Eli Lilly's Oral Weight-Loss Drug Foundayo Approved, the Only One That Can Be Taken Anytime Without Fasting

Eli Lilly's oral GLP-1 weight-loss drug Foundayo has received approval from the U.S. Food and Drug Administration (FDA), marking the official entry of the global weight-loss drug market into a new phase of oral medications.

On April 1, Eli Lilly announced that this weight-loss drug, named Foundayo, is taken once daily and is the only GLP-1 weight-loss pill that can be taken at any time of day without dietary or water intake restrictions.

The product will be shipped through LillyDirect, Eli Lilly's direct-to-patient platform, and will subsequently be available in major U.S. pharmacies and telehealth platforms. Insured patients can pay as little as $25 per month with a Lilly coupon, while self-paying patients will pay between $149 and $349 depending on the dosage.

According to forecasts by Wall Street analysts compiled by Bloomberg, Foundayo's sales are expected to reach $18 billion by 2030. Eli Lilly's U.S.-listed stock price saw intraday gains of up to 6% on Wednesday, while competitor Novo Nordisk ADR fell more than 2%.

(Eli Lilly closed up nearly 4% on Wednesday, while Novo Nordisk ADR fell slightly by about 1%)

Rapid Approval, Only Three Months Behind Novo Nordisk

Foundayo's approval took less than four months, benefiting from the FDA's expedited review pathway for innovative drugs of national priority.

After Eli Lilly submitted its application this year, Foundayo's launch timeline is only about three months later than Novo Nordisk's oral version of Wegovy, quickly shaping a competitive landscape between the two.

Eli Lilly acquired the global rights to orforglipron, Foundayo's active ingredient, from Japan's Chugai Pharmaceutical in 2018 for a $50 million upfront payment.

Currently, Eli Lilly has prepared substantial inventory to ensure rapid distribution and expects to obtain regulatory approval in over 40 countries within the next year.

Since 2020, Eli Lilly has invested over $55 billion in manufacturing, including building new facilities and expanding existing ones.

Slightly Inferior Efficacy, but Convenience and Accessibility Offer Differentiated Advantages

Efficacy remains a core challenge for Eli Lilly.

In their respective independent clinical trials, Wegovy's oral version helped patients lose an average of about 13.6% of their body weight over 64 weeks, while Foundayo achieved a weight loss of approximately 11% to 12.4% (varying due to different statistical methodologies).

In comparison, Eli Lilly's own injectable drug, Zepbound, resulted in a weight loss of over 20%.

Nevertheless, physicians generally agree that a weight loss of around 11% is clinically significant.

Foundayo's differentiating advantage lies in its ease of use, allowing patients to take it at any time of day without needing to fast or restrict water intake. In contrast, Wegovy's oral version must be taken in the early morning on an empty stomach with a small amount of water, and patients must wait 30 minutes before eating.

Eli Lilly CEO Dave Ricks stated in a media interview that injectables have not been the primary barrier to patient treatment uptake as Eli Lilly initially anticipated, but he still views Foundayo as an important option for patients who prefer oral medication or are seeking a lower price point.

Global Expansion Potential May Be Foundayo's Biggest Selling Point

Foundayo and Zepbound have fundamental differences in their product attributes.

Foundayo is a small molecule compound, whereas Zepbound and Wegovy injectables are both peptide-based drugs. The latter have more complex production processes and stricter cold chain logistics requirements. This characteristic gives Foundayo a unique advantage in rapid global expansion.

Ricks said:

This makes large-scale production possible, allowing us to achieve a global launch simultaneously from the outset. As long as we receive regulatory approval in various regions, we essentially have the capacity to supply oral GLP-1 inhibitors worldwide.

Currently, Wegovy's oral version is only available in the United States and has not yet been rolled out in other markets.

Ricks also pointed out that Foundayo, as a small molecule drug, will naturally avoid the competitive pressure from generic versions of Wegovy that competitors may launch in some markets (including India), as the barrier to entry for generic peptide-based drugs is inherently higher.

Price as a Key Variable, Medicare Coverage Opens Up a New Market

In terms of pricing, the lowest starting dose for both drugs is the same – $149 per month for self-paying patients, stemming from a prior agreement between Eli Lilly and Novo Nordisk with the Trump administration.

Starting this summer, Medicare beneficiaries aged 65 and older will be able to obtain Foundayo and other GLP-1 weight-loss drugs for $50 per month as part of this agreement. Ricks anticipates that this program will generate a "considerably strong" demand response, and related expectations have been incorporated into Eli Lilly's full-year financial guidance.

Nidhi Kansal, an obesity specialist at Northwestern Medicine, noted that price is currently the primary factor driving clinical decision-making.

Unfortunately, price is the driving factor in the drug selection decisions of doctors and patients. These drugs are all excellent, and we now have many options, but ultimately, this remains an economic decision.

Evan David Seigerman, an analyst at BMO Capital Markets, believes that the lower price threshold, combined with the preference for oral administration, is expected to attract previously hesitant potential patients into the market, further expanding the overall weight-loss drug market.

Foundayo's Approval is a Key Signal for Eli Lilly's Stock Stabilization

Analysts generally believe that Foundayo's successful ramp-up in sales is crucial for Eli Lilly's stock performance.

Eli Lilly's stock price has fallen about 14% from its peak year-to-date, after its market capitalization briefly exceeded $1 trillion, making it the first healthcare company in the U.S. to surpass this milestone.

Cantor Fitzgerald analyst Carter Gould stated that sales data lags actual demand, so the market will closely monitor prescription volumes to assess Foundayo's market penetration rate.

If prescription volumes trend positively and continue to gain momentum, I expect investors to be tolerant of one or two quarters of earnings fluctuations.

Concurrently, key clinical data readout for retatrutide, Eli Lilly's more potent weight-loss injectable, is also a significant catalyst for this year. Eli Lilly has disclosed some late-stage clinical data, but the core trial results specifically on weight loss effects have not yet been released.

It is analyzed that once retatrutide data meets expectations, Eli Lilly will build a comprehensive product matrix for obesity treatment covering oral and injectable medications with different efficacy tiers.

FactSet data shows that analysts expect sales for Foundayo, Zepbound, and Mounjaro (the latter approved for diabetes in the U.S. and for diabetes and obesity in other markets) to be approximately $14.8 billion, $24.7 billion, and $44.9 billion, respectively, by 2030.