Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1714 |
| INN | Ebdarokimab |
| Status | Regulatory review |
| Drug code(s) | AK101 |
| Brand name | (Pending) |
| mAb sequence source | mAb human |
| 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-12/23 p40 |
| Indications of clinical studies | Plaque psoriasis, ulcerative colitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Regulatory review China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 18, 2018 |
| Start of Phase 2 | July 01, 2019 |
| Start of Phase 3 | July 01, 2021 |
| 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 | Akesobio Australia Pty Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | Aug 2023: Akeso Inc., a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, announced that the New Drug Application (NDA) for its fully human IgG1 monoclonal antibody, ebdarokimab (IL-12/lL-23, AK101) has been accepted by the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) for the treatment of adult patients with moderate-to-severe plaque-type psoriasis. NCT05120297 Phase 3 posted as active not recruiting on Nov 15, 2021, but start date is listed as Nov 1 2021; primary completion date is Feb 2022. As of Jan 2020, the company indicated that they completed a Phase I and a Phase II clinical trials, and are currently conducting Phase IIb clinical trial, of AK101 in moderate to severe psoriasis patients in China. We have also received IND approval from the FDA for evaluating AK101 for the treatment of ulcerative colitis (UC) in the U.S. in October 2019. NCT04173637 Phase 2 in psoriasis due to start Nov 30 not yet recruiting as of Nov 22, 2019. |
| Full address of company | Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia Australia Australia https://www.akesobio.com/en/about-us/contact-us/ |
AK101 is an anti-IL-12/23p40 monoclonal antibody.
| Anticipated events | Regulatory review China - anticipate approval |
| Factor(s) contributing to discontinuation | None |