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UCB7665 Subcutaneous 1
UCB7665 Subcutaneous 1 is a Biologic drug developed by UCB Celltech. It is currently in Phase 1 development.
UCB7665 is an antibody that inhibits the IgG receptor FcRn large subunit p51. It is being studied in clinical trials for conditions such as Ocular Myasthenia Gravis, Thrombocytopenia, and Generalized Myasthenia Gravis.
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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 | UCB7665 Subcutaneous 1 |
|---|---|
| Sponsor | UCB Celltech |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis (PHASE3)
- An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis (PHASE3)
- A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis (PHASE3)
- A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women (PHASE1)
- A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis (PHASE3)
- Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia (PHASE2)
- A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis (PHASE3)
- A Study to Evaluate Safety and Tolerability of Single Ascending Doses of Rozanolixizumab Administered by Subcutaneous Infusion in Healthy Japanese, Chinese and Caucasian Study Participants (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:
- UCB7665 Subcutaneous 1 CI brief — competitive landscape report
- UCB7665 Subcutaneous 1 updates RSS · CI watch RSS
- UCB Celltech portfolio CI
Frequently asked questions about UCB7665 Subcutaneous 1
What is UCB7665 Subcutaneous 1?
Who makes UCB7665 Subcutaneous 1?
What development phase is UCB7665 Subcutaneous 1 in?
Related
- Manufacturer: UCB Celltech — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing