In short
Lanreotide acetate is a synthetic somatostatin analog used to treat acromegaly and certain neuroendocrine tumors. It is an authorized medicine in the EU and FDA-approved in the US, given as a prolonged-release subcutaneous injection. In the EU Clinical Trials Information System, it appears as an auxiliary medicine in trials for acromegaly, including a completed Phase 2 study of 60 participants.
Key points
- Lanreotide acetate is a somatostatin analog, a protein-based medicine given by subcutaneous injection.
- It is authorized as a medicine and FDA-approved for gastroenteropancreatic neuroendocrine tumors and carcinoid syndrome.
- In a completed Phase 2 trial in acromegaly, lanreotide acetate was used as a background therapy alongside the investigational drug ALXN2420.
- The trial enrolled 60 participants and measured the percentage change in serum IGF-1 levels at Week 15.
- Lanreotide acetate is available as a prolonged-release solution for injection in prefilled syringes of 60, 90, and 120 mg.
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. The medicine is authorized in the European Union and is FDA-approved in the United States under the brand name Somatuline Depot. 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. 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.
- 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.
- 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.
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. The FDA draft guidance describes administration as a deep subcutaneous injection into the superior external quadrant of the buttock. In the acromegaly trial, lanreotide acetate was administered at a dose of 120 mg subcutaneously.
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. 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. 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.