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Coagadex(R)
Coagadex(R) is a Recombinant clotting factor Biologic drug developed by Kedrion S.p.A.. It is currently in Phase 3 development for Congenital Factor X deficiency, Acquired Factor X deficiency.
Coagadex is a recombinant human vitamin K-dependent clotting factor X that replaces deficient or dysfunctional Factor X to restore blood coagulation.
Coagadex is a recombinant human vitamin K-dependent clotting factor X that replaces deficient or dysfunctional Factor X to restore blood coagulation. Used for Congenital Factor X deficiency, Acquired Factor X deficiency.
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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).
| 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 | Coagadex(R) |
|---|---|
| Sponsor | Kedrion S.p.A. |
| Drug class | Recombinant clotting factor |
| Target | Factor X (coagulation factor X) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Factor X is a critical serine protease in the intrinsic and extrinsic coagulation pathways. Coagadex provides active Factor X to patients with congenital or acquired Factor X deficiency, enabling formation of the prothrombinase complex and restoration of thrombin generation. This corrects the bleeding tendency associated with Factor X insufficiency.
Approved indications
- Congenital Factor X deficiency
- Acquired Factor X deficiency
Common side effects
- Thromboembolism
- Hypersensitivity reactions
- Inhibitor formation
Key clinical trials
- A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis (PHASE3)
- Rivaroxaban vs. Warfarin in CVT Treatment (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:
- Coagadex(R) CI brief — competitive landscape report
- Coagadex(R) updates RSS · CI watch RSS
- Kedrion S.p.A. portfolio CI
Frequently asked questions about Coagadex(R)
What is Coagadex(R)?
How does Coagadex(R) work?
What is Coagadex(R) used for?
Who makes Coagadex(R)?
What drug class is Coagadex(R) in?
What development phase is Coagadex(R) in?
What are the side effects of Coagadex(R)?
What does Coagadex(R) target?
Related
- Drug class: All Recombinant clotting factor drugs
- Target: All drugs targeting Factor X (coagulation factor X)
- Manufacturer: Kedrion S.p.A. — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Congenital Factor X deficiency
- Indication: Drugs for Acquired Factor X deficiency
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing