An unlicensed semaglutide-based product that is administered under the tongue is being marketed to private doctors in the UK despite the branded medicine’s manufacturer warning of safety concerns.
According to an alert sent by Professional Compounding Centers of America (PCCA) to its members, which has been seen by Pharmaceutical Technology, sublingual semaglutide is being offered as an alternative to injectable and tablet forms of glucagon-like peptide-1 receptor agonists (GLP-1RAs).
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Compounded drugs are custom-made and unbranded medications that contain the same active ingredient as a marketed drug. While the UK permits compounding for personalised drug regimens or formulations, mass compounding is not allowed. Sublingual semaglutide has neither been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) nor has its efficacy and safety been evaluated through formal clinical trials.
Semaglutide does have marketing authorisation under the brand name Wegovy. Manufactured by Novo Nordisk, it is available as a weekly injectable or daily pill.
In a statement to Pharmaceutical Technology, a Novo spokesperson said: “We work in close collaboration with healthcare systems, providers and other stakeholders to keep patients safe.
“We do not condone mass compounding, which provides a significant risk to the safety of patients. We recommend patients speak with their healthcare professional about the best treatment for them.”
PCCA says it offers its sublingual version to give patients improved comfort, flexibility, and tolerability. Drugs that dissolve under the tongue are absorbed through the oral mucosa, bypassing the gastrointestinal tract.
“PCCA is the first specials manufacturer to offer a sublingual semaglutide, filling the range gaps of tablets and pens while minimising gastric issues.”
Stomach pain is a recognised side effect of Wegovy because the drug slows down gastric emptying and affects gut motility. As with oral Wegovy, PCCA’s sublingual version must be taken on an empty stomach.
There is already a heightened focus on obesity treatment in the UK after a recent report found that most London-based patients opt to access weight loss drugs through the private sector. Findings from the London Assembly’s health committee suggest a “two-tier system” of weight loss drug accessibility emerging in the UK’s capital. As of November 2025, just 3,000 London residents were accessing weight loss medicines on the NHS, compared to tens of thousands buying them privately.
US sets pace for personalised drug alternatives
The UK’s compounding scene, meanwhile, is significantly smaller than that of the US, which has burgeoned in the wake of weight loss drug popularity. Some US telehealth companies took advantage of regulatory loopholes to mass-market products to patients. The US Food and Drug Administration (FDA) has since clamped down on many providers, though a legislatively grey area still exists.
A duality in the obesity market has emerged over recent years in the US, with some patients opting for branded products and others going for the cheaper compounded versions. Both Novo and its rival Eli Lilly – developer of Mounjaro (tirzepatide) – have launched a plethora of legal notices against players in the compounded sector. This includes Novo suing Hims & Hers – one of the largest providers of compounded weight loss products in the US. Others have opted to steer clear, such as WeightWatchers u-turning on its decision to offer compounded semaglutide.
The obesity market across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) is forecast to reach $173.5bn by 2031, as per GlobalData analysis.
GlobalData is the parent company of Pharmaceutical Technology.
