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Octaplex
Octaplex is a Small molecule drug developed by Octapharma. It is currently in Phase 3 development. Also known as: 4F PCC, 4 Factor PCC, 4 Factor Prothrombin Concentrate Complex.
Octaplex is a prothrombin complex concentrate, classified as an exogenous protein, and is used to treat conditions such as heart disease, traumatic hemorrhage, coagulopathy, massive hemorrhage, and hemophilia B. It works by providing coagulation factor VII, a key component in the blood clotting process.
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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 | Octaplex |
|---|---|
| Also known as | 4F PCC, 4 Factor PCC, 4 Factor Prothrombin Concentrate Complex |
| Sponsor | Octapharma |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) (PHASE3)
- Periinterventional Coagulation Management of Patients Undergoing a TIPS (NA)
- Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor (PHASE3)
- Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery (PHASE3)
- Coagulation in Cirrhosis (PHASE4)
- Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation (PHASE1, PHASE2)
- Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk. (PHASE3)
- Evaluation of the Efficacy of Early Bunching of a FF-PCC in Patients With Severe Traumatic Hemorrhage (NA)
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:
- Octaplex CI brief — competitive landscape report
- Octaplex updates RSS · CI watch RSS
- Octapharma portfolio CI
Frequently asked questions about Octaplex
What is Octaplex?
Who makes Octaplex?
Is Octaplex also known as anything else?
What development phase is Octaplex in?
Related
- Manufacturer: Octapharma — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: 4F PCC, 4 Factor PCC, 4 Factor Prothrombin Concentrate Complex