Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 34 |
| INN | Idarucizumab |
| Status | Approved |
| Drug code(s) | BI 655075 |
| Brand name | Praxbind |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Fragment |
| Format details | Fab |
| Isotype (Fc) | None |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Dabigatran |
| Indications of clinical studies | Hemorrhage caused by anticoagulation effect of dabigatran |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2012 |
| Start of Phase 2 | |
| Start of Phase 3 | May 15, 2014 |
| Date BLA/NDA submitted to FDA | February 19, 2015 |
| Year of first approval (global) | 2015 |
| Date of first US approval | October 16, 2015 |
| INN, US product name | Idarucizumab |
| US or EU approved indications | Treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding |
| Company | Boehringer Ingelheim |
| Licensee/Partner | None |
| Comments about company or candidate | BLA filed in Feb 2015; priority review; approved in Oct 2015 under accelerated approval regulations, 21 CFR 601.41, which require further adequate and well-controlled clinical trials to verify and describe clinical benefit. Two Phase 1 studies as of Oct 2013; intravenous doses of up to 8 g are administered. Phase 3 in patients started in May 2014. Breakthrough therapy designation |
| Full address of company | Binger Strasse 173 , 55216 Ingelheim am Rhein, Germany Europe Germany https://www.boehringer-ingelheim.com/contact-us |
Intended to reduce dabigatran-induced anti-coagulation
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |