Drugs / Lanreotide
Lanreotide
also known as
lanreotide Autogel · lanreotide acetate · Somatuline Autogel · Autogel · LAN · Somatuline Depot · ATG · ATG120 · +8 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LANREOTIDE ACETATE | — | 2024-09-16 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | SOMATULINE DEPOT | — | 2011-03-04 – 2017-09-15 | fda.gov ↗ |
| Approved | US (FDA) | SOMATULINE DEPOT | — | 2007-08-30 | fda.gov ↗ |
Trials 65 · started per year
today
US approved 2007
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02823691 | Apr 2016 → Dec 2021 | neuroendocrine neoplasm | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Unknown | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05048901 | Sep 2021 → Aug 2027 expected | digestive system neuroendocrine neoplasm | National Health Research Institutes, Taiwan | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03043664 | Jul 2017 → May 2021 | digestive system neuroendocrine neoplasm | Duke University | Completed | No outcome recorded |
| Phase 1/2 | NCT02396953 | Mar 2015 → Nov 2017 | acromegaly | Ipsen | Completed | No outcome recorded |
| Phase 218 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT04427787 | Jun 2020 → Nov 2023 | neuroendocrine neoplasm | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Unknown | No outcome recorded |
| Phase 2 | NCT03946527 | Jun 2019 → Mar 2027 expected | paraganglioma, pheochromocytoma | Antonio Fojo | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03174353 | Feb 2018 → Feb 2021 | hyperglycemia, pancreas disorder | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT02859064 | Jul 2017 → May 2022 | carcinoid tumor, digestive system neoplasm | SCRI Development Innovations, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03012594 | May 2017 → Oct 2018 | intestinal motility disease | Northwell Health | Completed | No outcome recorded |
| Phase 2 | NCT02698410 | Jul 2016 → Feb 2019 | neuroendocrine neoplasm | Ipsen | Completed | No outcome recorded |
| Phase 2 | NCT02651987 | Dec 2015 → Oct 2019 | pancreatic neuroendocrine tumor, small intestine neuroendocrine tumor, well differentiated, low or intermediate grade | Ipsen | Completed | No outcome recorded |
| Phase 2 | NCT02351128 | Apr 2015 → May 2017 | cutaneous neuroendocrine carcinoma | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 2 | NCT02365584 | Jan 2015 → Jan 2018 | intestinal obstruction | Ipsen | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT02275338 | Nov 2014 → Nov 2017 | intestinal obstruction | Ipsen | Completed | No outcome recorded |
| Phase 2 | NCT02231762 | Oct 2014 → Dec 2016 | digestive system neuroendocrine neoplasm | Ipsen | Completed | No outcome recorded |
| Phase 2 | NCT02054637 | Apr 2014 → Dec 2015 | peptic esophagitis | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 2 | NCT01076803 | Oct 2009 → Jul 2013 | intestinal obstruction | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 2 | NCT00517491 | May → Dec 2008 | acromegaly | Ipsen | Withdrawn | No outcome recorded |
| Phase 2 | NCT01923649 | Apr 2008 → Dec 2013 | dumping syndrome | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 2 | NCT00326469 | May 2006 → Nov 2009 | neuroendocrine neoplasm | Ipsen | Completed | No outcome recorded |
| Phase 2 | NCT00288522 | Jan 2006 → Apr 2007 | disease of orbital part of eye adnexa | Ipsen | Terminated | No outcome recorded |
| Phase 2 | NCT00993356 | Jan 2004 → Dec 2009 | acromegaly | Shanghai Jiao Tong University School of Medicine | Unknown | Met primary |
| Phase 2/37 trials | ||||||
| Phase 2/3 | NCT02288377 | Jan 2015 → Jan 2020 | digestive system neuroendocrine tumor, grade 1/2 | Federation Francophone de Cancerologie Digestive | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT01315795 | Mar 2011 → Jul 2014 | liver disorder | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 2/3 | NCT00891371 | Jul 2009 → Aug 2012 | diarrheal disease | Ipsen | Completed | No outcome recorded |
