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Lanreotide 120 mg is an artificially synthesized somatostatin analog that plays a crucial role in the treatment of acromegaly. As a long-acting growth hormone inhibitor octapeptide analogue, it effectively inhibits the secretion of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) by binding to somatostatin receptors (especially SSTR2 and SSTR5), thereby controlling the progression of acromegaly in patients.Suitable for the treatment of acromegaly in various situations, including patients with abnormal growth hormone secretion after surgery and/or radiation therapy, as well as patients who are not suitable for surgery or radiation therapy. Its administration method is flexible, usually using deep intramuscular injection or subcutaneous injection.
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lanreotide COA
Acromegaly is a chronic progressive endocrine metabolic disease with insidious onset, mainly caused by excessive secretion of growth hormone (GH) due to anterior pituitary neoplasms, which can lead to multiple organ/system complications and seriously endanger the patient's life and health. Lanreotide 120 mg as artificially synthesized somatostatin receptor ligands (SRLs), they play a crucial role in the tratment of acromegaly.
As a first-line drug treatment option
For patients with acromegaly who cannot tolerate surgery, have residual lesions after surgery, or have difficulty meeting biochemical standards, it is an important tretment option. For example, some patients may find it difficult to tolerate surgery due to cardiovascular or respiratory complications, or may refuse surgery. In such cases, drug therapy may be the first choice; Some patients still have residual neoplasms after surgery, and their levels of GH and insulin-like growth factor-1 (IGF-1) have not been controlled, so they also need to receive tratment.
Clinical validation:
Multiple Phase III clinical studies have confirmed its efficacy and safety. The IPSEN-081 study evaluated its efficacy and safety in patients with untreated or uncontrolled acromegaly, and the results showed that after 12 weeks of tretment, 26% of patients' IGF-1 levels returned to normal; After 48 weeks, 85% of patients had GH levels ≤ 2.5 μ g/L, and 43% of patients had normal IGF-1 levels. The PRIMARYS study evaluated its efficacy in reducing neoplasm volume in newly treated patients with GH secreting pituitary adenomas.
After 12 weeks of tratment, 54.1% of patients had a neoplasm volume reduction of ≥ 20%, and the trend of neoplasm reduction continued until the end of the study. After 48 weeks, 62.9% of patients had a neoplasm volume reduction of ≥ 20%, and GH and/or IGF-1 levels significantly decreased from week 12. The proportion of patients who met the criteria increased over time.
Realize biochemical control
Application Status
This substance can effectively help patients with acromegaly achieve biochemical control and reduce GH and IGF-1 levels. In real-world clinical practice in China, numerous patients have achieved effective control of GH and IGF-1 levels through the use of the product. For example, a study included 129 patients (with an average age of 43.3 years and a female proportion of 58.1%) who received at least one tratment. By the 12th month of tretment, 102 patients completed the study and collected GH and IGF-1 data from the 12th month. Among them, 19.6% (20/102) of patients achieved complete biochemical control, 11.8% (12/102) of patients achieved GH<1 μ g/L and normal IGF-1, and 34.3% (35/102) of patients achieved GH ≤ 2.5 μ g/L and IGF-1 ≤ 1.3 × ULN. Fasting GH levels decreased from baseline 23.17 μ g/L to 8.33 μ g/L, and IGF-1 decreased from 1.974 × ULN to 1.332 × ULN.
Clinical validation
In addition to the aforementioned real-world studies in China, multiple international studies have also validated its biochemical control effects. The SODA study is a large-scale multicenter real-world study conducted in the United States to investigate the efficacy of lanrelitide ATG in treating acromegaly. During the one-year tratment, 72% of the 87 eligible patients had IGF-1 levels below the upper limit of normal;
Among the 50 patients eligible for analysis, 60% had fasting GH levels<1 µ g/mL, and 80% had fasting GH levels ≤ 2.5 µ g/mL. During the 2-year tretment, the proportion of patients with GH levels ≤ 2.5 µ g/L at 12 months (M12) and 24 months (M24) was 83.3% and 80.0%, respectively; The proportion of patients with M12 and M24 GH levels<1.0 µ g/L was 61.7% and 61.4%, respectively; The proportions of M12 and M24 with normal levels of IGF-1 and GH levels ≤ 2.5 µ g/L were 65.0% and 54.8%, respectively; The proportion of M12 and M24 patients with normal IGF-1 levels and GH levels ≤ 1.0 µ g/L was 51.7% and 42.9%, respectively.
Improve clinical symptoms
Lanreotide 120 mg can significantly improve the clinical symptoms of patients with acromegaly. The typical symptoms of acromegaly include facial changes, enlarged fingers, thickened skin, headaches, changes in vision, joint pain, soft tissue swelling, excessive sweating, etc. After tratment, these symptoms can be relieved to varying degrees. For example, in real-world studies in China, the proportion of patients reporting any symptoms related to acromegaly decreased from 87.5% at baseline to 77.9% (-9.6%) at 12 months, with the most significant improvement in headache (-17.1%), followed by soft tissue swelling (-8.1%) and excessive sweating (-6.5%).
Improve the quality of life
It can improve the quality of life of patients with acromegaly by improving biochemical indicators and clinical symptoms, which can enhance their psychological and physical health. Patients with acromegaly often experience psychological pressure and their quality of life is severely affected due to changes in facial appearance, physical discomfort, and other reasons. After tretment with the product, patients' quality of life scale scores will significantly improve.
Clinical validation
The SODA study also focused on the quality of life of patients, evaluating the impact on their lives through methods such as patient questionnaire surveys during the 1-year and 2-year tratment periods. The results showed that the substance has good safety and is more convenient to use, with high patient acceptance, which indirectly reflects the positive impact of the drug on patients' quality of life.
