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Tezepelumab (APFS)
Tezepelumab (APFS) is a IL-33/ST2 pathway inhibitor Biologic drug developed by AstraZeneca. It is currently in Phase 3 development for Severe asthma, Eosinophilic esophagitis.
Tezepelumab is a monoclonal antibody that targets and blocks the activity of thymic stromal lymphopoietin (TSLP), a cytokine involved in the initiation of allergic inflammation.
Tezepelumab (APFS) is an antibody that inhibits thymic stromal lymphopoietin, a protein involved in the development of asthma and airway remodelling. It is being studied as a potential treatment for asthma and airway remodelling, among other conditions.
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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 | Tezepelumab (APFS) |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | IL-33/ST2 pathway inhibitor |
| Target | TSLP |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By blocking TSLP, tezepelumab prevents the activation of immune cells and the release of pro-inflammatory cytokines, which are key drivers of allergic inflammation. This mechanism of action is thought to be responsible for the therapeutic effects of tezepelumab in treating severe asthma and other allergic diseases.
Approved indications
- Severe asthma
- Eosinophilic esophagitis
Common side effects
- Injection site reactions
- Headache
- Nausea
- Fatigue
- Musculoskeletal pain
Key clinical trials
- REVErsing Airway Remodelling With Tezepelumab (PHASE3)
- Tezepelumab Home Use Study (PHASE3)
- A Study to Evaluate the Pharmacokinetics of Tezepelumab After Being Delivered by an Accessorized Pre Filled Syringe or Autoinjector Compared With Vial and Syringe in Healthy Adult Subjects (PHASE1)
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:
- Tezepelumab (APFS) CI brief — competitive landscape report
- Tezepelumab (APFS) updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Tezepelumab (APFS)
What is Tezepelumab (APFS)?
How does Tezepelumab (APFS) work?
What is Tezepelumab (APFS) used for?
Who makes Tezepelumab (APFS)?
What drug class is Tezepelumab (APFS) in?
What development phase is Tezepelumab (APFS) in?
What are the side effects of Tezepelumab (APFS)?
What does Tezepelumab (APFS) target?
Related
- Drug class: All IL-33/ST2 pathway inhibitor drugs
- Target: All drugs targeting TSLP
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Severe asthma
- Indication: Drugs for Eosinophilic esophagitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing