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
| 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 Stop: Enrollment |
| Phase 211 trials · 5 missed | ||||||
| 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 | Missed primary |
| Phase 2 | NCT02347176 | Jan → Nov 2015 | atopic eczema | MedImmune LLC | Completed | Mixed |
| 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 | Missed primary |
| Phase 2 | NCT01482884 | Mar 2012 → Mar 2013 | ulcerative colitis | AstraZeneca | Completed | Missed primary |
| Phase 2 | NCT01402986 | Aug 2011 → Jun 2013 | asthma | MedImmune LLC | Completed | Missed primary |
| Phase 2 | NCT00873860 | Jun 2009 → Aug 2010 | asthma | MedImmune LLC | Completed | Missed primary |
| Phase 2 | NCT00640016 | Jan → Jul 2008 | asthma | MedImmune LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 314 trials · 5 met primary · 4 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT03761537 | Dec 2018 → Apr 2020 | atopic eczema | LEO Pharma | Completed | Met primary |
| Phase 3 | NCT03526861 | Jun 2018 → Apr 2020 | atopic eczema | LEO Pharma | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT03160885 | Jun 2017 → Sep 2018 | atopic eczema | LEO Pharma | Completed | Met primary |
| Phase 3 | NCT03131648 | May 2017 → Aug 2018 | atopic eczema | LEO Pharma | Completed | Met primary |
| Phase 3 | NCT02902809 | Nov 2016 → Jan 2018 | asthma | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT02281357 | Feb 2015 → Sep 2017 | asthma | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT02194699 | Oct 2014 → May 2017 | asthma | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT02161757 | Jun 2014 → Feb 2017 | asthma | AstraZeneca | Completed | Missed primary |
| 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 |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT02684097 Comparator | Jan 2016 → Nov 2017 | alopecia areata | Emma Guttman | Completed | No outcome recorded |
| Phase 2/3 | NCT05378698 Comparator | Jun 2022 → Mar 2025 | atopic eczema | University of Zurich | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | LEO Pharma | Results LEO Pharma presents new tralokinumab data at EADV 2026 highlighting real-world outcomes and quality of life in adults and adolescents with atopic dermatitis (AD) involving high-burden areas leo-pharma.com ↗
In a post hoc analysis, adolescents aged 12-17 years treated across the phase 3 ECZTRA 6 trial and its ECZTEND extension, response rates remained high and stable through most of the extension period, and no new safety concerns were identified.⁵ |
| 2026-07-09 | LEO Pharma | Results LEO Pharma announces key results of Phase 2 TRAPEDS-1 trial evaluating pharmacokinetics and safety of tralokinumab in children with moderate-to-severe atopic dermatitis leo-pharma.com ↗
The pharmacokinetic profile was as expected and consistent with what has previously been observed with tralokinumab. |
| 2017-11-01 | AstraZeneca | Results AstraZeneca provides update on tralokinumab Phase III programme in severe, uncontrolled asthma astrazeneca.com ↗
In STRATOS 2, tralokinumab did not achieve a statistically-significant reduction in the annual asthma exacerbation rate (AAER), the primary endpoint, in patients with severe, uncontrolled asthma and elevated levels of a biomarker, Fractional exhaled Nitric Oxide (FeNO), compared to placebo. |
| 2017-05-10 | AstraZeneca | Results AstraZeneca provides update on STRATOS 1 Phase III trial of tralokinumab in severe, uncontrolled asthma astrazeneca.com ↗
Tralokinumab did not meet its primary endpoint of a significant reduction in the annual asthma exacerbation rate |
| 2015-09-22 | AstraZeneca | Results AstraZeneca to present data demonstrating diversity of its portfolio of innovative formulations and devices at the European Respiratory Society International Congress 2015 astrazeneca.com ↗
The reduction of serum periostin by tralokinumab in subjects with severe uncontrolled asthma further supports this concept. |
| 2014-05-15 | AstraZeneca | Results Continuing progress in accelerating late stage pipeline reinforces confidence in AstraZeneca’s strategy as an independent company astrazeneca.com ↗
Both showed improvement in key measures of asthma control for patients with specific, severe forms of asthma. |
| 2014-05-12 | AstraZeneca | Results AstraZeneca to present respiratory data at ATS 2014 International Conference astrazeneca.com ↗
In the Phase IIb data being presented, both benralizumab and tralokinumab show promising safety and efficacy outcomes, suggesting they may offer important new therapeutic options for patients with specific forms of severe, uncontrolled asthma. |
All press releases naming this drug 9 releases
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 ↗ |
| 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 ↗ |