What happens next in GLP-1 — and when.

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Regulatory timeline

Reported, not yet in the FDA record

Drugs@FDA publishes an action days to weeks after it is announced, so these are press reports, not primary records, and they are shown only while the database has nothing newer. Each is carried by at least two independent outlets. When the FDA publishes the action it appears in the table below and drops out of here.

Approved FDA submissions across all GLP-1 applications, newest first, from Drugs@FDA: original approvals, efficacy supplements and labeling changes. Labeling supplements are where new safety language and new indications actually land, and they are published months before most coverage notices them.

295
approved submissions
31
original approvals
31
applications
17
sponsors
DateDrugActionSponsorApplication
2026-08-27semaglutideLabeling
OZEMPIC
NOVONDA209637 · label
2026-08-27tirzepatideEfficacy
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2026-08-27tirzepatideEfficacy
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2026-08-26tirzepatideEfficacy
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2026-08-04orforglipronLabeling
FOUNDAYO
ELI LILLY AND CONDA220934 · label
2026-07-01liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
SANDOZANDA212972
2026-06-18semaglutideManufacturing (CMC)
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2026-06-18semaglutideLabeling
WEGOVY
NOVONDA218316 · label
2026-06-15liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
MYLAN INSTITUTIONALANDA213155
2026-06-02liraglutideLabeling
SAXENDA
NOVONDA206321 · label
2026-06-01semaglutideLabeling
OZEMPIC
NOVONDA209637 · label
2026-05-05semaglutideManufacturing (CMC)
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2026-05-05semaglutideLabeling
WEGOVY
NOVONDA218316 · label
2026-04-01orforglipronType 1 - New Molecular Entity original
FOUNDAYO
ELI LILLY AND CONDA220934 · label
2026-03-30liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
FRESENIUS KABI USAANDA212552
2026-03-19semaglutideEfficacy
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2026-03-19semaglutideLabeling
WEGOVY
NOVONDA218316 · label
2026-03-12dulaglutideLabeling
TRULICITY
ELI LILLY AND COBLA125469 · label
2026-03-12lixisenatideLabeling
SOLIQUA 100/33
SANOFI-AVENTIS USBLA208673 · label
2026-03-12lixisenatideLabeling
ADLYXIN
SANOFI-AVENTIS USBLA208471 · label
2026-03-11liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
BIOCON PHARMAANDA215245
2026-02-25semaglutideLabeling
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2026-02-25semaglutideLabeling
WEGOVY
NOVONDA218316 · label
2026-02-25tirzepatideLabeling
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2026-02-25liraglutideLabeling
SAXENDA
NOVONDA206321 · label
2026-02-24liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
BIOCON PHARMAANDA217063
2026-02-24liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
ORBICULARANDA217234
2026-01-30semaglutideLabeling
OZEMPIC, RYBELSUS
NOVONDA213051 · label
2026-01-29semaglutideLabeling
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2026-01-29semaglutideLabeling
WEGOVY
NOVONDA218316 · label
2026-01-20tirzepatideLabeling
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2026-01-20tirzepatideLabeling
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2026-01-14liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
ORBICULARANDA217590
2026-01-07tirzepatideManufacturing (CMC)
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2026-01-07tirzepatideManufacturing (CMC)
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2025-12-22semaglutideType 3 - New Dosage Form original
WEGOVY
NOVONDA218316 · label
2025-12-19tirzepatideEfficacy
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2025-11-21semaglutideEfficacy
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2025-10-17semaglutideLabeling
OZEMPIC, RYBELSUS
NOVONDA213051 · label
2025-10-17semaglutideLabeling
OZEMPIC, RYBELSUS
NOVONDA213051 · label
2025-10-17semaglutideEfficacy
OZEMPIC, RYBELSUS
NOVONDA213051 · label
2025-10-15liraglutideLabeling
LIRAGLUTIDE
NANJING KING FRIENDANDA218115
2025-10-14semaglutideLabeling
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2025-10-14semaglutideLabeling
OZEMPIC
NOVONDA209637 · label
2025-10-14semaglutideLabeling
OZEMPIC
NOVONDA209637 · label
2025-10-14liraglutideLabeling
VICTOZA
NOVO NORDISK INCNDA022341 · label
2025-10-14liraglutideLabeling
XULTOPHY 100/3.6
NOVOBLA208583 · label
2025-10-14liraglutideLabeling
SAXENDA
NOVONDA206321 · label
2025-09-25tirzepatideLabeling
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2025-09-25tirzepatideLabeling
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2025-09-02exenatideLabeling
BYETTA
ASTRAZENECA ABNDA021773 · label
2025-08-27liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
TEVA PHARMSANDA214568
2025-08-15semaglutideEfficacy
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2025-07-22liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
LUPINANDA215421
2025-05-28tirzepatideLabeling
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2025-05-28liraglutideLabeling
VICTOZA
NOVO NORDISK INCNDA022341 · label
2025-05-28liraglutideLabeling
XULTOPHY 100/3.6
NOVOBLA208583 · label
2025-05-28liraglutideLabeling
SAXENDA
NOVONDA206321 · label
2025-05-28dulaglutideLabeling
TRULICITY
ELI LILLY AND COBLA125469 · label
2025-05-28exenatideLabeling
BYDUREON, BYDUREON PEN
ASTRAZENECA ABNDA022200 · label
2025-05-28exenatideLabeling
BYDUREON BCISE
ASTRAZENECA ABNDA209210 · label
2025-05-28exenatideLabeling
BYETTA
ASTRAZENECA ABNDA021773 · label
2025-05-28lixisenatideLabeling
SOLIQUA 100/33
SANOFI-AVENTIS USBLA208673 · label
2025-05-28lixisenatideLabeling
ADLYXIN
SANOFI-AVENTIS USBLA208471 · label
2025-04-02liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
NANJING KING FRIENDANDA218115
2025-02-12liraglutideLabeling
VICTOZA
NOVO NORDISK INCNDA022341 · label
2025-02-07tirzepatideLabeling
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2025-01-28semaglutideEfficacy
OZEMPIC
NOVONDA209637 · label
2024-12-23liraglutideGeneric approval (ANDA) original
LIRAGLUTIDE
HIKMAANDA215503 · label
2024-12-20tirzepatideEfficacy
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2024-12-09semaglutideLabeling
OZEMPIC, RYBELSUS
NOVONDA213051 · label
2024-12-09semaglutideEfficacy
OZEMPIC, RYBELSUS
NOVONDA213051 · label
2024-11-27semaglutideEfficacy
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2024-11-19exenatideGeneric approval (ANDA) original
EXENATIDE SYNTHETIC
AMNEALANDA206697
2024-11-01semaglutideLabeling
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2024-11-01semaglutideLabeling
OZEMPIC, RYBELSUS
NOVONDA213051 · label
2024-11-01semaglutideLabeling
OZEMPIC
NOVONDA209637 · label
2024-11-01tirzepatideLabeling
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2024-11-01tirzepatideLabeling
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2024-11-01tirzepatideLabeling
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2024-11-01liraglutideLabeling
VICTOZA
NOVO NORDISK INCNDA022341 · label
2024-11-01liraglutideLabeling
XULTOPHY 100/3.6
NOVOBLA208583 · label
2024-11-01liraglutideLabeling
SAXENDA
NOVONDA206321 · label
2024-11-01dulaglutideLabeling
TRULICITY
ELI LILLY AND COBLA125469 · label
2024-11-01dulaglutideLabeling
TRULICITY
ELI LILLY AND COBLA125469 · label
2024-11-01exenatideLabeling
BYDUREON, BYDUREON PEN
ASTRAZENECA ABNDA022200 · label
2024-11-01exenatideLabeling
BYDUREON BCISE
ASTRAZENECA ABNDA209210 · label
2024-11-01exenatideLabeling
BYETTA
ASTRAZENECA ABNDA021773 · label
2024-11-01lixisenatideLabeling
SOLIQUA 100/33
SANOFI-AVENTIS USBLA208673 · label
2024-11-01lixisenatideLabeling
ADLYXIN
SANOFI-AVENTIS USBLA208471 · label
2024-10-18tirzepatideLabeling
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2024-10-18tirzepatideEfficacy
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2024-10-18tirzepatideLabeling
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2024-10-18tirzepatideLabeling
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2024-10-18tirzepatideLabeling
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2024-03-28tirzepatideLabeling
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2024-03-08semaglutideEfficacy
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2024-03-06exenatideLabeling
BYDUREON BCISE
ASTRAZENECA ABNDA209210 · label
2024-01-24semaglutideLabeling
OZEMPIC, RYBELSUS
NOVONDA213051 · label
2023-11-08tirzepatideType 10 - New Indication Submitted as Distinct NDA - Not Consolidated original
ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
ELI LILLY AND CONDA217806 · label
2023-09-28lixisenatideLabeling
SOLIQUA 100/33
SANOFI-AVENTIS USBLA208673 · label
2023-09-28lixisenatideLabeling
ADLYXIN
SANOFI-AVENTIS USBLA208471 · label
2023-09-22semaglutideLabeling
OZEMPIC
NOVONDA209637 · label
2023-09-22semaglutideLabeling
OZEMPIC
NOVONDA209637 · label
2023-07-28tirzepatideLabeling
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2023-07-28tirzepatideLabeling
MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN
ELI LILLY AND CONDA215866 · label
2023-07-21semaglutideEfficacy
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2023-07-10liraglutideLabeling
XULTOPHY 100/3.6
NOVOBLA208583 · label
2023-07-05liraglutideLabeling
VICTOZA
NOVO NORDISK INCNDA022341 · label
2023-04-20liraglutideLabeling
SAXENDA
NOVONDA206321 · label
2023-02-14semaglutideLabeling
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2023-01-12semaglutideLabeling
OZEMPIC, RYBELSUS
NOVONDA213051 · label
2022-12-23semaglutideEfficacy
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2022-12-21exenatideLabeling
BYDUREON, BYDUREON PEN
ASTRAZENECA ABNDA022200 · label
2022-12-21exenatideLabeling
BYDUREON BCISE
ASTRAZENECA ABNDA209210 · label
2022-12-21exenatideLabeling
BYETTA
ASTRAZENECA ABNDA021773 · label
2022-11-17dulaglutideEfficacy
TRULICITY
ELI LILLY AND COBLA125469 · label
2022-10-06semaglutideLabeling
OZEMPIC
NOVONDA209637 · label
2022-08-24semaglutideLabeling
WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
NOVONDA215256 · label
2022-07-26exenatideLabeling
BYDUREON, BYDUREON PEN
ASTRAZENECA ABNDA022200 · label

