Drugs / Tralokinumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ADBRY | — | 2023-12-14 – 2024-06-12 | fda.gov ↗ |
| Approved | US (FDA) | ADBRY | — | 2021-12-27 | fda.gov ↗ |
| Approved | EU (EMA) | Adtralza | — | 2021-06-17 | europa.eu ↗ |
Trials 35 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT04674826 | Feb → Dec 2021 | — | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT03556592 | Aug 2018 → Mar 2020 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02085473 | Mar → Jul 2014 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT01592396 | Jun 2012 → Jan 2013 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT01093040 | Apr → May 2010 | — | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT00638989 | Apr → Jun 2008 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT00974675 | Sep 2006 → Aug 2007 | — | MedImmune LLC | Terminated | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT05388760 | Sep 2022 → Oct 2023 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT04556461 | Sep 2020 → Jul 2022 | atopic eczema | Prof. Dr. Stephan Weidinger | Completed | No outcome recorded |
| Phase 2 | NCT03562377 | Jul 2018 → Sep 2019 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT02449473 | Sep 2015 → Jun 2017 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02347176 | Jan → Nov 2015 | atopic eczema | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT02036580 | Jan 2014 → Nov 2015 | idiopathic pulmonary fibrosis | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01629667 | Oct 2012 → May 2015 | idiopathic pulmonary fibrosis | MedImmune LLC | Terminated | No outcome recorded |
| Phase 2 | NCT01482884 | Mar 2012 → Mar 2013 | ulcerative colitis | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01402986 | Aug 2011 → Jun 2013 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00873860 | Jun 2009 → Aug 2010 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00640016 | Jan → Jul 2008 | asthma | MedImmune LLC | Terminated | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT06311682 | Jun 2024 → Oct 2026 expected | atopic eczema | LEO Pharma | Recruiting | No outcome recorded |
| Phase 3 | NCT05958407 | Aug 2023 → May 2025 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT05194540 | Jan 2022 → Jun 2023 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT04587453 | Oct 2020 → Jul 2021 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03761537 | Dec 2018 → Apr 2020 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03526861 | Jun 2018 → Apr 2020 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03587805 | Mar 2018 → Jul 2024 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03363854 | Feb 2018 → Mar 2019 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03160885 | Jun 2017 → Sep 2018 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03131648 | May 2017 → Aug 2018 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT02902809 | Nov 2016 → Jan 2018 | asthma | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT02281357 | Feb 2015 → Sep 2017 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02194699 | Oct 2014 → May 2017 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02161757 | Jun 2014 → Feb 2017 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06366932 | Sep 2023 → Sep 2025 | atopic eczema | Instituto de Investigación Hospital Universitario La Paz | Unknown | No outcome recorded |
| Phase 4 | NCT06773455 | Sep 2023 → Jan 2026 | atopic eczema | Psoriasis Treatment Center of Central New Jersey | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02684097 Comparator | Jan 2016 → Nov 2017 | alopecia areata | Emma Guttman | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05378698 Comparator | Jun 2022 → Mar 2025 | atopic eczema | University of Zurich | Terminated | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tralokinumab | “Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in...” NCT06366932 ↗31 |
| Known as | Adbry | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743081 ↗ |
| Known as | Adtralza | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743081 ↗ |
| Known as | CAT-354 | “evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13)” NCT01482884 ↗ |
| Action | Inhibit | “Tralokinumab is a human monoclonal antibody that blocks IL-13” NCT01402986 ↗ |
| Modality | Monoclonal antibody | “Tralokinumab is a human immunoglobulin G4 monoclonal antibody that specifically binds to IL-13.” PMID 28758192 ↗ Sep 2017 |
| Route | Intravenous | “intravenous infusion” NCT00638989 ↗ |
| Target | IL13 | “directed against interleukin-13 (IL-13)” NCT01482884 ↗ |