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zilucoplan (RA101495)
zilucoplan (RA101495) is a S1P receptor modulator Small molecule drug developed by UCB Biopharma SRL. It is currently in Phase 3 development for Relapsing forms of multiple sclerosis.
Zilucoplan is a sphingosine 1-phosphate receptor modulator.
Zilucoplan (RA101495) is a protein modality that inhibits the complement C5 protein. It is being studied in clinical trials for conditions including Paroxysmal Nocturnal Hemoglobinuria (PNH) and Generalized Myasthenia Gravis.
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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.
| 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 | zilucoplan (RA101495) |
|---|---|
| Sponsor | UCB Biopharma SRL |
| Drug class | S1P receptor modulator |
| Target | S1P1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
It works by binding to sphingosine 1-phosphate receptor 1 (S1P1), which is involved in the regulation of immune cell trafficking and activation. By modulating this receptor, zilucoplan aims to reduce inflammation and autoimmune responses.
Approved indications
- Relapsing forms of multiple sclerosis
Common side effects
- Nausea
- Headache
- Fatigue
- Injection site reactions
Key clinical trials
- A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gravis (PHASE3)
- An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis (PHASE3)
- A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis (PHASE2, PHASE3)
- A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women (PHASE1)
- Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis (PHASE3)
- A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants (PHASE1)
- An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors (PHASE3)
- Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis (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:
- zilucoplan (RA101495) CI brief — competitive landscape report
- zilucoplan (RA101495) updates RSS · CI watch RSS
- UCB Biopharma SRL portfolio CI
Frequently asked questions about zilucoplan (RA101495)
What is zilucoplan (RA101495)?
How does zilucoplan (RA101495) work?
What is zilucoplan (RA101495) used for?
Who makes zilucoplan (RA101495)?
What drug class is zilucoplan (RA101495) in?
What development phase is zilucoplan (RA101495) in?
What are the side effects of zilucoplan (RA101495)?
What does zilucoplan (RA101495) target?
Related
- Drug class: All S1P receptor modulator drugs
- Target: All drugs targeting S1P1
- Manufacturer: UCB Biopharma SRL — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Relapsing forms of multiple sclerosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing