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US-licensed Xolair
US-licensed Xolair is a Biologic drug developed by Celltrion. It is currently in Phase 1 development.
US-licensed Xolair is used to treat Chronic Idiopathic Urticaria, as indicated by ClinicalTrials.gov. Xolair, also known as omalizumab, is administered via injection or prefilled syringe, as listed on ClinicalTrials.gov.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | US-licensed Xolair |
|---|---|
| Sponsor | Celltrion |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
- Catheter site pain
- Fatigue
- Injection site reaction
- Headache
- Nausea
- Back pain
- Catheter site irritation
- Diarrhoea
- Dizziness
- Myalgia
- Rash
- Rhinitis
Key clinical trials
- Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair (PHASE1)
- PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects (PHASE1)
- Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (PHASE3)
- To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects (PHASE1)
- To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy 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:
- US-licensed Xolair CI brief — competitive landscape report
- US-licensed Xolair updates RSS · CI watch RSS
- Celltrion portfolio CI
Frequently asked questions about US-licensed Xolair
What is US-licensed Xolair?
Who makes US-licensed Xolair?
What development phase is US-licensed Xolair in?
What are the side effects of US-licensed Xolair?
Related
- Manufacturer: Celltrion — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing