Drug name
Last update: Jul 2026Semaglutide
Developer(s)
Drug information
Semaglutide
OZEMPIC; RYLEBUS; and WEGOVY
Biotherapeutic
GLP-1 receptor agonist
Semaglutide LAI is a once-weekly subcutaneous GLP-1 receptor agonist (94% homologous to human GLP-1) indicated for glycemic control in type 2 diabetes. It enhances glucose-dependent insulin secretion, suppresses glucagon, and delays gastric emptying, lowering glucose and promoting weight loss. Peak plasma concentration occurs 1–3 days post-dose; high albumin binding confers a ~7-day half-life. Apparent clearance is ~0.05 L/h, and steady state is reached in 4–5 weeks. Furthermore, phase 3 trials show ~1.5% HbA1c reduction and up to 15% weight loss. To add on, semaglutide LAI has a black box warning i.e. risk of thyroid c-cell tumor. Other Adverse events include pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury, and acute gallbladder diseases.
Ozempic (2 mg/3 mL, 4 mg/3 mL, and 8 mg/3 mL prefilled syringes) is approved in 54 countries, while Wegovy (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg) is approved in 43 countries. Additionally, a biosimilar version of long-acting semaglutide injection, marketed as Semavic Next, is approved in the Russian Federation for the treatment of obesity.
Semaglutide has received regulatory approval in 96 countries, including authorizations from major agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA, Japan), Therapeutic Goods Administration (TGA, Australia), Health Canada, and Medsafe (New Zealand). The long-acting injectable (LAI) formulation of semaglutide is approved for the treatment of both type 2 diabetes mellitus and obesity/overweight, with indications and dosing regimens varying by therapeutic use.
Therapeutic area(s)
- Diabetes : "Type 2"
- Obesity / Weight Management
- Treatment
Administration route
Subcutaneous
Associated long-acting platforms
Aqueous drug particle suspension
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Self-administered
- Weekly
2. No dose adjustment needed for hepatic or renal impairment.
Dosage
OZEMPIC: 2mg/3mL (0.68mg/mL); 4mg/3mL (1.34 mg/mL) & 8mg/3mL (2.68mg/mL) and WEGOVY: 0.25 mg / 0.5 mL; 0.5 mg / 0.5 mL; 1 mg / 0.5 mL ; 1.7 mg / 0.75 mL & 2.4 mg / 0.75 mL
OZEMPIC 2 mg once a week; WEGOVY 2.4 mg once a week
Start at Semaglutide 0.25 mg SC once weekly injection (with/without meals). After 4 weeks, increase the dose to 0.5 mg once weekly. If after at least 4 weeks additional glycemic control is needed, increase to 1 mg once weekly
1. OZEMPIC is approved for adults with type 2 diabetes mellitus (≥ 18 years old). 2. WEGOVY is approved for adults and adolescents aged < 12 years and older. 3. Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. 4. Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic therapy. 5. Not indicated for use in type 1 diabetes mellitus or treatment of diabetic ketoacidosis.
Associated compounds, formulations and regimens
Not provided
Associated technologies
CompareAdditional information
Developer(s)
Novo Nordisk
Novo Nordisk A/S, founded in 1989 through the merger of two Danish insulin pioneers—Nordisk Insulinlaboratorium (1923) and Novo Terapeutisk Laboratorium (1925)—traces its roots to Nobel laureate August Krogh’s efforts to bring insulin production to Denmark. Headquartered in Bagsværd, Denmark, the company operates production facilities in nine countries and offices in over 75.
Various generic manufacturersVarious generic manufacturers
Drug structure
Scale-up and manufacturing prospects
The semaglutide LAI market is projected to grow from $28.4 billion in 2024 to $93.6 billion by 2035, at a CAGR (Compound Annual Growth Rate) of ~10.5%
1. Solid-phase peptide synthesizer (e.g., Merrifield-type) 2. Reagents for Fmoc or t-Boc chemistry 3. Protective group handling systems 4. Bioreactors 5. Fermentation tanks 6. Lyophilizers (freeze-drying) 7. Spray dryers (optional) 8. Sterile mixing tanks for aqueous formulations 9. Automated purification systems (HPLC)
Semaglutide LAI synthesis involves peptide chain assembly via solid-phase synthesis, cleavage, purification (HPLC), and lyophilization. Manufacturing requires ISO Class 7 cleanrooms, strict temperature/humidity control, and aseptic fill-finish areas. Facilities must meet cGMP and FDA/EMA standards, with HEPA filtration, stainless steel surfaces, and validated HVAC systems. Process includes: 1. Peptide Backbone synthesis 2. Non natural amino acids incorporation 3. Albumin binding moiety attachment (acylation) 4. Purification 5. Final Formulation preparation
1. UPLC/HPLC systems (for purity and stability) 2. MALDI-TOF mass spectrometer 3. ELISA and LOCI assay kits (for potency and plasma concentration) 4. AlphaScreen cAMP assay system 5. LC-MS systems (for pharmacokinetic profiling)
Excipients & delivery device(s)
No proprietary excipient used
1.5 mL of prefilled ozempic injection contains: 1. Disodium phosphate dihydrate 2. 1.42 mg; propylene glycol, 3. 14.0 mg phenol, 4. 5.50 mg water for injections
No residual solvent used
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided