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Novo Nordisk reports CagriSema submitted to FDA

Chronic weight management

Novo Nordisk's 2025 annual report states that CagriSema was submitted to the FDA in December 2025 for weight management.

Why it matters: A submission is not an approval. The latest disposition (acceptance, review timetable, decision) is being verified before any present-day status or forecast is shown.

Source: Novo Nordisk, February 2026

Last checked 13 Sep 2026 · Report a correction

FDA approves Trulicity (dulaglutide) for type 2 diabetes

Trulicity (once-weekly injection) · Type 2 diabetes (glycaemic control)

Original approval of BLA 125469 on 18 September 2014 for glycaemic control in adults with type 2 diabetes.

Why it matters: A once-weekly GLP-1 agonist without a weight-management indication; the workbook's 'FDA expiry 2024' refers to patent status, not to the approval, and is quarantined.

Source: US Food and Drug Administration (Drugs@FDA)

Last checked 13 Sep 2026 · Report a correction

FDA approves Victoza (liraglutide) for type 2 diabetes

Victoza (once-daily injection) · Type 2 diabetes (glycaemic control)

Original approval of NDA 022341 on 25 January 2010 for glycaemic control in adults with type 2 diabetes.

Why it matters: The earliest approval in this tracker; liraglutide's core patents have since expired, which matters for generic availability rather than for its approval status.

Source: US Food and Drug Administration (Drugs@FDA)

Last checked 13 Sep 2026 · Report a correction

FDA approves Saxenda (liraglutide 3 mg) for chronic weight management

Saxenda (once-daily injection) · Chronic weight management

Original approval of NDA 206321 on 23 December 2014 for chronic weight management in adults.

Why it matters: The first GLP-1 medicine licensed for weight management; it set the template later followed by Wegovy and Zepbound.

Source: US Food and Drug Administration (Drugs@FDA)

Last checked 13 Sep 2026 · Report a correction

FDA approves Foundayo (orforglipron) for chronic weight management

Foundayo (once-daily tablet) · Chronic weight management

FDA approved Foundayo, a once-daily oral non-peptide GLP-1 receptor agonist, for adults with obesity, or overweight with a weight-related condition, alongside diet and physical activity.

Why it matters: The first oral small-molecule GLP-1 medicine approved in the US. UK and EU status are separate records and are verified independently.

Source: US Food and Drug Administration, 1 Apr 2026

Last checked 13 Sep 2026 · Report a correction

Chronic weight management

No UK filing plan has been verified. An illustrative 2028 to 2029 scenario would depend on a 2027 or 2028 filing and a positive national or eligible international-recognition decision; it stays out of the headline until a filing anchor exists.

Next observable milestone: Sponsor statement on UK filing

Source: MHRA

Reviewed by GLPInfo editorial · next review 13 Oct 2026 · version 1

Lilly plans a US submission for retatrutide in Q1 2027

Chronic weight management

Announcing two further Phase 3 results on 23 July 2026, Lilly said it planned to submit retatrutide to the FDA in the first quarter of 2027 while completing manufacturing-related documentation.

Why it matters: This is sponsor guidance, not an application acceptance or an approval date. Any approval timing is an estimate conditional on the filing happening.

Source: Eli Lilly, 23 Jul 2026

Last checked 13 Sep 2026 · Report a correction

Chronic weight management

Conditional on submission in Q1 2027, filing acceptance, a standard original-application review and a positive first-cycle decision. A Q1 filing plus roughly 12 months of review centres on Q1 2028; H1 2028 allows limited slippage. Priority review, if actually granted, could allow a 2027 decision. Delays or a negative decision remain possible.

Confidence in timing: low. No filing has been made; the timing rests entirely on sponsor guidance and standard review goals. This describes confidence in the timing only, not a probability of approval.

Next observable milestone: FDA submission (sponsor target Q1 2027)

Sources: Eli Lilly, 23 Jul 2026; US Food and Drug Administration, September 2021

Reviewed by GLPInfo editorial · next review 13 Oct 2026 · version 1

Chronic weight management

No EU application timing has been verified. An illustrative 2028 to 2029 scenario would depend on a 2027 submission and an assessment with ordinary clock stops; it stays out of the headline until a filing anchor exists.

Next observable milestone: Sponsor statement on EU filing

Source: European Medicines Agency

Reviewed by GLPInfo editorial · next review 13 Oct 2026 · version 1

MHRA approves semaglutide (Wegovy) to reduce the risk of serious heart problems

Wegovy (once-weekly injection) · Cardiovascular risk reduction

MHRA announced approval of semaglutide to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and a BMI of 27 or more.

Why it matters: The UK decision came four and a half months after the US one and is a separate regulatory event with its own wording; approval is not NHS funding.

Source: MHRA, 23 Jul 2024

Last checked 13 Sep 2026 · Report a correction

FDA approves Ozempic (semaglutide) for type 2 diabetes

Ozempic (once-weekly injection) · Type 2 diabetes (glycaemic control)

Original approval of NDA 209637 on 5 December 2017 to improve glycaemic control in adults with type 2 diabetes.

Why it matters: Weight loss seen in Ozempic's diabetes trials is not a weight-management indication; that came with Wegovy in 2021.

Source: US Food and Drug Administration (Drugs@FDA)

Last checked 13 Sep 2026 · Report a correction

FDA approves Rybelsus (oral semaglutide) for type 2 diabetes

Rybelsus (once-daily tablet) · Type 2 diabetes (glycaemic control)

Original approval of NDA 213051 on 20 September 2019, the first oral GLP-1 receptor agonist, for glycaemic control in adults with type 2 diabetes.

Why it matters: A different formulation of the same molecule with its own application and label; oral semaglutide for weight management is a separate product.

Source: US Food and Drug Administration (Drugs@FDA)

Last checked 13 Sep 2026 · Report a correction

FDA approves Wegovy (semaglutide 2.4 mg) for chronic weight management

Wegovy (once-weekly injection) · Chronic weight management

Original approval of NDA 215256 on 4 June 2021 for chronic weight management in adults with obesity, or overweight with at least one weight-related condition.

Why it matters: The first once-weekly GLP-1 medicine approved for weight management in the US; the workbook's 'June 2021' is confirmed to the day by the Drugs@FDA record.

Source: US Food and Drug Administration (Drugs@FDA)

Last checked 13 Sep 2026 · Report a correction

FDA adds cardiovascular risk reduction to Wegovy's indications

Wegovy (once-weekly injection) · Cardiovascular risk reduction

FDA approved an additional indication for Wegovy (semaglutide) injection: reducing the risk of cardiovascular death, heart attack and stroke in adults with established cardiovascular disease and either obesity or overweight, alongside a reduced-calorie diet and increased physical activity.

Why it matters: An additional use of an existing molecule, not a new medicine. It is the first weight-management medicine with a cardiovascular outcome indication in the US.

Source: US Food and Drug Administration, 8 Mar 2024

Last checked 13 Sep 2026 · Report a correction

CHMP recommends adding SELECT cardiovascular study information to Wegovy's product information

Wegovy (once-weekly injection) · Cardiovascular risk reduction

At its July 2024 meeting the CHMP recommended an update to Wegovy's product information to reflect the SELECT cardiovascular outcomes data. It did not recommend a separate cardiovascular-prevention indication.

Why it matters: The same scientific story produced different regional outcomes: a new indication in the US and UK, a product-information update in the EU. Regional labels must be read separately.

Source: European Medicines Agency, 26 Jul 2024

Last checked 13 Sep 2026 · Report a correction

FDA approves Mounjaro (tirzepatide) for type 2 diabetes

Mounjaro (once-weekly injection) · Type 2 diabetes (glycaemic control)

Original approval of NDA 215866 on 13 May 2022 to improve glycaemic control in adults with type 2 diabetes.

Why it matters: The first dual GIP and GLP-1 receptor agonist. Its weight-management use in the US is a separate product (Zepbound).

Source: US Food and Drug Administration (Drugs@FDA)

Last checked 13 Sep 2026 · Report a correction

FDA approves Zepbound (tirzepatide) for chronic weight management

Zepbound (once-weekly injection) · Chronic weight management

Original approval of NDA 217806 on 8 November 2023 for chronic weight management in adults with obesity, or overweight with a weight-related condition.

Why it matters: Same molecule as Mounjaro, separate US brand and application for the weight-management indication. In the UK and EU tirzepatide is marketed as Mounjaro for both uses.

Source: US Food and Drug Administration (Drugs@FDA)

Last checked 13 Sep 2026 · Report a correction

FDA approves Zepbound for moderate to severe obstructive sleep apnoea in adults with obesity

Zepbound (once-weekly injection) · Obstructive sleep apnoea

Supplement 13 to NDA 217806 approved on 20 December 2024: the first medicine approved to treat obstructive sleep apnoea, for adults with obesity, alongside diet and physical activity.

Why it matters: The workbook gave one date for both Zepbound indications; the sleep-apnoea indication is a separate event thirteen months later.

Sources: US Food and Drug Administration (Drugs@FDA); US Food and Drug Administration, 20 Dec 2024

Last checked 13 Sep 2026 · Report a correction