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Lanreotide: The Somatostatin Copy That Forms Its Own Depot — and Now Has Three US Makers

Lanreotide is a ring-shaped peptide of eight amino acids that copies the hormone somatostatin. It treats acromegaly, slows the growth of certain neuroendocrine tumours and reduces carcinoid-syndrome rescue treatment. It needs no polymer to last a month: the peptide itself settles into a gel under the skin and seeps out with a half-life of 23 to 30 days.

FDA-approved (since 2007)Monthly deep injection under the skinThree US makers as of 2026-09-30

Caroline S · Published 2026-09-30

Length

8 amino acids, closed into a ring by a disulfide bond between the two cysteines

Sequence

D-2-Nal-Cys-Tyr-D-Trp-Lys-Val-Cys-Thr-NH2 — cyclic S–S; begins with a mirror-image (D) naphthylalanine and ends in threoninamide. Molecular weight 1,096.34 (base, Somatuline Depot label)

Origin

A synthetic analogue of somatostatin developed by Ipsen. Somatuline Depot's original FDA approval is dated 2007-08-30 in Drugs@FDA

Last reviewed

2026-09-30

What is it good for?

Holding down hormones and tumour growth driven by somatostatin receptors. In acromegaly it lowers growth hormone and IGF-1 when surgery or radiation have not been enough; in inoperable gut and pancreatic neuroendocrine tumours it lengthened the time before the tumours grew in a 204-patient placebo-controlled trial; in carcinoid syndrome it cut the days on which rescue injections were needed.

Illustration: A clear Erlenmeyer flask with pale green gel on a white lab bench, copper reflections.
Illustration

What it is

Lanreotide is an eight-amino-acid peptide drug that copies somatostatin, the hormone the body uses to switch other hormones off. The label spells out its structure:

  • Eight amino acids closed into a ring by a disulfide bond between two cysteines;
  • A mirror-image D-2-naphthylalanine at the start — a bulky, non-natural amino acid — and a D-tryptophan at position 4;
  • Threoninamide at the end, which caps the chain.

The free peptide weighs 1,096.34. Natural somatostatin is 14 amino acids long; a single lanreotide injection is designed to cover four weeks.

How it works

The Somatuline Depot label describes lanreotide binding strongly to somatostatin receptors 2 and 5 and more weakly to 1, 3 and 4, with receptors 2 and 5 responsible for lowering growth hormone. After a single injection, growth hormone falls quickly and stays down for at least 28 days.

Like the hormone it copies, it suppresses a long list of others: motilin, gastric inhibitory peptide and pancreatic polypeptide at baseline; gastrin and cholecystokinin after meals. It also delays and reduces insulin release after a meal, which the label reports as a transient, mild glucose intolerance in healthy volunteers, and it slows gallbladder emptying — the mechanism behind its gallstone warning.

A depot made of the drug itself

Lanreotide's monthly form carries no polymer or other slow-release carrier. The syringe holds a supersaturated solution — 24.6% lanreotide by weight in water, with acetic acid to set the pH and nothing else. The label says the formulation "is thought to form a drug depot at the injection site" on contact with body fluids, and that the drug most likely leaves it by passive diffusion.

The result, per the label:

Measure Figure
Half-life 23 to 30 days
Absolute bioavailability (healthy volunteers, 60 / 90 / 120 mg) 73.4% / 69.0% / 78.4%
Peak level During the first day
Level above 1 ng/mL Throughout 28 days at 90 and 120 mg

What it is approved for

Condition Evidence on the label
Acromegaly Two long-term randomised studies; the first began with a 4-week placebo-controlled phase in 108 patients
Gastroenteropancreatic neuroendocrine tumours (inoperable, well- or moderately-differentiated) Study 3: 204 patients, 120 mg or placebo every 4 weeks for up to 96 weeks. Progression or death: 31.7% vs 58.3%; median progression-free survival not reached at 22 months vs 16.6 months; hazard ratio 0.47
Carcinoid syndrome Study 4: 115 patients, 16 weeks. Rescue octreotide used on 34% of days vs 49% on placebo (p = 0.02)

The tumour result is what separates lanreotide's label from octreotide's: octreotide's label states that its trials did not show an effect on tumour size or growth, while lanreotide's carries a tumour-growth indication backed by a placebo-controlled trial. The trial enrolled only patients whose tumours produced no hormone symptoms, and 45% of them had pancreatic primaries.

