Lixudebart

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National Institutes of Health Divider Arrow

NCATS

Approval Year

Substance Class	Protein Created by `admin` on `Wed Apr 02 12:24:30 GMT 2025` Edited by `admin` on `Wed Apr 02 12:24:30 GMT 2025`
Protein Type	MONOCLONAL ANTIBODY
Protein Sub Type	IGG1\|KAPPA
Sequence Origin	HUMANIZED MOUSE
Sequence Type	COMPLETE
Record UNII	STN3UZ6YBJ
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

ALE.F02

Preferred Name

English

Lixudebart

Official Name

English

RECOMBINANT HUMANISED IgG1 KAPPA ANTI-CLDN1 MONOCLONAL ANTIBODY ALE.F02

Common Name

English

Gamma1 heavy chain humanized (1-448) [VH (Homo sapiens IGHV3-21*01 (94.9%) -(IGHD) -IGHJ1*01 (92.9%), CDR-IMGT [8.8.12] (26-33.51-58.97-108)) (1-119) -Homo sapiens IGHG1*03, G1m3, nG1m1 CH1 R120, CH3 E12, M14, CH2 IGHG1v39 CH2 F1.3, E1.2, S116 (CH1 R120

Common Name

English

lixudebart [INN]

Common Name

English

LIXUDEBART [USAN]

Common Name

English

Immunoglobulin G1 [236-phenylalanine,237-glutamic acid,333-serine,de-449-lysine], anti-(human claudin-1) (human-Rattus norvegicus monoclonal ALE.F02 ?1-chain), disulfide with human-Rattus norvegicus monoclonal ALE.F02 ?-chain, dimer

Common Name

English

Code System Code Type Description

CAS

2749515-10-2

Created by admin on Wed Apr 02 12:24:31 GMT 2025 , Edited by admin on Wed Apr 02 12:24:31 GMT 2025

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INN

12552

Created by admin on Wed Apr 02 12:24:31 GMT 2025 , Edited by admin on Wed Apr 02 12:24:31 GMT 2025

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SMS_ID

300000045910

Created by admin on Wed Apr 02 12:24:31 GMT 2025 , Edited by admin on Wed Apr 02 12:24:31 GMT 2025

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FDA UNII

STN3UZ6YBJ

Created by admin on Wed Apr 02 12:24:31 GMT 2025 , Edited by admin on Wed Apr 02 12:24:31 GMT 2025

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NCI_THESAURUS

C199065

Created by admin on Wed Apr 02 12:24:31 GMT 2025 , Edited by admin on Wed Apr 02 12:24:31 GMT 2025

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USAN

MN-157

Created by admin on Wed Apr 02 12:24:31 GMT 2025 , Edited by admin on Wed Apr 02 12:24:31 GMT 2025

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From	To
1_22	1_96
2_22	2_96
2_146	2_202
2_222	4_214
2_263	2_323
1_146	1_202
2_369	2_427
3_23	3_88
3_134	3_194
4_23	4_88
4_134	4_194
1_222	3_214
1_228	2_228
1_231	2_231
1_263	1_323
1_369	1_427

Glycosylation Type

MAMMALIAN

Glycosylation Link Type	Site
N	1_299
N	2_299

Related Record Type Details


					DHD0GV07RG

CLAUDIN-1

TARGET->LIGAND

Comments:

The nonclinical profile of ALE.F02 supports its potential as a treatment for advanced liver fibrosis. In vitro, ALE.F02 has displayed a highly specific binding affinity for CLDN1. Treatment by ALE.F02 was correlated with significant down-regulation of the expression of key fibrosis promoting signaling pathways as well as the suppression of gene expression linked to the Ras/Raf/MEK/ERK signaling pathways in human liver tissue ex vivo; these pathways are hypothesized to play an important role in liver fibrosis. In diet-induced liver fibrosis in humanized mice,

Amount:

Related Record Type Details


					STN3UZ6YBJ

ACTIVE MOIETY

Amount:

Structural Modifications

Modification Type	Location Site	Location Type	Residue Modified	Extent	Fragment Name	Fragment Approval
AMINO_ACID_SUBSTITUTION				Amount:	PIDOLIC ACID	SZB83O1W42

Name	Property Type	Amount	Referenced Substance	Defining	Parameters	References
MOL_WEIGHT:NUMBER(CALCULATED)	CHEMICAL
Molecular Formula	CHEMICAL