Market atlas / Incretins / Dulaglutide
Dulaglutide (GLP-1 agonist)
repurposedbiologicglp1-receptor-agonismmetabolicweight-loss● body-weight● hba1c
Stage by geography
Same development stage across markets, but United Kingdom reached it about 11 years before China.
signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSUKCNJPCHSGILKRIN+1 stages
MarketsUS United States FDAUK United Kingdom MHRA / NICECN China NMPAIN India CDSCOJP Japan PMDACH Switzerland SwissmedicSG Singapore HSAIL Israel Ministry of HealthKR South Korea MFDS
What each market approved it for
| Market | Stage | Since | Indication / class / form |
|---|---|---|---|
| US | approved | not dated | class GLP-1 Receptor Agonist [EPC] |
| UK | approved | 2014-11-21 | indication Type 2 Diabetes Mellitus Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an… |
| CN | approved | 2025-08-05 | form Injection, biologic |
| IN | RCT | 2026-09-01 | not published |
| JP | approved | 2015-07-03 | indication A drug with a new active ingredient indicated for the treatment of type 2 diabetes mellitus. |
| CH | approved | 2015-05-06 | indication Antidiabetic, prevention of cardiovascular events |
| SG | approved | 2016-03-18 | form Injection, solution, subcutaneous, prescription only |
| IL | approved | 2020-08-31 | indication Type 2 Diabetes Mellitus Trulicity is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and… |
| KR | approved | 2015-05-26 | class Diabetes agents [MFDS 03960] |
China registers · NMPA
What each NMPA register actually approved. Reference approval NMPA S20250045. Domestic generics vs imported originator.
4domestic approvals
- Forms listed
- 1
- Product
- Dulaglutide Injection
- Form
- injection
- Strength
- 1.5 mg (0.5ml) /unit (prefilled pen)
- Holder
- Shandong Boan Biotechnology
- Origin
- China
- Approved
- 2025-08-05
- Approval no
- NMPA S20250045
2imported approvals
approval count only; per-product detail not captured
Biomarker trends
no biomarker readings yet
Studies
The studies on Dulaglutide, what they found, in whom and how strongly, are on its evidence page, each linked to its source.
What the trials measure
Registered primary outcomes this development's trials are powered on, commonest first (ClinicalTrials.gov). What is measured, across markets.
| Registered primary endpoint | Markets measuring it |
|---|---|
| Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse… | IL, IN, JP, KR |
| Change from Baseline in Hemoglobin A1c (HbA1c) | IN, JP, KR |
| Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events… | IN |
| Number of Participants With One or More Hypoglycemic Events, Including Severe Hypoglycemic Events. | IN |
| Percentage of Participants Reporting AEs and SAEs From Baseline to Week 24 | IN |
| Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24 | IN |
| Change in HbA1c | IN |
| Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 | IN |
| Fluid intake | CH |
| Point prevalence abstinence rate at week 12 | CH |
Connections
Trajectory
2014
MarketUK: approved-other (MHRA-authorised (UK), per eMC SmPC)
EMC:dulaglutide (product 7482) · machine-extracted
2015
MarketCH: approved-other (Swissmedic-authorised (Switzerland))
Swissmedic:dulaglutid (2015-05-06) · machine-extracted
2015
MarketKR: approved-other (MFDS-approved (South Korea))
MFDS:dulaglutide (2015-05-26) · machine-extracted
2015
MarketJP: approved-other (PMDA-approved (Japan))
PMDA:dulaglutide (2015-07-03) · machine-extracted
2016
MarketSG: approved-other (HSA-registered (Singapore))
HSA:dulaglutide (2016-03-18) · machine-extracted
2020
MarketIL: approved-other (Israel MoH-registered)
IsraelMoH:dulaglutide (2020-08-31) · machine-extracted
2025
MarketCN: approved-other (NMPA-approved (domestic + imported))
NMPA:NMPA S20250045 · machine-extracted
Get into the weeds: raw observations + provenance
