLETED
Acromegaly
Ipsen
 2000-05 PHASE2; PHASE3
NCT00210457 COMPLETED
Acromegaly
Ipsen
 2000-09 PHASE3
NCT00543179 UNKNOWN
Dumping Syndrome
Radboud University Medical Center
 2007-10 PHASE4
NCT00145405 COMPLETED
Acromegaly
Odense University Hospital
 2002-09 PHASE4
NCT00092287 TERMINATED
Malignant Carcinoid Syndrome
Ipsen
 2004-07 PHASE3
NCT00499993 COMPLETED
Acromegaly
Ipsen
 2001-01 PHASE3
NCT00565097 COMPLETED
Polycystic Liver Disease; Hepatomegaly; Liver Diseases; Polycystic Kidney, Autosomal Dominant
Radboud University Medical Center
 2007-10 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2025-09-02)

Check the Lanreotide acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lanreotide acetate selectively binds to somatostatin receptors on target cell membranes, inhibiting adenylate cyclase activity and suppressing downstream intracellular cyclic AMP signaling alongside calcium influx. This biochemical blockade inhibits the exocytosis of growth hormone and suppresses tumor cell proliferation, thereby offering therapeutic efficacy in clinical conditions such as acromegaly and gastroenteropancreatic neuroendocrine tumors.

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.