dulaglutide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
Glucagon-like Peptide (GLP) analogues	4885	923950-08-7

Description:

Molecule	Description
Synonyms: dulaglutide trulicity LY2189265	a glucagon-like peptide-1 receptor agonist; GLP-1 immunoglobulin G (IgG4) Fc fusion protein with extended activity Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

dulaglutide
trulicity
LY2189265

a glucagon-like peptide-1 receptor agonist; GLP-1 immunoglobulin G (IgG4) Fc fusion protein with extended activity

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
0.16	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Nov. 22, 2014	EMA
Sept. 18, 2014	FDA	ELI LILLY AND CO

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Nausea	477.49	21.35	621	8848	755470	52584127
Blood glucose increased	440.15	21.35	232	9237	77129	53262468
Injection site pain	392.67	21.35	246	9223	113145	53226452
Accidental underdose	350.23	21.35	66	9403	616	53338981
Glycosylated haemoglobin increased	240.74	21.35	87	9382	11568	53328029
Diabetic ketoacidosis	198.81	21.35	88	9381	19827	53319770
Vomiting	186.01	21.35	322	9147	496817	52842780
Extra dose administered	185.54	21.35	59	9410	5311	53334286
Inappropriate schedule of product administration	169.11	21.35	125	9344	74753	53264844
Pancreatitis	139.10	21.35	92	9377	46050	53293547
Incorrect dose administered	137.70	21.35	95	9374	50950	53288647
Injection site haemorrhage	130.27	21.35	68	9401	21983	53317614
Accidental overdose	126.21	21.35	66	9403	21413	53318184
Abdominal pain upper	120.88	21.35	148	9321	166143	53173454
Injection site pruritus	118.30	21.35	80	9389	41509	53298088
Product dose omission issue	111.84	21.35	153	9316	191467	53148130
Diabetic metabolic decompensation	104.99	21.35	29	9440	1599	53337998
Injection site erythema	104.90	21.35	96	9373	77153	53262444
Injection site mass	84.47	21.35	46	9423	16168	53323429
Product administered at inappropriate site	83.14	21.35	27	9442	2595	53337002
Hypoglycaemia	77.47	21.35	72	9397	58941	53280656
Injection site bruising	76.34	21.35	59	9410	37587	53302010
Blood glucose abnormal	71.88	21.35	32	9437	7287	53332310
Underdose	67.44	21.35	44	9425	21478	53318119
Diarrhoea	66.65	21.35	252	9217	625294	52714303
Injury associated with device	66.34	21.35	24	9445	3191	53336406
Injection site rash	64.80	21.35	39	9430	16540	53323057
Euglycaemic diabetic ketoacidosis	56.68	21.35	21	9448	2986	53336611
Blood glucose decreased	48.67	21.35	35	9434	19981	53319616
Transcription medication error	48.53	21.35	11	9458	267	53339330
Acute kidney injury	44.89	21.35	122	9347	253746	53085851
Injection site urticaria	40.04	21.35	26	9443	12581	53327016
Lactic acidosis	38.67	21.35	40	9429	37213	53302384
Pancreatitis acute	38.44	21.35	34	9435	26075	53313522
Pancreatic carcinoma	36.96	21.35	20	9449	6934	53332663
Ketoacidosis	36.07	21.35	17	9452	4409	53335188
Wrong technique in product usage process	34.98	21.35	48	9421	59984	53279613
Diabetes mellitus inadequate control	34.74	21.35	25	9444	14285	53325312
Eructation	34.68	21.35	20	9449	7835	53331762
Hyperglycaemic hyperosmolar nonketotic syndrome	34.62	21.35	10	9459	648	53338949
Weight decreased	32.03	21.35	103	9366	234845	53104752
Accidental exposure to product	31.26	21.35	29	9440	23645	53315952
Blood calcitonin increased	29.76	21.35	5	9464	22	53339575
Blood glucose fluctuation	29.64	21.35	15	9454	4536	53335061
Lipase increased	28.94	21.35	19	9450	9359	53330238
Rheumatoid arthritis	28.74	21.35	10	9459	314521	53025076
Thirst decreased	27.81	21.35	7	9462	268	53339329
Injection site injury	26.93	21.35	8	9461	572	53339025
Dehydration	26.83	21.35	78	9391	168332	53171265
Injection site swelling	26.21	21.35	35	9434	42593	53297004
COVID-19	25.36	21.35	32	9437	36856	53302741
Impaired gastric emptying	24.74	21.35	17	9452	9026	53330571
Decreased appetite	24.67	21.35	89	9380	214885	53124712
Toxicity to various agents	23.77	21.35	5	9464	219593	53120004
Hyperglycaemia	21.77	21.35	31	9438	40053	53299544

