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Mazdutide
Mazdutide Mazdutide

Mazdutide(玛仕度肽注射液)

Mazdutide Injection delivers the triple benefits of hypoglycemic effect, weight reduction and liver protection, with a more comprehensive mechanism of action than single-target GLP-1 drugs.

  • 2mg*2prefilled syringe
  • 4mg*2prefilled syringe
  • 6mg*2prefilled syringe

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Introduction of Mazdutide

Mazdutide Injection is the world’s only approved glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) dual agonist. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2025, with its indication for diabetes approved in October of the same year.

Indications

This product is indicated for long-term weight management in adult patients, as an adjunct to a reduced-calorie diet and increased physical activity, in those with an initial body mass index (BMI) of:

≥28kg/m² (obesity), or ≥24kg/m² (overweight) and accompanied by at least one weight-related comorbidity (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome, etc.).

Overview

Generic Name
Mazdutide Injection,玛仕度肽注射液
Brand Name
信尔美
Drug Type
Rx Drug
Approval No.
2mg:国药准字H20250036;4mg:国药准字H20250037;6mg:国药准字H20250038
Active Ingredient
Mazdutide
Dosage Form
2mg;4mg;6mg
Specification
Injection
Description
Masidutide Injection is a clear or nearly clear, colorless or nearly colorless liquid.
Expiry Date
24 months
Manufacturer
Innovent Biologics (Suzhou) Co., Ltd.
Storage
Store protected from light, in a tightly sealed container, at 2–8℃. Do not freeze.If special needs arise, the product may be stored in its original packaging at room temperature (10–30℃) for up to 30 days, and must not be returned to refrigerated storage (2–8℃) afterwards. Discard any unused product if it is not administered within 30 days of being stored under this condition.

Dosage and Administration

The recommended initial dose of mazdutide is 2mg, administered subcutaneously once weekly.

After 4 weeks of recommended administration, the dose should be increased to 4mg, administered subcutaneously once weekly. If further weight improvement is required, the dose may be increased to 6mg once weekly after receiving treatment with the current dose for at least 4 weeks.

The recommended maintenance dose of mazdutide is 4mg or 6mg, administered subcutaneously once weekly. If the 6mg dose is not tolerated, the dose may be considered for reduction back to 4mg for maintenance.

Contraindications

Hypersensitivity to the active ingredient of this product or any of its excipients.

Personal history or family history of medullary thyroid carcinoma (MTC), or diagnosis of multiple endocrine neoplasia type 2 (MEN2).

Adverse Reactions

In overweight or obese patients receiving mazdutide for long-term weight management, the adverse reactions with an incidence rate ≥ 2% and higher than that in the placebo group are as follows:

Mazdutide 4 mg group: The most common adverse reactions are nausea, diarrhea, and vomiting; other common adverse reactions include abdominal distension, abdominal pain, injection site reactions, dizziness, gastroesophageal reflux disease, fatigue, belching, constipation, hiccups, and dyspepsia.

Mazdutide 6 mg group: The incidence of adverse reactions is generally higher than that in the 4 mg group, with the main adverse reactions being nausea, diarrhea, and vomiting; other adverse reactions include abdominal distension, abdominal pain, injection site reactions, dizziness, gastroesophageal reflux disease, fatigue, belching, constipation, hiccups, and dyspepsia.

Use in Special Populations

Use in Pregnancy and Lactation

Pregnancy

The effects of mazdutide on pregnant women are not yet clear; therefore, this product is contraindicated in pregnant women. If a patient is planning to become pregnant or is already pregnant, mazdutide treatment should be discontinued. Given the long half-life of this product, mazdutide should be discontinued at least 3 months prior to planned pregnancy.

Lactation

It is not known whether mazdutide is excreted in human milk. Risks to neonates/infants cannot be excluded. This product must not be used during lactation.

Women of Childbearing Potential

Women of childbearing potential receiving mazdutide treatment are recommended to take contraceptive measures.

Fertility

The effects of mazdutide on human fertility are not yet clear.

Pediatric Use

The safety and effectiveness of mazdutide in pediatric and adolescent patients under 18 years of age have not been established.

Geriatric Use

In clinical trials of mazdutide for the treatment of obese or overweight patients, the number of patients aged 65 years and above was limited (N=3), and thus the safety and effectiveness of mazdutide in geriatric patients cannot be determined.

For more detailed drug information, please consult the official package leaflet.

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