tremelimumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
monoclonal antibodies (human origin); immunomodulator	5690	745013-59-6

Description:

Molecule	Description
Molfile Synonyms: tremelimumab tremelimumab-actl CP-675206 imjudo tremelimumab (genetical recombination)	CTLA-4 is a negative regulator of T-cell activity. Tremelimumab-actl is a monoclonal antibody that binds to CTLA-4 and blocks the interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation. In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Molfile

Synonyms:

tremelimumab
tremelimumab-actl
CP-675206
imjudo
tremelimumab (genetical recombination)

CTLA-4 is a negative regulator of T-cell activity. Tremelimumab-actl is a monoclonal antibody that binds to CTLA-4 and blocks the interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation. In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors.

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company
Feb. 20, 2023	EMA	ASTRAZENECA AB
Oct. 21, 2022	FDA	ASTRAZENECA AB
Dec. 23, 2023	PMDA	AstraZeneca K.K.

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
Biliary tract infection	230.94	79.00	33	987	669	63487333
Pyrexia	99.94	79.00	72	948	470406	63017596
Urinary tract obstruction	94.32	79.00	18	1002	2190	63485812
Embolism	86.61	79.00	21	999	7885	63480117

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
Immune-mediated hepatitis	148.94	51.68	30	1204	2185	34953512
Pneumonitis	116.58	51.68	44	1190	33834	34921863
Biliary tract infection	115.44	51.68	20	1214	635	34955062
Colitis	101.46	51.68	41	1193	37709	34917988
Enterocolitis infectious	96.46	51.68	20	1214	1675	34954022
Enterocolitis	53.00	51.68	17	1217	8009	34947688

FDA Adverse Event Reporting System (Geriatric)

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
Biliary tract infection	328.68	56.76	53	2245	1335	79740755
Immune-mediated hepatitis	180.27	56.76	37	2261	3619	79738471
Colitis	164.17	56.76	66	2232	73241	79668849
Pneumonitis	136.88	56.76	55	2243	60805	79681285
Pyrexia	119.50	56.76	120	2178	678589	79063501
Bile duct stenosis	85.38	56.76	18	2280	1998	79740092
Febrile neutropenia	79.21	56.76	60	2238	230939	79511151
Drug-induced liver injury	77.92	56.76	38	2260	66079	79676011
Embolism	74.61	56.76	24	2274	13958	79728132
Hepatic infection	66.01	56.76	13	2285	1027	79741063
Presyncope	65.13	56.76	29	2269	41025	79701065
Urinary tract obstruction	60.32	56.76	16	2282	4749	79737341
Sepsis	58.97	56.76	54	2244	269374	79472716
Cholangitis infective	58.73	56.76	11	2287	666	79741424
Enterocolitis infectious	57.97	56.76	14	2284	2855	79739235
Myocarditis	57.02	56.76	22	2276	21711	79720379

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FX20	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates
MeSH PA	D000970	Antineoplastic Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Liver cell carcinoma	indication	109841003	DOID:684
Non-small cell lung cancer, negative for epidermal growth factor receptor expression	indication	427038005
Metastatic non-small cell lung cancer with no anaplastic lymphoma kinase genomic tumor aberrations	indication	830055006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
Cytotoxic T-lymphocyte protein 4	Surface antigen	P16410	CTLA4_HUMAN	BINDING AGENT	Kd	8.23		SCIENTIFIC LITERATURE	DRUG LABEL

External reference:

ID	Source
CHEMBL2108658	ChEMBL_ID
C520704	MESH_SUPPLEMENTAL_RECORD_UI
8462	IUPHAR_LIGAND_ID
DB11771	DRUGBANK_ID
019215	NDDF
4041790	VANDF
4041791	VANDF
C2351038	UMLSCUI
8716	INN_ID
D06657	KEGG_DRUG
2619312	RXNORM
362315	MMSL
40997	MMSL
d09937	MMSL
QEN1X95CIX	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
IMJUDO	HUMAN PRESCRIPTION DRUG LABEL	1	0310-4505	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	25 sections
IMJUDO	HUMAN PRESCRIPTION DRUG LABEL	1	0310-4505	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	25 sections
IMJUDO	HUMAN PRESCRIPTION DRUG LABEL	1	0310-4535	INJECTION, SOLUTION	300 mg	INTRAVENOUS	BLA	25 sections
IMJUDO	HUMAN PRESCRIPTION DRUG LABEL	1	0310-4535	INJECTION, SOLUTION	300 mg	INTRAVENOUS	BLA	25 sections