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Experimental: Tralokinumab
Experimental: Tralokinumab is a Monoclonal antibody; IL-13 inhibitor Biologic drug developed by AstraZeneca. It is currently in Phase 3 development for Moderate-to-severe atopic dermatitis, Asthma (type 2 inflammation).
Tralokinumab is a monoclonal antibody that blocks interleukin-13 (IL-13), a key cytokine driving type 2 inflammatory responses.
Tralokinumab is an interleukin-13 inhibitor, classified as an antibody, used to treat various skin conditions. It is being studied in clinical trials for conditions such as Chronic Spontaneous Urticaria, Hidradenitis Suppurativa, Psoriasis, Atopic Dermatitis, and CTCL/ Mycosis Fungoides.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Experimental: Tralokinumab |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Monoclonal antibody; IL-13 inhibitor |
| Target | IL-13 (Interleukin-13) |
| Modality | Biologic |
| Therapeutic area | Immunology; Dermatology |
| Phase | Phase 3 |
Mechanism of action
IL-13 is a critical mediator of type 2 inflammation involved in conditions like atopic dermatitis and asthma. By neutralizing IL-13, tralokinumab reduces the downstream inflammatory cascade, including IgE production, eosinophil recruitment, and barrier dysfunction. This mechanism addresses the underlying pathophysiology of IL-13-driven allergic and inflammatory diseases.
Approved indications
- Moderate-to-severe atopic dermatitis
- Asthma (type 2 inflammation)
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Conjunctivitis
Key clinical trials
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
- Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7 (PHASE3)
- Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4 (PHASE1)
- A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma (PHASE3)
- D2212C00002 J-Phase II Study (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Experimental: Tralokinumab CI brief — competitive landscape report
- Experimental: Tralokinumab updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Experimental: Tralokinumab
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Related
- Drug class: All Monoclonal antibody; IL-13 inhibitor drugs
- Target: All drugs targeting IL-13 (Interleukin-13)
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Immunology; Dermatology
- Indication: Drugs for Moderate-to-severe atopic dermatitis
- Indication: Drugs for Asthma (type 2 inflammation)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing