Lanreotide
A monthly deep-subcutaneous injection that slows growth hormone release and the growth of neuroendocrine tumours
Lanreotide is a somatostatin analogue given as a deep subcutaneous injection every four weeks. It is approved in the US as Somatuline Depot for acromegaly, for advanced gastroenteropancreatic neuroendocrine tumours and for carcinoid syndrome. Its landmark trial, CLARINET, roughly halved the risk of tumour progression or death.
What is it?
Somatostatin switches off the release of growth hormone and several gut hormones, but it lasts minutes in blood. Lanreotide is a synthetic eight-amino-acid version that lasts weeks: the autogel formulation is injected deep under the skin once every 28 days. The label describes a depot that forms at the injection site and releases the drug by diffusion, with an apparent half-life of 23 to 30 days and serum levels above 1 ng/mL throughout the 28-day interval at 90 and 120 mg; absolute bioavailability is about 70% to 78%.
The label covers three uses: acromegaly that surgery or radiotherapy has not controlled, unresectable well or moderately differentiated gastroenteropancreatic neuroendocrine tumours, where it improves progression-free survival, and carcinoid syndrome, where it reduces the need for short-acting rescue injections. Acromegaly starts at 90 mg every four weeks for three months and is then adjusted to growth hormone and IGF-1; tumours and carcinoid syndrome take 120 mg every four weeks. It is given by a healthcare provider, deep under the skin of the upper outer buttock.
In acromegaly it is used to bring growth hormone and IGF-1 down, and a systematic review of 22 studies found the tumour shrank to some degree in about a third of patients, more often in those given lanreotide first. When lanreotide or octreotide is not enough, the PAOLA trial showed that switching to pasireotide controlled more patients than continuing. Pushing the dose has limits: in a randomised study of higher-dose or more frequent lanreotide in patients still uncontrolled, IGF-1 normalised in 27.6%, about a third, with no difference between the two intensified regimens.
Its other major use came from CLARINET: 204 people with advanced, non-functioning, well or moderately differentiated neuroendocrine tumours of the pancreas or gut took 120 mg of lanreotide or placebo every 28 days for 96 weeks. The risk of progression or death fell by more than half, and at 24 months 65.1% on lanreotide were alive without progression against 33.0% on placebo. In the open-label extension, patients who stayed on lanreotide throughout had a median progression-free survival of 38.5 months and fewer adverse events than during the core study.
When tumours progress on the standard dose, CLARINET FORTE tested giving 120 mg every 14 days instead of every 28. In 99 patients, median progression-free survival was 8.3 months for midgut tumours and 5.6 months for pancreatic tumours, with no treatment-related serious adverse events and no decline in quality of life; it was a single-arm phase 2 study.
One other use is less settled: in a three-year trial in 144 people with polycystic kidney disease, monthly lanreotide did not slow the fall in measured kidney function, gut side effects were commoner and low blood sugar affected 11.1% against 1.4% on placebo. An earlier, larger trial, DIPAK 1, randomised 309 people with polycystic kidney disease and also found no slowing of eGFR decline (-3.53 against -3.46 mL/min/1.73 m² a year), although total kidney volume grew more slowly (4.15% against 5.56% a year). In polycystic liver disease, six months of lanreotide reduced liver volume by 2.9% while it grew 1.6% on placebo.
Its warnings follow from suppressing somatostatin-regulated hormones. The label lists gallstones and their complications, both high and low blood sugar, slowing of the heart rate, reduced thyroid function, and fatty stools from pancreatic insufficiency. It may lower cyclosporine absorption, raise bromocriptine absorption, add to the heart-rate effect of beta-blockers, and slow the clearance of drugs metabolised by liver enzymes, and the label asks for glucose monitoring when treatment starts or the dose changes.
Mechanism of Action
Lanreotide mimics somatostatin, switching off growth hormone and gut hormone release, in a depot that lasts about four weeks.
Somatostatin receptor agonist
Suppresses growth hormone and IGF-1 in acromegaly and hormone release from neuroendocrine tumours.
Slow-release depot
Forms a depot under the skin; apparent half-life 23 to 30 days (label).
Glucose effects
Also inhibits insulin and glucagon, so blood sugar can rise or fall and needs monitoring (label).
Published Research
The studies behind lanreotide, read from their PubMed abstracts: neuroendocrine tumour trials, acromegaly, and polycystic kidney and liver disease.
CLARINET: 204 people with neuroendocrine tumours
120 mg or placebo every 28 days for 96 weeks in advanced, non-functioning tumours of the pancreas or gut. Median progression-free survival was not reached on lanreotide against 18.0 months on placebo (hazard ratio 0.47); at 24 months, 65.1% against 33.0% were progression-free.
CLARINET open-label extension: 89 patients
Everyone received 120 mg every 28 days. Patients on lanreotide in both phases had a median exposure of 59 months and a median progression-free survival of 38.5 months, with fewer adverse events than in the core study.
CLARINET FORTE: every 14 days after progression
In 99 patients with progressive tumours, 120 mg every 14 days gave median progression-free survival of 8.3 months (midgut) and 5.6 months (pancreatic), with no treatment-related serious adverse events.
PAOLA: when lanreotide or octreotide is not enough
198 people with acromegaly inadequately controlled on 120 mg lanreotide or 30 mg octreotide were randomised to switch to pasireotide or continue. At 24 weeks, 15% and 20% of the pasireotide groups reached biochemical control against none of those who continued.
Tumour shrinkage in acromegaly: 22 studies
Across 22 studies measuring adenoma size, 32.8% of patients had some tumour shrinkage on lanreotide, from 10% to 77%. Shrinkage was commoner in patients given lanreotide first than in those already treated by surgery, radiotherapy or other drugs.
High-dose or high-frequency in acromegaly
In uncontrolled acromegaly, IGF-1 fell over 24 weeks and normalised in 27.6%, without a difference between the high-dose and high-frequency regimens; adverse events were mild to moderate.
Polycystic kidney disease: 144 adults, 3 years
Monthly 120 mg or placebo did not slow the fall in measured kidney function: the between-group difference was -0.3 mL/min/1.73 m² a year. Gut side effects were commoner on lanreotide, and low blood sugar affected 11.1% against 1.4%.
DIPAK 1: polycystic kidney disease, 309 patients
Annual eGFR decline was -3.53 on lanreotide and -3.46 on standard care (no difference), while total kidney volume grew more slowly (4.15% against 5.56% a year).
Polycystic liver disease
After six months, liver volume fell 2.9% on lanreotide and rose 1.6% on placebo (P < 0.01).
Dosing Data
Somatuline Depot is injected deep under the skin of the buttock every four weeks by a healthcare provider.
Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
Side Effects & Contraindications
Reported Side Effects
From the trials above and the Somatuline Depot prescribing information (Ipsen; DailyMed set 6e4a41fd, version 16, effective October 11, 2024).
Contraindications & Cautions
From the label.
Legal Status
Lanreotide is approved in the US as Somatuline Depot.
Frequently Asked Questions
?What is lanreotide?
A long-acting somatostatin analogue injected deep under the skin every four weeks, sold as Somatuline Depot.
?What is it approved for?
Acromegaly, advanced gastroenteropancreatic neuroendocrine tumours and carcinoid syndrome.
?How well does it work in neuroendocrine tumours?
In CLARINET it more than halved the risk of progression or death; 65.1% were progression-free at 24 months against 33.0% on placebo.
?Does it help polycystic kidney disease?
No. A three-year trial in 144 adults found no effect on kidney function, with more gut side effects and low blood sugar.
?What dose is used?
90 mg every four weeks for acromegaly for three months, then adjusted; 120 mg every four weeks for neuroendocrine tumours and carcinoid syndrome (label).
?How long does one injection last?
The label gives the depot an apparent half-life of 23 to 30 days, keeping levels above 1 ng/mL through the four-week interval.
?What if tumours progress on the standard dose?
CLARINET FORTE tested 120 mg every 14 days and found median progression-free survival of 8.3 months in midgut and 5.6 months in pancreatic tumours, in a single-arm study.
?Does it interact with other drugs?
Yes: it may lower cyclosporine absorption, raise bromocriptine absorption, add to beta-blockers' slowing of the heart, and require diabetes treatment changes (label).
References
- [fda] FDA. Drugs@FDA (openFDA): SOMATULINE DEPOT (lanreotide acetate) injection, prescription. Read September 30, 2026.
- [pubmed] Caplin ME, et al. "Lanreotide in metastatic enteropancreatic neuroendocrine tumors." N Engl J Med, 2014;371(3):224-33. PMID: 25014687.
- [pubmed] Caplin ME, et al. "Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study." Endocrine, 2021;71(2):502-513. PMID: 33052555.
- [pubmed] Pavel M, et al. "Efficacy and safety of high-dose lanreotide autogel in patients with progressive pancreatic or midgut neuroendocrine tumours: CLARINET FORTE phase 2 study results." Eur J Cancer, 2021;157:403-414. PMID: 34597974.
- [pubmed] Gadelha MR, et al. "Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial." Lancet Diabetes Endocrinol, 2014;2(11):875-84. PMID: 25260838.
- [pubmed] Mazziotti G, et al. "Effects of lanreotide SR and Autogel on tumor mass in patients with acromegaly: a systematic review." Pituitary, 2010;13(1):60-7. PMID: 19189218.
- [pubmed] Giustina A, et al. "High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study." J Clin Endocrinol Metab, 2017;102(7):2454-2464. PMID: 28419317.
- [pubmed] Joly D, et al. "A three-year randomized, double-blind, placebo-controlled study of lanreotide in stage 2/3 autosomal dominant polycystic kidney disease." Kidney Int, 2026;110(4):988-999. PMID: 42320793.
- [pubmed] Meijer E, et al. "Effect of Lanreotide on Kidney Function in Patients With Autosomal Dominant Polycystic Kidney Disease: The DIPAK 1 Randomized Clinical Trial." JAMA, 2018;320(19):2010-2019. PMID: 30422235.
- [pubmed] van Keimpema L, et al. "Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial." Gastroenterology, 2009;137(5):1661-8.e1-2. PMID: 19646443.
- [fda-pi] Somatuline Depot (lanreotide acetate) injection Prescribing Information, sections 1 and 2 (DailyMed version 16, effective October 11, 2024; read September 30, 2026).
Sources & Citations
Studies were read from their PubMed records (October 6, 2026); the label and Drugs@FDA are listed below with their read dates.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.