TheraRadar
Data updated: May 26, 2026

Kcentra (prothrombin complex concentrate (human))

Approved 2013-04-28
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2013-04-28
Patent Cliff
2020

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Routes
Intravenous
Dosage Forms
For Injection

Companies

CSL Behring
Active Ingredient: Prothrombin Complex Concentrate (Human) , Prothrombin Complex Concentrate (Human)

Kcentra Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2013 to 2013
Apr 2013 ORIGINAL
Update · CBER biologic (Purple Book)

What Kcentra Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT03341156 OPSTAHT STUDY19020099 Ph 3 terminated Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
NCT02557672 results posted 14-009579 Ph 4 completed PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
NCT02270918 4PAR 14P.366 Ph 1 completed Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Kcentra FDA Label Details

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Data Sources

FDA Approval: BLA125421 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.