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Market atlas / Incretins / Dulaglutide

Dulaglutide (GLP-1 agonist)

repurposedbiologicglp1-receptor-agonismmetabolicweight-loss● body-weight● hba1c
PositionEvidenceRulers

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

MarketStageSinceIndication / class / form
USapprovednot datedclass GLP-1 Receptor Agonist [EPC]
UKapproved2014-11-21indication 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…
CNapproved2025-08-05form Injection, biologic
INRCT2026-09-01not published
JPapproved2015-07-03indication A drug with a new active ingredient indicated for the treatment of type 2 diabetes mellitus.
CHapproved2015-05-06indication Antidiabetic, prevention of cardiovascular events
SGapproved2016-03-18form Injection, solution, subcutaneous, prescription only
ILapproved2020-08-31indication 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…
KRapproved2015-05-26class 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 endpointMarkets 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 24IN
Number of Participants With One or More Gastrointestinal (GI) AEs From Baseline to Week 24IN
Change in HbA1cIN
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26IN
Fluid intakeCH
Point prevalence abstinence rate at week 12CH

Connections

shared mechanismDulaglutideSemaglutide

Trajectory

2014
MarketUK: approved-other (MHRA-authorised (UK), per eMC SmPC)
EMC:dulaglutide (product 7482) · machine-extracted
2015
MarketCH: approved-other (Swissmedic-authorised (Switzerland))
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
2018
Relatedshares a mechanism with Semaglutide
NCT03495102 · machine-extracted
2018
ProfileDulaglutide (GLP-1 agonist)
NCT03495102 · machine-extracted
2020
MarketIL: approved-other (Israel MoH-registered)
2025
MarketCN: approved-other (NMPA-approved (domestic + imported))
NMPA:NMPA S20250045 · machine-extracted
2026
MarketCH: rct (clinical trials (highest phase 2))
NCT04687514 · machine-extracted
2026
MarketIL: rct (clinical trials (highest phase 3))
NCT02787551 · machine-extracted
2026
MarketJP: rct (clinical trials (highest phase 3))
NCT07668336 · machine-extracted
2026
MarketKR: rct (clinical trials (highest phase 3))
NCT07668336 · machine-extracted
2026
MarketSG: rct (clinical trials (highest phase 3))
NCT07282041 · machine-extracted
2026
MarketUS: approved-other (approved, marketed)
BLA125469 · machine-extracted
2026
MarketIN: rct (clinical trials (highest phase 3))
NCT07668336 · 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