All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

cemiplimab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
primate origin	5317	1801342-60-8

Description:

Molecule

Description

Synonyms: cemiplimab libtayo REGN2810 cemiplimab-rwlc

Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
16.70	mg	P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
Sept. 28, 2018	FDA	REGENERON PHARMACEUTICALS
June 28, 2019	EMA	REGENERON IRELAND U.C.
Dec. 23, 2022	PMDA	Sanofi 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
Disease progression	182.75	33.03	68	976	156547	90470856
Interstitial lung disease	56.48	33.03	24	1020	76381	90551022
Hypothyroidism	43.62	33.03	18	1026	53109	90574294
Hyperthyroidism	40.87	33.03	13	1031	18297	90609106
Cholangitis	33.33	33.03	9	1035	7173	90620230

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
Pemphigoid	85.04	30.81	29	2140	11438	42607728
Myocarditis	77.77	30.81	31	2138	18907	42600259
Disease progression	72.14	30.81	59	2110	143597	42475569
Blood thyroid stimulating hormone increased	53.80	30.81	17	2152	5275	42613891
Myositis	46.34	30.81	20	2149	14846	42604320
Pneumocephalus	45.48	30.81	8	2161	189	42618977
Squamous cell carcinoma of skin	42.56	30.81	18	2151	12708	42606458
Cholangitis	38.65	30.81	16	2153	10711	42608455
Pneumonitis	34.03	30.81	23	2146	41695	42577471
Cytokine storm	33.29	30.81	8	2161	900	42618266
Ear haemorrhage	31.81	30.81	8	2161	1086	42618080

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
Disease progression	126.79	31.70	76	2534	243958	110342731
Myocarditis	110.27	31.70	37	2573	30018	110556671
Pemphigoid	79.20	31.70	26	2584	19681	110567008
Cholangitis	67.45	31.70	22	2588	16313	110570376
Immune-mediated hepatitis	53.46	31.70	15	2595	6696	110579993
Pneumonitis	53.46	31.70	29	2581	76502	110510187
Blood thyroid stimulating hormone increased	48.49	31.70	16	2594	12285	110574404
Pneumocephalus	44.21	31.70	8	2602	490	110586199
Myositis	43.61	31.70	19	2591	31097	110555592
Squamous cell carcinoma of skin	43.24	31.70	16	2594	17187	110569502
Interstitial lung disease	41.99	31.70	31	2579	139303	110447386
Cytokine release syndrome	36.60	31.70	22	2588	70284	110516405
Hepatic cytolysis	36.05	31.70	20	2590	55033	110531656
Cholestasis	35.70	31.70	21	2589	64497	110522192
Cytokine storm	35.46	31.70	8	2602	1482	110585207
Immune-mediated enterocolitis	35.19	31.70	12	2598	10173	110576516
Immune-mediated lung disease	33.95	31.70	10	2600	5293	110581396
Hypothyroidism	33.33	31.70	21	2589	72878	110513811
Dermatitis bullous	32.26	31.70	13	2597	17516	110569173
Adrenal insufficiency	32.21	31.70	17	2593	42373	110544316

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FF06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
MeSH PA	D000074322	Antineoplastic Agents, Immunological
MeSH PA	D000970	Antineoplastic Agents
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:64946	anti-HIV agent
CHEBI has role	CHEBI:64951	anti-HBV agent

Related Drugs by ATC class:

L01FF PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors 11 drugs

atezolizumabavelumabdostarlimabdurvalumabnivolumabpembrolizumabretifanlimabserplulimabsugemalimabtislelizumabtoripalimab

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

Disease	Relation	SNOMED_ID	DOID
Malignant tumor of cervix	indication	363354003	DOID:4362
Squamous cell carcinoma	indication	402815007	DOID:1749
Non-small cell lung cancer without mutation in epidermal growth factor receptor	indication	703230006
Nonsmall cell lung cancer without mutation in epidermal growth factor receptor	indication	703230006
Metastatic basal cell carcinoma	indication	40641000146101

🐶 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
Programmed cell death protein 1	Membrane receptor	Q15116	PDCD1_HUMAN	ANTIBODY BINDING	Kd	7.10		SCIENTIFIC LITERATURE	DRUG LABEL

External reference:

ID	Source
6QVL057INT	UNII
4037905	VANDF
4037906	VANDF
C4724806	UMLSCUI
CHEBI:757176	CHEBI
CHEMBL4297723	ChEMBL_ID
DB14707	DRUGBANK_ID
D11108	KEGG_DRUG
10691	INN_ID
C000627974	MESH_SUPPLEMENTAL_RECORD_UI
10090	IUPHAR_LIGAND_ID
781555007	SNOMEDCT_US
781611008	SNOMEDCT_US
292661	MMSL
35140	MMSL
35147	MMSL
d08950	MMSL
017771	NDDF
2058825	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
LIBTAYO	HUMAN PRESCRIPTION DRUG LABEL	1	61755-008	INJECTION	50 mg	INTRAVENOUS	BLA	30 sections
LIBTAYO	HUMAN PRESCRIPTION DRUG LABEL	1	61755-008	INJECTION	50 mg	INTRAVENOUS	BLA	30 sections