Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 530 |
| INN | Ziltivekimab |
| Status | Clinical |
| Drug code(s) | COR-001, WBP216 , MEDI5117 |
| Brand name | None |
| 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 | Phage display |
| Target(s) | IL-6 |
| Indications of clinical studies | Atherosclerosis, Cardiovascular Risk and Heart Failure, Anemia, Chronic Kidney Diseases |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2015 |
| Start of Phase 2 | June 03, 2019 |
| Start of Phase 3 | August 30, 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 | AstraZeneca |
| Licensee/Partner | Novo Nordisk |
| Comments about company or candidate | NCT06263244 Phase 3 study for Atherosclerosis and inflammation sue to start in April 2024 NCT06200207 Phase 3 started in Apr 2024. NCT06118281 Phase 3 ARTEMIS study started in June 2024. Phase 3 studies for Atherosclerotic cardiovascular disease, chronic kidney disease (NCT05021835 is recruiting as of May 18, 2023); Heart Failure (NCT05636176 is recruiting as of June 12, 2023) NCT05636176 Phase 3 in heart failure due to start in May 2023. NCT05021835 Phase 3 study of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation started in Aug 2021 recruiting as of last update in Mar 2023. May 2021: Novo Nordisk press release “We are very encouraged by these promising phase 2 data, which is an important step towards a new potential anti-inflammatory treatment approach for people living with atherosclerotic CVD and CKD,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “Based on these results, we are planning to progress ziltivekimab to a large-scale phase 3 cardiovascular outcomes trial to further assess its potential, as we continue to advance our commitment in cardiovascular disease.” NCT04626505 Phase 2 study started in Oct 2020. June 11, 2020: Novo Nordisk announced that it has entered into a definitive agreement to acquire Corvidia Therapeutics. Corvidia Therapeutics' lead candidate, ziltivekimab, a fully human monoclonal antibody directed against Interleukin-6 (IL-6), is being developed to reduce the risk of major adverse cardiovascular events in chronic kidney disease (CKD) patients with atherosclerotic cardiovascular disease (ASCVD) and inflammation. Ziltivekimab is being evaluated in a Phase IIb dose-finding clinical trial in patients who have an increased risk of ASCVD with CKD and inflammation. NCT03926117 phase 2 study to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition started in June 2019. NCT02868229 Phase 1 study, started in Aug 2016, and NCT03126318 Phase 1 study recruiting as of July 2018. COR-001, a monoclonal antibody initially developed by MedImmune, AstraZeneca's global biologics research and development arm, was previously in a Phase 1 study for a different indication. It was repurposed by AstraZeneca's Emerging Innovations Unit, Scientific Partnering and Alliances (SP&A), prior to licensing to Corvidia |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
Human IgG1k anti-human IL-6 monoclonal antibody Fc (fragment crystallizable) engineered to enhance pharmacokinetic half-life (YTE) (https://www.sciencedirect.com/science/article/abs/pii/S0022283611006772)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |