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Tibulizumab Dose A
Tibulizumab Dose A is a Biologic drug developed by Zura Bio Inc. It is currently in Phase 2 development.
Tibulizumab Dose A is being studied as a potential treatment for Primary Sjogren's Syndrome and Hidradenitis Suppurativa (HS). Tibulizumab Dose A is a BAFF/IL-17 bispecific antibody, according to its mechanism as recorded in ChEMBL.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Tibulizumab Dose A |
|---|---|
| Sponsor | Zura Bio Inc |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense (PHASE2)
- BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome (PHASE2, PHASE3)
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:
- Tibulizumab Dose A CI brief — competitive landscape report
- Tibulizumab Dose A updates RSS · CI watch RSS
- Zura Bio Inc portfolio CI
Frequently asked questions about Tibulizumab Dose A
What is Tibulizumab Dose A?
Who makes Tibulizumab Dose A?
What development phase is Tibulizumab Dose A in?
Related
- Manufacturer: Zura Bio Inc — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing