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CSL300
CSL300 is a Complement inhibitor Small molecule drug developed by CSL Behring. It is currently in Phase 2 development for Paroxysmal nocturnal hemoglobinuria (PNH). Also known as: Clazakizumab.
CSL300 is a recombinant human monoclonal antibody that targets the complement system.
CSL300 is a recombinant human monoclonal antibody that targets the complement system. Used for Paroxysmal nocturnal hemoglobinuria (PNH).
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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). -
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 | 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 | CSL300 |
|---|---|
| Also known as | Clazakizumab |
| Sponsor | CSL Behring |
| Drug class | Complement inhibitor |
| Target | C5 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
CSL300 works by inhibiting the complement system, specifically the C5 component, to prevent excessive inflammation and tissue damage. This mechanism is thought to be beneficial in treating conditions associated with complement system dysregulation.
Approved indications
- Paroxysmal nocturnal hemoglobinuria (PNH)
Common side effects
- Headache
- Nausea
- Infusion-related reactions
Key clinical trials
- Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (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:
- CSL300 CI brief — competitive landscape report
- CSL300 updates RSS · CI watch RSS
- CSL Behring portfolio CI
Frequently asked questions about CSL300
What is CSL300?
How does CSL300 work?
What is CSL300 used for?
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Is CSL300 also known as anything else?
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What does CSL300 target?
Related
- Drug class: All Complement inhibitor drugs
- Target: All drugs targeting C5
- Manufacturer: CSL Behring — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Paroxysmal nocturnal hemoglobinuria (PNH)
- Also known as: Clazakizumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing