Idarucizumab

Summary

Idarucizumab (CHEMBL3544996) is an approved antibody (ATC V03AB37); indicated across 1 condition.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: V03AB37
• Indications: 1 condition
• Clinical trials: 10

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3544996
Name	Idarucizumab
Type	Antibody
Max phase	4
ATC	V03AB37

Also known as: Adabi-fab, BI 655075, BI-655075, BI655075, Idarucizumab, Praxbind, IDARUCIZUMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 indication record carries no mapped disease name (EFO/MeSH-only); none shown.

Clinical trials

Total trials: 10.

Phase distribution

Phase	Trials
PHASE3	4
PHASE1	4
Not specified	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02104947	PHASE3	COMPLETED	Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
NCT02815670	PHASE3	COMPLETED	Reversal Dabigatran Anticoagulant Effect With Idarucizumab
NCT02831660	PHASE3	COMPLETED	CU Programme of Idarucizumab for Japanese Patients
NCT03343704	PHASE3	COMPLETED	This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
NCT01688830	PHASE1	COMPLETED	Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate
NCT01955720	PHASE1	COMPLETED	Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
NCT02028780	PHASE1	COMPLETED	Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
NCT03086356	PHASE1	COMPLETED	Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State
NCT02798107	Not specified	WITHDRAWN	Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
NCT04062097	Not specified	COMPLETED	Registration of Idarucizumab for Patients with IntraCranial Hemorrhage

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).