lanreotide
Trade name: somatuline depot
Approved
Aug 30, 2007
Lanreotide is a medication used in the management of acromegaly and symptoms caused by neuroendocrine tumors, most notably carcinoid syndrome. It is a long-acting analog of somatostatin. It is available in several countries, including the United Kingdom, Australia and Canada, and was approved for sale in the United States by the Food and Drug Administration on August 30, 2007. Lanreotide was developed in the lab of Dr. David H. Coy, School of Medicine. Dr. Coy serves as Director of the Peptide Laboratory. Lanreotide (as lanreotide acetate) is manufactured by Ipsen, and marketed under the trade name Somatuline. The mechanism of action of lanreotide is believed to be similar to that of natural somatostatin. Lanreotide has a high affinity for human somatostatin receptors (SSTR) 2 and 5 and a reduced binding affinity for human SSTR1, 3, and 4. Activity at human SSTR 2 and 5 is the primary mechanism believed responsible for GH inhibition. Like somatostatin, lanreotide is an inhibitor of various endocrine, neuroendocrine, exocrine and paracrine functions. Lanreotide inhibits the basal secretion of motilin, gastric inhibitory peptide and pancreatic polypeptide, but has no significant effect on the secretion of secretin. Lanreotide inhibits postprandial secretion of pancreatic polypeptide, gastrin and cholecystokinin (CCK). In healthy subjects, lanreotide produces a reduction and a delay in post-prandial insulin secretion, resulting in transient, mild glucose intolerance. — NCATS
Clinical trial activity
74 trials · 66 clinical orgs · 3 marketing orgs
Earliest trial started Apr 1, 2000 (NCT00729313)
Timeline
2000s
2020s
- Dec 17, 2021
Invagen Pharms — Marketing Organization
- Dec 17, 2021
Cipla — NDA Secondary Org
Indications
Approved for
Studied for
- Carcinoid Heart Disease · Phase 3
- Carcinoid Tumor · Phase 2
- Carcinoma · Phase 3
- Carcinoma, Hepatocellular · Phase 2/Phase 3
- Carcinoma, Merkel Cell · Phase 2
- Colorectal Neoplasms · Phase 3
- Congenital Hyperinsulinism · Phase 4
- Diarrhea · Phase 2/Phase 3
- Digestive System Diseases · Phase 3
- Dumping Syndrome · Phase 4
- Gastroesophageal Reflux · Phase 2
- Gastrointestinal Neoplasms · Phase 2
- Genetic Diseases, Inborn · Phase 2/Phase 3
- Graves Ophthalmopathy · Phase 2
- Growth Hormone-Secreting Pituitary Adenoma · Phase 3
- Hepatomegaly · Phase 2/Phase 3
- Hyperglycemia · Phase 2
- Intestinal Diseases · Phase 2
- Intestinal Neoplasms · Phase 3
- Intestinal Obstruction · Phase 3
- Liver Diseases · Phase 2/Phase 3
- Lung Neoplasms · Phase 3
- Lymphocele · Phase 3
- Malignant Carcinoid Syndrome · Phase 3
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 3
- Neuroendocrine Tumors · Phase 4
- Pancreatic Diseases · Phase 2
- Pancreatic Fistula · Phase 2
- Pancreatic Neoplasms · Phase 3
- Paraganglioma · Phase 2
- Peritoneal Neoplasms · Phase 3
- Pheochromocytoma · Phase 2
- Polycystic Kidney, Autosomal Dominant · Phase 3
- Polycystic Kidney Diseases · Phase 2/Phase 3
- Prostatic Neoplasms · Phase 3
Mechanism of action
- Somatostatin receptor 2AGONIST
SSTR2 agonist
- Somatostatin receptor 5AGONIST
SSTR5 agonist
- SomatostatinSupplementation
SST supplementation
Approval history
- approvedAug 30, 2007
Chemistry & pharmacology
SMILES
CC(C)[C@@H]1NC(=O)[C@H](CCCCN)NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](NC(=O)[C@H](N)Cc2ccc3ccccc3c2)CSSC[C@@H](C(=O)N[C@H](C(N)=O)[C@@H](C)O)NC1=O- Mol. weight
- 1096.35 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL1201185 ↗
- WikipediaLanreotide ↗
- NCATS0G3DE8943Y ↗
- ChEMBLCHEMBL1201184 ↗
Also known as
- 188re-lanreotide
- 2-naphthylalanyl-cyclo(cysteinyl-tyrosyl-tryptophyl-lysyl-valyl-cysteinyl)-threoninamide
- angiopeptin
- bim 23014
- bim-23014
- bim 23014c
- bim-23014c
- bim-23014c
- dc 13-116
- dc-13-116
- dc13-116
- ipstyl
- lanreotide
- lanreotide
- lanreotide
- lanreotide
- lanreotide
- lanreotide
- lanreotide
- lanreotide
- lanreotide
- lanreotide
- lanreotide acetate
- lanreotide acetate
- lanreotide acetate
- lanreotide acetate
- lanreotide acetate
- lanreotide autogel
- lanreotide-sr
