Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 5 |
| INN | Risankizumab |
| Status | Approved |
| Drug code(s) | ABBV066, BI 655066 |
| Brand name | SKYRIZI |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-23p19 |
| Indications of clinical studies | Atopic dermatitis, Psoriasis, Crohn's Disease, asthma, Ankylosing spondylitis, psoriatic arthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 15, 2012 |
| Start of Phase 2 | January 15, 2014 |
| Start of Phase 3 | February 15, 2016 |
| Date BLA/NDA submitted to FDA | April 23, 2018 |
| Year of first approval (global) | 2019 |
| Date of first US approval | April 23, 2019 |
| INN, US product name | Risankizumab, risankizumab-rzaa |
| US or EU approved indications | Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; treatment of adults with active psoriatic arthritis |
| Company | Boehringer Ingelheim |
| Licensee/Partner | AbbVie |
| Comments about company or candidate | Approved in US on April 23, 2019. First approved in Japan in March 2019 for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies. April 2018: BLA for plaque psoriasis submitted. Based on a standard 12-month original BLA filing under PDUFA V guidelines, the PDUFA decision should occur on April 25, 2019. Seven Phase 3 studies in psoriasis completed or active, one not yet recruiting as of Oct 2017; three studies in Crohn's disease not yet recruiting. In April 2016, AbbVie acquired all rights to risankizumab (BI 655066) for psoriasis, from Boehringer Ingelheim (BI) pursuant to a global collaboration agreement. AbbVie is also evaluating the potential of this biologic in Crohn’s disease, psoriatic arthritis, and asthma. |
| Full address of company | Binger Strasse 173 , 55216 Ingelheim am Rhein, Germany Europe Germany https://www.boehringer-ingelheim.com/contact-us |
L234A, L235A mutations reduce effector function
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |