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Eculizumab Injection
Eculizumab Injection is a Complement C5 inhibitor Small molecule drug developed by Wuhan Createrna Science and Technology Co., Ltd. It is currently in Phase 3 development for Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS), Generalized myasthenia gravis (gMG). Also known as: Soliris.
Eculizumab is a monoclonal antibody that inhibits the complement protein C5, blocking the formation of the membrane attack complex and reducing complement-mediated cell destruction.
Eculizumab is a monoclonal antibody that inhibits the complement protein C5, blocking the formation of the membrane attack complex and reducing complement-mediated cell destruction. Used for Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS), Generalized myasthenia gravis (gMG).
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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 | Eculizumab Injection |
|---|---|
| Also known as | Soliris |
| Sponsor | Wuhan Createrna Science and Technology Co., Ltd |
| Drug class | Complement C5 inhibitor |
| Target | C5 (Complement protein 5) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Eculizumab binds to C5, a key component of the complement cascade, preventing its cleavage into C5a and C5b. This blocks the terminal complement pathway and prevents formation of the C5b-9 membrane attack complex, which would otherwise cause cell lysis. By inhibiting this pathway, eculizumab reduces complement-mediated hemolysis and tissue damage in complement-driven diseases.
Approved indications
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
- Generalized myasthenia gravis (gMG)
- Neuromyelitis optica spectrum disorder (NMOSD)
Common side effects
- Meningococcal infection
- Headache
- Nausea
- Fatigue
- Back pain
Key clinical trials
- Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study (PHASE4)
- A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors (PHASE3)
- A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy (PHASE3)
- A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy (PHASE3)
- Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx (PHASE3)
- Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy (PHASE3)
- GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers (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:
- Eculizumab Injection CI brief — competitive landscape report
- Eculizumab Injection updates RSS · CI watch RSS
- Wuhan Createrna Science and Technology Co., Ltd portfolio CI
Frequently asked questions about Eculizumab Injection
What is Eculizumab Injection?
How does Eculizumab Injection work?
What is Eculizumab Injection used for?
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Is Eculizumab Injection also known as anything else?
What drug class is Eculizumab Injection in?
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What does Eculizumab Injection target?
Related
- Drug class: All Complement C5 inhibitor drugs
- Target: All drugs targeting C5 (Complement protein 5)
- Manufacturer: Wuhan Createrna Science and Technology Co., Ltd — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Paroxysmal nocturnal hemoglobinuria (PNH)
- Indication: Drugs for Atypical hemolytic uremic syndrome (aHUS)
- Indication: Drugs for Generalized myasthenia gravis (gMG)
- Also known as: Soliris
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing