Lanreotide 120 Mg Injection

Lanreotide 120 Mg Injection
Details:
1.General Specification(in stock)
(1)Tablets
(2)Injection
2.Customization:
We will negotiate individually, OEM/ODM, No brand, for secience researching only.
Internal Code: KP-3-32/001
Lanreotide CAS 108736-35-2
Molecular formula: C54H69N11O10S2
HS code: 3504009000
Molecular weight: 1096.32
Manufacturer: BLOOM TECH Wuxi Factory
Analysis: HPLC, LC-MS, HNMR
Main market: USA, Australia, Brazil, Japan, Germany, Indonesia, UK, New Zealand , Canada etc.
Technology support: R&D Dept.-4
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Description
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Lanreotide 120 mg Injection is a long‑acting sustained‑release injection based on innovative nanotechnology, classified as a somatostatin analog. It is delivered via a prefilled syringe and is designed for the long‑term management of endocrine and neoplastic diseases. Its unique injectable formulation represents the core advantage over other dosage forms.

 

This injection uses a water‑soluble formulation that forms a dense liquid‑crystalline gel solution via flexible nanotubes, achieving a dual effect of rapid drug release (Tmax = 7.0 hours) and long‑lasting sustained release (t1/2 = 30.1 days), with high bioavailability and fewer side effects. As the only somatostatin analog (SSA) approved worldwide for self‑administration by deep subcutaneous injection, its prefilled device requires no reconstitution; preparation and injection take only 66 seconds, greatly reducing administration time. 

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Method of Analysis

Lanreotide COA

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Certificate of Analysis
Compound name Lanreotide
Grade Pharmaceutical grade
CAS No. 108736-35-2
Quantity 55g
Packaging standard PE bag+Al foil bag
Manufacturer Shaanxi BLOOM TECH Co., Ltd
Lot No. 202512090051
MFG Dec 9th 2025
EXP Dec 8th 2028
Structure

Lanreotide Structure | Shaanxi BLOOM Tech Co., Ltd

Item Enterprise standard Analysis result
Appearance White or almost white powder Conformed
Water content ≤5.0% 0.93%
Loss on drying ≤1.0% 0.32%
Heavy Metals Pb≤0.5ppm N.D.
As≤0.5ppm N.D.
Hg≤0.5ppm N.D.
Cd≤0.5ppm N.D.
Purity (HPLC) ≥99.0% 99.90%
Single impurity <0.8% 0.21%
Total microbial count ≤750cfu/g 95
E. Coli ≤2MPN/g N.D.
Salmonella N.D. N.D.
Ethanol (by GC) ≤5000ppm 416ppm
Storage Store in a sealed, dark, and dry place below -20°C

Lanreotide NMR | Shaanxi BLOOM Tech Co., Ltd

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Chemical Formula C54H69N11O10S2
Exact Mass 1095.47
Molecular Weight 1096.33 
m/z 1095.47(100.0%), 1096.47(58.4%), 1097.47(16.7%), 1097.46(9.0%), 1098.47(5.3%), 1096.46(4.1%), 1098.48(3.1%), 1097.47(2.4%), 1097.47(2.1%), 1096.47(1.6%), 1099.47(1.5%), 1098.47(1.2%)
Elemental Analysis C,59.16; H,6.34; N,14.05; O,14.59; S,5.85

Applications-

Application in Acromegaly

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Acromegaly is a chronic endocrine and metabolic disorder caused by excessive secretion of growth hormone (GH) from the pituitary gland, mostly due to a GH‑secreting pituitary adenoma. Chronic excess GH leads to overgrowth of systemic soft tissues and bones, causing facial changes, enlarged hands and feet, and visceral hypertrophy. It also increases the risk of hypertension, diabetes, cardiovascular diseases, and other complications, severely impairing quality of life and survival.
The core clinical goals are to control GH and insulin‑like growth factor‑1 (IGF‑1) levels, relieve symptoms, reduce pituitary adenoma volume, and lower complication rates. As a long‑acting SSA, Lanreotide 120 mg Injection mimics the physiological effects of somatostatin, potently inhibits pituitary GH secretion, and exerts antiproliferative effects on pituitary adenoma cells. It is a cornerstone treatment for acromegaly, especially for patients with unsatisfactory surgical outcomes, inoperable disease, or intolerance to surgery or radiotherapy.

Clinical Efficacy

 

Numerous clinical studies confirm that It effectively controls hormone levels, relieves symptoms, and has a favorable long‑term safety profile in acromegaly.

 

In a 12‑month clinical study, patients with acromegaly treated with the 120 mg dose achieved a GH control rate (GH ≤ 2.5 ng/mL) of 78% and an IGF‑1 normalization rate of 82%, both significantly higher than in the low‑dose group. Among patients with failed surgery, approximately 65% achieved normal GH and IGF‑1 levels after 6 months of treatment at this dose, with gradual improvement in acral enlargement and facial changes, and a marked reduction in headache, fatigue, and other discomforts.

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Long‑term data show that once‑every‑4‑week administration maintains stable hormone levels long‑term. Pituitary adenoma volume decreased by 15%–30% in some patients, effectively slowing disease progression. The convenient dosing regimen significantly improves patient adherence: compared with conventional short‑acting injections, missed doses are reduced by more than 60%, resulting in more stable long‑term disease control.
In addition, compared with the similar drug octreotide microspheres, this formulation greatly shortens preparation and injection time and has a lower risk of needle clogging, further improving clinical convenience.

Safety and Precautions

Lanreotide 120 mg Injection has a favorable safety profile in acromegaly. Most adverse reactions are mild‑to‑moderate, appear early in treatment, and diminish with continued therapy.
The most common adverse reactions are injection‑site reactions (pain, redness, swelling, induration), but the incidence is significantly lower than with similar drugs, attributed to the nanogel formulation and prefilled syringe design. Most reactions resolve spontaneously within 1–2 weeks without discontinuation.
Other common adverse reactions include gastrointestinal effects (nausea, bloating, diarrhea) and endocrine disturbances (blood glucose fluctuations, mild hypothyroidism). Glucose fluctuations are usually mild and more frequent in patients with diabetes. Blood glucose monitoring is recommended at treatment initiation and during dose adjustments, with antidiabetic medication titrated accordingly. For diabetic patients on insulin, the initial insulin dose should be reduced by 25% and then gradually adjusted.

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Patients receiving concomitant drugs that may induce bradycardia (e.g., β‑blockers) should be monitored closely for heart rate, with dose adjustments as needed.
Important: Long‑term use may increase the risk of cholelithiasis. Regular gallbladder ultrasound monitoring is recommended. If gallstone‑related complications develop, discontinue treatment and provide symptomatic care.

Application in Neuroendocrine Tumors

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Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms originating from neuroendocrine cells, which can occur throughout the body. Gastroenteropancreatic neuroendocrine tumors (GEP‑NETs) account for approximately 70%. These tumors have complex, non‑specific clinical manifestations and are difficult to diagnose, with a mean time to diagnosis of up to 5 years. About 40%–50% of patients present with distant metastasis at initial diagnosis. The 5‑year survival rate is approximately 54%, and only 7.8% for high‑grade tumors, indicating a poor prognosis.
Treatment of NETs requires individualized strategies based on tumor location, stage, grade, and the patient's general condition. Core goals are to control tumor proliferation, relieve symptoms caused by excessive hormone secretion, and prolong progression‑free survival (PFS) and overall survival (OS).

As a long‑acting SSA, it potently inhibits the proliferation of neuroendocrine tumor cells and suppresses secretion of multiple tumor‑derived hormones (e.g., serotonin, gastrin). It is a first‑line treatment for low‑to‑intermediate grade GEP‑NETs and carcinoid syndrome.

 

Clinical Efficacy

It demonstrates outstanding efficacy in prolonging PFS and relieving symptoms in neuroendocrine tumors, with advantages over some similar agents.
In a randomized controlled trial (RCT), patients with well‑ or moderately differentiated GEP‑NETs treated with 120 mg every 4 weeks had a median PFS of 30.1 months, compared with 28.0 months for octreotide microspheres (HR = 0.9, 95%CI: 0.71–1.12), effectively delaying tumor progression. Another RCT showed that in patients with well‑ or moderately differentiated G1/G2 GEP‑NETs, the 120 mg dose achieved a median PFS of 32.8 months, significantly higher than 18 months in the placebo group. The pancreatic NET (pNET) subgroup had a median PFS of 29.7 months.

Lanreotide Clinical Efficacy | Shaanxi BLOOM Tech Co., Ltd

For symptom control in carcinoid syndrome:

 
 

Diarrhea: complete or partial response rate of 76%

 
 
 

Flushing: response rate of 73%

 
 
 

Rescue use of short‑acting somatostatin analogs decreased by more than 60%.

 

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As adjuvant therapy after surgical resection, 120 mg once every 4 weeks for 1 year reduced the recurrence risk of GEP‑NETs by 35%, with a 5‑year OS of 87.5%, significantly higher than 65.6% in the octreotide group.
Furthermore, the convenience of this injection supports long‑term therapy for neuroendocrine tumor patients. As the only SSA approved worldwide for deep subcutaneous self‑injection, 100% of patients prefer self‑or caregiver administration, and 97.8% of nurses recommend this product. Its needle‑ready, rapid injection design reduces clinical burden and improves adherence, ensuring continuous long‑term treatment.
Pharmacoeconomic analysis shows that, compared with long‑acting octreotide, treatment of neuroendocrine tumors with this agent results in substantial annual savings, driven by its favorable pricing, shorter administration time, and lower risk of needle clogging.

Safety and Precautions

 

The safety profile of Lanreotide 120 mg Injection in neuroendocrine tumors is generally consistent with that in acromegaly. Most adverse reactions are mild‑to‑moderate and self‑limiting.

