How are small-molecule drugs faring in new drug approvals by FDA and among potential blockbuster contenders? DCAT Value Chain Insights takes an inside look.

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Small-molecule contenders
In terms of rising stars among small-molecule drugs, a key entry is Eli Lilly and Company’s oral obesity drug, Foundayo (orforglipron), a once-daily small-molecule (non-peptide) oral glucagon-like peptide-1 (GLP-1) receptor agonist for treating obesity, which received US Food and Drug Administration approval in April (April 2026). The drug can be taken any time of the day without restrictions on food and water intake. Analysts project blockbuster potential (defined as sales of $1 billion or more) for the drug with the oral administration being a key driver for revenue potential.

The drug will enter the high-growth obesity and metabolic disease market, which is projected to reach $150 billion by 2035, according to a recent analysis by Clarivate. The industry’s success stories in this area were peptide drugs with Novo Nordisk riding a blockbuster wave with Ozempic/Wegovy (semaglutide), respectively for treating Type 2 diabetes and obesity, and Eli Lilly and Company also riding the wave with Mounjaro/Zepbound (tirzepatide), a dual-activating GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 medication, respectively for treating Type 2 diabetes and obesity.   

Orforglipron has once-daily oral administration to manage overweight/obesity and treat Type 2 diabetes. It can be taken without food or water restrictions at any time of the day. As such, it represents a breakthrough in convenience and accessibility compared with injectable alternatives, according to the Clarivate analysis. 

Clarivate projects a blockbuster future for orforglipron with expected sales of $11.1 billion for obesity in G7 markets (Canada, France, Germany, Italy, Japan, the UK, and the US) in 2031, and $5.2 billion in expected sales for Type 2 diabetes in the G7 markets in 2031. Near term, the drug is expected to launch in 2026 in the US for treating Type 2 diabetes, and in 2027 in the US for treating obesity and in the European Union (EU), Japan, and the UK for treating obesity and Type 2 diabetes in 2027. The drug is also being evaluated for obstructive sleep apnea and hypertension in individuals with obesity.