Mazdutide Application Scope

Mazdutide (trade name: Xinermei®) is a first-in-class dual glucagon-like peptide-1 (GLP-1) receptor and glucagon receptor (GCG) agonist approved by China’s National Medical Products Administration (NMPA) for two primary indications:

First Indication – Chronic Weight Management: As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with:

BMI ≥ 28 kg/m² (obesity), or
BMI ≥ 24 kg/m² (overweight) with at least one weight-related comorbidity such as hyperglycemia, hypertension, dyslipidemia, fatty liver disease, or obstructive sleep apnea syndrome

Second Indication – Type 2 Diabetes: For glycemic control in adults with type 2 diabetes as monotherapy or combination therapy with other oral antidiabetic medications

The medication is being evaluated in additional Phase 3 clinical studies for potential treatment of metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), adolescent obesity, and alcohol use disorder.

Mazdutide Characteristics

Ingredients: Mazdutide (a synthetic peptide analog of oxyntomodulin, CAS: 2259884-03-0), with excipients for injection formulation.
Properties: Clear, colorless to slightly yellow sterile solution for subcutaneous injection.
Packaging Specification: Pre-filled injection pens or vials in doses such as 0.5 ml: 2 mg, with options for 4 mg and 6 mg strengths.
Storage: Store in a sealed container, protected from light, at 2–8°C. Do not freeze. If needed, it may be kept at room temperature (10–30°C) in original packaging for up to 30 days but cannot be returned to refrigeration afterward; discard if unused.
Expiry Date: Typically 24–36 months from manufacture date; check packaging for specific date.
Executive Standard: In compliance with Chinese National Medical Products Administration (NMPA) standards for biologics.
Approval Number: 国药准字S20250006 (for weight management indication, approved June 2025).
Date of Revision: July 2025 (latest package insert revision)
Manufacturer: Innovent Biologics (Suzhou) Co., Ltd.

Guidelines for the Use of Mazdutide

Dosage and Administration:
- Recommended Dose: Initiate at 2 mg once weekly for 4 weeks (1 month), then increase to 4 mg once weekly for 4 weeks (1 month), followed by maintenance at 6 mg once weekly. If intolerance occurs at 6 mg, reduce to and maintain at 4 mg. Dose titration is essential to minimize adverse reactions.
- Administration: Subcutaneous injection once weekly, at any time of day, independent of meals. Do not self-adjust doses; follow physician guidance.
- Missed Dose: If a dose is missed and it has been ≤5 days since the scheduled time, administer as soon as possible and resume the regular schedule. If >5 days have passed, skip the missed dose and administer the next dose on the scheduled day. Do not double-dose.
Adverse Reactions:
- Common Adverse Reactions: Gastrointestinal symptoms including nausea, vomiting, diarrhea, or constipation. These are usually mild to moderate, transient, and more frequent during dose escalation but decrease over time. Management tips: For nausea, consume ginger, mint, or light snacks like crackers; for vomiting, replenish electrolytes and eat small, frequent meals; for diarrhea, stay hydrated and avoid high-fat/spicy foods; for constipation, increase water/fiber intake and physical activity.
- Serious Adverse Reactions: Pancreatitis (monitor for persistent abdominal pain), gallbladder disorders (e.g., cholelithiasis), or hypersensitivity reactions. Discontinue if suspected and seek medical attention.
Contraindications: Personal or family history of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia syndrome type 2 (MEN 2), history of pancreatitis, or known hypersensitivity to mazdutide or its components. Avoid in patients with thyroid nodules identified on examination or imaging.
Precautions:
- Assess gallbladder status before starting. Monitor for gastrointestinal symptoms and adjust lifestyle (e.g., balanced diet, 30 minutes daily moderate exercise) to prevent weight rebound upon discontinuation. Use caution in patients with renal impairment or history of GI disorders. Not recommended during pregnancy or breastfeeding. Regular monitoring of metabolic parameters is advised.

Mazdutide Interactions

Use caution when combining with medications that may affect gastrointestinal motility or absorption (e.g., oral contraceptives, antibiotics). Monitor blood glucose in diabetic patients as mazdutide may enhance hypoglycemic effects of other antidiabetics. No major interactions reported, but consult a physician for concomitant use with insulin or sulfonylureas.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.