Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 42 |
| INN | Tralokinumab |
| Status | Approved |
| Drug code(s) | CAT-354 |
| Brand name | Adtralza |
| 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 | Phage display-derived |
| Target(s) | IL-13 |
| Indications of clinical studies | Atopic dermatitis, Asthma, Idiopathic Pulmonary Fibrosis, Ulcerative Colitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2004 |
| Start of Phase 2 | April 15, 2008 |
| Start of Phase 3 | June 15, 2014 |
| Date BLA/NDA submitted to FDA | April 27, 2020 |
| Year of first approval (global) | 2021 |
| Date of first US approval | December 27, 2021 |
| INN, US product name | Tralokinumab, Tralokinumab-ldrm |
| US or EU approved indications | Treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable |
| Company | AstraZeneca |
| Licensee/Partner | LEO Pharma |
| Comments about company or candidate | Approved in EU on June 17, 2021. PDUFA date is in Q2 2021. June 11, 2020: LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for tralokinumab, an investigational product for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD). The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Three Phase 3 studies in atopic dermatitis started between Jun and Dec 2018; all are still recruiting patients as of Aug 1, 2019. Feb 2018: AstraZeneca decided to discontinue the development of tralokinumab, an investigational antiIL-13 human immunoglobulin-G4 monoclonal antibody, in severe, uncontrolled asthma. The decision followed the publication of results of the Phase III programme, in which the primary endpoint of a significant reduction in the annual asthma exacerbation rate was not met in the two pivotal trials, STRATOS 1 and STRATOS 2. In an OCSsparing trial, TROPOS, tralokinumab did not achieve a statistically-significant reduction in OCS use when added to the standard of care, in patients dependent on OCS. June 15, 2017: LEO Pharma today announced that the first patients have been dosed in a phase 3 clinical study of tralokinumab. Tralokinumab is an investigational human monoclonal antibody that specifically targets the cytokine IL-13[1], which plays an important role in the development of moderate-to-severe atopic dermatitis. May 2017: Tralokinumab, an anti-interleukin-13 (IL-13) human monoclonal antibody, did not meet its primary endpoint of a significant reduction in the annual asthma exacerbation rate (AAER) in the overall population of severe, uncontrolled asthma patients, compared with placebo in STRATOS 1, the first of two pivotal Phase III trials. July 2016: AstraZeneca sold the rights to atopic dermatitis drug tralokinumab to LEO Pharma, but retained rights to develop the drug as a treatment for severe asthma. NCT02161757 Phase 3 in asthma recruiting as of June 2014. NCT02036580 Phase 2 recruiting as of Feb 2014; Phase II Tralokinumab data is expected to be presented at the 2014 American Thoracic Society (ATS) annual meeting on May 16-21, 2014. |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
Wild-type hinge
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |