Plain-language definitions of every regulatory, clinical, and pharmacy term used in our reviews. 33 entries.
A once-weekly subcutaneous (or once-daily oral) GLP-1 receptor agonist manufactured by Novo Nordisk. Brand names: Ozempic (FDA-approved for type 2 diabetes), Wegovy (chronic weight management; cardiovascular risk reduction in adults with overweight/obesity + established CVD), and Rybelsus (oral type 2 diabetes formulation).
Brand name for semaglutide manufactured by Novo Nordisk, FDA-approved for type 2 diabetes mellitus (December 2017). Once-weekly subcutaneous injection (max 2.0 mg).
Brand name for semaglutide 2.4 mg manufactured by Novo Nordisk. FDA-approved for chronic weight management (June 2021); expanded in March 2024 for cardiovascular risk reduction in adults with overweight/obesity and established cardiovascular disease.
Brand name for oral semaglutide manufactured by Novo Nordisk, FDA-approved for type 2 diabetes (September 2019). Daily oral tablet (3, 7, 14 mg).
Patient-specific or office-stock semaglutide preparation dispensed by a 503A licensed compounding pharmacy or 503B FDA-registered outsourcing facility. Compounded semaglutide is NOT FDA-approved and is NOT the same as Ozempic, Wegovy, or Rybelsus.
A dual GLP-1/GIP receptor agonist manufactured by Eli Lilly. Brand names: Mounjaro (T2D), Zepbound (chronic weight management; OSA in adults with obesity).
A state-licensed compounding pharmacy under Section 503A of the FDCA. Patient-specific compounded preparations under valid prescriptions, USP <797> sterile compounding standards. State pharmacy board oversight.
An FDA-registered outsourcing facility under Section 503B of the FDCA. Office-stock compounded medications under cGMP. Subject to FDA inspection. Listed in the FDA's public Outsourcing Facility Registration database.
Pharmacy Compounding Accreditation Board. Voluntary third-party accreditation administered by ACHC. Signals USP <797> sterile compounding adherence above state minimums.
United States Pharmacopeia chapter governing sterile compounding. Defines facility, equipment, personnel, environmental, and procedural standards for sterile compounded medications.
USP chapter on sterility testing. Required for sterile compounded medications including injectable peptides.
USP chapter on bacterial endotoxins testing for sterile preparations.
High-Performance Liquid Chromatography test that measures concentration of an active pharmaceutical ingredient.
Document issued by a pharmacy or manufacturer for a specific lot, listing test results including sterility, endotoxin, and potency. Reputable telehealth providers supply per-vial CoAs on patient request.
Medication that has completed the FDA's NDA process. Compounded medications are NOT FDA-approved.
Third-party certification verifying online pharmacies and telehealth providers. Required by Google, Bing, and Meta to advertise prescription medications.
Medications that activate the glucagon-like peptide-1 receptor: enhanced glucose-dependent insulin secretion, glucagon suppression, slowed gastric emptying, reduced caloric intake.
A medication that activates the glucose-dependent insulinotropic polypeptide receptor. Tirzepatide is the first dual GLP-1/GIP; semaglutide is GLP-1-only.
Standard semaglutide titration for weight management: 0.25 → 0.5 → 1.0 → 1.7 → 2.4 mg weekly subcutaneous, ~4 weeks per step. 0.25 mg is starting/tolerability dose, not maintenance.
Standard semaglutide titration for type 2 diabetes: 0.25 → 0.5 → 1.0 → 2.0 mg weekly subcutaneous.
Body Mass Index criteria for Wegovy: BMI ≥30, OR BMI ≥27 with weight-related comorbidity. 2024 expansion: adults with overweight/obesity + established CVD (no BMI floor for CV indication).
Medullary thyroid carcinoma. Personal or family history of MTC is a contraindication for semaglutide.
Multiple Endocrine Neoplasia syndrome type 2. Hereditary cancer syndrome characterized by MTC. Contraindication for semaglutide.
Pivotal semaglutide weight-loss trial in adults without diabetes (NEJM 2021, n=1,961, PMID 33567185). 14.9% mean weight loss at 2.4 mg / 68 weeks vs 2.4% placebo.
Cardiovascular outcomes trial in non-diabetic adults with overweight/obesity + established CVD (NEJM 2023, PMID 37952131). 20% MACE reduction over median 39.8 months. Led to Wegovy's 2024 FDA expansion.
Kidney outcomes trial in T2D + CKD (NEJM 2024, PMID 38785189). 24% reduction in major kidney/CV events over median 3.4 years.
Semaglutide CV safety trial in T2D + high CV risk (NEJM 2016, PMID 27633186). 26% MACE reduction. Led to Ozempic's 2017 FDA approval.
Head-to-head trial of tirzepatide vs semaglutide 1 mg in adults with type 2 diabetes (NEJM 2021, PMID 34170647). Tirzepatide ~47% greater weight loss.
FDA's most stringent warning. Semaglutide carries a boxed warning regarding thyroid C-cell tumors observed in rodent studies; relevance to humans unknown.
US Telehealth Review's v3.0 scoring rubric: clinical protocol & MD (20 pts), pharmacy traceability & CoA (20), cohort outcomes & AE (20), flat pricing (15), labs & follow-up (15), regulatory clarity (10). 100 points total. 70% per-pillar threshold for transparency-compliant designation.
NexLife's structured lifestyle and clinical-coaching layer included with all NexLife semaglutide plans.
Pricing model where monthly cost stays constant across full medication titration — no price increase as the patient escalates from 0.25 mg to 2.4 mg. NexLife's $145/mo (12-mo plan) is flat across the entire 0.25-2.4 mg titration.
Semaglutide sodium and semaglutide acetate are unapproved active ingredients targeted by FDA warning letters to compounders. Reputable 503A and 503B pharmacies dispense only semaglutide base (peptide form), not salt forms.