Eli Lilly(LLY.US) prepares for the oral weight loss drug market! Building sufficient inventory awaiting FDA approval

According to a regulatory document, pharmaceutical giant Eli Lilly (LLY.US) has built up inventory for its experimental weight-loss oral drug orforglipron, awaiting a potential approval decision from the U.S. Food and Drug Administration (FDA) within the next few months.

In the company’s 10-K annual report filed on Thursday, it was recorded that as of December 31, 2025, the pre-market inventory related to orforglipron amounted to $1.5 billion, up from $548.1 million a year earlier. Lilly’s Chief Medical Officer stated in January that once the FDA approves this once-daily pill, the company will have enough orforglipron supply to meet expected demand.

Lilly’s experimental weight-loss oral drug orforglipron has received a U.S. Breakthrough Therapy designation. Currently, the drug is expected to gain regulatory approval in the U.S. by the second quarter of 2026 as an oral treatment option for obese or overweight adults. Its competitor, Novo Nordisk (NVO.US), has already gained an early advantage in the oral weight-loss drug market. Last month, the Danish pharmaceutical company launched a tablet version of Wegovy for self-paying customers in the U.S.

Last June, Lilly announced detailed data from its Phase 3 clinical trial ACHIEVE-1 of the oral small-molecule GLP-1 drug orforglipron. The data showed that across all dose groups, the investigational drug achieved an average HbA1c reduction of 1.3% to 1.6% in adults with type 2 diabetes, with improvements observed within four weeks of treatment. Additionally, the high-dose group achieved an average weight loss of nearly 8% by week 40.

In the trial, orforglipron was administered once daily at doses of 3 mg, 12 mg, and 36 mg. Results indicated that only the 12 mg and 36 mg dose groups showed clinically meaningful and statistically significant weight loss compared to placebo. Furthermore, Lilly noted that the safety profile of orforglipron was consistent with previous tolerability data for the GLP-1 drug class, with gastrointestinal discomfort being the most frequently reported adverse event.

Notably, reports on Thursday indicated that Novo Nordisk plans to increase investment in Ireland to locally produce its best-selling weight-loss drug Wegovy in oral form, to supply markets outside the U.S. CEO Mads Dyrholm stated that Novo Nordisk will expand its manufacturing facility in Athlone, central Ireland, but declined to disclose the investment amount.

Dyrholm said that the oral Wegovy launched in early January has become one of the most successful drug launches in history, with over 240,000 U.S. patients currently taking it. Novo Nordisk currently produces and supplies the oral weight-loss medication for the U.S. market domestically. Despite intensifying price competition in the weight-loss drug market, Novo Nordisk hopes this oral drug will be a key weapon in regaining its former dominance in the weight-loss market and closing the gap with competitor Lilly.