Drugs / Lanreotide
Lanreotide
also known as
Lanreotide Autogel · Lanreotide (acetate) · Somatuline Autogel · Autogel · LAN · Somatuline ATG · Somatuline Depot · ATG · +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 64 · 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 | ||||||
| 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 |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| 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 322 trials | ||||||
| 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 |
| 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 | No outcome recorded |
| Phase 3 | NCT02127437 | Sep 2014 → Jul 2019 | autosomal dominant polycystic kidney disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT01616927 | Jun 2012 → Aug 2017 | autosomal dominant polycystic kidney disease | University Medical Center Groningen | Unknown | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00353496 | Jun 2006 → Apr 2013 | digestive system neuroendocrine neoplasm | Ipsen | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT03289741 | Sep 2017 → Apr 2023 | neuroendocrine neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 4 | NCT01861717 | May 2013 → Jan 2016 | acromegaly | Saint John's Cancer Institute | Terminated | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05364944 Background | May 2022 → Oct 2024 | acromegaly, digestive system neuroendocrine neoplasm | Debiopharm International SA | Terminated | No outcome recorded |
| Phase 24 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 36 trials | ||||||
| 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. | 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 | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05701241 Comparator | Jun 2023 → Apr 2029 expected | digestive system neuroendocrine neoplasm | University Hospital, Antwerp | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01538966 Comparator | Mar 2012 → May 2022 | acromegaly | Cedars-Sinai Medical Center | Terminated | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-03-16 | Ipsen | Ipsen announces investment in new state-of-the-art electronic autoinjector for Somatuline® Autogel® / Somatuline® Depot (lanreotide) designed to improve patient experience ipsen.com ↗ |
| 2022-03-08 | Ipsen | New patient-reported data demonstrated high satisfaction levels and fewer patients reporting injection-site pain with Somatuline® Autogel®/Somatuline® Depot (lanreotide) ipsen.com ↗ |
| 2021-02-22 | Ipsen | 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 ↗ |
| 2020-09-18 | Ipsen | 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 ↗ |
| 2019-03-06 | Ipsen | Ipsen to Present Improvements to Somatuline® Autogel® Pre-filled Syringe at the 16th European Neuroendocrine Tumor Society (ENETS) Annual Conference ipsen.com ↗ |
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 ↗74“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 “Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate).” NCT02493517 ↗ “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 “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 “Lanreotide autogel (LAN) and temozolomide (TMZ) are” PMID 36044870 ↗ Aug 2022 “Lanreotide Autogel 90 mg and 120 mg” NCT01315795 ↗ “Somatuline (Lanreotide Autogel®)” NCT00543179 ↗ “Drug: Lanreotide autogel” NCT01070758 ↗ |
| 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 ↗ |