Lanreotide Acetate

(Lanreotide)

ApprovedPeptide

Lanreotide Acetate is a peptide that works as a Somatostatin Receptor 2 Agonist; Somatostatin Receptor 5 Agonist.[2] It is being used across 19 indications, with its most advanced program in Approved.[1]

Lanreotide Acetate is one of 129 small molecule programs targeting Merkel cell skin cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

128

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Merkel Cell Skin CancerApproved

ParagangliomaActive, not recruiting

Pancreatic Neuroendocrine TumorTerminated

Adrenal Gland PheochromocytomaApproved

Pituitary Gland AdenomaApproved

Graves OphthalmopathyApproved

Endocrine NeoplasmApproved

Peptic EsophagitisApproved

Digestive System Neuroendocrine NeoplasmApproved

Intestinal ObstructionApproved

Merkel Cell Skin CancerApproved

Approved

ParagangliomaPhase 2

Active, not recruiting

Pancreatic Neuroendocrine TumorPhase 3

Terminated

Adrenal Gland PheochromocytomaApproved

Approved

Pituitary Gland AdenomaApproved

Approved

Graves OphthalmopathyApproved

Approved

Endocrine NeoplasmApproved

Approved

Peptic EsophagitisApproved

Approved

Digestive System Neuroendocrine NeoplasmApproved

Approved

Intestinal ObstructionApproved

Approved

Showing 10 of 18 indications

Competition

Competitive Landscape

251 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Lanreotide Acetate

AAlbireo, an Ipsen Company

Approved

37 2

Sovaldi

Gilead

Preclinical

1 3

Cysteine Hydrochloride

Novartis

Preclinical

1 4

Viread

Gilead

Preclinical

1 5

Coreg

Akero Therapeutics

Preclinical

2 6

Doptelet

AAkarx

Preclinical

1 7

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Preclinical

1 8

Vermox

WWim Janssens

Preclinical

1 9

Statin

Bristol-Myers Squibb

Preclinical

1 10

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Pancreatic Neuroendocrine Tumor

NCT05048901

Q1 2027

Phase 2Active, not recruiting

Paraganglioma

NCT03946527

Q4 2027

Phase 3Recruiting

Complication

NCT06807437

Q4 2030

Phase 3Active, not recruiting

GEP-NET

NCT05477576

Clinical

Trials by Indication[1]

Acromegaly5 trials

Acromegaly Combination Treatment Study

Terminated·—·N/A·NCT01538966·76 enrolled

Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

Withdrawn· Ipsen logo

Ipsen·Phase 2·NCT00517491

Somatuline Autogel: Acromegaly Self/Partner Injection Study

Completed· Ipsen logo

Ipsen·Phase 4·NCT00149188·30 enrolled

Show 2 more trials

Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Completed· Ipsen logo

Ipsen·Phase 2/3·NCT00234572·108 enrolled

Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

Completed· Ipsen logo

Ipsen·Phase 4·NCT00216398·8 enrolled

Treatment3 trials

Lanreotide as Treatment of Polycystic Livers

Completed·RRadboud University Medical Center·Phase 2/3·NCT00565097·38 enrolled

Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)

Completed·RRadboud University Medical Center··NCT01354405·43 enrolled

Lanreotide in the Treatment of Small Bowel Motility Disorders

Completed·NNorthwell Health·Phase 2·NCT03012594·12 enrolled

Pancreatic Neuroendocrine Tumor3 trials

Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors

Completed·—·Phase 1/2·NCT03043664·22 enrolled

Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors

Recruiting·NNational Health Research Institutes, Taiwan·Phase 1/2·NCT05048901·49 enrolled

A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)

Terminated·FFederation Francophone de Cancerologie Digestive·Phase 2/3·NCT02288377·53 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours

Terminated· Ipsen logo

Ipsen·Phase 3·NCT02683941·77 enrolled

Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

Completed· Ipsen logo

Ipsen·Phase 3·NCT00210457·63 enrolled

Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours

Completed· Ipsen logo

Ipsen·Phase 2·NCT00326469·30 enrolled

Polycystic Kidney Disease2 trials

Lanreotide In Polycystic Kidney Disease Study

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02127437·159 enrolled

Study of Lanreotide to Treat Polycystic Kidney Disease

Unknown status·UUniversity Medical Center Groningen·Phase 3·NCT01616927·300 enrolled

18 more indications

Trial2 trials

Open-Label Extension of LOCKCYST Trial

Unknown status·RRadboud University Medical Center·Phase 2/3·NCT00771888·54 enrolled

A Trial Aiming to Assess the Safety and Activity of the Combination of Cabozantinib Plus Lanreotide in GEP and NET

Unknown status·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 2·NCT04427787·69 enrolled

Carcinoid Syndrome2 trials

An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome

Completed· Ipsen logo

Ipsen·Phase 3·NCT00774930·115 enrolled

Lanreotide Combined With Telotristat Ethyl or Placebo for the First-line Treatment in Patients With Advanced Well Differentiated Small Intestinal Neuroendocrine Tumours (siNET) With Highly-functioning Carcinoid Syndrome

Withdrawn·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT04065165

Pancreatic2 trials

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

Completed· Ipsen logo

Ipsen·Phase 3·NCT00353496·264 enrolled

Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour

Completed· Ipsen logo

Ipsen·Phase 3·NCT00842348·89 enrolled

Paraganglioma1 trial

LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)

Active, not recruiting·AAntonio Fojo·Phase 2·NCT03946527·10 enrolled

Complication1 trial

Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula

Recruiting·SSWOG Cancer Research Network·Phase 3·NCT06807437·274 enrolled

Neuroendocrine Tumors1 trial

Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres

Terminated·SSCRI Development Innovations, LLC·Phase 2·NCT02859064·6 enrolled

Merkel Cell Carcinoma1 trial

Treatment of Unresecable and/or Metastatic Merkel Cell Carcinoma by Somatostatine Analogues

Completed·UUniversity Hospital, Grenoble·Phase 2·NCT02351128·35 enrolled

Circulating Tumor Cells1 trial

Circulating Tumor Cells and Tumor DNA in HCC and NET

Completed·UUniversity of Aarhus··NCT02973204·167 enrolled

Carcinoid Tumor1 trial

A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors

Unknown status·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2·NCT01731925·44 enrolled

Metastatic1 trial

Study of Lanreotide in Metastatic or Recurrent Grade I-II Hindgut NET

Unknown status·SSamsung Medical Center·Phase 4·NCT03083210·28 enrolled

Peritoneal Carcinomatosis1 trial

Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis

Completed· Ipsen logo

Ipsen·Phase 3·NCT00216372·80 enrolled

Combination Therapy1 trial

Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

Completed· Ipsen logo

Ipsen·Phase 3·NCT00383708·125 enrolled

Quality of Life1 trial

Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

Terminated· Ipsen logo

Ipsen·Phase 2·NCT02365584·43 enrolled

Diarrhea1 trial

Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Completed· Ipsen logo

Ipsen·Phase 2/3·NCT00891371·42 enrolled

Pilot Study1 trial

A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.

Terminated·SSaint John's Cancer Institute·Phase 4·NCT01861717·4 enrolled

Reflux1 trial

Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 2·NCT02054637·10 enrolled

GEP-NET1 trial

Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy

Active, not recruiting·RRayzeBio, Inc.·Phase 3·NCT05477576·343 enrolled

Unspecified1 trial

Somatuline Autogel Preference and Health Economy Study

Completed· Ipsen logo

Ipsen·Phase 4·NCT00681187·26 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 30, 2007

SOMATULINE DEPOT

NDA NDA022074

Dec 17, 2021

LANREOTIDE ACETATE

NDA NDA215395

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for Lanreotide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lanreotide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lanreotide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215395). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Albireo, an Ipsen Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Somatostatin Receptor 2 Agonist; Somatostatin Receptor 5 Agonist[2]
Modality: Peptide[2]
Highest Phase: Approved[1]
Company: AAlbireo, an Ipsen Company

Lanreotide Acetate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q4 2030

Trials by Indication[1]

Acromegaly5 trials

Treatment3 trials

Pancreatic Neuroendocrine Tumor3 trials

Efficacy and Safety3 trials

Polycystic Kidney Disease2 trials

Trial2 trials

Carcinoid Syndrome2 trials

Pancreatic2 trials

Paraganglioma1 trial

Complication1 trial

Neuroendocrine Tumors1 trial

Merkel Cell Carcinoma1 trial

Circulating Tumor Cells1 trial

Carcinoid Tumor1 trial

Metastatic1 trial

Peritoneal Carcinomatosis1 trial

Combination Therapy1 trial

Quality of Life1 trial

Diarrhea1 trial

Pilot Study1 trial

Reflux1 trial

GEP-NET1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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