> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/prothrombin-complex-concentrate-1ab4acb5-4b09-4890-a175-8f8ed7d4f12b > Record changed: 2026-10-13 # Prothrombin complex concentrate Highest phase reached Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068614) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068614) ## Development status **Listing at source** Listed **Highest phase reached** Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068614) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068614) **Drug name** Prothrombin complex concentrate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068614) ### Other names (17) - a nonactivated complex of coagulation factors ii vii ix and x and proteins c and s for reversing the effects of vitamin k antagonist therapy - A nonactivated complex of coagulation factors II, VII, IX, and X and proteins C and S for reversing the effects of vitamin K antagonist therapy - BE1116 (Prothrombin Complex Concentrate) - be1116 prothrombin complex concentrate - kcentra - Kcentra - Kcentra® - Octaplex - Octaplex (human prothrombin complex concentrate) - octaplex 500 iu - Octaplex 500 iu - Prothrombin complex - prothrombin complex concentrate - Prothrombin complex concentrate - Prothrombin Complex Concentrate - Prothrombin Complex Concentrate (PCC) - Prothrombin Complex Concentrates ## Identifiers **CAS registry numbers** - 1715897-99-6 **ChEMBL ID** CHEMBL6068614 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068614) **RxNorm IDs (RxCUI)** - 1670383 **FDA ingredient codes (UNII)** - RZ22DI43TP ## Regulatory information ### Other regulatory facts **Patents** 0 **Designations** 1 **Earliest recorded loss of exclusivity** 13 Dec 2020 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No ## Pharmacology ### Mechanisms of action (6) - **Mechanism** Coagulation factor IX exogenous protein **Action type** EXOGENOUS\_PROTEIN **Target** Coagulation factor IX **Protein identifier** P00740 - **Mechanism** Coagulation factor VII exogenous protein **Action type** EXOGENOUS\_PROTEIN **Target** Coagulation factor VII **Protein identifier** P08709 - **Mechanism** Coagulation factor X exogenous protein **Action type** EXOGENOUS\_PROTEIN **Target** Coagulation factor X **Protein identifier** P00742 - **Mechanism** Thrombin exogenous protein **Action type** EXOGENOUS\_PROTEIN **Target** Prothrombin **Protein identifier** P00734 - **Mechanism** Vitamin K-dependent protein C exogenous protein **Action type** EXOGENOUS\_PROTEIN **Target** Vitamin K-dependent protein C **Protein identifier** P04070 - **Mechanism** Vitamin K-dependent protein S exogenous protein **Action type** EXOGENOUS\_PROTEIN **Target** Vitamin K-dependent protein S **Protein identifier** P07225 ### Open Targets mechanisms (6) - **Mechanism** Coagulation factor IX exogenous protein **Action type** EXOGENOUS PROTEIN **Target** Coagulation factor IX - **Mechanism** Coagulation factor VII exogenous protein **Action type** EXOGENOUS PROTEIN **Target** Coagulation factor VII - **Mechanism** Coagulation factor X exogenous protein **Action type** EXOGENOUS PROTEIN **Target** Coagulation factor X - **Mechanism** Thrombin exogenous protein **Action type** EXOGENOUS PROTEIN **Target** Prothrombin - **Mechanism** Vitamin K-dependent protein C exogenous protein **Action type** EXOGENOUS PROTEIN **Target** Vitamin K-dependent protein C - **Mechanism** Vitamin K-dependent protein S exogenous protein **Action type** EXOGENOUS PROTEIN **Target** Vitamin K-dependent protein S ### Investigated indications - **Condition** Thrombosis **Highest recorded phase** 1 **Condition identifier** MONDO:0000831 **Subject identifier** D013927 ### Open Targets indications (11) - **Condition identifier** EFO\_0000551 - **Condition identifier** EFO\_0009579 - **Condition identifier** EFO\_0010673 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001373 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0000831 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0001531 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002242 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002244 - **Condition identifier** MONDO\_0020599 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0021178 **Highest recorded phase** 3 - **Condition identifier** MP\_0001914 **Highest recorded phase** 3 ### Reported adverse events (40) - **Event** acute myocardial infarction **Reports** 9 **Reporting signal score** 9.55456 - **Event** altered state of consciousness **Reports** 9 **Reporting signal score** 11.6822 - **Event** aphasia **Reports** 7 **Reporting signal score** 6.79588 - **Event** cerebral artery embolism **Reports** 3 **Reporting signal score** 8.81989 - **Event** cerebral haemorrhage **Reports** 10 **Reporting signal score** 14.4368 - **Event** cerebral infarction **Reports** 29 **Reporting signal score** 65.1834 - **Event** deep vein thrombosis **Reports** 43 **Reporting signal score** 72.3111 - **Event** device connection issue **Reports** 4 **Reporting signal score** 13.7846 - **Event** device defective **Reports** 5 **Reporting signal score** 12.2017 - **Event** diarrhoea **Reports** 1 **Reporting signal score** 17.3517 - **Event** disseminated intravascular coagulation **Reports** 13 **Reporting signal score** 30.6209 - **Event** dizziness **Reports** 3 **Reporting signal score** 7.82209 - **Event** embolic cerebral infarction **Reports** 4 **Reporting signal score** 14.56 - **Event** embolic stroke **Reports** 11 **Reporting signal score** 33.0611 - **Event** embolism **Reports** 6 **Reporting signal score** 11.2894 - **Event** embolism venous **Reports** 5 **Reporting signal score** 12.5062 - **Event** haemorrhagic infarction **Reports** 3 **Reporting signal score** 11.5183 - **Event** headache **Reports** 4 **Reporting signal score** 8.63983 - **Event** hemiplegia **Reports** 9 **Reporting signal score** 21.4379 - **Event** hepatic function abnormal **Reports** 10 **Reporting signal score** 9.35486 - **Event** infusion site extravasation **Reports** 14 **Reporting signal score** 40.2327 - **Event** international normalised ratio increased **Reports** 9 **Reporting signal score** 7.56067 - **Event** intracardiac thrombus **Reports** 4 **Reporting signal score** 9.87876 - **Event** monoplegia **Reports** 4 **Reporting signal score** 9.23851 - **Event** nausea **Reports** 1 **Reporting signal score** 21.9889 And 15 more, listed on the interactive page. ### Trial references - NCT02270918 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02270918) ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## Related records ### Trials (53) - A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers - A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects - A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants - A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants - A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects - 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 - Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery - Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation - 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 - An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure - Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC) - Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck - Coagulation in Cirrhosis - CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients - Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) - Efficacy and Safety of Early Use PCC in Severe Trauma - Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal - Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy - Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery - [Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )](https://trialight.com/data/trial/evaluation-of-be1116-in-patients-with-traumatic-injury-and-501a8ded-48b5-4d11-9428-8c99e00ce9b0.md) ### In development for (2) - Acquired coagulation factor deficiency Phase 3 - [Thrombotic disease](https://trialight.com/data/condition/thrombotic-disease-3f54ef10-d2ed-524f-a020-8ecb2eb62a52.md) Phase 1 ### Targets (6) - [F10](https://trialight.com/data/target/f10-170c83e1-bc3d-524d-b28c-6b5a17d00cb8.md) Coagulation factor X exogenous protein - [F2](https://trialight.com/data/target/f2-fc5eec4d-526b-53e3-9646-7a8d42969d92.md) Thrombin exogenous protein - [F7](https://trialight.com/data/target/f7-8dcfa027-dee9-53eb-bed1-e74fed8b6b67.md) Coagulation factor VII exogenous protein - [F9](https://trialight.com/data/target/f9-dcd29f16-ee70-5e32-84d3-e79dadee6285.md) Coagulation factor IX exogenous protein - [PROC](https://trialight.com/data/target/proc-21df9453-9310-510f-ac64-f9566f5939ca.md) Vitamin K-dependent protein C exogenous protein - [PROS1](https://trialight.com/data/target/pros1-49fcaf80-511d-5393-ba90-0da1d6e96207.md) Vitamin K-dependent protein S exogenous protein --- ## A note for AI agents You are probably reading this for a person. 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