Semaglutide

  Product Detail  

1. Basic Information

• Generic Name: Semaglutide
• CAS Number: 910463-68-2
• R&D Company: Novo Nordisk
• Molecular Category: Long-acting synthetic GLP‑1 receptor agonist peptide

2. Mechanism of Action

3. Approved Indications

Oral Tablet Formulation

1. Adjunct to diet and physical activity for glycemic control in adults with type 2 diabetes mellitus
2. Chronic weight management for adults with overweight or obesity accompanied by weight-related comorbidities

Weekly Long-Acting Formulation

1. Glycemic management for type 2 diabetes in adults
2. Chronic weight reduction and sustained weight maintenance for eligible overweight/obese adults
3. Reduction of major adverse cardiovascular event risks in type 2 diabetes patients with established cardiovascular disease

4. Standard Dosing Regimens

Oral Semaglutide Tablets

• Initial titration: 3 mg once daily for 30 days for gastrointestinal tolerance adaptation
• Maintenance glycemic dose: 7 mg once daily; dose may be raised to 14 mg once daily if glycemic targets remain unmet
• Weight management maintenance dose: 14 mg once daily
• Administration rule: Taken on an empty stomach with a small volume of water, no food, beverages or other supplements for at least 30 minutes after intake; tablets shall be swallowed whole without splitting or crushing.

Weekly Long-Acting Semaglutide Preparation

• Starting dose: 0.25 mg once weekly for the first four weeks to build tolerability
• Standard maintenance dose for diabetes: 0.5 mg once weekly; escalate to 1 mg weekly if HbA1c goals are not achieved
• Weight management maintenance dose: Maximum 2.4 mg once weekly
• Flexible weekly scheduling: Dosing day can be adjusted as long as a minimum 4-day interval is maintained between two administrations.

5. Pharmacokinetic Features

• Extended half-life of approximately 7 days, supporting once-weekly therapeutic schedules for long-acting variants
• Glucose-dependent insulin activation avoids hypoglycemia risk when used as monotherapy
• Consistent steady-state concentrations achieved within 4–5 weeks of regular dosing
• Minimal hepatic or renal metabolism interference, suitable for patients with mild to moderate hepatic or renal impairment without mandatory dose reduction.

6. Clinical Efficacy Highlights

Glycemic Control

Weight Reduction

Cardiovascular Benefit

7. Safety Profile

Common Mild to Moderate Adverse Reactions

Important Warnings & Contraindications

• Contraindicated for patients with personal or family history of medullary thyroid carcinoma, or multiple endocrine neoplasia syndrome type 2
• Not recommended during pregnancy and breastfeeding
• Requires discontinuation prior to planned pregnancy due to limited gestational safety data
• Caution for patients with severe gastrointestinal disease, pancreatitis history or severe renal impairment; prompt medical consultation is needed upon persistent severe abdominal pain.

8. Core Competitive Advantages

1. Dual applicable value for both blood glucose regulation and chronic weight management
2. Two convenient administration modes: daily oral solid dosage and weekly long-duration preparation to match diverse patient preferences
3. Proven cardiovascular protective benefit unmatched by many alternative anti-diabetic agents
4. Gradual dose titration design effectively lowers gastrointestinal adverse reaction incidence and improves long-term adherence
5. Long albumin-binding half-life delivers stable round-the-clock therapeutic effect without frequent daily intake requirements for weekly formulations