European authorisations

The same molecules as authorised by the European Medicines Agency, from the public register of medicines. A drug approved in one jurisdiction is often not approved in the other, and the indication wording frequently differs — both are worth checking before assuming a US approval carries over.

First authorisedMedicineMoleculeStatusTherapeutic areaRecord
2022-07-18MounjarotirzepatideAuthorisedDiabetes Mellitus, Type 2EPAR
2021-11-11WegovysemaglutideAuthorisedObesity, OverweightEPAR
2020-05-27RybelsussemaglutideAuthorisedDiabetes Mellitus, Type 2EPAR
2018-07-02TrulicitydulaglutideAuthorisedDiabetes Mellitus, Type 2EPAR
2018-06-28SaxendaliraglutideAuthorisedObesity, OverweightEPAR
2018-06-26ByettaexenatideAuthorisedDiabetes Mellitus, Type 2EPAR
2018-06-07XultophyliraglutideAuthorisedDiabetes Mellitus, Type 2EPAR
2018-05-31OzempicsemaglutideAuthorisedDiabetes MellitusEPAR
2017-11-10BydureonexenatideAuthorisedDiabetes Mellitus, Type 2EPAR
2017-09-22VictozaliraglutideAuthorisedDiabetes Mellitus, Type 2EPAR
2017-09-18LyxumialixisenatideAuthorisedDiabetes Mellitus, Type 2EPAR
2017-09-14SuliqualixisenatideAuthorisedDiabetes Mellitus, Type 2EPAR
2017-09-14EperzanalbiglutideWithdrawnDiabetes Mellitus, Type 2EPAR