A U.S. compounding organization is marketing an unlicensed, under-the-tongue form of the weight-loss drug semaglutide to private doctors in the U.K., prompting a safety warning from Novo Nordisk, which makes the branded versions.
The Professional Compounding Centers of America (PCCA) is offering a sublingual semaglutide — a custom-made, unbranded preparation designed to dissolve under the tongue and be absorbed through the lining of the mouth. It is marketed as a way to reduce the stomach side effects associated with oral formulations.
Not approved, not tested
Crucially, the product is not approved by the U.K.’s MHRA and has not been clinically tested for safety or effectiveness. U.K. rules permit compounding to tailor a medicine for an individual patient but prohibit mass compounding — making unlicensed medicines at scale — which is where products like this raise legal and safety questions.
Novo Nordisk pushes back
“We do not condone mass compounding, which provides a significant risk to the safety of patients,” Novo Nordisk said. The company markets authorized versions of semaglutide, including injectable Wegovy and an oral pill. The dispute echoes a running battle between manufacturers and compounders in the U.S., and highlights a “two-tier” system in U.K. weight-loss care, where private clinics move faster than the public system.
This article describes a regulatory dispute and is not a recommendation. Unlicensed compounded medicines have not been assessed by regulators for safety or effectiveness.