Semaglutide salt versus base formulations: a regulatory and pharmacovigilance imperative
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20261130Abstract
Obesity is one of the most dreaded epidemics in the world, and it is a significant challenge to global public health that must be addressed aggressively through clinical and pharmacological interventions. The unprecedented rise in the global use of glucagon-like peptide-1 receptor agonists for the treatment of obesity and type 2 diabetes has created a critical regulatory and pharmacological challenge related to the proliferation of mass-marketed compounded alternatives.
References
Selvan N. Modern pharmacotherapy of obesity: molecular mechanisms, clinical efficacy and future therapeutic directions. Int J Basic Clin Pharmacol. 2026;15(2):385-91.
FDA. FDA intends to take action against non-FDA-approved GLP-1 drugs. News release. 2026. Available at: https://www.fda.gov/news-events/press-announce ments/fda-intends-take-action-against-non-fda-approved-glp-1-drugs?utm_medium=email&utm_ source=govdelivery. Accessed on 11 February 2026.
FDA. FDA’s concerns with unapproved GLP-1 drugs used for weight loss. 2026. Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss. Accessed on 11 February 2026.
Lovells H. FDA and HHS taking action against telehealth’s compounded drug advertising. 2025. Available at: https://www.hklaw.com/en/insights/ publications/2025/09/fda-hhs-taking-action-against-telehealths-compounded-drug-advertising. Accessed on 11 February 2026.
FDA. Understanding the risks of compounded drugs. 2026. Available at: https://www.fda.gov/drugs/ human-drug-compounding/understanding-risks-compounded-drugs. Accessed on 11 February 2026.
Tyrer JH, Eadie MJ, Sutherland JM, Hooper WD. Outbreak of anticonvulsant intoxication in an Australian city. Br Med J. 1970;4(5730):271-3.
Jeremias S. FDA to Restrict Ingredients Used in Mass-Marketed Compounded GLP-1s, Crack Down on Misleading Ads. Am J Manag Care. 2026;6.
Kommu S, Whitfield P. Semaglutide. In: StatPearls. Treasure Island (FL): StatPearls Publishing. 2024. Available at: https://www.ncbi.nlm.nih.gov/books/ NBK562888/. Accessed on 11 February 2026.
U.S. Food and Drug Administration. FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs. Silver Spring (MD): FDA. 2026. Available at: https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs. Accessed on 11 February 2026.