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Lilly's oral GLP-1 Foundayo clears cardiovascular safety bar in largest type 2 diabetes trial

Lilly's oral GLP-1 Foundayo clears cardiovascular safety bar in largest type 2 diabetes trial

New Capabilities

Lilly's oral GLP-1 wins approval in China and shows sleep-apnea benefits, while EU and US decisions remain pending

3 days ago: China approves Foundayo for weight management

Overview

Updated 7 hours ago

Lilly's Foundayo won approval in China on November 12 for weight management, making it the first oral GLP-1 pill cleared there for that use. The drug is already approved in the US, the United Arab Emirates and the UK, and European regulators recommended it for obesity and type 2 diabetes on October 15.

Lilly filed its US type 2 diabetes application in September and plans to ask the FDA to add obstructive sleep apnea by the end of the year, after a phase 3 trial showed the pill cut nighttime breathing pauses by 43.8% in patients not using a breathing machine. Foundayo generated $184 million in third-quarter sales, and Lilly says its share of new US oral obesity prescriptions is approaching four in 10. The European Commission is expected to decide on EU approval around December 21.

Why it matters

A pill that works without fasting or injections gives millions another option for obesity and diabetes, and Lilly now sells it in four countries.

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Key Indicators

16%
Lower risk of MACE-4 events vs insulin glargine
Heart attack, stroke, cardiovascular death, or hospitalization for unstable chest pain (hazard ratio 0.84).
57%
Lower risk of all-cause death vs insulin glargine
Pre-planned analysis; not controlled for multiplicity (nominal p = 0.002).
43.8%
Fewer apnea-hypopnea events in non-PAP OSA patients
Foundayo cut events per hour by 21.1 at 52 weeks, compared with 4.3 for placebo, in patients not using positive airway pressure therapy.
$184M
Third-quarter Foundayo sales
Citi said the total fell short of analyst expectations.
Nov 12, 2026
China approval for weight management
China's drug regulator cleared Foundayo, the first oral GLP-1 of its kind approved for weight management there.
Oct 15, 2026
EU panel recommends approval
CHMP backed Foundayo for obesity and type 2 diabetes; the European Commission decision is expected around December 21.
April 2026
FDA approval for obesity
Orforglipron cleared for chronic weight management; the type 2 diabetes application was filed in September 2026.

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People Involved

RB
Rachel Batterham
Senior vice president of medical innovation and external engagement, Lilly Cardiometabolic Health
Active

Organizations Involved

Eli Lilly and Company
Eli Lilly and Company
Pharmaceutical company
Markets Foundayo in the US, UAE, UK and China after China's November 12 approval; CHMP recommended EU approval on October 15; filed US type 2 diabetes application in September; reported $184 million in third-quarter sales.

Indianapolis drugmaker that developed Foundayo, an oral GLP-1 receptor agonist.
Novo Nordisk
Novo Nordisk
Pharmaceutical company
Markets oral semaglutide (Rybelsus) for diabetes and an oral Wegovy pill for obesity; its oral Wegovy application is under review in China after Lilly's Foundayo won approval there first.

Danish drugmaker that markets oral semaglutide (Rybelsus) for diabetes and an oral Wegovy pill for obesity.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulator
Approved Foundayo for obesity in April 2026; reviewing Lilly's type 2 diabetes application filed in September 2026; expects an obstructive sleep apnea application by the end of 2026.

US regulator responsible for approving new drugs and reviewing clinical trial data.

Timeline

April 2026 November 2026

9 events Latest: 3 days ago
Tap a bar to jump to that date

  1. China approves Foundayo for weight management

    Latest Regulatory

    China's National Medical Products Administration cleared Foundayo, making it the first oral GLP-1 pill approved for weight management in the country. Lilly's drug is also approved in the US, UAE and UK.

  2. Foundayo cuts sleep apnea events in phase 3 trial

    Trial Results

    Lilly said the Attain-OSA program met its primary endpoint, with Foundayo reducing apnea-hypopnea events by 43.8% in patients not using positive airway pressure therapy. The company plans to file with the FDA by the end of 2026.

  3. CHMP recommends EU approval of Foundayo for obesity and type 2 diabetes

    Regulatory

    The European Medicines Agency's CHMP adopted a positive opinion on October 15 for both indications. The European Commission normally issues its decision within 67 days, which points to about December 21.

  4. Foundayo posts $184 million in third-quarter sales

    Financial

    Third-quarter Foundayo sales fell short of Citi's estimate. Lilly said its share of new US oral obesity prescriptions is approaching four in 10.

  5. Full ACHIEVE-4 results reaffirm safety and sustained metabolic gains

    Trial Results

    Lilly detailed 16% lower MACE-4 risk and 53% lower cardiovascular death risk, with A1C and weight benefits persisting through 104 weeks.

  6. EASD indirect comparison favors Foundayo over oral semaglutide 25 mg

    Conference Presentation

    Analysis of ACHIEVE-3 and PIONEER PLUS data showed greater A1C and weight reduction for Foundayo 17.2 mg at 52 weeks.

  7. Lilly files US type 2 diabetes application for Foundayo

    Regulatory

    Lilly submitted its type 2 diabetes application to the FDA in September 2026. A decision is pending.

  8. ACHIEVE-4 topline shows non-inferior heart risk, 57% lower death

    Trial Results

    Lilly reported orforglipron matched insulin glargine on heart safety and beat it on A1C and weight; FDA submission planned by end of Q2.

  9. FDA approves Foundayo for obesity

    Regulatory

    The FDA cleared orforglipron for chronic weight management. Its approval letter asked Lilly for more data on heart risk, liver injury, delayed stomach emptying, and effects in lactating women.

Scenarios

1

FDA approves Foundayo for type 2 diabetes

Likely Resolves by Q2 2027

Discussed by: Lilly company statements; analysts covering the diabetes market

Lilly filed the US type 2 diabetes application in September 2026. If the FDA accepts it with priority review, a decision could land within roughly six to ten months. Approval would make orforglipron the first small-molecule oral GLP-1 with no fasting requirement.

2

FDA approval for obesity extends Foundayo beyond diabetes

Possible Resolves by Q2 2028

Discussed by: Lilly's ATTAIN program; obesity market analysts

Lilly is running the ATTAIN program studying orforglipron for chronic weight management. Success would put the pill into the broader obesity market, where oral dosing could draw patients who avoid injectable weight-loss drugs. The timeline for a filing and decision would follow the diabetes approval.

3

Foundayo overtakes oral semaglutide in US prescriptions

Possible Resolves by End of 2028

Discussed by: Market analysts; EASD indirect comparison data

Indirect comparisons show Foundayo 17.2 mg delivers more A1C reduction and weight loss than oral semaglutide 25 mg, with no fasting rules. If approved, prescription share will reveal whether the pill becomes the standard oral GLP-1 or whether Novo's brand loyalty holds.

4

European Commission approves Foundayo for obesity and type 2 diabetes

Likely Resolves by Nov 30, 2026

Discussed by: European Medicines Agency CHMP; Lilly's international regulatory strategy

The CHMP adopted a positive opinion on October 15. The European Commission normally issues its decision within 67 days, which points to about December 21. Approval would make Foundayo the second oral GLP-1 for weight management in the EU, after Novo's Wegovy pill.

5

Lilly files Foundayo for obstructive sleep apnea with FDA

Likely Resolves by End of 2026

Discussed by: Lilly executives; Fierce Pharma

Lilly said it plans to submit phase 3 Attain-OSA data to the FDA by the end of 2026. The trial showed Foundayo cut apnea-hypopnea events by 43.8% in patients not using positive airway pressure therapy.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

September 2019

Rybelsus oral semaglutide launch (2019)

The FDA approved Rybelsus, the first oral GLP-1 drug, for type 2 diabetes. Patients had to fast 30 minutes before and after each dose and take it on an empty stomach, which limited convenience.

Then

Rybelsus sold far below Novo's injectable Ozempic, whose once-weekly dosing dominated.

Now

It proved an oral GLP-1 could work, setting the stage for small-molecule versions without the fasting burden.

Why this matters now

Orforglipron targets the same mechanism but removes the fasting requirement and shows stronger results in indirect comparisons, attacking the exact weakness that held Rybelsus back.

2017-2021

Semaglutide becomes a blockbuster (2017-2021)

Novo Nordisk's injectable semaglutide, sold as Ozempic for diabetes and Wegovy for obesity, turned GLP-1 drugs into the best-selling medicine class in the world.

Then

Demand for weight-loss drugs outstripped supply and drove Novo's valuation past most European companies.

Now

The category's scale drew Lilly and others into a fierce race for the next generation of oral options.

Why this matters now

The blockbuster market shows what an oral competitor stands to capture and why Lilly pushed orforglipron through a huge cardiovascular trial before filing.

Sources

(17)
+11
Eli Lilly and Company PR Newswire Eli Lilly Investor Relations Healio / Endocrine Today Drugs.com MedNews Nova Pharma News Cardiac Vascular News Fierce Pharma Reuters Pharmaceutical Executive Pharmaceutical Technology European Medicines Agency Pharma Journal PR Newswire Fierce Pharma Fierce Pharma European Medicines Agency