| Phase 2/3 | NCT00771888 | Apr → Oct 2008 | liver disorder, polycystic kidney disease | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 2/3 | NCT00565097 | Oct 2007 → ? | autosomal dominant polycystic kidney disease, autosomal dominant polycystic liver disease | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2/3 | NCT00495846 | Apr 2007 → Apr 2008 | hepatocellular carcinoma | Federico II University | Completed | No outcome recorded |
| Phase 2/3 | NCT00234572 | May 2000 → Jan 2003 | acromegaly | Ipsen | Completed | No outcome recorded |
| Phase 323 trials · 4 met primary · 3 missed | ||||||
| Phase 3 | NCT07842172 | Nov 2026 → Nov 2034 expected | digestive system neuroendocrine neoplasm | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06807437 | May 2025 → Nov 2027 expected | malignant pancreatic neoplasm | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 3 | NCT04852679 | May 2021 → Jun 2022 | digestive system neuroendocrine tumor, grade 1/2 | Ipsen | Completed | No outcome recorded |
| Phase 3 | NCT02683941 | Mar 2017 → Feb 2020 | lung neuroendocrine neoplasm | Ipsen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02354768 | Oct 2015 → Dec 2017 | — | University Hospital, Strasbourg, France | Terminated | No outcome recorded |
| Phase 3 | NCT02493517 | Oct 2014 → Nov 2016 | acromegaly | Ipsen | Completed | Met primary |
| Phase 3 | NCT02127437 | Sep 2014 → Jul 2019 | autosomal dominant polycystic kidney disease | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 3 | NCT01616927 | Jun 2012 → Aug 2017 | autosomal dominant polycystic kidney disease | University Medical Center Groningen | Unknown | Missed primary |
| Phase 3 | NCT01372007 | Jul 2011 → Dec 2014 | rectal carcinoma | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 3 | NCT01313273 | Jun 2011 → Jun 2013 | prostate cancer | Ipsen | Terminated | No outcome recorded |
| Phase 3 | NCT00774930 | May 2009 → May 2013 | carcinoid syndrome | Ipsen | Completed | Met primary |
| Phase 3 | NCT00842348 | Feb 2009 → Dec 2015 | digestive system neuroendocrine tumor, grade 1/2 | Ipsen | Completed | No outcome recorded |
| Phase 3 | NCT00690898 | May 2008 → Feb 2012 | acromegaly | Ipsen | Completed | Missed primary |
| Phase 3 | NCT00630695 | Mar 2008 → Jun 2011 | lymphocele | University Hospital, Limoges | Completed | No outcome recorded |
| Phase 3 | NCT00447499 | Apr 2007 → Dec 2008 | acromegaly | Ipsen | Completed | No outcome recorded |
| Phase 3 | NCT00383708 | Oct 2006 → Oct 2008 | acromegaly | Ipsen | Completed | Mixed |
| Phase 3 | NCT00353496 | Jun 2006 → Apr 2013 | digestive system neuroendocrine neoplasm | Ipsen | Completed | Met primary |
| Phase 3 | NCT00444873 | Jan 2005 → Jan 2008 | acromegaly | Ipsen | Completed | No outcome recorded |
| Phase 3 | NCT00092287 | Jul → Oct 2004 | carcinoid syndrome | Ipsen | Terminated | No outcome recorded |
| Phase 3 | NCT00216372 | Sep 2003 → Oct 2008 | carcinoma, intestinal obstruction, peritoneal neoplasm | Ipsen | Completed | No outcome recorded |
| Phase 3 | NCT00499993 | Jan 2001 → May 2003 | acromegaly | Ipsen | Completed | No outcome recorded |
| Phase 3 | NCT00210457 | Sep 2000 → Jul 2002 | acromegaly | Ipsen | Completed | No outcome recorded |
| Phase 3 | NCT00729313 | Apr 2000 → Apr 2005 | intestinal fistula | Ipsen | Completed | Met primary |
| Phase 412 trials · 2 missed | ||||||
| Phase 4 | NCT03289741 | Sep 2017 → Apr 2023 | neuroendocrine neoplasm | Memorial Sloan Kettering Cancer Center | Completed | Missed primary |
| Phase 4 | NCT03083210 | Jul 2017 → Feb 2020 | neuroendocrine neoplasm | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02075606 | May 2014 → Jun 2017 | neuroendocrine neoplasm | Ipsen | Completed | Missed primary |
| Phase 4 | NCT01861717 | May 2013 → Jan 2016 | acromegaly | Saint John's Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01070758 | Feb 2010 → Feb 2015 | congenital isolated hyperinsulinism | Sheba Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00701363 | Oct 2008 → Mar 2013 | acromegaly | Ipsen | Completed | No outcome recorded |
| Phase 4 | NCT00681187 | Jun 2008 → Aug 2010 | carcinoid syndrome | Ipsen | Completed | No outcome recorded |
| Phase 4 | NCT00543179 | Oct 2007 → ? | dumping syndrome | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00216398 | Jun 2004 → Jun 2006 | acromegaly | Ipsen | Completed | No outcome recorded |
| Phase 4 | NCT00149188 | Feb 2004 → Aug 2005 | acromegaly | Ipsen | Completed | No outcome recorded |
| Phase 4 | NCT00627796 | Jan 2003 → Dec 2007 | acromegaly | Federico II University | Completed | No outcome recorded |
| Phase 4 | NCT00145405 | Sep 2002 → Dec 2004 | acromegaly | Odense University Hospital | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00652379 | Jun 2008 → Nov 2009 | acromegaly, glucose intolerance | University of Aarhus | Completed | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 2 | NCT03967249 Background | Jul 2019 → Mar 2022 | acromegaly | Ionis Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02795858 Background | Jun 2016 → Dec 2022 | carcinoid tumor | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02736448 Background | May 2016 → Aug 2019 | digestive system neuroendocrine neoplasm | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Terminated | No outcome recorded |
| Phase 2 | NCT01731925 Background | Jan 2013 → Dec 2017 | carcinoid tumor | GERCOR - Multidisciplinary Oncology Cooperative Group | Unknown | No outcome recorded |
| Phase 3 | NCT06878664 Background | Jun 2025 → Jan 2029 expected | intestinal neuroendocrine neoplasm | Spanish Group for Research in Neuroendocrine Tumors | Recruiting | No outcome recorded |
| Phase 3 | NCT05477576 Comparator | Mar 2022 → Dec 2026 expected | carcinoid tumor, pancreatic neuroendocrine tumor | RayzeBio, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05050942 Comparator | Oct 2021 → Jul 2026 overdue | digestive system neuroendocrine neoplasm | Camurus AB | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04065165 Background | Apr 2020 → Jul 2023 | carcinoid heart disease, small intestine neuroendocrine neoplasm | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 3 | NCT03439709 Background | Mar 2018 → Jun 2022 | growth hormone-producing pituitary gland adenoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT01137682 Comparator | Jul 2010 → Jan 2013 | acromegaly | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT05701241 Comparator | Jun 2023 → Apr 2029 expected | digestive system neuroendocrine neoplasm | University Hospital, Antwerp | Recruiting | No outcome recorded |
| — | NCT01538966 Comparator | Mar 2012 → May 2022 | acromegaly | Cedars-Sinai Medical Center | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Impax Laboratories, LLC | Regulatory Amneal Announces FDA Approval and Launch of Lanreotide Injection amneal.com ↗
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its lanreotide injection, 120 mg/0.5 mL, in a sterile, single-dose prefilled syringe. |
| 2025-05-15 | Crinetics Pharmaceuticals Inc. | Results Crinetics to Present New Research on Paltusotine, Atumelnant and Unmet Needs in Acromegaly Treatment at the American Association of Clinical Endocrinology Annual Meeting 2025 crinetics.com ↗
In a three-month daily symptom diary study, patients receiving the long-acting injected depot somatostatin receptor ligands octreotide and lanreotide reported symptom exacerbations on 32% of days. |
| 2023-07-30 | Pharco Pharmaceuticals | Regulatory The Selection and Use of Essential Medicines 2023 pharco.org ↗
The Committee did not recommend the inclusion of lanreotide depot injection either as an individual listing or as a therapeutic alternative to octreotide, because it was not shown to be superior to octreotide, is more expensive, and unlike octreotide, is not yet available as generics. |
| 2022-03-08 | Ipsen | Results New patient-reported data demonstrated high satisfaction levels and fewer patients reporting injection-site pain with Somatuline® Autogel®/Somatuline® Depot (lanreotide) ipsen.com ↗
New data presented at ENETS 2022 showed patients treated with Somatuline® Autogel®/Somatline® Depot (lanreotide) pre-filled syringe reported less frequent injection-site pain lasting more than two days than those treated with octreotide long-acting release syringe |
| 2021-02-22 | Ipsen | Results Ipsen announces new data from the Phase II CLARINET FORTE study which demonstrated preservation of quality of life when increasing dose frequencies of Somatuline® Autogel® (lanreotide) ipsen.com ↗
Latest data from the Phase II CLARINET FORTE study are the subject of an oral presentation showing quality of life is maintained when doubling the dose regimen of lanreotide autogel with no new safety signals |
| 2020-09-18 | Ipsen | Results ESMO 2020: Phase II CLARINET FORTE results show increasing dose frequencies of Somatuline® Autogel® (lanreotide) allows patients with NETs to delay treatment escalation by up to 8.3 months ipsen.com ↗
An extension of progression-free survival (PFS) rates and encouraging disease-control rates (DCR) were recorded in both tumor types, with no new safety signals. |
| 2019-02-28 | Ipsen | Regulatory Ipsen to Present New Data on Enhancement of Patient Care at the 16th European Neuroendocrine Tumor Society (ENETS) Annual Conference ipsen.com ↗
Input from patients and their caregivers, as well as nurses and other healthcare professionals, was used to design a new pre-filled syringe1 that was submitted to the European Union as a type II variation via a work-sharing procedure with HPRA (Ireland) as the reference country. |
All press releases naming this drug 14 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 93 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lanreotide | “Somatostatin analog (octreotide long-acting release (LAR) 30 mg or lanreotide 120 mg) will be given every four weeks for a duration of 18 months.” NCT05701241 ↗75“Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.” NCT03967249 ↗ “long acting octreotide or lanreotide” NCT02736448 ↗ “lanreotide” NCT02795858 ↗ |
| Known as | ATG | “OBJECTIVE: To evaluate efficacy and safety of lanreotide autogel (ATG) 120 mg injections every 4-8 weeks in somatostatin analogue-naïve patients with acromegaly.” PMID 19542735 ↗ Mar 2009 |
| Known as | ATG120 | “Objective: Lanreotide Autogel 120 mg (ATG120; Ipsen S.p.A, Milan, Italy) is a high-dose, sustained-release aqueous gel formulation, supplied in a prefilled syringe and given by...” PMID 17555511 ↗ Jun 2007 |
| Known as | Autogel | “Patients were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide (Autogel [known in the United States as Depot], Ipsen) at a dose of 120 mg” PMID 25014687 ↗ Jul 20142“This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs.” PMID 24053191 ↗ Sep 2013 “Lanreotide Autogel 120 mg by deep subcutaneous route, at the maximal scheduled standard dose of 120 mg/28 days, just for 1 administration.” NCT02365584 ↗ |
| Known as | Depot | “Patients were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide (Autogel [known in the United States as Depot], Ipsen) at a dose of 120 mg” PMID 25014687 ↗ Jul 2014 |
| Known as | Depot in USA | “METHODS: PRIMARYS was a 1-year, open-label study of lanreotide Autogel (Depot in USA) 120 mg every 4 weeks in 90 treatment-naïve patients with acromegaly.” PMID 26603536 ↗ Apr 2016 |
| Known as | L-autogel | “Recently, a new somatostatin analogue with a prolonged release formulation, Lanreotide autogel (L-autogel), has become available.” NCT00543179 ↗ |
| Known as | LAN | “This academic randomised, double-blind, placebo-controlled phase II study aims to evaluate lanreotide autogel 120 mg (LAN) as maintenance treatment after at least 2 months of...” PMID 36087395 ↗ Sep 20222“patients with midgut neuroendocrine tumours (NETs) treated with lanreotide autogel (LAN).” PMID 35132704 ↗ Feb 2022 “Lanreotide autogel (LAN) and temozolomide (TMZ) are” PMID 36044870 ↗ Aug 2022 |
| Known as | Lan-ATG | “Lanreotide Autogel(Lan-ATG)- a long-acting somatostatin analog that can be administered by injection once a month.” NCT01070758 ↗ |
| Known as | Lan-Autogel | “The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel)...” PMID 19639415 ↗ Jul 2009 |
| Known as | lanreotide acetate | “Treatment with the long-acting somatostatin analog lanreotide acetate (Somatuline Autogel), administered by deep sc injection of 30 mg once a month, was started at the ages of...” PMID 21697252 ↗ Jun 2011 |
| Known as | Lanreotide ATG | “Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection” NCT05050942 ↗ |
| Known as | lanreotide Autogel | “This academic randomised, double-blind, placebo-controlled phase II study aims to evaluate lanreotide autogel 120 mg (LAN) as maintenance treatment after at least 2 months of...” PMID 36087395 ↗ Sep 202214“Lanreotide Autogel (LAN) is a new formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be injected intramuscularly or deep subcutaneously...” NCT00145405 ↗ “Lanreotide Autogel is a new long-acting aqueous preparation of lanreotide for the treatment of acromegaly and is administered by deep sc injection from a small volume,...” PMID 11788630 ↗ Jan 2002 “Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial.” PMID 27423779 ↗ Aug 2016 “METHODS: PRIMARYS was a 1-year, open-label study of lanreotide Autogel (Depot in USA) 120 mg every 4 weeks in 90 treatment-naïve patients with acromegaly.” PMID 26603536 ↗ Apr 2016 “OBJECTIVE: To evaluate the efficacy and safety of coadministered lanreotide Autogel (LA; 120 mg/month) and pegvisomant (40-120 mg/week) in acromegaly.” PMID 21148630 ↗ Dec 2010 “Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate).” NCT02493517 ↗ “The introduction of ready-to-use lanreotide Autogel has presented the possibility of patients receiving their acromegaly treatment at home.” PMID 17892497 ↗ Sep 2007 “patients with midgut neuroendocrine tumours (NETs) treated with lanreotide autogel (LAN).” PMID 35132704 ↗ Feb 2022 “Lanreotide Autogel 120 mg subcutaneous (s.c) - injection, every 28 days (+/-2 days).” NCT02231762 ↗ “Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel)” PMID 19542735 ↗ Mar 2009 |
| Known as | Somatuline | “Somatuline (Lanreotide Autogel®)” NCT00543179 ↗ |
| Known as | Somatuline ATG | “Lanreotide Autogel (Somatuline ATG)” NCT00517491 ↗ |
| Known as | Somatuline Autogel | “Somatuline® Autogel is a slow-release formulation that requires only monthly injection and supply high-dose, stable serum levels of lanreotide.” NCT01923649 ↗3“30 mg octreotide long-acting repeatable or 120 mg lanreotide (Somatuline Autogel; Ipsen, UK) as monotherapy for 6 months or longer” PMID 25260838 ↗ Sep 2014 “Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment” NCT00288522 ↗ “Somatuline Autogel (lanreotide acetate)” NCT00447499 ↗ |
| Known as | Somatuline Depot | “It is marketed with a trade name "Somatuline Depot".” NCT03012594 ↗1“Somatuline depot (lanreotide) 90 mg SQ every 3 weeks” NCT03043664 ↗ |
| Action | Inhibit | “Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and insulin growth factor (IGF-1) levels” NCT00690898 ↗ |
| Modality | Other / unclassified | “somatostatin analog lanreotide” PMID 23109694 ↗ Oct 2012 |
| Route | Subcutaneous | “Lanreotide Autogel® (90 and 120 mg) Administered by Deep Subcutaneous Injection Every Four Weeks” NCT00092287 ↗ |