During the 2-year tratment, for patients who received long-acting octreotide before enrollment (n=100), a higher proportion (81.0%) considered ATG to be "very" or "relatively" convenient compared to the previous regimen after switching to ATG tretment; Compared with previous studies of the same type, patients in M12 (77.4%) and M24 (80.0%) have a higher proportion of patients who evaluate the convenience of Lanrui Peptide ATG injection. Convenient tratment methods help improve patients' quality of life.
Primary Indication: Well-Differentiated Metastatic Neuroendocrine neoplasms
Core neoplasm Type: Gastroenteropancreatic Neuroendocrine neoplasms (GEP-NETs)
The 120 mg sustained-release injectable lanreotide (somatuline) is primarily indicated for well-differentiated metastatic gastroenteropancreatic neuroendocrine neoplasms and represents a preferred first-line agent for this disease. GEP-NETs comprise a heterogeneous group of neoplasms arising from neuroendocrine cells of the gastrointestinal tract and pancreas. Compared with poorly differentiated, high-grade neuroendocrine carcinomas, well-differentiated GEP-NETs exhibit slower proliferation and lower malignant potential.
Their neoplasm cells abundantly express somatostatin receptors, which constitutes the key pathological basis for somatuline-mediated targeted therapy. Clinical criteria specify that the 120 mg formulation applies to all metastatic GEP-NETs classified as G1 or G2 regardless of the primary site, including gastric, intestinal and pancreatic origins.
Based on hormone secretory function, the drug covers both functioning and non-functioning GEP-NETs, accommodating most clinical cases.
Functioning GEP-NETs overproduce multiple gastrointestinal hormones and cause characteristic systemic syndromes with overt symptoms that severely impair quality of life and organ function.Non-functioning GEP-NETs lack excessive hormone release and typically present without early specific manifestations. Patients mostly develop non-specific complaints such as abdominal pain, bloating and weight loss due to mass effect and distant metastasis; the disease is often diagnosed at a metastatic stage owing to its insidious course. Lanreotide 120 mg delivers consistent therapeutic benefit for both subtypes by achieving dual objectives: symptom control and suppression of neoplasm progression. It fills an unmet clinical need for long-acting targeted therapy in well-differentiated metastatic GEP-NETs.
Treatment of Functioning neoplasms: Precise Control of Hormone-Mediated Carcinoid Syndrome
For patients with functioning well-differentiated metastatic GEP-NETs, the primary therapeutic role of the product is suppression of excessive neoplasm hormone secretion. This effectively mitigates hallmark carcinoid syndrome symptoms and improves patient quality of life. Carcinoid syndrome is the most distinctive complication of functioning GEP-NETs, triggered by neoplasm overproduction of bioactive mediators including serotonin, bradykinin and prostaglandins.
Paroxysmal cutaneous flushing and refractory watery diarrhea are the two most prevalent and persistent clinical manifestations, representing major unmet treatment challenges.
Paroxysmal flushing typically affects the face, neck and trunk, presenting as erythema, warmth and burning sensation. Individual episodes last several minutes to tens of minutes and can be provoked by emotional stress, meals or physical exertion. Frequent attacks cause persistent discomfort, psychological distress and disruption of daily activities. Refractory watery diarrhea is often continuous, occurring several to over ten times daily.
Stools contain no blood or pus and are not consistently associated with abdominal pain; conventional antidiarrheal agents show limited efficacy. Chronic diarrhea may lead to dehydration, electrolyte disturbances, malnutrition and rapid weight loss, progressively compromising physical performance and potentially inducing organ injury.
As a long-acting sustained-release preparation, it enables slow, continuous drug release after subcutaneous injection. It stably engages SSTR2 and SSTR5 on neoplasm cells and inhibits pathways driving hormone synthesis and secretion, thereby reducing release of bioactive hormones at the source.
Clinical data demonstrate that standard treatment with this formulation markedly reduces flushing frequency, shortens episode duration and attenuates severity. It also alleviates refractory watery diarrhea, decreases bowel frequency, restores intestinal absorptive function and corrects electrolyte imbalance and malnutrition. Compared with short-acting formulations, the 120 mg long-acting depot maintains steady plasma concentrations without pronounced pharmacodynamic fluctuations. The once-every-28-day dosing schedule sustains control of carcinoid syndrome symptoms and substantially enhances treatment adherence and quality of life.
As a long-acting somatostatin analog, somatuline was developed to overcome the clinical limitations of native somatostatin. Endogenous somatostatin has an extremely short half-life of merely 2–3 minutes and requires continuous intravenous infusion, making it unsuitable for long-term management of chronic oncological conditions.
Frequent administration also compromises patient adherence and increases treatment costs. In the 1980s, researchers performed synthetic modification based on the molecular structure of native somatostatin.
By optimizing amino acid sequences and improving molecular stability, they successfully generated somatuline, a novel long-acting derivative that circumvents the drawbacks of the endogenous peptide. Subsequent studies confirmed that somatuline binds with high affinity to human somatostatin receptors SSTR2 and SSTR5, enabling precise suppression of aberrant hormone secretion and neoplasm proliferation in neuroendocrine cells.
Pharmacological and preliminary clinical validation of the long-acting somatuline formulation was completed in 1990.
It obtained its first marketing authorization in Europe in 1995, followed by iterative development of the 120 mg sustained-release formulation. Owing to its prolonged release profile and stable plasma drug concentrations, this formulation has become a core therapy for well-differentiated metastatic neuroendocrine neoplasms and is recommended as first-line treatment in clinical guidelines worldwide.
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