Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 144 |
| INN | Tildrakizumab |
| Status | Approved |
| Drug code(s) | SCH 900222, MK-3222 |
| Brand name | ILUMYA, Ilumetri |
| 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 | Psoriasis, Ankylosing spondylitis and Non-Radiographic Axial Spondyloarthritis, 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) | July 01, 2008 |
| Start of Phase 2 | October 15, 2010 |
| Start of Phase 3 | December 15, 2012 |
| Date BLA/NDA submitted to FDA | March 23, 2017 |
| Year of first approval (global) | 2018 |
| Date of first US approval | March 20, 2018 |
| INN, US product name | Tildrakizumab, Tildrakizumab-asmn |
| US or EU approved indications | Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
| Company | Merck |
| Licensee/Partner | Sun, Almirall |
| Comments about company or candidate | BLA submitted for moderate-to-severe plaque psoriasis. Phase 3 study NCT01722331 started in December 2012; Phase 3 study NCT01729754 started in Feb 2013. July 27, 2016: Sun Pharma and Almirall today announced a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. |
| Full address of company | Rahway, NJ 07065 USA North America United States of America https://www.merck.com/contact-us/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |