Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1722 |
| INN | Garadacimab |
| Status | Approved |
| Drug code(s) | CSL312 |
| Brand name | ANDEMBRY® |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Factor XIIa |
| Indications of clinical studies | Idiopathic Pulmonary Fibrosis, Hereditary Angioedema, COVID-19, Phase 1 in healthy volunteers |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Approved EU, Japan, Australia, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 25, 2016 |
| Start of Phase 2 | October 29, 2018 |
| Start of Phase 3 | January 13, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2025 |
| Date of first US approval | |
| INN, US product name | Garadacimab |
| US or EU approved indications | None |
| Company | CSL Limited |
| Licensee/Partner | None |
| Comments about company or candidate | Approval in the EU announced on Feb 13, 2025. ANDEMBRY was approved by the United Kingdom's Medicines and Healthcare products Regulatory Agency on January 24, 2025. Approved in Australia on Jan 14, 2025 (https://www.tga.gov.au/resources/artg/443611) EMA’s CHMP started the evaluation of a MAA for garadacimab on November 23, 2023. CSL anticipates global regulatory submissions in 2023 for approval of garadacimab. Phase 3 studies for Hereditary Angioedema: NCT04656418 completed, NCT04739059 active not recruiting as of May 26, 2023, NCT05819775 recruiting as of June 1, 2023). May 1, 2023: The Lancet Publishes Pivotal Phase 3 Data on CSL's First-in-Class Garadacimab for HAE https://newsroom.csl.com/2023-03-01-The-Lancet-Publishes-Pivotal-Phase-3-Data-on-CSLs-First-in-Class-Garadacimab-for-HAE NCT05819775 Phase 3 in Hereditary Angioedema due to start in May 2023. August 17, 2022 I Global biotechnology leader CSL announced positive top-line Phase 3 results for garadacimab (CSL312), the company's investigational first-in-class monoclonal antibody inhibiting Factor XIIa being developed as a long-term preventive treatment for patients with hereditary angioedema (HAE). The study met its primary and secondary efficacy objectives and also demonstrated favorable safety and tolerability. CSL aims to begin filing with global health authorities at the end of the current fiscal year for full approval. NCT04739059 Phase 3 started in March 2021 has primary completion date in Nov 2025. NCT04656418 Phase 3 in Prophylactic Treatment of Hereditary Angioedema started Jan 2021 completed as of last update in Aug 2022. June 2020: the U.S. Food and Drug Administration (FDA) granted orphan drug designation to garadacimab as an investigational therapy for the prevention of bradykinin-mediated angioedema. NCT04409509 Phase 2 in COVID-19. NCT03712228 Phase 2 study in Hereditary Angioedema started in Oct 2018 still recruiting as of Aug 2019. Phase 1 ACTRN12616001438448 in Australia; data collection complete as of Sep 2017. Intended for Hereditary Angioedema |
| Full address of company | Melbourne, Australia Australia Australia https://www.csl.com/ |
CSL312 is a fully human recombinant anti-FXIIa antibody (Factor XIIa antagonist monoclonal antibody); Hinge stabilized S228P
| Anticipated events | Regulatory review US, Switzerland, Canada |
| Factor(s) contributing to discontinuation | None |