Lanreotide acetate

Table of contents

• What is lanreotide acetate?
• How does lanreotide acetate work?
• Which conditions is it used or studied for?
• How is lanreotide acetate given?
• What do the clinical trials show?

What is lanreotide acetate?

Lanreotide acetate is a synthetic somatostatin analog, a protein-based substance that mimics the natural hormone somatostatin. It is classified in the therapeutic area of hormonal diseases.^[1] The medicine is authorized in the European Union and is FDA-approved in the United States under the brand name Somatuline Depot.^[3] Lanreotide acetate belongs to a class of medicines known as somatostatin analogs, which are used to control hormone-related conditions and certain tumors.

How does lanreotide acetate work?

Lanreotide acetate works by mimicking the action of somatostatin, a natural hormone that inhibits the release of other hormones, including growth hormone and insulin-like growth factor 1 (IGF-1). In acromegaly, excessive growth hormone leads to elevated IGF-1 levels, which cause tissue overgrowth. By binding to somatostatin receptors, lanreotide acetate reduces the secretion of growth hormone and lowers IGF-1 levels.^[3] In neuroendocrine tumors, this action helps control symptoms caused by excessive hormone secretion, such as carcinoid syndrome.

Which conditions is it used or studied for?

• Acromegaly — a hormonal disorder caused by excess growth hormone, leading to enlarged hands, feet, and facial features. Lanreotide acetate is used as a background therapy in clinical trials for this condition.^[1]
• Gastroenteropancreatic neuroendocrine tumors — tumors that arise from hormone-producing cells in the digestive system and pancreas. Lanreotide acetate is FDA-approved for adults whose tumors cannot be removed by surgery, are locally advanced, or have spread.^[3]
• Carcinoid syndrome — a group of symptoms, including flushing and diarrhea, caused by hormone-secreting neuroendocrine tumors. Lanreotide acetate is FDA-approved for this condition in adults.^[3]

How is lanreotide acetate given?

Lanreotide acetate is given as a subcutaneous injection, meaning it is injected under the skin. It is available as a prolonged-release solution for injection in prefilled syringes of 60, 90, and 120 mg.^[4] The FDA draft guidance describes administration as a deep subcutaneous injection into the superior external quadrant of the buttock.^[2] In the acromegaly trial, lanreotide acetate was administered at a dose of 120 mg subcutaneously.^[1]

What do the clinical trials show?

In the EU Clinical Trials Information System, lanreotide acetate appears as an auxiliary medicine in trials for acromegaly, meaning it is used as a background or supportive therapy alongside an investigational drug.^[1] One completed Phase 2 trial evaluated the investigational drug ALXN2420 versus placebo, with both groups receiving lanreotide acetate or octreotide acetate as background somatostatin analog therapy. The trial enrolled 60 adult participants with acromegaly.^[1] The primary outcome measured was the percentage change from baseline in serum IGF-1 level at Week 15. The trial aimed to evaluate whether adding ALXN2420 to somatostatin analog therapy could further decrease IGF-1 levels in adults with acromegaly.^[1]