Eli Lilly

Molecules

• Tirzepatide · Mounjaro, Zepbound
• Dulaglutide · Trulicity
• Orforglipron · Foundayo
• Retatrutide
• Eloralintide
• Mazdutide · Xinermei

Key events

1. 2026-08-28

   FDA approves Mounjaro to lower cardiovascular risk in adults with type 2 diabetes

   Eli Lilly announced on 28 August 2026 that the FDA approved Mounjaro to lower the risk of major cardiovascular events in adults with type 2 diabetes at high risk. The approval was based on SURPASS-CVOT, which compared tirzepatide with dulaglutide and showed non-inferiority.[src]

2. 2026-08-27

   Fifth Circuit upholds the FDA's tirzepatide shortage decision

   On 27 August 2026 the US Court of Appeals for the Fifth Circuit affirmed the lower court's ruling in Outsourcing Facilities Association v. FDA (No. 25-10600). It held that the FDA's decision to remove tirzepatide from its shortage list did not violate the Administrative Procedure Act, either for lack of notice-and-comment rulemaking or as arbitrary and capricious. The opinion is not designated for publication.[src]

3. 2026-08-12

   Lilly files six lawsuits over unapproved retatrutide products

   On 12 August 2026 Eli Lilly said it had filed six new lawsuits against US entities including compounding pharmacies, medical spas and online sellers over products marketed as retatrutide, which is not approved anywhere. Lilly said it had reported more than 14,000 websites, advertisements, social media posts and product listings and referred more than 200 parties to authorities. The allegations are Lilly's and had not been decided by a court at the time of the announcement.[src]

4. 2026-08-10

   UK MHRA approves orforglipron, the first approval in Europe

   The MHRA authorised orforglipron (Foundayo) on 10 August 2026 for weight management and for type 2 diabetes, saying the UK was the first country in Europe to do so. The MHRA noted it was not currently available via the NHS, where decisions follow established processes including a NICE evaluation.[src]

5. 2026-07-23

   Lilly reports two more phase 3 retatrutide trials, with up to about 21% to 23% weight loss at 80 weeks

   Lilly announced on 23 July 2026 that TRIUMPH-2 (adults with obesity or overweight and type 2 diabetes) reached up to 20.8% average weight loss and TRIUMPH-3 (severe obesity and established cardiovascular disease) up to 22.6% at 80 weeks, figures reported as if everyone had stayed on treatment. These are company-reported results. Lilly said it plans to submit retatrutide to the FDA for approval in the first quarter of 2027.[src]

6. 2026-07-21

   Novo Nordisk sues Eli Lilly over GLP-1 advertising

   On 21 July 2026 Novo Nordisk filed a lawsuit against Eli Lilly in federal court in New Jersey, according to CNBC. Novo alleges false advertising and unfair competition, including under the Lanham Act, in Lilly's advertising for its obesity and diabetes medicines such as Zepbound. Lilly said it stands firmly behind its advertising. These are allegations that no court had ruled on at the time of the report.[src]

7. 2026-07-01

   Medicare GLP-1 Bridge set to start, with a $50 co-pay for eligible weight-management prescriptions

   CMS's Medicare GLP-1 Bridge, a short-term demonstration, was set to give eligible Part D beneficiaries access to certain GLP-1 drugs for weight management at a $50 co-pay from 1 July 2026, outside the normal Part D benefit. CMS lists Wegovy (injection and tablets), Foundayo and Zepbound (KwikPen) as eligible. In April 2026 CMS extended the Bridge to run through 31 December 2027.[src]

8. 2026-05-21

   Lilly reports phase 3 TRIUMPH-1 results for retatrutide: up to about 28% weight loss at 80 weeks

   Lilly announced topline results from the TRIUMPH-1 phase 3 trial on 21 May 2026. On the highest dose, average weight loss at 80 weeks was 28.3% (versus 2.2% on placebo) if everyone had stayed on treatment, and 25.0% (versus 3.9%) counting everyone regardless of whether they stayed on treatment. These are company-reported results from a press release. Retatrutide is investigational and was not approved anywhere at the time of the release.[src]

9. 2026-04-01

   FDA approves Foundayo (orforglipron), a once-daily GLP-1 pill

   The FDA approved Foundayo (orforglipron), a tablet GLP-1 receptor agonist made by Eli Lilly, on 1 April 2026. It is taken by mouth as a tablet.[src][src]

10. 2026-02-05

    TrumpRx.gov launches with GLP-1 cash prices from Lilly and Novo Nordisk

    The White House launched TrumpRx.gov on 5 February 2026. Its fact sheet said Ozempic and injectable Wegovy would cost an average of $350 and as low as $199 per month, the Wegovy pill as low as $149, and Zepbound an average of $346 and as low as $299. These are government-stated prices for cash purchases.[src]

11. 2025-11-06

    White House announces pricing agreements with Eli Lilly and Novo Nordisk

    On 6 November 2025 the White House announced agreements with Lilly and Novo Nordisk that it said would set Medicare and Medicaid prices for Ozempic, Wegovy, Mounjaro and Zepbound at $245, with a $50 monthly co-pay for Medicare patients covered for obesity. It also described lower cash prices through TrumpRx, and US manufacturing investment pledges from both companies.[src]

12. 2025-09

    Mounjaro's UK list price rises from September 2025

    The Drug Tariff reimbursement prices for Mounjaro (tirzepatide) were redetermined from September 2025 to reflect an increase in the NHS list price. For example, the highest-priced pack rose from £122 to £330 and the lowest-priced pack from £92 to £133.[src]

13. 2025-07-01

    CVS Caremark stops covering Zepbound and keeps Wegovy

    From 1 July 2025, CVS Caremark, a large US pharmacy benefit manager, stopped covering Zepbound for its members and continued to cover Wegovy. CVS said the decision was intended to make the two manufacturers compete on price.[src]

14. 2025-06-27

    China approves mazdutide for chronic weight management

    Innovent announced on 27 June 2025 that China's NMPA approved mazdutide, a dual glucagon and GLP-1 receptor agonist, for chronic weight management in adults with overweight or obesity. The approval was supported by the GLORY-1 phase 3 trial.[src]

15. 2025-05-25

    GLORY-1: mazdutide produces about 14% weight loss at 48 weeks in Chinese adults

    In the GLORY-1 phase 3 trial of 610 Chinese adults with obesity or overweight, mean body weight fell by up to 14.0% at week 48 with mazdutide, while the placebo group changed by +0.3%.[src]

16. 2025-05-11

    SURMOUNT-5: tirzepatide beats semaglutide for weight loss in a head-to-head trial

    In a 72-week randomised trial of 751 adults with obesity, average weight loss was 20.2% with tirzepatide and 13.7% with semaglutide. Results were published in NEJM.[src]

17. 2025-04-24

    Court denies compounders' request to block the semaglutide shortage decision

    On 24 April 2025 the federal district court in the Northern District of Texas denied the preliminary injunction sought by the Outsourcing Facilities Association in its case over the FDA's semaglutide decision. The court had denied a similar request about tirzepatide on 5 March 2025, so the FDA's enforcement grace periods proceeded.[src]

18. 2025-04-23

    Lilly files lawsuits against four telehealth companies over compounded tirzepatide

    On 23 April 2025 Eli Lilly filed complaints against four telehealth companies, according to NPR. One complaint alleges the defendant switched patients to compounded tirzepatide with added ingredients such as niacinamide. These are allegations in complaints that had not been decided by a court when they were reported.[src]

19. 2024-12-23

    NICE recommends tirzepatide for obesity on the NHS in England, with a phased roll-out

    NICE published its final guidance TA1026 on 23 December 2024, recommending tirzepatide (Mounjaro) for adults with obesity who meet BMI and weight-related condition criteria. Funding was set to be introduced in phases, following NHS England's interim commissioning guidance.[src]

20. 2024-12-19

    FDA reevaluates and again finds the tirzepatide shortage resolved

    On 19 December 2024 the FDA issued a declaratory order that revoked and replaced its October decision and again determined the tirzepatide shortage was resolved. The FDA said it would not act against compounders for shortage-dependent conditions until 18 February 2025 for state-licensed pharmacies and 19 March 2025 for outsourcing facilities.[src][src]

21. 2024-10-02

    FDA declares the tirzepatide shortage resolved and removes it from the shortage list

    The FDA determined on 2 October 2024 that the shortage of tirzepatide injection products (Mounjaro and Zepbound) was resolved and removed them from its shortage list. A compounder trade group and a compounding business challenged the decision in court, and the FDA later reevaluated it.[src][src]

22. 2023-11-08

    FDA approves Zepbound (tirzepatide) for chronic weight management

    The FDA approved Zepbound on 8 November 2023 for chronic weight management in adults with obesity, or with overweight and at least one weight-related condition, alongside diet and physical activity.[src][src]

23. 2023-06-26

    Retatrutide phase 2 trial: up to about 24% weight loss at 48 weeks

    In a phase 2 trial of 338 adults with obesity or overweight, retatrutide, an investigational triple GIP, GLP-1 and glucagon receptor agonist, produced average weight loss of up to 24.2% at 48 weeks versus 2.1% with placebo. Retatrutide was an investigational medicine at the time of this trial.[src]

24. 2022-12-15

    FDA adds tirzepatide (Mounjaro and Zepbound) to its drug shortage list

    According to the FDA's later declaratory order, tirzepatide injection products were first added to the FDA drug shortage list on 15 December 2022. This opened the same temporary room for compounded copies that applied to semaglutide.[src]

25. 2022-06-04

    SURMOUNT-1 trial: tirzepatide leads to up to about 21% weight loss over 72 weeks

    In the SURMOUNT-1 phase 3 trial of adults with obesity or overweight without diabetes, average weight change at week 72 was between -15.0% and -20.9% across three tirzepatide groups, versus -3.1% with placebo. Results were published in NEJM.[src]

26. 2022-05-13

    FDA approves Mounjaro (tirzepatide) for type 2 diabetes

    The FDA approved Mounjaro on 13 May 2022 for adults with type 2 diabetes. Tirzepatide is a dual GIP and GLP-1 receptor agonist.[src]