Eli Lilly's oral weight loss drug shows effectiveness in diabetic patients and is expected to submit for FDA approval within the year

The weight loss drug market has made a key breakthrough.

On August 26, Tuesday, American pharmaceutical giant Eli Lilly announced that the latest clinical trial data for its oral weight loss drug Orforglipron showed positive results, with an average weight loss of 10.5% in obese patients with diabetes, and side effects similar to Eli Lilly's injectable weight loss drugs, which has boosted confidence in applying for FDA approval within the year.

Although it is generally more difficult for diabetic patients to lose weight, Orforglipron still achieved ideal efficacy, outperforming Novo Nordisk's previous oral drug's 9.2% effect. Additionally, patients receiving the highest dose of Orforglipron lost an average of about 21 pounds, and significant improvements were observed in patients' blood sugar, blood pressure, blood lipids, and inflammation indicators.

As a result of this news, Eli Lilly's stock rose over 4.7% in early trading, while Novo Nordisk's stock fell over 3%.

Previous trial disappointed the market, Eli Lilly's stock plummeted

However, it hasn't been smooth sailing. Earlier this month, the trial results of Orforglipron in the "non-diabetic" group disappointed the market, with an average weight loss of only 12.4%, and both the weight loss effect and incidence of side effects were below investor expectations.

After the results were announced, Eli Lilly's stock plummeted, reaching its lowest point since January 2024. As of the close on Monday, Eli Lilly's stock had fallen over 10% this year, while its Copenhagen-listed competitor Novo Nordisk had dropped over 43%.

In response to market pressure, Eli Lilly executives and board members collectively "stepped in to buy the dip," purchasing a total of $4.5 million in company stock after the disappointing trial results, marking the largest internal buyback since 2019.

A new round of "oral drug wars" has begun

Analysts expect the global weight loss drug market to reach $95 billion by 2030. Although Eli Lilly and its competitor Novo Nordisk's injectable weight loss drugs have fundamentally changed the treatment of obesity, oral drugs are key to unlocking a larger market.

Injectable drugs are expensive and require cold chain storage and transportation, which poses real limitations to their widespread use. In contrast, oral drugs are not only easier to store and transport but also have lower manufacturing costs. Once approved, they are expected to cover a potential global market of 1 billion users. Eli Lilly's Executive Vice President Kenneth Custer stated:

"There are over 1 billion people worldwide who could benefit from weight loss drugs, and injectable drugs alone cannot meet the demand."

However, to date, oral drugs still face scientific challenges, with many trial results not meeting investor expectations. Currently, no pharmaceutical company has received approval for an oral weight loss drug, so every round of trial results is closely watched by the market.

Novo Nordisk has submitted its first oral weight loss drug for approval in May 2025. Eli Lilly stated that it will submit its Orforglipron approval application to the FDA by the end of this year, and if approved smoothly, it is expected to be on the market in 2026. Custer stated that it expects to apply for approval from the U.S. FDA later this year, and we are very much looking forward to bringing this potential drug to patients as soon as possible