Lanreotide (Somatuline Depot)
Lanreotide acetate ([cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt; BIM 23014)
An FDA-approved long-acting somatostatin analog (brand: Somatuline Depot) indicated for acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome, with Phase 3 RCT evidence of antiproliferative activity (PMID 25014687, CLARINET trial, HR 0.47 for PFS) and reduced rescue-octreotide use in carcinoid syndrome (PMID 27214300).
Last updated: 2026-03-10
Safety Summary
Most common adverse reactions in acromegaly (>5%): diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection site reactions (9%), and dysglycemia (14%) (FDA label). In label-based cardiac safety pooling, sinus bradycardia occurred in 5.5% and bradycardia in 2.8% of acromegaly patients (FDA label). In GEP-NET trials (>10%): abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis (FDA label). In the CLARINET trial, treatment-related diarrhea occurred in 26% of lanreotide vs 9% of placebo patients (PMID 25014687). In the carcinoid syndrome ELECT trial, headache, dizziness, and muscle spasm occurred at >=5% and at least 5% greater than placebo (FDA label, PMID 27214300). In the DIPAK-1 ADPKD trial, injection site discomfort (32%), loose stools (91%), and abdominal discomfort (79%) were notably frequent (PMID 30422235). A gallstone analysis from DIPAK-1 found incident gallstones in 15% of lanreotide-treated patients versus 1% of controls (OR 25.9, 95% CI 3.37-198.8), with 9 of 19 patients developing complications, usually after treatment discontinuation (PMID 33779943). Hepatic cyst infection was observed exclusively in lanreotide-treated ADPKD patients at a rate of 0.23/10 patient-years, particularly in those with prior cyst infection history (PMID 27995519). Switching from lanreotide 30 mg IM to Autogel formulation showed similar or improved GI tolerability (PMID 11788630).
Known Side Effects
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Who Should NOT Use This
Allergic reactions including angioedema and anaphylaxis have been reported (FDA label).
Lanreotide inhibits insulin and glucagon secretion, potentially causing hyperglycemia or hypoglycemia. Blood glucose should be monitored when treatment is initiated or dose is altered, and antidiabetic treatment adjusted accordingly (FDA label, PMID 9056054).
Lanreotide reduces gallbladder motility and leads to gallstone formation. In DIPAK-1 imaging data, incident gallstones formed in 15% of lanreotide-treated patients (OR 25.9 vs controls), with complications occurring even after discontinuation. Monitor periodically with ultrasound. Discontinue if complications are suspected (FDA label, PMID 33779943).
Lanreotide may decrease heart rate. Sinus bradycardia in 5.5% and bradycardia in 2.8% of acromegaly patients in label pooling. Use with caution in patients at risk for cardiac conduction disturbances (FDA label).
Additive effect on heart rate reduction. Dosage adjustment of concomitant drug may be necessary (FDA label).
Starting dose of 60 mg recommended for patients with moderate-severe hepatic impairment in acromegaly (FDA label).
Starting dose of 60 mg recommended for patients with severe renal impairment in acromegaly (FDA label).
Limited human data. Animal studies showed decreased embryo/fetal survival in rats (5x MRHD) and increased fetal abnormalities in rabbits (2x MRHD). Use only if clearly needed (FDA label).
No data on presence in human milk. Lanreotide passes into milk of lactating rats. Advise women not to breastfeed during treatment and for 6 months after last dose (FDA label).
Lanreotide may decrease cyclosporine absorption, necessitating dose adjustment to maintain therapeutic levels (FDA label).
Somatostatin analogs may decrease metabolic clearance of CYP3A4 substrates due to GH suppression. Use caution with narrow therapeutic index drugs (FDA label).
DIPAK-1 interim analysis showed hepatic cyst infections occurred exclusively in lanreotide-treated ADPKD patients, especially those with prior cyst infection history (29% vs 0.7%, P<0.001) (PMID 27995519).
Talk to Your Doctor
Before considering Lanreotide (Somatuline Depot), discuss it with your healthcare provider. Ask about potential interactions with your current medications, whether it is appropriate for your health conditions, and what monitoring may be needed.
Sources: [1-32]
Evidence Assessment
Tier 1: FDA-approved for three indications (acromegaly 2007, GEP-NETs 2014, carcinoid syndrome 2017). Supported by multiple Phase 3 RCTs including a placebo-controlled acromegaly study (n=108, PMID 19639415), the CLARINET trial (n=204, PMID 25014687) for GEP-NETs, the ELECT trial (n=115, PMID 27214300) for carcinoid syndrome, and the PRIMARYS study (n=108, PMID 24423301) for tumor shrinkage. Multiple additional Phase 3 trials (PMID 11788630, n=107; PMID 16918950, n=63; PMID 19542735, n=51), extensive post-marketing surveillance data since 2007, and over 90 registered clinical trials on ClinicalTrials.gov.
