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

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

Stem definition	Drug id	CAS RN
monoclonal antibodies (humanized origin); interleukin and interleukin receptors	5478	1418205-77-2

Description:

Molecule

Description

Molfile Synonyms: bimekizumab bimzelx UCB4940 bimekizumab (genetical recombination)

Bimekizumab is a humanised IgG1/kappa monoclonal antibody that selectively binds with high affinity to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex. Elevated concentrations of IL-17A and IL-17F have been implicated in the pathogenesis of several immune-mediated inflammatory diseases including plaque psoriasis. Bimekizumab inhibits these proinflammatory cytokines, resulting in the normalization of skin inflammation and as a consequence improvement in clinical symptoms associated with psoriasis. From in vitro models, bimekizumab was shown to inhibit psoriasis-related gene expression and cytokine production to a greater extent than inhibition of IL-17A alone. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
5.70	mg	P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
Aug. 20, 2021	EMA	UCB Pharma S.A.
Jan. 20, 2022	PMDA	UCB JAPAN CO., LTD.

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
Product availability issue	229.54	29.14	52	2821	7352	90618222
Therapy interrupted	178.55	29.14	65	2808	50043	90575531
Oral candidiasis	160.61	29.14	55	2818	35400	90590174
Oesophageal candidiasis	158.84	29.14	38	2835	6791	90618783
Psoriatic arthropathy	130.20	29.14	84	2789	228251	90397323
Intentional dose omission	82.05	29.14	28	2845	17755	90607819
Surgery	78.71	29.14	35	2838	44852	90580722
Product dose omission issue	75.52	29.14	67	2806	291620	90333954
Candida infection	70.96	29.14	30	2843	34027	90591547
Injection site pain	66.16	29.14	50	2823	173649	90451925
Insurance issue	57.44	29.14	19	2854	10939	90614635
Product distribution issue	48.33	29.14	13	2860	3692	90621882
Inappropriate schedule of product administration	48.05	29.14	39	2834	149894	90475680
Incorrect dose administered	44.68	29.14	29	2844	78901	90546673
Off label use	41.92	29.14	101	2772	1102151	89523423
Drug ineffective	38.62	29.14	113	2760	1384185	89241389
Psoriasis area severity index increased	35.50	29.14	6	2867	182	90625392
Hidradenitis	33	29.14	10	2863	4337	90621237
Fungal infection	32.62	29.14	19	2854	42642	90582932
Therapeutic response shortened	31.20	29.14	15	2858	22864	90602710
Psoriasis	30.51	29.14	30	2843	147724	90477850

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
Product availability issue	226.47	40.87	46	1452	3521	42616316
Therapy interrupted	180.70	40.87	55	1443	22195	42597642
Psoriatic arthropathy	145.72	40.87	48	1450	24919	42594918
Oral candidiasis	105.71	40.87	33	1465	14372	42605465
Oesophageal candidiasis	86.73	40.87	23	1475	5612	42614225
Insurance issue	78.86	40.87	20	1478	4096	42615741
Product dose omission issue	54.02	40.87	44	1454	154321	42465516
Inappropriate schedule of product administration	52.99	40.87	36	1462	95866	42523971
Surgery	46.79	40.87	19	1479	17597	42602240
Psoriasis	41.30	40.87	24	1474	48580	42571257

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
Product dose omission issue	4795.89	35.66	1729	13095	320053	110254422
Product availability issue	2318.42	35.66	456	14368	7434	110567041
Therapy interrupted	782.79	35.66	282	14542	49540	110524935
Injection site pain	614.92	35.66	349	14475	177573	110396902
Insurance issue	583.74	35.66	157	14667	10455	110564020
Oral candidiasis	484.08	35.66	193	14631	44567	110529908
Inappropriate schedule of product administration	448.93	35.66	300	14524	203337	110371138
Condition aggravated	444.68	35.66	517	14307	734319	109840156
No adverse event	436.64	35.66	208	14616	73631	110500844
Incorrect dose administered	295.92	35.66	180	14644	103461	110471014
Candida infection	292.05	35.66	138	14686	47871	110526604
Drug ineffective	265.96	35.66	608	14216	1519932	109054543
Adverse drug reaction	245.39	35.66	161	14663	105398	110469077
Acne	233.89	35.66	106	14718	33414	110541061
Product distribution issue	228.09	35.66	62	14762	4284	110570191
Fungal infection	192.11	35.66	106	14718	50700	110523775
Device issue	190.91	35.66	93	14731	34442	110540033
Illness	190.09	35.66	125	14699	82046	110492429
Intentional dose omission	160.93	35.66	70	14754	20010	110554465
Psoriasis	138.86	35.66	129	14695	139864	110434611
Off label use	137.84	35.66	476	14348	1499709	109074766
Pruritus	137.16	35.66	264	14560	581296	109993179
Therapeutic response shortened	123.69	35.66	66	14758	29517	110544958
Oesophageal candidiasis	115.09	35.66	47	14777	11487	110562988
Device defective	113.40	35.66	35	14789	3787	110570688
Surgery	98.32	35.66	64	14760	41219	110533256
Injection site swelling	96.48	35.66	74	14750	61716	110512759
Device malfunction	95.67	35.66	53	14771	25505	110548970
Injection site reaction	84.27	35.66	80	14744	88990	110485485
Product leakage	79.86	35.66	22	14802	1596	110572879
Injection site pruritus	79.17	35.66	61	14763	51197	110523278
Psoriatic arthropathy	76.59	35.66	112	14712	196649	110377826
Injection site rash	70.13	35.66	42	14782	23377	110551098
Dyspnoea	66.22	35.66	33	14791	1106839	109467636
Acute kidney injury	63.47	35.66	6	14818	635424	109939051
Injection site erythema	60.93	35.66	69	14755	94107	110480368
Skin burning sensation	59.85	35.66	37	14787	21788	110552687
Hypotension	57.91	35.66	3	14821	523846	110050629
Anaemia	55.07	35.66	5	14819	547081	110027394
Skin disorder	53.37	35.66	45	14779	42868	110531607
Ear infection	53.05	35.66	53	14771	62679	110511796
Toxicity to various agents	52.34	35.66	3	14821	480552	110093923
Hidradenitis	51.30	35.66	21	14803	5159	110569316
Confusional state	50.82	35.66	3	14821	468677	110105798
Drug interaction	49.20	35.66	5	14819	500178	110074297
Pain	48.60	35.66	254	14570	954701	109619774
Therapeutic product effect incomplete	46.98	35.66	97	14727	223708	110350767
Loss of personal independence in daily activities	45.26	35.66	76	14748	149944	110424531
Rash	42.86	35.66	220	14604	820744	109753731
Vomiting	41.15	35.66	37	14787	910638	109663837
Drug intolerance	40.13	35.66	4	14820	406508	110167967
Nasopharyngitis	39.14	35.66	129	14695	394232	110180243
Neutropenia	38.84	35.66	3	14821	374617	110199858
Needle issue	38.45	35.66	26	14798	17814	110556661
Cyst	37.86	35.66	25	14799	16471	110558004

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AC21	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors
CHEBI has role	CHEBI:35842	antirheumatic drug
CHEBI has role	CHEBI:50748	antipsoriatic
CHEBI has role	CHEBI:67079	anti-inflammatory agent

Related Drugs by ATC class:

L04AC Interleukin inhibitors 18 drugs

anakinrabasiliximabbrodalumabcanakinumabdaclizumabguselkumabixekizumabmirikizumabrilonaceptrisankizumabsarilumabsatralizumab show all 18 →

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

Disease	Relation	SNOMED_ID	DOID
Plaque psoriasis	indication	200965009
Pustular psoriasis	indication	200973000
Erythrodermic psoriasis	indication	200977004
Inflammatory bowel disease	contraindication	24526004	DOID:0050589
Upper respiratory tract infection	contraindication	54150009
Oral candidiasis	contraindication	79740000	DOID:14262
Active tuberculosis	contraindication	427099000

🐶 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
Interleukin-17A	Cytokine	Q16552	IL17_HUMAN	ANTIBODY BINDING	Kd	11.46		DRUG LABEL	DRUG LABEL
Interleukin-17F	Cytokine	Q96PD4	IL17F_HUMAN	ANTIBODY BINDING	Kd	10.55		DRUG LABEL	DRUG LABEL
Interleukin-17AF	Cytokine	Q16552 Q96PD4	IL17_HUMAN IL17F_HUMAN	ANTIBODY BINDING	Kd	10.59		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
09495UIM6V	UNII
C4519734	UMLSCUI
CHEBI:757155	CHEBI
CHEMBL4297700	ChEMBL_ID
DB12917	DRUGBANK_ID
D11550	KEGG_DRUG
9878	INN_ID
C000625981	MESH_SUPPLEMENTAL_RECORD_UI
9411	IUPHAR_LIGAND_ID
1340107005	SNOMEDCT_US
278221000202100	SNOMEDCT_US
4042681	VANDF
39937	MMSL
d09814	MMSL
2668041	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Bimzelx	HUMAN PRESCRIPTION DRUG LABEL	1	50474-780	INJECTION, SOLUTION	160 mg	SUBCUTANEOUS	BLA	31 sections
Bimzelx	HUMAN PRESCRIPTION DRUG LABEL	1	50474-781	INJECTION, SOLUTION	160 mg	SUBCUTANEOUS	BLA	31 sections
Bimzelx	HUMAN PRESCRIPTION DRUG LABEL	1	50474-782	INJECTION, SOLUTION	320 mg	SUBCUTANEOUS	BLA	31 sections
Bimzelx	HUMAN PRESCRIPTION DRUG LABEL	1	50474-783	INJECTION, SOLUTION	320 mg	SUBCUTANEOUS	BLA	31 sections