Lanreotide (Somatuline Depot)_Dosage, benefits & legal status
Also known as Somatuline Depot, Somatuline Autogel, Somatuline, lanreotide acetate, Lanreotide Ipsen
An approved monthly somatostatin shot that lowers growth hormone and slows some gut and pancreatic tumours.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Lanreotide (Somatuline Depot)?
Plain language first. The technical label stays, but it never stands alone.Overview
It shuts down growth hormone in acromegaly and calms hormone-secreting gut tumours, and unlike octreotide in the US it carries a label claim for slowing tumour growth, from the CLARINET trial. It was approved in the US in 2007, and an equivalent generic has been approved since 2024.
Lanreotide is a ring-shaped eight-residue somatostatin analogue, like octreotide, made by Ipsen and sold as Somatuline Depot. Its acetate salt, mixed only with water, forms a depot under the skin with no polymer, so one deep injection lasts four weeks or more.
What it's used for
A monthly prescription depot for acromegaly, gut and pancreatic neuroendocrine tumours, and carcinoid syndrome. It suppresses growth hormone rather than raising it.
How does Lanreotide (Somatuline Depot) work?
What it does in the body, and where.Lanreotide is a ring-shaped eight-residue somatostatin analogue whose acetate salt, mixed only with water, sets into a depot under the skin.
- 01Receptors 2 and 5It binds somatostatin receptors 2 and 5 strongly and receptors 1, 3 and 4 weakly. Receptors 2 and 5 are thought to drive the drop in growth hormone.
- 02Hormones downGrowth hormone falls quickly after an injection and stays down for at least 28 days. Insulin release after meals is also reduced and delayed, and the night-time rise in TSH is blocked.
- 03Slow releaseThere is no polymer: the concentrated solution forms a depot and the drug diffuses out, giving an apparent half-life of 23 to 30 days.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Neuroendocrine tumours
FDA-approved- Human trialCLARINET, 204 patients: median progression-free survival not reached on lanreotide against 16.6 months on placebo (US label); 24-month progression-free survival 65.1% against 33.0% (NEJM).
- Human trialELECT, 115 patients with carcinoid syndrome: rescue octreotide needed on 34% of days against 49%. Diarrhoea and flushing were lower but not significantly.
Acromegaly
FDA-approved- Human trial108 patients: growth hormone fell by more than half in 63% after one injection against none on placebo; median GH fell from 10.3 to 2.4 ng/mL over a year.
- Human trialA 63-patient open-label study: 43% had normal IGF-1 at 48 weeks.
Against octreotide
Clinical use- No dataNo randomised head-to-head trial appears in any US label.
- Human observationA 68-patient post-surgical acromegaly study found biochemical cure in 63.9% on octreotide LAR and 78.1% on lanreotide, not significantly different; a 25-patient switch study found no change in GH or IGF-1.
Cipla's 2021 product is often called the first generic; it was a separate 505(b)(2) application, and the AB-rated generic came in May 2024. The 23 to 30 day half-life comes from single doses in healthy volunteers; the UK label gives about 50 days in tumour patients. CLARINET's placebo median progression-free survival is 16.6 months in the US label and 18.0 months in the NEJM paper. It does not raise growth hormone: it suppresses it, like octreotide. Self-injection after training is allowed in the UK, EU and Canada, not under the US label.
The published record
Papers and trials about Lanreotide (Somatuline Depot)
424 papers tagged human · 243 not reviews or lab · 78 clinical trial publications
118 registered trials · 30 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count. 490 papers and 100 trials indexed in detail.
At a glance
Four things to know about Lanreotide (Somatuline Depot)
Evidence
FDA-approved
Category
Sexual and hormonal
Common vial
Varies
Half-life
23 to 30 days (depot release)
How much, and do you cycle it?
The range, and whether you take breaks.60 to 120 mg every 4 weeks (label), every 4 weeks (6 to 8 weeks for some acromegaly patients). Continuous, set by the prescription FDA label
Injected every 4 weeks long term; well-controlled acromegaly patients can stretch 120 mg to every 6 or 8 weeks.
How long does it stay in the body?
The half-life, and where the figure comes from.23 to 30 days (depot release)FDA label
Single depot doses in healthy volunteers. This is the slow release from the depot; the drug itself lasts about 1.1 hours when given into a vein. In tumour patients the UK label gives an apparent half-life of 49.8 days.
Source: Somatuline Depot prescribing information section 12.3; Lanreotide Ipsen UK SmPC
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How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Lanreotide (Somatuline Depot) keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 38% charged residues, 62% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Allergy to lanreotide, including past angioedema or anaphylaxis (the only label contraindication)
- Gallbladder disease, since gallstones or sludge appear in about one in five long-term users
- Slow heart rate or heart conduction problems, especially alongside beta-blockers
- Breastfeeding, during treatment and for 6 months after the last dose
- Use to suppress growth hormone without a diagnosed condition
Stop and get help
- Severe pain under the right ribs, fever or yellowing skin, possible gallstone complications
- Severe stomach pain spreading to your back, since pancreatitis has been reported
- Fainting, dizziness or a very slow pulse
- Swelling of the face or throat, or trouble breathing
Common effects
- Diarrhoea in 37%, stomach pain in 19% and nausea in 11% of acromegaly patients
- Gallstones or sludge in 20%
- Injection-site reactions in 9 to 15%
- Raised blood sugar in 14% of tumour patients against 5% on placebo
- Heart rate below 60 in 23% against 16% on placebo in the tumour trial
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Lanreotide (Somatuline Depot) approved?
And where the numbers on this page come from.Yes. Lanreotide (Somatuline Depot) is FDA approved and available on prescription in the United States. It is also approved in the European Union and the United Kingdom.
- Approval statusFDA-approved
- RouteDeep under the skin of the buttock (depot)
- Checked12 October 2026
- Approved outside the USEuropean Union, United Kingdom: Authorised nationally in EU countries as Somatuline Autogel (Sweden since 17 December 2002) and in the UK since 16 October 2001, now as Lanreotide Ipsen, for acromegaly, gut and pancreatic neuroendocrine tumours and tumour symptoms. Also approved in the US.This does not change the United States position above.
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesSomatuline Depot prescribing information (revised 7/2024)Somatuline Depot on DailyMedDrugs@FDA, NDA 022074Caplin ME et al., New England Journal of Medicine 2014;371:224-233 (CLARINET)ClinicalTrials.gov, CLARINET posted results (NCT00353496)ClinicalTrials.gov, ELECT posted results (NCT00774930)Drugs@FDA, ANDA 217193 (generic lanreotide)Lanreotide Ipsen UK summary of product characteristicsFDA GSRS codes, lanreotide (UNII 0G3DE8943Y)
What has happened recently
FDA-approved on 30 August 2007 for acromegaly (NDA 022074), with a 120 mg every 6 to 8 weeks option added in 2011, gut and pancreatic neuroendocrine tumours in December 2014 and carcinoid syndrome in September 2017. Cipla's Lanreotide Injection was approved in December 2021 through a separate 505(b)(2) application, and an AB-rated generic (ANDA 217193) was approved on 21 May 2024. In Europe it is authorised nationally as Somatuline Autogel (Sweden since 2002) and in the UK since 2001, now as Lanreotide Ipsen; there, trained patients may inject themselves, while the US label says a healthcare provider gives it.
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What else is like Lanreotide (Somatuline Depot)?
Others in Sexual and hormonal, side by side.If you're weighing Lanreotide (Somatuline Depot), it's worth reading Leuprolide (Lupron), Octreotide (Sandostatin), and PT-142 in the same class.
An approved monthly somatostatin shot that lowers growth hormone and slows some gut and pancreatic tumours.
- Dose
- 60 to 120 mg every 4 weeks (label)
- How often
- Every 4 weeks (6 to 8 weeks for some acromegaly patients)
The GnRH agonist that shuts hormones down by overstimulating them first.
- Dose
- Set by the label and the depot formulation
- How often
- Monthly to six-monthly depot
An approved hormone blocker since 1988: it lowers growth hormone instead of raising it.
- Dose
- 50 to 500 mcg three times daily, or a 10 to 40 mg monthly depot (label)
- How often
- Two to four times daily, or every 4 weeks (depot)
A Palatin-style code number with no published compound behind it.
- Dose
- Research only
- How often
- Not established
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- Somatuline Depot prescribing information (revised 7/2024)(2024)Indications, dosing and pharmacokinetics: half-life 23 to 30 days for the depot, bioavailability 69 to 78%. Sequence D-2-Nal-Cys-Tyr-D-Trp-Lys-Val-Cys-Thr-NH2, MW 1096.34.
- Somatuline Depot on DailyMed(2024)CLARINET: progression or death 31.7% against 58.3%, HR 0.47. ELECT: rescue octreotide on 34% against 49% of days (p=0.02). Acromegaly pooled side effects: diarrhoea 37%, gallstones 20%.
- Drugs@FDA, NDA 022074(2024)Approved 30 August 2007 for acromegaly; GEP-NET supplement 16 December 2014; carcinoid syndrome 15 September 2017.
- Caplin ME et al., New England Journal of Medicine 2014;371:224-233 (CLARINET)(2014)204 patients with grade 1 or 2 non-functioning tumours: 24-month progression-free survival 65.1% against 33.0%; no overall survival difference.
- ClinicalTrials.gov, CLARINET posted results (NCT00353496)(2014)Gallstones 14.9% against 6.8%; serious adverse events 24.8% against 31.1%.
- ClinicalTrials.gov, ELECT posted results (NCT00774930)(2016)Carcinoid syndrome, 115 patients: days needing rescue octreotide 33.7% against 48.5% (p=0.0165).
- Drugs@FDA, ANDA 217193 (generic lanreotide)(2024)Approved 21 May 2024, therapeutic equivalence code AB to Somatuline Depot.
- Lanreotide Ipsen UK summary of product characteristics(2025)First authorised 16 October 2001. Self-injection allowed after training. Population half-life in tumour patients 49.8 days.
- FDA GSRS codes, lanreotide (UNII 0G3DE8943Y)(2026)INN lanreotide, CAS 108736-35-2, ATC H01CB03. 3-(2-naphthyl)-D-alanine at 1, D-Trp at 4, threoninamide at 8.
Beyond these, 590 records are indexed. Browse the records