Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2453 |
| INN | Etrolizumab |
| Status | Terminated |
| Drug code(s) | rhuMAb beta7, RG7413, PRO 145223, RO5490261 |
| Brand name | None |
| 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) | Integrin beta-7 |
| Indications of clinical studies | Crohn's disease, Ulcerative Colitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2008 |
| Start of Phase 2 | September 15, 2011 |
| Start of Phase 3 | May 15, 2014 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Genentech |
| Licensee/Partner | None |
| Comments about company or candidate | Removed from Roche pipeline for Crohn's disease as of Feb 2022 update. Roche H1 2021 update: BLA submission in Crohn's planned for 2022. 10 August 2020 - Roche announced topline results from its phase III study programme evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis. Mixed results were seen in studies evaluating etrolizumab as an induction therapy, and both studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints, showing no significant difference in the proportion of people achieving remission with subcutaneous etrolizumab versus placebo. Etrolizumab continues to be studied as an investigational induction and maintenance treatment in people with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment in a global phase III study (BERGAMOT) and open-label extension and safety monitoring study (JUNIPER), involving more than 1,100 people with Crohn’s disease. Total of 8 Phase 3 studies recruiting as of Sep 2 2018. NCT02100696 and NCT02118584 Phase 3 studies recruiting as of Aug 2017. US Orphan drug designations for pediatric Crohn's disease and UC. NCT02100696, NCT02118584, NCT02165215 Phase 3 studies in UC recruiting as of Feb 2015. A Phase III program in inflammatory bowel disease investigating etrolizumab in ulcerative colitis and also in Crohn’s disease comprising more than 3000 patients is expected to start in the first half of 2014. |
| Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
Non-clinical results published: Our data suggest that etrolizumab does not elicit secondary effector functions on the single cell level. Integrin internalization may be an important mechanism of action of etrolizumab, which might explain some but not all immunological effects observed with etrolizumab. Front. Pharmacol., 01 February 2019 | https://doi.org/10.3389/fphar.2019.00039. Target is the integrin beta-7 subunit of integring alpha-4 beta-7 and alpha-E beta-7 (https://pubmed.ncbi.nlm.nih.gov/36240801/ and https://gut.bmj.com/content/62/8/1122)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |