Lilly (LLY.US) prepares for the oral weight loss drug market! Establish sufficient inventory to await FDA approval.

According to a regulatory document, pharmaceutical giant Eli Lilly (LLY.US) has established inventory for its experimental oral weight loss drug orforglipron, and is awaiting the approval decision that the US Food and Drug Administration (FDA) may make on the oral GLP-1 drug in the coming months. In the 10-K annual report filed on Thursday, the company recorded that as of December 31, 2025, the main pre-commercial inventory related to orforglipron amounted to $1.5 billion, compared to $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 has sufficient supply of orforglipron to meet expected demand. Lilly's experimental oral weight loss drug orforglipron has received a priority review designation from the US. It is expected that the drug will receive regulatory approval in the second quarter of 2026 as an oral treatment option for obese or overweight adults. Its competitor Novo Nordisk A/S Sponsored ADR Class B (NVO.US) has taken the lead in the oral weight loss drug market. Last month, the Danish pharmaceutical company launched its Wegovy tablet version for self-pay customers in the US. In June last year, Lilly released detailed data from the Phase III clinical trial ACHIEVE-1 of its oral small molecule GLP-1 drug orforglipron. The data showed that in all dose groups, this investigational drug achieved a reduction in glycated hemoglobin levels 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 taken once daily at doses of 3 mg, 12 mg, and 36 mg. Results showed that only the 12 mg and 36 mg dose groups demonstrated clinically meaningful and statistically significant effects on weight loss compared to placebo. Furthermore, Lilly noted that the safety profile of orforglipron was consistent with past tolerability data for GLP-1 drugs, with gastrointestinal discomfort being the most commonly reported adverse event. It is worth mentioning that on Thursday, it was reported that Novo Nordisk A/S Sponsored ADR Class B plans to increase its investment in Ireland to produce the oral version of its popular weight loss drug Wegovy for markets outside the US. Novo Nordisk A/S Sponsored ADR Class B's CEO, Mike Doustdar, stated that Novo Nordisk A/S Sponsored ADR Class B will expand its production facilities in Athlone, central Ireland. However, he refused to disclose the investment size. Doustdar mentioned that the oral version of Wegovy was launched in January and has become one of the most successful drug launches in history, with over 240,000 US patients currently taking it. Novo Nordisk A/S Sponsored ADR Class B is currently producing and supplying the oral version of the weight loss drug for the US market domestically. Despite intensifying price wars in the weight loss drug market, Novo Nordisk A/S Sponsored ADR Class B hopes that this oral drug will become a key weapon in reclaiming its dominance in the weight loss market and bridging the gap with its competitor Lilly.