Pharma giants vie for oral GLP-1R approval

Race to create first oral drug for obesity intensifies

The competition to gain approval for the first oral GLP-1R drug for obesity is heating up, with four phase 3 trials currently in progress, according to GlobalData.

Obesity, defined as an excessive accumulation of body fat, has reached epidemic levels. Predictions suggest that by 2030, half of all US adults will be obese, according to the New England Journal of Medicine. This trend presents a lucrative opportunity for drugmakers, particularly in the market for oral GLP-1R products.

Jasper Morley, Pharma Analyst at GlobalData, explains the significance: “Novo Nordisk and Eli Lilly are leading the charge to expand their GLP-1R portfolios and secure their positions as frontrunners in the oral GLP-1R for obesity category.”

Currently, four innovative GLP-1R drugs for obesity are approved globally, including Novo Nordisk’s Wegovy and Saxenda, Eli Lilly’s Zepbound, and Shanghai Benemae Pharmaceutical’s Yishengtai.

However, all these drugs are injectables, which require professional administration. Morley highlights the benefits of oral alternatives: “Oral drugs offer convenience, lower development costs, and simpler marketing.”

The current front-runners in the oral GLP-1R market include Novo Nordisk’s Rybelsus and NN-9932, as well as Eli Lilly’s orforglipron calcium.

Rybelsus, already approved for cardiovascular risk factors and type 2 diabetes, is being considered for an obesity label expansion. NN-9932 is expected to launch by the end of 2025, with a 35% likelihood of approval, according to Morley.

Eli Lilly’s orforglipron calcium could become the first oral GLP-1R approved for obesity by 2026, aiming to solidify Eli Lilly’s market dominance.

China-based Jiangsu Hengrui’s HRS-9531 is the only phase 3 contender not developed by pharma giants Novo Nordisk or Eli Lilly, highlighting the growing interest from global players in this market.

Morley concludes: “With expected sales for GLP-1Rs in obesity to surpass $126 billion by 2030, this drug category is highly lucrative for developers. Novo Nordisk and Eli Lilly are poised to capitalise on their success in the injectable segment as the emergence of oral therapies reshapes the landscape.”