lanreotide

Trade name: somatuline depot

PeptideapprovedOrphan Drug FDA

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

Phase 1
6
Phase 2
52
Phase 3
35
Phase 4
12

Earliest trial started Apr 1, 2000 (NCT00729313)

Timeline

2000s

  1. Jan 1, 2000

    Ipsen — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2000

    Ipsen — Earliest Phase 3 Sponsor(trial)

  3. Sep 11, 2000

    Orphan Drug Designation

  4. Aug 30, 2007

    Ipsen — Earliest FDA Approval

  5. Aug 30, 2007

    Ipsen — NDA Organization

2010s

  1. Jan 1, 2015

    Ipsen — Earliest Phase 1 Sponsor(trial)

2020s

  1. Dec 17, 2021

    Invagen Pharms — Marketing Organization

  2. Dec 17, 2021

    Cipla — NDA Secondary Org

Indications

Mechanism of action

Approval history

  • approvedAug 30, 2007

Chemistry & pharmacology

Loading structure…

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

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 IDPhaseStart dateSponsor(s)
NCT06807437Phase 3Jun 28, 2025National Cancer Institute (NCI), SWOG Cancer Research Network
NCT06878664Phase 3Jun 12, 2025Grupo Espanol de Tumores Neuroendocrinos (GETNE), Institut Gustave Roussy, Universidad Complutense de Madrid
NCT05364944Phase 1May 18, 2022Debiopharm
NCT05477576Phase 1/Phase 2 (Phase 2)Mar 24, 2022RayzeBio, Inc.
NCT05050942Phase 3Oct 22, 2021Camurus AB, University of Toronto
NCT05048901Phase 1/Phase 2 (Phase 2)Sep 30, 2021Changhua 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
NCT04852679Phase 3May 24, 2021Ipsen
NCT04427787Phase 2Jun 20, 2020University of Milan
NCT04065165Phase 3Apr 30, 2020European Organisation for Research and Treatment of Cancer, Ipsen, The Christie NHS Foundation Trust
NCT03946527Phase 2May 31, 2019Columbia University, Ipsen
NCT03439709Phase 3Mar 1, 2018Sungkyunkwan University
NCT03174353Phase 2Oct 1, 2017University of Washington
NCT03289741Phase 4Sep 19, 2017Memorial Sloan-Kettering Cancer Center
NCT03043664Phase 1/Phase 2 (Phase 2)Jul 1, 2017Duke University, Ipsen, Merck
NCT02859064Phase 2Jun 1, 2017Ipsen, SCRI Development Innovations
NCT03083210Phase 4Dec 1, 2016Sungkyunkwan University
NCT03012594Phase 2Nov 1, 2016Ipsen, Northwell Health
NCT02698410Phase 2Jul 1, 2016Ipsen
NCT02736448Phase 2May 1, 2016Istituto Nazionale per lo Studio e la Cura dei Tumori
NCT02823691Early Phase 1 (Phase 1)Apr 1, 2016National Cancer Institute, Milan, University of Milan
Showing 20 of 74 trials
Page 1 / 4

Organizations

Research & Development (66)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
IpsenFor profit463232000
Katholieke Universiteit LeuvenAcademic/Hospital4222007
Radboud UniversityAcademic/Hospital4322007
Ghent UniversityAcademic/Hospital2222009
Sungkyunkwan UniversityAcademic/Hospital2222016
University of MilanAcademic/Hospital2122016
University of Naples Frederico IIAcademic/Hospital2222003
University of ParisAcademic/Hospital2122014
Aix-University of MarseilleAcademic/Hospital1012015
Annecy Interregional HospitalAcademic/Hospital1012015
Azienda Ospedaliera D Cotugno Hospital of Infectious DiseasesAcademic/Hospital1012007
Camurus ABFor profit1112021
Cedars-Sinai Medical CenterAcademic/Hospital1112012
Changhua Christian HospitalAcademic/Hospital1012021
Chiasma, Inc.For profit1112016
China Medical UniversityAcademic/Hospital1012021
Columbia UniversityAcademic/Hospital1112019
DebiopharmFor profit1112022
Duke UniversityAcademic/Hospital1112017
Erasmus University RotterdamAcademic/Hospital1012012
66 organizations
Page 1 / 4

Marketing (3)

OrganizationOrg typeRelationshipDate
CiplaFor profitNDA2Dec 17, 2021
Invagen PharmsFor profitMKTGDec 17, 2021
IpsenFor profitNDAAug 30, 2007