Dulaglutide: dosing, evidence and sources

Regulatory status

Approved by the FDA. Marketed as TRULICITY. Earliest approval 2014-09-18. Application BLA125469.

An approval grades as rung 1 on this site, because 21 CFR 314.126 requires adequate and well-controlled human investigations and one cannot be granted without them. It covers specific indications and doses, though, and does not transfer to other uses of the same molecule.

Dosing on file unverified

0.75 - 1.5 mg/week

Carried from a source that labels it unverified, and reproduced with that label attached. A record of what is reported, not a recommendation. No citation on this page establishes it.

Literature on file 6

human RCT
Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial (Lancet 2019) graded on: a randomised trial — “randomised placebo-controlled trial”
human observational
Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial (Lancet 2019) graded on: a secondary or post-hoc analysis — “exploratory analysis”
human observational
Efficacy and safety outcomes of dulaglutide by baseline HbA1c: A post hoc analysis of the REWIND trial (Diabetes Obes Metab 2022) graded on: a secondary or post-hoc analysis — “post hoc”
human RCT
Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial (The Lancet 2019, cited 2659x) graded on: a randomised trial — “randomised placebo-controlled trial”
human RCT
Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial (The Lancet Diabetes & Endocrinology 2018, cited 583x) graded on: a randomised trial — “randomised trial”
human RCT
FDA approval BLA125469 graded on: an FDA approval (BLA125469), which requires adequate and well-controlled human investigations — “BLA125469”

Identity

Space-filling 3D model of Dulaglutide, carbon grey, nitrogen blue, oxygen red — Built from the SMILES on this record — the atoms, bonds and stereochemistry are exact. The shape is **one computed low-energy pose**, not a measured structure: a flexible peptide in solution has no single conformation. The skeletal formula below claims connectivity and nothing more, which is what we actually know.

2D chemical structure of Dulaglutide — Built from the SMILES on this record — the atoms, bonds and stereochemistry are exact. The shape is **one computed low-energy pose**, not a measured structure: a flexible peptide in solution has no single conformation. The skeletal formula below claims connectivity and nothing more, which is what we actually know.

Molecular weight: 3314.6
Molecular formula: C149H221N37O49
CAS number: 1197810-60-8
PubChem CID: 171042928
UniProt: P43220 (Target)
InChI key: HPNPLWNTQBSMAJ-FBXRENMFSA-N
Sequence: HGEGTFTSDVSSYLEEQAAKEFIAWLVKGGG
SMILES: CC[C@H](C)[C@@H](C(=O)N[C@@H](C)C(=O)N[C@@H](CC1=CNC2=CC=CC=C21)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)NCC(=O)NCC(=O)O)NC(=O)[C@H](CC3=CC=CC=C3)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC4=CC=C(C=C4)O)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC5=CC=CC=C5)NC(=O)[C@H]([C@@H](C)O)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@H](CC6=CNC=N6)N
InChI: InChI=1S/C149H221N37O49/c1-16-76(10)121(147(233)164-79(13)126(212)172-103(58-85-61-155-90-34-24-23-33-88(85)90)137(223)174-99(54-73(4)5)138(224)183-119(74(6)7)145(231)171-91(35-25-27-51-150)128(214)159-64-110(195)156-63-109(194)157-67-118(208)209)185-139(225)101(55-82-29-19-17-20-30-82)175-134(220)97(45-50-116(204)205)168-131(217)92(36-26-28-52-151)166-125(211)78(12)162-124(210)77(11)163-130(216)94(41-46-108(153)193)167-132(218)95(43-48-114(200)201)169-133(219)96(44-49-115(202)203)170-135(221)98(53-72(2)3)173-136(222)100(57-84-37-39-87(192)40-38-84)176-142(228)105(68-187)179-144(230)107(70-189)180-146(232)120(75(8)9)184-141(227)104(60-117(206)207)177-143(229)106(69-188)181-149(235)123(81(15)191)186-140(226)102(56-83-31-21-18-22-32-83)178-148(234)122(80(14)190)182-112(197)66-160-129(215)93(42-47-113(198)199)165-111(196)65-158-127(213)89(152)59-86-62-154-71-161-86/h17-24,29-34,37-40,61-62,71-81,89,91-107,119-123,155,187-192H,16,25-28,35-36,41-60,63-70,150-152H2,1-15H3,(H2,153,193)(H,154,161)(H,156,195)(H,157,194)(H,158,213)(H,159,214)(H,160,215)(H,162,210)(H,163,216)(H,164,233)(H,165,196)(H,166,211)(H,167,218)(H,168,217)(H,169,219)(H,170,221)(H,171,231)(H,172,212)(H,173,222)(H,174,223)(H,175,220)(H,176,228)(H,177,229)(H,178,234)(H,179,230)(H,180,232)(H,181,235)(H,182,197)(H,183,224)(H,184,227)(H,185,225)(H,186,226)(H,198,199)(H,200,201)(H,202,203)(H,204,205)(H,206,207)(H,208,209)/t76-,77-,78-,79-,80+,81+,89-,91-,92-,93-,94-,95-,96-,97-,98-,99-,100-,101-,102-,103-,104-,105-,106-,107-,119-,120-,121-,122-,123-/m0/s1

Caveat on these identifiers

P43220 is the GLP-1 RECEPTOR, not the drug itself. This CID is the GLP-1 moiety of dulaglutide, not the full Fc-fusion protein.

Notes unverified prose

FDA-approved; REWIND trial; PMID: 31189511; PMID: 31189509; PMID: 35546279

Not on file 0

All 8 tracked fields hold a value on this record: molecular weight and formula, CAS number, PubChem CID, amino-acid sequence, SMILES, InChI and InChI key.

Counted from the record itself, not from what a source said it was missing. 136 of 185 records still have at least one empty.