Quick answer
A non-FDA-approved salt form of semaglutide. The FDA has explicitly stated that semaglutide salts (acetate, sodium) are not the same active ingredient as FDA-approved semaglutide base and should not be compounded as such.
Full definition
Semaglutide acetate and semaglutide sodium are salt forms of the semaglutide molecule that some compounding pharmacies used during the shortage period. The FDA issued multiple statements (2023-2024) clarifying that these salt forms are NOT the same as the active pharmaceutical ingredient in FDA-approved Ozempic, Wegovy, or Rybelsus, and they have not been demonstrated safe or effective. The FDA warned consumers about adverse events linked to these compounded products, and Novo Nordisk pursued legal action against pharmacies distributing them.
Deep dive
Semaglutide Acetate (Salt Forms): complete reference
Semaglutide acetate is a salt form of the semaglutide molecule that the FDA has explicitly stated is NOT an approved form для compounding into finished pharmaceutical products. The FDA-approved semaglutide active pharmaceutical ingredient (used в Wegovy/Ozempic/Rybelsus и legitimately in 503A compounding) is the base semaglutide molecule. Salt forms — including semaglutide acetate and semaglutide sodium — are chemically modified versions that haven't been evaluated for safety, potency, or efficacy. The FDA issued specific warnings against semaglutide salt-form compounding in 2023-2024, noting that cheap salt-form raw materials were being sourced by some compounders from non-FDA-registered suppliers, then compounded into finished products marketed как "semaglutide." Patients should verify their compounded preparation is labeled as "semaglutide" only — not "semaglutide acetate," "semaglutide sodium," или any variant. Reputable compounding pharmacies disclose API supplier + form on product label or upon request.
- In practice
- Your compounded GLP-1 label says "Active ingredient: semaglutide" — that's legitimate. If it says "semaglutide acetate" or "semaglutide sodium" — FDA has flagged those forms как unapproved.
- Clinical context
- Salt forms (acetate, sodium) are NOT approved. Always verify API form on compounded product label.
Medications
Semaglutide Acetate (Salt Forms) is most directly relevant to the following GLP-1 medications:
Related terms
- Compounded Semaglutide — A non-FDA-approved version of semaglutide prepared by a licensed compounding pharmacy. Was permitted…
- 503A Compounding Pharmacy — A state-licensed pharmacy that prepares patient-specific compounded medications based on a valid pre…
- FDA Drug Shortage List — An FDA-maintained list of drugs in short supply. Inclusion historically permitted compounding pharma…
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GLP1Zoom glossary is educational reference. Definitions are summary interpretations of clinical sources and not a substitute for prescribing-information detail. Full disclaimer.
References
Glucagon-Like Peptide-1 Receptor Agonists: Mechanisms и Clinical Use (Drucker, Cell Metabolism)(2018)
Tirzepatide GIP/GLP-1 Dual Agonism: Mechanism Review (Lancet Diabetes & Endocrinology)(2021)
GLP-1 Effects on Gastric Emptying: Pharmacology Review (American J Physiology)(2020)
Endocrine Society Clinical Practice Guideline: Pharmacological Management of Obesity(2015)
STEP-1 trial: Once-Weekly Semaglutide in Adults with Overweight or Obesity (Wilding et al., NEJM)(2021)
SURMOUNT-1 trial: Tirzepatide Once Weekly для Treatment of Obesity (Jastreboff et al., NEJM)(2022)
SUSTAIN-6 trial: Semaglutide and Cardiovascular Outcomes (Marso et al., NEJM)(2016)
SURPASS-2 trial: Tirzepatide vs Semaglutide в Type 2 Diabetes (Frias et al., NEJM)(2021)
LEADER trial: Liraglutide and Cardiovascular Outcomes в T2D (Marso et al., NEJM)(2016)