- l-threoninamide, 3-(1-naphthalenyl)-d-alanyl-l-cysteinyl-l-tyrosyl-d-tryptophyl-l-lysyl-l-valyl-l-cysteinyl-, cyclic (2-7)-disulfide
- l-threoninamide, 3-(2-naphthalenyl)-d-alanyl-l-cysteinyl-l-tyrosyl-d-tryptophyl-l-lysyl-l-valyl-l-cysteinyl-, cyclic (2-7)-disulfide
- nal-cyclo(cys-tyr-trp-lys-val-cys)-thr-nh2
- nal-cyclo(cys-tyr-trp-lys-val-cys)thr-nh2
- naphthalenyl-cyclo(cysteinyl-tyrosyl-tryptophyl-lysyl-valyl-cysteinyl)threoninamide
- naphthyl-cyclo(cys-tyr-trp-lys-val-cys)thr-nh2
- somatulin
- somatulina
- somatulin-autogel
- somatuline
- somatuline
- somatuline
- somatuline
- somatuline
- somatuline autogel
- somatuline autogel
- somatuline depot
- somatuline depot
- somatuline la
- somatuline la
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06807437 | Phase 3 | Jun 28, 2025 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT06878664 | Phase 3 | Jun 12, 2025 | Grupo Espanol de Tumores Neuroendocrinos (GETNE), Institut Gustave Roussy, Universidad Complutense de Madrid |
| NCT05364944 | Phase 1 | May 18, 2022 | Debiopharm |
| NCT05477576 | Phase 1/Phase 2 (Phase 2) | Mar 24, 2022 | RayzeBio, Inc. |
| NCT05050942 | Phase 3 | Oct 22, 2021 | Camurus AB, University of Toronto |
| NCT05048901 | Phase 1/Phase 2 (Phase 2) | Sep 30, 2021 | Changhua Christian Hospital, China Medical University, Government of Taiwan, Kaohsiung Medical University, Mackay Medical College, National Cheng Kung University, National Taiwan University, Taipei Veteran General hospital |
| NCT04852679 | Phase 3 | May 24, 2021 | Ipsen |
| NCT04427787 | Phase 2 | Jun 20, 2020 | University of Milan |
| NCT04065165 | Phase 3 | Apr 30, 2020 | European Organisation for Research and Treatment of Cancer, Ipsen, The Christie NHS Foundation Trust |
| NCT03946527 | Phase 2 | May 31, 2019 | Columbia University, Ipsen |
| NCT03439709 | Phase 3 | Mar 1, 2018 | Sungkyunkwan University |
| NCT03174353 | Phase 2 | Oct 1, 2017 | University of Washington |
| NCT03289741 | Phase 4 | Sep 19, 2017 | Memorial Sloan-Kettering Cancer Center |
| NCT03043664 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2017 | Duke University, Ipsen, Merck |
| NCT02859064 | Phase 2 | Jun 1, 2017 | Ipsen, SCRI Development Innovations |
| NCT03083210 | Phase 4 | Dec 1, 2016 | Sungkyunkwan University |
| NCT03012594 | Phase 2 | Nov 1, 2016 | Ipsen, Northwell Health |
| NCT02698410 | Phase 2 | Jul 1, 2016 | Ipsen |
| NCT02736448 | Phase 2 | May 1, 2016 | Istituto Nazionale per lo Studio e la Cura dei Tumori |
| NCT02823691 | Early Phase 1 (Phase 1) | Apr 1, 2016 | National Cancer Institute, Milan, University of Milan |
Organizations
Research & Development (66)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Ipsen | For profit | 46 | 32 | 3 | 2000 |
| Katholieke Universiteit Leuven | Academic/Hospital | 4 | 2 | 2 | 2007 |
| Radboud University | Academic/Hospital | 4 | 3 | 2 | 2007 |
| Ghent University | Academic/Hospital | 2 | 2 | 2 | 2009 |
| Sungkyunkwan University | Academic/Hospital | 2 | 2 | 2 | 2016 |
| University of Milan | Academic/Hospital | 2 | 1 | 2 | 2016 |
| University of Naples Frederico II | Academic/Hospital | 2 | 2 | 2 | 2003 |
| University of Paris | Academic/Hospital | 2 | 1 | 2 | 2014 |
| Aix-University of Marseille | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Annecy Interregional Hospital | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Azienda Ospedaliera D Cotugno Hospital of Infectious Diseases | Academic/Hospital | 1 | 0 | 1 | 2007 |
| Camurus AB | For profit | 1 | 1 | 1 | 2021 |
| Cedars-Sinai Medical Center | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Changhua Christian Hospital | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Chiasma, Inc. | For profit | 1 | 1 | 1 | 2016 |
| China Medical University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Debiopharm | For profit | 1 | 1 | 1 | 2022 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Erasmus University Rotterdam | Academic/Hospital | 1 | 0 | 1 | 2012 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Cipla | For profit | NDA2 | Dec 17, 2021 |
| Invagen Pharms | For profit | MKTG | Dec 17, 2021 |
| Ipsen | For profit | NDA | Aug 30, 2007 |