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Beriplex
Beriplex is a Small molecule drug developed by University Medical Center Groningen. It is currently in Phase 2 development. Also known as: Prothrombin Complex Concentrate, RVG 101094, B02BD01.
Beriplex, also known as Kcentra, is a prothrombin complex concentrate used to treat and prevent bleeding in various conditions, including hemophilia B and bleeding associated with cardiopulmonary bypass. It contains blood clotting factors II, IX, X, and VII, and is administered to reverse coagulopathy and prevent hemorrhage.
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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).
| 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 | Beriplex |
|---|---|
| Also known as | Prothrombin Complex Concentrate, RVG 101094, B02BD01 |
| Sponsor | University Medical Center Groningen |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
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)
- 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)
- An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding
- A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation (PHASE1)
- Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
- A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers (PHASE1)
- Strategy of Transfusion in Trauma Patients - STATA Trial (PHASE4)
- Reversal of Dabigatran With Prothrombin Complex Concentrate (PHASE2)
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:
- Beriplex CI brief — competitive landscape report
- Beriplex updates RSS · CI watch RSS
- University Medical Center Groningen portfolio CI
Frequently asked questions about Beriplex
What is Beriplex?
Who makes Beriplex?
Is Beriplex also known as anything else?
What development phase is Beriplex in?
Related
- Manufacturer: University Medical Center Groningen — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Prothrombin Complex Concentrate, RVG 101094, B02BD01
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing