According to a regulatory filing, pharmaceutical giant Eli Lilly (LLY.US) has built up inventory for its experimental oral weight-loss drug orforglipron, awaiting a potential approval decision from the U.S. Food and Drug Administration (FDA) in the coming months. In the 10-K annual report filed on Thursday, the company recorded $1.5 billion in pre-launch inventory related to orforglipron as of December 31, 2025, compared to $548.1 million a year earlier. Eli Lilly's Chief Medical Officer stated in January that once the FDA approves the once-daily pill, the company has sufficient orforglipron supply to meet anticipated demand. The experimental oral weight-loss drug orforglipron has received a U.S. Priority Review voucher. The drug is expected to receive U.S. regulatory approval in the second quarter of 2026 as an oral treatment option for obese or overweight adults. Its competitor Novo-Nordisk A/S (NVO.US) has already gained a first-mover advantage in the oral weight-loss drug market. Last month, the Danish drugmaker launched a U.S. version of its Wegovy pill for self-paying customers. In June of last year, Eli Lilly released detailed data from the phase 3 clinical trial ACHIEVE-1 for its oral small-molecule GLP-1 drug orforglipron. The data showed that across all dose groups, the investigational drug achieved an average reduction in HbA1c of 1.3% to 1.6% in adult patients with type 2 diabetes, with improvements observed within four weeks of treatment. Furthermore, the high-dose group achieved an average weight loss of nearly 8% at 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 demonstrated clinically meaningful and statistically significant weight loss compared to placebo. Additionally, Eli Lilly noted that orforglipron's safety profile was consistent with previous tolerability data for the GLP-1 drug class, with gastrointestinal discomfort being the most frequently reported adverse event. Notably, a report on Thursday stated that Novo-Nordisk plans to increase investment in Ireland to produce an oral version of its blockbuster weight-loss drug Wegovy for markets outside the U.S. Novo-Nordisk CEO Mike Darsdal stated the company will expand its production facility in Athlone, central Ireland, but declined to disclose the investment size. Darsdal said the oral Wegovy, launched in early January, has become one of the most successful drug launches ever, with over 240,000 U.S. patients already taking it. Novo-Nordisk currently produces the oral version of its weight-loss drug for the U.S. market domestically. Although price competition in the weight-loss drug market is intensifying, Novo-Nordisk hopes this oral formulation will be a key weapon to regain its former dominance in the weight-loss market and close the gap with competitor Eli Lilly.