Makers of knockoff in-demand weight loss drugs are fast running out of options to manufacture them legitimately as a federal court this week dismissed an attempt by compounding pharmacies to continue to produce copycats of Novo Nordisk’s semaglutide while a lawsuit plays out.

Lexicon Pharmaceuticals’ pursuit of the last word in obesity candidates has attracted Novo Nordisk. The Danish drugmaker is betting $75 million in upfront and near-term milestone payments to secure global rights to a preclinical prospect that paired well with its GLP-1 blockbuster semaglutide in mice.

Brazilian drugmaker Hypera plans to launch next year a generic version of semaglutide, the active ingredient of Novo Nordisk's blockbuster diabetes and weight-loss drug Ozempic, Hypera's chief executive said on Friday.

A recent study published in Diabetes Technology & Therapeutics has demonstrated that off-label use of semaglutide and tirzepatide leads to significant reductions in glycated haemoglobin (HbA1c) levels and body weight among adults with type 1 diabetes (T1D). These findings suggest a potential new therapeutic approach for improving glycemic control and addressing obesity in T1D, an area with few pharmacologic advancements beyond insulin therapy.

In the ongoing quest to expand semaglutide’s clinical pedigree and cement the GLP-1's market position, Novo Nordisk is rolling out new data on a higher-dose injection in obesity.

In the phase 3b STEP UP study, an experimental 7.2-mg semaglutide dose helped patients lose more weight on average at 72 weeks compared to placebo or semaglutide 2.4 mg, which is currently the highest dose of the drug marketed under the Wegovy brand for obesity.

Readouts from Novo Nordisk and Viking Therapeutics at AASLD 2024 strengthen the argument for GLP-1 therapies as an emerging backbone of MASH treatment, with the potential to combine it with other drug classes to achieve deeper responses, according to BMO Capital Markets analyst Evan Seigerman.

Novo Nordisk's CEO told CNN he is "alarmed" by the risks compounded versions of semaglutide — the active ingredient in the company's diabetes drug Ozempic and weight loss drug Wegovy — are posing to users. 

The findings position semaglutide to become the first drug of its kind for the liver disease. But they also confirm GLP-1s aren’t a “silver bullet” for MASH, one analyst argued.