ADBRY (tralokinumab)
ADBRY is indicated for the treatment of Atopic Dermatitis.
How ADBRY Works
Tralokinumab-ldrm is a human IgG4 monoclonal antibody that specifically binds to the cytokine interleukin-13 (IL-13) to inhibit its interaction with the IL-13 receptor α1 and α2 subunits. By blocking the interaction with the IL-13Rα1/IL-4Rα receptor complex, the drug suppresses the bioactivity of the Type 2 immune response. This action inhibits IL-13-induced responses, including the release of proinflammatory cytokines, chemokines, and IgE.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-12-27
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ADBRY Approval History
What ADBRY Treats
1 indicationsADBRY is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atopic Dermatitis
ADBRY Target & Pathway
ProTarget
ADBRY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ADBRY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ADBRY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ADBRY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05388760 | LP0162-1335 2021-005573-12, U1111-1282-4394 | Ph 2 | completed | Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05958407 ADHAND | LP0162-2328 U1111-1285-7014, 2022-502653-34-00 | Ph 3 | completed | A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy |
| NCT03562377 ECZTRA 5 results posted | LP0162-1341 | Ph 2 | completed | Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5) |
| NCT03587805 results posted | LP0162-1337 2018-000746-19, U1111-1282-4519 | Ph 3 | completed | Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND |
| NCT03761537 ECZTRA 7 results posted | LP0162-1346 | Ph 3 | completed | Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7 |
| NCT04587453 ECZTRA 8 results posted | LP0162-1343 | Ph 3 | completed | Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis |
| NCT03131648 ECZTRA 1 results posted | LP0162-1325 2016-004200-65 | Ph 3 | completed | Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1) |
| NCT03160885 ECZTRA 2 results posted | LP0162-1326 2016-004201-13 | Ph 3 | completed | Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2) |
| NCT05194540 INJECZTRA results posted | LP0162-1338 U1111-1283-2072 | Ph 3 | completed | Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA) |
| NCT03526861 results posted | LP0162-1334 2017-005143-33 | Ph 3 | completed | Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6). |
| NCT03363854 results posted | LP0162-1339 2017-002065-21 | Ph 3 | completed | Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3 |
| NCT03556592 | LP0162-1342 2018-000534-35 | Ph 1 | completed | Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4 |
| NCT06773455 | ETC05 | Ph 4 | active not recruiting | Tralokinumab for Dupilumab Failures |
| NCT04556461 TraSki | TRA-WEI-0015-I | Ph 2 | completed | Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function |
| NCT02684097 results posted | GCO 15-1497 | Ph 2 | completed | A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata |
| NCT02281357 TROPOS results posted | D2210C00013 | Ph 3 | completed | Phase 3 Study to Evaluate the Efficacy & Safety of Tralokinumab in Adults & Adolescents With OCS Dependent Asthma |
| NCT02449473 MESOS results posted | D2210C00014 | Ph 2 | completed | Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids |
| NCT02161757 STRATOS1 results posted | D2210C00007 | Ph 3 | completed | A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma |
| NCT01629667 results posted | CD-RI-CAT-354-1066 | Ph 2 | terminated | A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis |
| NCT01482884 results posted | D2211C00001 EudraCT number 2011-004812-40 | Ph 2 | completed | Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADBRY FDA Label Details
Indications & Usage
FDA Label (PDF)ADBRY is indicated for the treatment of Atopic Dermatitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment