Tralokinumab: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Tralokinumab appears in the FDA drug-label database. Marketed as Adbry.
- Drug class
- Interleukin-13 Antagonist (FDA established pharmacologic class)
- Mechanism of action
- Interleukin-13 Antagonists (as stated on the FDA label)
FDA-approved use
ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids. ADBRY is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids. ( 1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. — LEO PHARMA INC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2026-02-10 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Eczema · Tralokinumab for Eczema | 3 |
| Atopic Dermatitis | 2 |
| Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region | 1 |
| Psoriasis | 1 |
Recruiting trials involving Tralokinumab
- Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
- Molecular Signatures in Inflammatory Skin Disease
- Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
Common questions
Is Tralokinumab FDA-approved?
Yes, marketed as Adbry.
How many recruiting trials involve Tralokinumab?
3 recruiting trials across 4 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.