dula_uk 2026-07-14 kind=geography_stage verify=M UK marketing authorisation (MHRA), per the eMC SmPC: TRULICITY 0.75 mg solution for injection in pre-filled pen [active substance: dulaglutide], first authorised 2014-11-21. [electronic Medicines Compendium, medicines.org.uk] source EMC:dulaglutide (product 7482) https://www.medicines.org.uk/emc/product/7482/smpc swissmedic__dev_dulaglutide__CH 2026-07-13 kind=geography_stage verify=M Swissmedic-authorised in Switzerland: dulaglutidum (Trulicity 1.5 mg, solution for injection, single-use prefilled pen), first authorisation 2015-05-06. [Swissmedic list of authorised medicinal products] source Swissmedic:dulaglutid (2015-05-06) https://www.swissmedic.ch/dam/swissmedic/en/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/erweiterte_ham_ind.xlsx mfds__dev_dulaglutide__KR 2026-07-13 kind=geography_stage verify=M MFDS-approved in South Korea: Dulaglutide (Trulicity 0.75mg/0.5mL (dulaglutide, recombinant) single-dose pen), first approval 2015-05-26. [MFDS drug product-approval list] source MFDS:dulaglutide (2015-05-26) https://nedrug.mfds.go.kr/pbp/CCBGA01 pmda__dev_dulaglutide__JP 2026-07-13 kind=geography_stage verify=M PMDA-approved in Japan: Dulaglutide (genetical recombination) (Trulicity Subcutaneous Injection 0.75 mg Ateos (Eli Lilly Japan K.K.)), first approval 2015-07-03. [PMDA List of Approved Drugs] source PMDA:dulaglutide (2015-07-03) https://www.pmda.go.jp/files/000281190.pdf hsa__dev_dulaglutide__SG 2026-07-13 kind=geography_stage verify=M HSA-registered in Singapore: Dulaglutide (TRULICITY INJECTION 1.5MG/0.5ML), first registration 2016-03-18. [HSA Listing of Registered Therapeutic Products] source HSA:dulaglutide (2016-03-18) https://data.gov.sg/datasets/d_767279312753558cbf19d48344577084/view dula_edge_sema 2026-06-29 kind=edge verify=M both GLP-1 receptor agonists source NCT03495102 https://clinicaltrials.gov/study/NCT03495102 dula_facets 2026-06-29 kind=facets verify=M Dulaglutide facets source NCT03495102 https://clinicaltrials.gov/study/NCT03495102 israelmoh__dev_dulaglutide__IL 2026-07-13 kind=geography_stage verify=M Registered in Israel (Israeli Drug Registry): DULAGLUTIDE 1.5 MG/ML (TRULICITY 0.75 MG), current registration 2020-08-31. [Israel MoH Drug Registry] source IsraelMoH:dulaglutide (2020-08-31) https://israeldrugs.health.gov.il/ dula_cn 2026-06-29 kind=geography_stage verify=M NMPA-approved in China (dulaglutide): 4 domestic approval(s) (e.g. Dulaglutide Injection, 1.5 mg (0.5ml) /unit (prefilled pen) , Shandong Boan Biotechnology, China); 2 imported approval(s). Reference NMPA S20250045. source NMPA:NMPA S20250045 https://www.nmpa.gov.cn/datasearch/home-index.html ctsearch__CH__dev_dulaglutide 2026-07-10 kind=geography_stage verify=M dulaglutide: 4 registered trial(s) in CH, highest phase 2 [NCT04687514] source NCT04687514 https://clinicaltrials.gov/study/NCT04687514 ctsearch__IL__dev_dulaglutide 2026-07-10 kind=geography_stage verify=M dulaglutide: 4 registered trial(s) in IL, highest phase 3 [NCT02787551] source NCT02787551 https://clinicaltrials.gov/study/NCT02787551 ctsearch__JP__dev_dulaglutide 2026-07-10 kind=geography_stage verify=M dulaglutide: 7 registered trial(s) in JP, highest phase 3 [NCT07668336] source NCT07668336 https://clinicaltrials.gov/study/NCT07668336 ctsearch__KR__dev_dulaglutide 2026-07-10 kind=geography_stage verify=M dulaglutide: 6 registered trial(s) in KR, highest phase 3 [NCT07668336] source NCT07668336 https://clinicaltrials.gov/study/NCT07668336 ctsearch__SG__dev_dulaglutide 2026-07-10 kind=geography_stage verify=M dulaglutide: 3 registered trial(s) in SG, highest phase 3 [NCT07282041] source NCT07282041 https://clinicaltrials.gov/study/NCT07282041 openfda__BLA125469__US 2026-07-13 kind=geography_stage verify=M FDA-approved in the US (DULAGLUTIDE); approved, marketed [BLA125469] source BLA125469 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=BLA125469 dula_in 2026-06-29 kind=geography_stage verify=M Dulaglutide: registered phase 3 trials in India [NCT07668336] source NCT07668336 https://clinicaltrials.gov/study/NCT07668336