● TIER 1 — FDA-approved / recognizedGRADE AGLP-1 / incretins & amylin
Semaglutide
GLP-1 RA. Research verification: Yes (TGA pending). Origin: India. Citations verified: yes. 8 human study record(s) in the FitClinicMD studies database.
GOALS · Weight loss
FDA status
Approved: Ozempic (T2D, CV, CKD), Wegovy SC (obesity ≥12 y, CV risk reduction), Rybelsus (oral T2D), Wegovy oral 25 mg (obesity; approved Dec 2025 — label
Compounding (503A/503B)
Shortage resolved Feb 21 2025; 503A enforcement discretion ended Apr 22 2025, 503B May 22 2025. Not on 503B bulks list; 'essentially a copy' limits apply (FDA update Apr 1 2026: no action if ≤4 Rx/month of a copy)
DEA
Not controlled.
WADA (sport)
Not listed on 2026 Prohibited List (no matching section found)
Mechanism
GLP-1R agonist; t½ ~7 d (SC weekly); oral formulation with SNAC.
Human evidence · 8
Oral 25 mg in obesity. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity.
T2D+CKD kidney outcomes; 24% relative risk reduction in primary kidney composite. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes.
Network meta-analysis of GLP-1RAs (BMJ 2024). Comparative effectiveness of GLP-1 receptor agonists on glycaemic control, body weight, and lipid profile for type 2 diabetes: systematic review and network meta-analysis.
n=17,604, CVD without diabetes: MACE HR 0.80. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.
Adolescents 12-<18 y, n=201: BMI −16.1% vs +0.6%. Once-Weekly Semaglutide in Adolescents with Obesity.
n=1,961 adults, BMI≥30 (or ≥27+comorbidity), 68-wk RCT: −14.9% vs −2.4%. Once-Weekly Semaglutide in Adults with Overweight or Obesity.
T2D CV outcomes (n=3,297): MACE HR 0.74. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.
SIZE-DM trial.
RCT
Reference only. This page summarizes publicly available regulatory and research information about Semaglutide. It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.