Safety

The label's warnings follow from what a broad hormone suppressor does: gallstones and their complications (cholecystitis, cholangitis and pancreatitis have been reported after marketing), high or low blood sugar because insulin and glucagon are both suppressed, slow heart rate (sinus bradycardia in 5.5% of patients across three pooled cardiac studies in acromegaly), reduced thyroid function, and fatty stools that can point to reduced pancreatic enzyme output. The most common reactions in the acromegaly studies were diarrhoea, gallstones, abdominal pain, nausea and injection-site reactions.

Where it stands

Drugs@FDA lists four lanreotide applications on 2026-09-30:

Application Holder Type Approved
NDA 022074 — Somatuline Depot Ipsen New molecular entity 2007-08-30
NDA 215395 — lanreotide injection InvaGen (Cipla) New formulation or new manufacturer 2021-12-17
ANDA 217193 InvaGen (Cipla) Generic 2024-05-21
ANDA 218217 Amneal Generic 2026-09-18

PubMed indexes 1,559 records for lanreotide, 92 tagged as randomised controlled trials (2026-09-30). The label specifies administration by a healthcare provider, as a deep injection in the upper outer buttock; how much and how often is set by the prescriber against growth-hormone and IGF-1 results.

Lanreotide is one of two eight-amino-acid copies of somatostatin in this library; the other is octreotide, whose capsule form lists lanreotide-treated patients among those it may switch. The hormone it lowers is the one that growth-hormone releasers such as tesamorelin push up, and the IGF-1 it reduces is the natural counterpart of IGF-1 LR3.

What the research shows

Lowers growth hormone and IGF-1 in acromegaly

FDA-approved indication on the Somatuline Depot label; established in two long-term randomised studies, the first with a 4-week placebo-controlled phase in 108 patients

Slows the growth of inoperable gastroenteropancreatic neuroendocrine tumours

FDA-approved indication. Label Study 3: 204 patients, progression or death in 31.7% on lanreotide vs 58.3% on placebo; hazard ratio 0.47

Reduces the need for rescue treatment in carcinoid syndrome

FDA-approved indication. Label Study 4: 115 patients over 16 weeks, rescue octreotide used on 34% of days vs 49% on placebo (p = 0.02)

Bars show how much of the evidence is in humans, not how well anything works.

Where it stands

United States

Approved. Drugs@FDA lists four lanreotide applications (2026-09-30): Ipsen's Somatuline Depot (NDA 022074, 2007), Cipla/InvaGen's lanreotide injection (NDA 215395, 2021, filed as a new formulation or manufacturer), and two generics — InvaGen (ANDA 217193, 2024-05-21) and Amneal (ANDA 218217, 2026-09-18).

How it is given

The label specifies a deep injection under the skin of the upper outer buttock, given by a healthcare provider every 4 weeks.

Published record

PubMed indexes 1,559 records for lanreotide, 92 tagged as randomised controlled trials (2026-09-30).

Frequently asked questions

What is lanreotide?

A man-made, eight-amino-acid copy of somatostatin, the body's hormone for switching other hormones off. It has been an FDA-approved medicine since 2007, sold first as Somatuline Depot.

What is lanreotide used for?

On the current US label: acromegaly when surgery or radiotherapy have not controlled it; inoperable, well- or moderately-differentiated neuroendocrine tumours of the gut and pancreas, to delay their growth; and carcinoid syndrome, where it reduces how often short-acting rescue treatment is needed.

How is lanreotide different from octreotide?

Both are eight-amino-acid somatostatin copies closed into a ring. Their sequences differ at three positions and in the cap on the last residue, and lanreotide's label describes the peptide itself settling into a depot under the skin. Their labels also differ on tumours: lanreotide's carries a tumour-growth indication, octreotide's states its trials did not show one. This entry records the two molecules; it does not compare them as treatments.

Why does one injection last a month?

The syringe holds a very concentrated, gel-like solution of the peptide. The label states it is thought to form a depot where it is injected and to release lanreotide by passive diffusion, giving a half-life of 23 to 30 days.

Is there a generic lanreotide?

Yes. Drugs@FDA lists two generic approvals — InvaGen's on 2024-05-21 and Amneal's on 2026-09-18 — alongside Cipla's lanreotide injection approved in 2021 through a separate new-drug application.

What are the main side effects?

The label's most common reactions in acromegaly were diarrhoea, gallstones, abdominal pain, nausea and injection-site reactions. Its warnings cover gallstone complications, blood-sugar swings, slow heart rate, thyroid changes and fatty stools.