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Blood glucose increased	356.39	21.38	214	7883	65027	32440402
Injection site pain	303.65	21.38	153	7944	32905	32472524
Accidental underdose	298.32	21.38	56	8041	348	32505081
Inappropriate schedule of product administration	241.25	21.38	147	7950	45678	32459751
Nausea	229.17	21.38	335	7762	320514	32184915
Pancreatitis	212.64	21.38	127	7970	38024	32467405
Glycosylated haemoglobin increased	194.04	21.38	79	8018	10310	32495119
Diabetic ketoacidosis	185.22	21.38	90	8007	17842	32487587
Extra dose administered	142.72	21.38	47	8050	3356	32502073
Diarrhoea	135.23	21.38	286	7811	364516	32140913
Vomiting	119.21	21.38	211	7886	235346	32270083
Diabetes mellitus inadequate control	115.36	21.38	60	8037	13708	32491721
Injection site mass	110.14	21.38	44	8053	5457	32499972
Pancreatitis acute	109.66	21.38	74	8023	27261	32478168
Accidental overdose	98.89	21.38	61	8036	19278	32486151
Incorrect dose administered	93.21	21.38	74	8023	34954	32470475
Injection site erythema	92.57	21.38	53	8044	14615	32490814
Injection site haemorrhage	85.57	21.38	42	8055	8486	32496943
Euglycaemic diabetic ketoacidosis	83.62	21.38	30	8067	2768	32502661
Injection site pruritus	82.79	21.38	37	8060	6053	32499376
Product dose omission issue	82.55	21.38	114	7983	102461	32402968
Obstructive pancreatitis	67.73	21.38	17	8080	454	32504975
Underdose	63.69	21.38	40	8057	13029	32492400
Weight decreased	56.82	21.38	126	7971	164692	32340737
Eructation	56.52	21.38	25	8072	3988	32501441
Ketoacidosis	55.64	21.38	25	8072	4139	32501290
Injection site swelling	53.51	21.38	32	8065	9552	32495877
Lactic acidosis	49.74	21.38	51	8046	33485	32471944
Pancreatic carcinoma	49.69	21.38	29	8068	8277	32497152
Lipase increased	46.78	21.38	29	8068	9228	32496201
Injection site rash	36.35	21.38	18	8079	3702	32501727
Injury associated with device	36.34	21.38	12	8085	862	32504567
Injection site bruising	35.76	21.38	23	8074	7797	32497632
Injection site discomfort	35.58	21.38	13	8084	1263	32504166
Hypoglycaemia	32.95	21.38	53	8044	54329	32451100
Pancreatic carcinoma metastatic	32.21	21.38	16	8081	3313	32502116
Blood glucose abnormal	32.08	21.38	19	8078	5569	32499860
Injection site reaction	31.93	21.38	25	8072	11544	32493885
Abdominal discomfort	31.49	21.38	51	8046	52573	32452856
Hyperkinetic heart syndrome	30.56	21.38	7	8090	125	32505304
Blood glucose decreased	30.52	21.38	26	8071	13508	32491921
Abdominal pain	30.48	21.38	94	8003	149435	32355994
Dyspepsia	29.96	21.38	39	8058	33016	32472413
Glycosylated haemoglobin abnormal	29.31	21.38	7	8090	151	32505278
Injection site urticaria	28.99	21.38	12	8085	1627	32503802
Hyperlipasaemia	28.70	21.38	9	8088	548	32504881
Acute kidney injury	28.45	21.38	146	7951	293322	32212107
Gastric dilatation	28.22	21.38	9	8088	579	32504850
Wrong drug	27.77	21.38	6	8091	81	32505348
Ketonuria	27.30	21.38	9	8088	643	32504786
Pneumonia	26.24	21.38	30	8067	355222	32150207
Injection site nodule	26.22	21.38	11	8086	1542	32503887
Flatulence	26.12	21.38	28	8069	19327	32486102
Gastrointestinal disorder	25.73	21.38	35	8062	30896	32474533
Product storage error	25.38	21.38	18	8079	7160	32498269
Abdominal pain upper	22.57	21.38	51	8046	67287	32438142
Product administration error	21.78	21.38	23	8074	15602	32489827

Pharmacologic Action:

Source	Code	Description
ATC	A10BJ05	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Glucagon-like peptide-1 (GLP-1) analogues
FDA CS	M0160181	Glucagon-Like Peptide 1
FDA MoA	N0000020058	Glucagon-like Peptide-1 (GLP-1) Agonists
MeSH PA	D007004	Hypoglycemic Agents
FDA EPC	N0000178480	GLP-1 Receptor Agonist

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucagon-like peptide 1 receptor	GPCR	P43220	GLP1R_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
WTT295HSY5	UNII
D09889	KEGG_DRUG
4033739	VUID
N0000191089	NUI
4033739	VANDF
C3179549	UMLSCUI
CHEMBL2108027	ChEMBL_ID
DB09045	DRUGBANK_ID
C555680	MESH_SUPPLEMENTAL_RECORD_UI
7638	IUPHAR_LIGAND_ID
9164	INN_ID
1551291	RXNORM
228834	MMSL
30573	MMSL
d08290	MMSL
015693	NDDF
714080005	SNOMEDCT_US
714081009	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Trulicity	HUMAN PRESCRIPTION DRUG LABEL	1	0002-1433	INJECTION, SOLUTION	0.75 mg	SUBCUTANEOUS	BLA	36 sections
Trulicity	HUMAN PRESCRIPTION DRUG LABEL	1	0002-1434	INJECTION, SOLUTION	1.50 mg	SUBCUTANEOUS	BLA	36 sections
Trulicity	HUMAN PRESCRIPTION DRUG LABEL	1	0002-2236	INJECTION, SOLUTION	3 mg	SUBCUTANEOUS	BLA	36 sections
Trulicity	HUMAN PRESCRIPTION DRUG LABEL	1	0002-3182	INJECTION, SOLUTION	4.50 mg	SUBCUTANEOUS	BLA	36 sections
Trulicity	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3483	INJECTION, SOLUTION	1.50 mg	SUBCUTANEOUS	BLA	35 sections
Trulicity	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3484	INJECTION, SOLUTION	0.75 mg	SUBCUTANEOUS	BLA	35 sections
Trulicity	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5467	INJECTION, SOLUTION	3 mg	SUBCUTANEOUS	BLA	35 sections