1Lanreotide in metastatic enteropancreatic neuroendocrine tumorsNCT00353496PMID 25014687
Caplin ME et al. - The New England Journal of Medicine (2014) - Phase 3 RCT (CLARINET) - N=204 (101 lanreotide, 103 placebo)
Lanreotide 120 mg q28d significantly prolonged PFS vs placebo in non-functioning GEP-NETs (median PFS not reached vs 18.0 months; HR 0.47, 95% CI 0.30-0.73, P<0.001). 24-month PFS: 65.1% vs 33.0%. Most common treatment-related AE: diarrhea (26% vs 9%).
Limitations: 96% of patients had stable disease at baseline (limited progressive disease subset). Industry-funded (Ipsen). No significant OS benefit demonstrated. MANUFACTURER_STUDY.
2Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension studyNCT00353496PMID 26743120
Caplin ME et al. - Endocrine-related cancer (2016) - Open-label extension of Phase 3 RCT - N=88 (41 continued lanreotide, 47 from placebo switched to lanreotide)
Median PFS on lanreotide from core study randomization was 32.8 months (95% CI 30.9-68.0). Median time to further PD after placebo-to-lanreotide switch was 14.0 months (95% CI 10.1-not reached). Favorable long-term safety/tolerability.
Limitations: Open-label extension with potential selection bias. Industry-funded (Ipsen). MANUFACTURER_STUDY.
3Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension studyNCT00353496PMID 33052555
Caplin ME et al. - Endocrine (2021) - Final analysis of open-label extension - N=88
Final CLARINET OLE results confirming long-term safety and continued antitumor benefit of lanreotide autogel 120 mg in indolent and progressive pancreatic/intestinal NETs.
Limitations: Industry-funded (Ipsen). Open-label design. MANUFACTURER_STUDY.
4Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment (ELECT): A Randomized, Double-Blind, Placebo-Controlled TrialNCT00774930PMID 27214300
Vinik AI et al. - Endocrine Practice (2016) - Phase 3 RCT (ELECT) - N=115
Adjusted mean percentage of days with rescue octreotide use was 33.7% with lanreotide versus 48.5% with placebo, an absolute difference of -14.8 percentage points (95% CI -26.8 to -2.8, P=0.017). Odds ratio for full or partial treatment success was 2.4 (95% CI 1.1-5.3).
Limitations: 16-week duration. Primary endpoint was rescue-medication use rather than direct antitumor efficacy. Industry-funded (Ipsen). MANUFACTURER_STUDY.
5A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT TrialNCT00774930PMID 31754316
Blot K et al. - Patient Related Outcome Measures (2019) - Post hoc analysis of Phase 3 RCT - N=115
Lanreotide patients more likely to experience improvement in C30 summary score (RR 2.42, P=0.023) and diarrhea burden (RR 2.85, P=0.005) compared to placebo.
Limitations: Post hoc analysis. Industry-funded (Ipsen). MANUFACTURER_STUDY.
6Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extensionPMID 19639415
Melmed S et al. - Pituitary (2010) - Randomized placebo-controlled trial with open extension - N=108 enrolled; N=99 completed 52 weeks
At week 4, 63% of lanreotide-treated patients had >50% GH reduction versus 0% placebo (P<0.001). By week 52: 82% >50% GH reduction, 54% GH <=2.5 ng/mL, 59% normalized IGF-1, 43% combined criterion. In patients not requiring dose escalation to 120 mg, 85% achieved biochemical control.
Limitations: Initial randomized comparison was short; later phases were open-label or dose-tailored.
7Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in the management of acromegalyPMID 11788630
Caron Ph et al. - The Journal of Clinical Endocrinology and Metabolism (2002) - Phase 3 clinical trial (open-label switch) - N=107
Lanreotide Autogel 60-120 mg q28d at least as efficacious as lanreotide 30 mg IM. GH <2.5 ng/mL in 33% and normalized IGF-1 in 39%. Improved GI tolerability: diarrhea 29% vs 38%, abdominal pain 17% vs 22% compared with lanreotide 30 mg.
Limitations: Open-label, non-randomized switch design. Selected population (previously SSA-responsive). Industry-funded (Ipsen). MANUFACTURER_STUDY.
8Efficacy of lanreotide Autogel administered every 4-8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trialNCT00210457PMID 16918950
Lucas T, Astorga R - Clinical Endocrinology (2006) - Phase 3 clinical trial - N=63
Lanreotide Autogel 60-120 mg every 4-8 weeks maintained GH and IGF-1 control in previously responsive acromegaly patients. Demonstrated feasibility of extended dosing intervals.
Limitations: Selected population (previously responsive). Open-label. Industry-funded. MANUFACTURER_STUDY.
9Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial (PRIMARYS)NCT00690898PMID 24423301
Caron PJ et al. - The Journal of Clinical Endocrinology and Metabolism (2014) - Phase 3 prospective multicenter trial (PRIMARYS) - N=108 (90 evaluated for tumor volume)
62.9% achieved clinically significant tumor volume reduction (>=20%) at week 48 or last value, with 54.1% reaching that threshold by week 12. GH <2.5 ng/mL in 47.3% and normalized IGF-1 in 34.5% at 48 weeks.
Limitations: Single-arm, no comparator. Industry-funded (Ipsen). MANUFACTURER_STUDY.
10Significant tumour shrinkage after 12 months of lanreotide Autogel-120 mg treatment given first-line in acromegalyPMID 19094074
Colao A et al. - Clinical Endocrinology (2009) - Open, prospective - N=26
First-line lanreotide ATG 120 mg controlled GH and IGF-1 in 53.8% and induced >=25% tumor shrinkage in 76.9% (20/26 patients) over 12 months. Mean tumor volume decreased 48.4 +/- 27.6% at 12 months (P<0.0001).
Limitations: Small sample (n=26). Open-label, no comparator.
11Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegalyPMID 19542735
Lombardi G et al. - Journal of Endocrinological Investigation (2009) - Phase 3, open-label, multicenter - N=51
In SSA-naive acromegaly patients, ATG 120 mg normalized GH in 63% and IGF-1 in 37%. GH decreased 80 +/- 17%, IGF-1 44 +/- 27%, ALS 30 +/- 17%. Gallstones developed in 12%. Diarrhea in 76.2%.
Limitations: Open-label, non-comparative. Small sample. Industry-funded. MANUFACTURER_STUDY.
12Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegalyPMID 18248639
Chanson P et al. - Clinical Endocrinology (2008) - Phase 3, open-label, dose-titration - N=130
Titrated dosing of lanreotide Autogel (60-120 mg) over 48 weeks achieved IGF-1 normalization in 43% of patients.
Limitations: Open-label. No placebo comparator. Industry-funded (Ipsen). MANUFACTURER_STUDY.
13Coadministration of lanreotide Autogel and pegvisomant normalizes IGF1 levels and is well tolerated in patients with acromegaly partially controlled by somatostatin analogs alonePMID 21148630
van der Lely AJ et al. - European Journal of Endocrinology (2011) - 28-week, multicenter, open-label, single-arm sequential study - N=92 entered run-in; N=57 entered coadministration
Lanreotide 120 mg/month plus pegvisomant 40-120 mg/week normalized IGF-1 in 57.9% at end of coadministration and 78.9% at any time. Median effective pegvisomant dose was 60 mg/week, suggesting a pegvisomant-sparing effect.
Limitations: Open-label, single-arm. No comparator. Selected population (uncontrolled on SSA alone).
14Efficacy of a slow-release formulation of lanreotide (Autogel 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR)PMID 17555511
Ronchi CL et al. - Clinical Endocrinology (2007) - Phase 3, open-label, multicenter switch study - N=23
Lanreotide ATG 120 mg achieved GH and IGF-1 control comparable to prior octreotide LAR. In ~50% of patients, ATG120 could be administered every 6-8 weeks without loss of efficacy.
Limitations: Small sample (n=23). Open-label, non-randomized. MANUFACTURER_STUDY.
15Efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release in Chinese patients with active acromegaly (LANTERN)NCT02493517PMID 32366244
An Z et al. - BMC Endocrine Disorders (2020) - Phase 3, randomized, open-label, non-inferiority - N=128
Lanreotide autogel was non-inferior to lanreotide 40 mg PR in Chinese patients with acromegaly. 45.5% achieved >=20% tumor volume reduction.
Limitations: Open-label design. Specific to Chinese population. Industry-funded (Ipsen). MANUFACTURER_STUDY.
16Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trialNCT00565097PMID 19646443
van Keimpema L et al. - Gastroenterology (2009) - Phase 2/3 RCT (double-blind, placebo-controlled) - N=54
Mean liver volume decreased 2.9% with lanreotide vs increased 1.6% with placebo over 24 weeks (P<0.01) in polycystic liver disease from ADPKD or PCLD.
Limitations: Small sample. Short duration (6 months). Investigator-driven.
17Effect of Lanreotide on Kidney Function in Patients With Autosomal Dominant Polycystic Kidney Disease: The DIPAK 1 Randomized Clinical TrialNCT01616927PMID 30422235
Meijer E et al. - JAMA (2018) - Phase 3 RCT (open-label with blinded endpoint assessment) - N=309 (153 lanreotide, 152 standard care)
Lanreotide did NOT slow eGFR decline vs standard care (-3.53 vs -3.46 mL/min/1.73m2/year, P=0.81). Did reduce kidney volume growth (4.15% vs 5.56%/year, P=0.02). High rate of GI side effects: loose stools 91%, abdominal discomfort 79%.
Limitations: Open-label. Later-stage ADPKD only (eGFR 30-60). Primary endpoint negative. Investigator-driven.
18Lanreotide Reduces Liver Growth In Patients With Autosomal Dominant Polycystic Liver and Kidney DiseaseNCT01616927PMID 31022403
van Aerts RMM et al. - Gastroenterology (2019) - Sub-analysis of Phase 3 RCT (DIPAK-1) - N=175 (93 lanreotide, 82 standard care)
At 120 weeks, hTLV decreased 1.99% with lanreotide vs increased 3.92% with controls, a 5.91% relative reduction (P<0.001). Effect persisted 4 months after last injection (3.87% reduction, P=0.04).
Limitations: Sub-analysis of a trial with a negative primary kidney endpoint. Open-label. Investigator-driven.
19Hepatic Cyst Infection During Use of the Somatostatin Analog Lanreotide in Autosomal Dominant Polycystic Kidney Disease (DIPAK-1 interim analysis)NCT01616927PMID 27995519
Lantinga MA et al. - Drug Safety (2017) - Interim safety analysis of Phase 3 RCT - N=309; 7 patients developed 8 hepatic cyst infection episodes
Hepatic cyst infection rate: 0.23 per 10 patient-years, exclusively in lanreotide-treated patients (P<0.001). Prior hepatic cyst infection history was a strong risk factor (29% vs 0.7%, P<0.001).
Limitations: Interim analysis. Open-label. Specific to ADPKD population. Investigator-driven.
20Incident Gallstones During Somatostatin Analog Treatment are Associated with Acute Biliary Complications Especially After DiscontinuationNCT01616927PMID 33779943
Aapkes SE et al. - Drugs in R&D (2021) - Randomized-trial safety analysis with imaging data - N=249 with imaging data
New gallstones formed in 19/124 lanreotide-treated patients (15%) vs 1/125 standard care (1%), OR 25.9 (95% CI 3.37-198.8). Gallstones were multiple (>20 stones in 69%) and small (<=3 mm in 63%). 9 of 19 patients developed gallstone-associated complications, 8 after discontinuation (median time 2.5 years).
Limitations: Population had polycystic kidney disease rather than approved lanreotide indications. Investigator-driven.
21Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosisNCT00216372PMID 23109694
Mariani P et al. - Journal of Clinical Oncology (2012) - Phase 3 RCT (double-blind, placebo-controlled) - N=80
Lanreotide did NOT significantly improve treatment success rate in inoperable bowel obstruction from peritoneal carcinomatosis. Negative trial.
Limitations: Negative result. Industry-funded (Ipsen). MANUFACTURER_STUDY.
22Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulaePMID 19953707
Gayral F et al. - Annals of Surgery (2009) - Phase 3 RCT (double-blind, placebo-controlled) - N=65
Lanreotide 30 mg PR did not significantly improve fistula closure rates. Negative trial.
Limitations: Negative trial. Used older lanreotide 30 mg PR formulation, not Autogel.
23Pharmacokinetics of a new Autogel formulation of the somatostatin analogue lanreotide after a single subcutaneous dose in healthy volunteersPMID 15099442
Antonijoan RM et al. - The Journal of Pharmacy and Pharmacology (2004) - Phase 1 pharmacokinetic study - N=24
Lanreotide Autogel produced prolonged-release PK profile. Mean AUC: 53.73 and 79.48 ng/mL-day for 40 and 60 mg. Mean Cmax: 4.38 and 5.71 ng/mL. Mean t1/2: 21.63 and 22.01 days. Linear PK.
Limitations: Healthy volunteers, single dose. Small sample. Industry-funded (Ipsen). MANUFACTURER_STUDY.
24Effects of lanreotide, a somatostatin analogue, on postprandial gastric functions and biliopancreatic secretions in humansPMID 9056054
Lamrani A et al. - British Journal of Clinical Pharmacology (1997) - Crossover study in healthy volunteers - N=8
Lanreotide (IV) significantly decreased gastric acid secretion by 90%, almost completely abolished bile salt and lipase responses to meals, increased duodeno-caecal transit time.
Limitations: Very small sample (n=8). IV administration (not depot). Single-blind.
25Dose-dependent gastrointestinal effects of the somatostatin analog lanreotide in healthy volunteersPMID 10223779
Drewe J et al. - Clinical Pharmacology and Therapeutics (1999) - Placebo-controlled, double-blind crossover studies - N=20
Lanreotide IV raised intragastric pH dose-dependently from 1.4 to 2.5-4.3 (all P<0.002). All doses completely inhibited postprandial gallbladder contraction. No significant gastrin suppression.
Limitations: Healthy volunteers. IV not depot formulation. Short-term.
26Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumorsPMID 30536151
Kang J et al. - Investigational New Drugs (2019) - Retrospective observational - N=38
Lanreotide showed efficacy in Korean GEP-NET patients, supporting CLARINET findings in an Asian population.
Limitations: Retrospective. Small sample. Single-center.
27Multicenter, Observational Study of Lanreotide Autogel for the Treatment of Patients with Neuroendocrine Tumors in Routine Clinical Practice in Germany and AustriaNCT01840449PMID 34293802
Rinke A et al. - Experimental and Clinical Endocrinology and Diabetes (2021) - Non-interventional, observational, 24-month - N=80
Primary endpoint (CgA <50% increase at month 12) achieved by 89.5%. Stable disease (RECIST 1.1): 76.9% at 12 months, 75.0% at 24 months.
Limitations: Observational, no control group. Industry-funded (Ipsen). MANUFACTURER_STUDY.
28A Randomized Trial Evaluating Patient Experience and Preference Between Octreotide Long-Acting Release and Lanreotide for Treatment of Well-Differentiated Neuroendocrine TumorsPMID 35724357
Raj N et al. - JCO Oncology Practice (2022) - Randomized crossover preference trial - N=51
No significant difference in mean pain scores over first three injections (2.4 vs 1.9, P=0.5). Among 19 patients indicating a preference, more trended toward octreotide LAR over lanreotide. 42-47% of patients expressed no drug preference.
Limitations: Small sample. Preference endpoint (subjective). Crossover design.
29Lanreotide vs octreotide LAR for patients with advanced gastroenteropancreatic neuroendocrine tumors: An observational time and motion analysisNCT03017690PMID 30924737
Ryan P et al. - Journal of Oncology Pharmacy Practice (2019) - Observational time-and-motion study - N=44 (22 lanreotide, 22 octreotide LAR)
Lanreotide mean delivery time significantly shorter than octreotide LAR (2.5 vs 6.2 min, P=0.004). Nurses reported more device concerns with octreotide LAR. Lanreotide median satisfaction score 5.0 vs 4.0 for octreotide LAR (P=0.03).
Limitations: Small sample. Observational. Not blinded.
30Rationale and design of the DIPAK 1 studyNCT01616927PMID 24342522
Meijer E et al. - American Journal of Kidney Diseases (2014) - Study design/protocol paper - Planned N=300
Protocol description for DIPAK-1 RCT evaluating lanreotide for ADPKD. Rationale based on somatostatin receptor-mediated inhibition of cAMP-driven cyst growth.
Limitations: Protocol paper only, no results.
31Assessing the safety and activity of cabozantinib combined with lanreotide in gastroenteropancreatic and thoracic neuroendocrine tumors: the LOLA trial protocolNCT04427787PMID 37752423
Corti F et al. - BMC Cancer (2023) - Phase 2 protocol/rationale - Planned N=49
Protocol for LOLA trial evaluating cabozantinib plus lanreotide in NETs.
Limitations: Protocol paper only, no results yet.
32Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours (REMINET)NCT02288377PMID 28292641
Lepage C et al. - Digestive and Liver Disease (2017) - Phase 2/3 RCT protocol (REMINET) - Planned N=222; 25 randomized at publication
Protocol for REMINET trial evaluating lanreotide maintenance after chemotherapy in duodeno-pancreatic NETs.
Limitations: Protocol paper, study terminated early (per ClinicalTrials.gov). Academic study.