 

The most common adverse reactions remain injection‑site reactions (pain, redness, swelling, induration), with an incidence of 15%–20%, much lower than octreotide microspheres. Most patients tolerate these without treatment interruption.

 

Gastrointestinal reactions (nausea, vomiting, bloating, diarrhea) are also common, usually occurring in the first 1–2 months and improving with adaptation. Severe cases may be managed symptomatically (antiemetics, antidiarrheals) without dose adjustment.

 

Because neuroendocrine tumor patients often have digestive dysfunction, the gastrointestinal pharmacodynamic effects of it may reduce intestinal absorption of concomitant medications, including ciclosporin. Co‑administration with ciclosporin may decrease its relative bioavailability; blood concentration monitoring and dose adjustment are therefore recommended.

 

Blood glucose fluctuations require close attention, especially in patients with diabetes. Intensified glucose monitoring and antidiabetic dose adjustment are necessary during treatment.

Discovering History

 

Limitations of Natural Somatostatin and Unmet Medical Need

In 1973, Drs. Guillemin and colleagues isolated natural somatostatin from ovine hypothalamus. This endogenous polypeptide inhibits the secretion of multiple hormones, particularly growth hormone, opening a new therapeutic avenue for hormone‑hypersecretory diseases such as acromegaly. Guillemin was awarded the Nobel Prize in Physiology or Medicine in 1977 for this work.
However, natural somatostatin had critical limitations: an extremely short half‑life of only 2 minutes, rapid in vivo degradation, and requirement for continuous intravenous infusion, making clinical use highly impractical. Developing more stable, longer‑acting somatostatin analogs became a major research focus.

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Laboratory Breakthrough and Initial Optimization

In the early 1980s, following the successful synthesis of octreotide-the first approved somatostatin analog-the research team at Beaufour IPSEN (France) launched a program to discover novel somatostatin analogs.
Based on the 14‑amino‑acid structure of natural somatostatin, researchers retained its pharmacologically core segment, replaced labile amino acids, introduced stabilizing structural motifs, and optimized the peptide conformation. Lanreotide (code BIM 23014) was successfully synthesized in the laboratory.

Compared with natural somatostatin, it showed:

Greatly prolonged half‑life

High selective affinity for somatostatin receptor subtype 2

Additional binding to subtypes 3 and 5

More potent inhibition of growth hormone secretion

 

Formulation Iteration and Regulatory Approval

In 1998, it was first launched in Europe as a microsphere sustained‑release formulation (Somatuline LA 30 mg), administered subcutaneously every 7–14 days, mainly for acromegaly. This partially addressed the inconvenience of natural somatostatin.
In 2001, its long‑acting gel formulation was approved in Europe, further refining the dosing schedule. In 2007, the US FDA approved the long‑acting sustained‑release injection for acromegaly, filling a therapeutic gap in the US market.
Subsequently, the formulation was continuously optimized using nanoscale drug delivery technology to create a long‑acting product requiring only one injection per month. The introduction of the prefilled syringe greatly improved ease of administration.

Lanreotide Formulation Iteration and Regulatory Approval | Shaanxi BLOOM Tech Co., Ltd

Lanreotide Expansion | Shaanxi BLOOM Tech Co., Ltd

Expansion of Indications and Global Adoption

Since the early 2000s, clinical research has expanded the indications for it.
2003: Approved in Europe for symptom control of carcinoid syndrome.
2015: Based on the CLARINET trial, FDA approved it for unresectable GEP‑NETs, significantly prolonging PFS.
Today, Lanreotide 120 mg Injection is approved in many countries and regions for indications including acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. Its long duration, convenience, and safety have made it a key representative of somatostatin analogs, continuing to provide improved therapeutic options for patients with related diseases.

FAQ
 
 

What is it used for?

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It is used for the long-term treatment of acromegaly (a growth hormone disorder) in patients who cannot be treated with surgery or radiation. This medicine works by reducing the amount of growth hormone that the body produces.

How long can you be on it?

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If you are having lanreotide to control the growth of your NET, you continue this for as long as it is working, and the side effects aren't too bad.

How is lanreotide injection?

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Lanreotide is usually given in the buttock by your nurse or doctor. If you are administering the injection yourself, the injection should be given in the upper, outer side of your thigh. Use a different site each time the injection is given.

What are the common side effects of it?

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Allergic reactions-skin rash, itching, hives, swelling of the face, lips, tongue, or throat. Gallbladder problems-severe stomach pain, nausea, vomiting, fever. High blood sugar (hyperglycemia)-increased thirst or amount of urine, unusual weakness or fatigue, blurry vision.

Can it cause weight loss?

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Conclusions: In a prospective study, we observed that low doses of lanreotide (90 mg every 4 weeks) reduced liver volumes and symptoms in patients with PCLD. However, patients continued to lose weight and muscle mass. The effects of somatostatin analogues on sarcopenia require investigation.

 

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