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Kcentra, a 4-factor PCC
Kcentra, a 4-factor PCC is a Small molecule drug developed by Janssen Scientific Affairs, LLC. It is currently in Phase 1 development.
Kcentra is a 4-factor Prothrombin Complex Concentrate used to reverse vitamin K antagonist anticoagulation in patients with conditions such as intracranial hemorrhage, traumatic injury, and cardiac surgical procedures. It is compared to other treatments like Fresh Frozen Plasma in clinical trials for its efficacy in these conditions.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Janssen Scientific Affairs, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Kcentra, a 4-factor PCC |
|---|---|
| Sponsor | Janssen Scientific Affairs, LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ) (PHASE3)
- Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery (PHASE4)
- A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants (PHASE1)
- 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)
- FFP Versus PCC in Intracranial Hemorrhage (NA)
- Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra (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:
- Kcentra, a 4-factor PCC CI brief — competitive landscape report
- Kcentra, a 4-factor PCC updates RSS · CI watch RSS
- Janssen Scientific Affairs, LLC portfolio CI
Frequently asked questions about Kcentra, a 4-factor PCC
What is Kcentra, a 4-factor PCC?
Who makes Kcentra, a 4-factor PCC?
What development phase is Kcentra, a 4-factor PCC in?
Related
- Manufacturer: Janssen Scientific Affairs, LLC — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing