Lanreotide
Somatuline Depot (US), Somatuline Autogel (EU/UK/AU), Somatuline LA (older formulation), BIM 23014, lanreotide acetate; generic lanreotide injection (Cipla 2021, Amneal 2026)
1What it is
Lanreotide is the second somatostatin analogue to reach the clinic, developed by Ipsen in the late 1980s as an alternative to octreotide (profile 124). It targets the same two receptors and does the same job. Its distinguishing feature is its formulation: lanreotide acetate at very high concentration in water spontaneously forms a gel of nanotubes (the "Autogel" / "Depot"), which releases drug steadily for a month or more after a single deep injection, with no microspheres or mixing step. Patients or carers can be trained to self-inject it, unlike octreotide LAR.
It is approved for acromegaly, for slowing the growth of gastroenteropancreatic neuroendocrine tumours (GEP-NETs), and for carcinoid syndrome symptoms. The CLARINET trial made it the first somatostatin analogue with a placebo-controlled progression-free survival benefit across pancreatic and midgut NETs.
2How it's thought to work
Identical in principle to octreotide: high affinity for SSTR2, moderate for SSTR5, little for SSTR1/3/4. Receptor activation suppresses GH release from pituitary tumours (and so IGF-1), suppresses secretion of serotonin and other peptides from neuroendocrine tumours, and exerts direct anti-proliferative effects (cell-cycle arrest, apoptosis) plus indirect effects via lowered IGF-1 and reduced tumour blood supply. The gel formulation gives flatter, more stable drug levels than daily injections.
3What the research shows
Anti-proliferative effect in GEP-NETs
Acromegaly
Carcinoid syndrome
Polycystic liver and kidney disease
Thyroid-eye disease, hyperinsulinism, dumping syndrome
4Reported side effects and interactions
Literature-reported
gastrointestinal effects (diarrhoea 26–65%, abdominal pain, flatulence, nausea, loose fatty stools), gallstones and biliary sludge (~20–25% develop stones over years, mostly asymptomatic; acute cholecystitis and cholangitis reported, including after stopping), injection-site nodules and pain (deep injection into the buttock), hyperglycaemia or hypoglycaemia, bradycardia, hypothyroidism, vitamin B12 reduction, fatigue, headache. Pancreatitis is rare. Antibodies are uncommon.Community-reported
none documented.Theoretical. as for octreotide — chronic GH/IGF-1 suppression in a healthy person has no benefit and plausible harm.
Interactions. cyclosporine (reduced absorption), bromocriptine (increased bioavailability), insulin and oral antidiabetics (dose adjustments), beta-blockers and other bradycardic drugs, slowed absorption of oral medicines; possible reduced clearance of CYP3A4 substrates.
Markers researchers commonly monitor
| Marker | Why it's watched |
|---|---|
| IGF-1 and GH | targets in acromegaly, checked before each dose adjustment (typically every 3 months initially). |
| Fasting glucose and HbA1c | bidirectional glucose effects. |
| TSH and free T4 | hypothyroidism risk with chronic use. |
| Gallbladder ultrasound | baseline and every 6–12 months, or if biliary symptoms. |
| Heart rate and ECG | bradycardia, especially with beta-blockers. |
| Vitamin B12 | periodically on long-term therapy. |
| Chromogranin A, 5-HIAA and cross-sectional imaging | tumour tracking in NET patients. |
| Liver enzymes and lipase | if abdominal pain, to catch biliary or pancreatic complications. |
Free for everyone. Safety information is never behind a paywall.
5Reconstitution and handling
Supplied as a ready-to-inject supersaturated gel in a pre-filled syringe (60, 90, 120 mg in 0.2–0.5 mL) with a safety needle. No . Given by deep injection into the upper outer buttock (not the abdomen), alternating sides; the plunger is pressed slowly over about 20 seconds because the gel is viscous. The calculator is not applicable.
6Commonly studied alongside
Octreotide (profile 124) and pasireotide (profile 126); telotristat ethyl (carcinoid syndrome diarrhoea); lutetium-177 DOTATATE and everolimus (NETs, often continued with lanreotide); pegvisomant and cabergoline (acromegaly). Short-acting octreotide is used as rescue for breakthrough symptoms.
Informational cross-links. Not stack recommendations.
7Regulatory status by region
| Region | Status (checked —) |
|---|---|
| United States | FDA-approved Somatuline Depot: acromegaly (2007), GEP-NETs (Dec 2014), carcinoid syndrome (2017). Generic lanreotide injection approved for Cipla (Dec 2021) and Amneal (Sept 2026) |
| European Union | Nationally authorised (Somatuline Autogel) for acromegaly, GEP-NET anti-proliferative treatment and carcinoid syndrome symptoms |
| United Kingdom | MHRA-licensed; prescription-only; NICE-supported for NETs |
| Australia | TGA-registered; PBS-listed for acromegaly and functional/non-functional GEP-NETs |
| South Africa | SAHPRA-registered; prescription-only † |
| Sport | Not on the WADA Prohibited List |
8Open questions
- Whether somatostatin analogues improve overall survival in NETs (CLARINET showed progression-free, not overall, survival benefit).
- Head-to-head equivalence with octreotide LAR in acromegaly has only been shown in small or retrospective studies.
- Benefit in NETs with Ki-67 >10% and in above-label doses (CLARINET FORTE tested 120 mg every 14 days).
9References
- 1Caplin ME et al. (2014). Lanreotide in metastatic enteropancreatic neuroendocrine tumors (CLARINET). NEJM. PubMed · DOI
- 2Caplin ME et al. (2016). Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study. Endocr Relat Cancer. PubMed
- 3Caron PJ et al. (2014). Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial (PRIMARYS). J Clin Endocrinol Metab. PubMed · DOI
- 4Neggers SJ et al. (2015). Lanreotide Autogel 120 mg at extended dosing intervals in patients with acromegaly biochemically controlled with octreotide LAR or lanreotide Autogel (LEAD). J Clin Endocrinol Metab. PubMed · DOI
- 5Vinik AI et al. (2016). ELECT: a phase 3 study of efficacy and safety of lanreotide depot/autogel in carcinoid syndrome. Endocr Pract. PubMed
- 6Meijer E et al. (2018). Effect of lanreotide on kidney function in patients with autosomal dominant polycystic kidney disease (DIPAK-1). JAMA. PubMed · DOI
- 7Ipsen. Somatuline Depot (lanreotide) injection prescribing information (current label). PubMed
References are being resolved to PubMed/DOI identifiers; links search PubMed for the citation until then.
† Being confirmed by our reviewers against current sources.
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Self-reported side effects Phase 2
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