> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/protein-c-concentrate-human-41664a77-cfe5-4593-a5d4-dd958f5e6bb7 > Record changed: 2026-10-13 # Protein C concentrate (human) Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315087) Drug type Unknown First approval year 2001 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315087) ## Development status **First approval year** 2001 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315087) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315087) ## Names and chemistry **Drug type** Unknown **Drug name** Protein C concentrate (human) Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315087) ### Brand names (4) - ceprotin - Ceprotin - protein c component of balfaxar - Protein c component of balfaxar ### Other names (18) - ceprotin - human protein c - Human protein c - human protein c concentrate - Human protein C concentrate - protein c - Protein c - Protein c (coagulation inhibitor) - Protein c (homo sapiens) - protein c coagulation inhibitor - Protein C concentrate - Protein c concentrate (human) - protein c concentrate human - protein c homo sapiens - protein c human - Protein c human - protexel - Protexel ## Identifiers **ATC classification codes** - B01AD12 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315087) **ChEMBL ID** CHEMBL5315087 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5315087) ### RxNorm IDs (RxCUI) (2) - 8834 - 723868 ## Regulatory information ### Other regulatory facts **Patents** 0 **Designations** 1 **Earliest recorded loss of exclusivity** 30 Mar 2014 **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 - **Mechanism** Vitamin K-dependent protein C exogenous protein **Action type** EXOGENOUS\_PROTEIN **Target** Vitamin K-dependent protein C **Protein identifier** P04070 ### Open Targets mechanisms - **Mechanism** Vitamin K-dependent protein C exogenous protein **Action type** EXOGENOUS PROTEIN **Target** Vitamin K-dependent protein C ### Investigated indications (4) - **Condition** Venous Thrombosis **Highest recorded phase** 4 **Condition identifier** EFO:0003907 **Subject identifier** D020246 - **Condition** Protein C Deficiency **Highest recorded phase** 4 **Condition identifier** EFO:0009316 **Subject identifier** D020151 - **Condition** Purpura Fulminans **Highest recorded phase** 4 **Condition identifier** EFO:1001913 **Subject identifier** D055665 - **Condition** Thrombosis **Highest recorded phase** 4 **Condition identifier** HP:0004419 **Subject identifier** D013927 ### Open Targets indications (10) - **Condition identifier** EFO\_0004286 - **Condition identifier** EFO\_0009315 - **Condition identifier** EFO\_0009316 - **Condition identifier** EFO\_0009316 **Highest recorded phase** 4 - **Condition identifier** EFO\_1001913 - **Condition identifier** EFO\_1001913 **Highest recorded phase** 4 - **Condition identifier** HP\_0004419 - **Condition identifier** HP\_0004419 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0002305 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005399 **Highest recorded phase** 4 ### Reported adverse events (4) - **Event** amputation **Reports** 3 **Reporting signal score** 18.1426 - **Event** leg amputation **Reports** 2 **Reporting signal score** 9.47018 - **Event** purpura fulminans **Reports** 2 **Reporting signal score** 13.9902 - **Event** vascular device infection **Reports** 3 **Reporting signal score** 15.6678 ## Dosing **Dose** 100-120 IU/kg, 60-80 IU/kg, 45-60 IU/kg **Route** Intravenous **How often** Every 6 hours, every 12 hours, until desired anticoagulation is achieved, and then maintained ### Conditions of use - Administer at a maximum rate of 2 mL per minute, or 0.2 mL/kg/min in children under 10kg ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## Related records ### Trials (486) - A Clinical Study of Intravenous Immunoglobulin - A Clinical Study to Evaluate the Safety and Efficacy of Anti-human CD 7 CAR-NK Cell Injection in Subjects With Relapsed and Refractory CD7-positive Hematological Malignancy - A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers - A Comparison of TCC-EZ Using Human Amnion Allograft vs TCC-EZ and Standard Wound Care in Treating Diabetic Foot Ulcers. - A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults - A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion - A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent/Sequential Chemoradiotherapy and Chemotherapy Combined With/Without Immunotherapy in Solid Tumors - A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection - A Novel Therapeutic Treatment of Pyoderma Gangrenosum - A Phase 1 Study of ProMetic Plasminogen (Human) Intravenous in Adults and Children With Plasminogen Deficiency - A Phase 2 Open-label Study to Evaluate the Safety of Laruparetigene Zovaparvovec Administered Bilaterally in Male Participants With X-Linked Retinitis Pigmentosa - A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents - A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant - A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine - A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children - A Phase I/III Clinical Study to Evaluate NouvNeu001 Injection for Multiple System Atrophy - A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine - A Phase Ⅲ Clinical Study of SNA02-48 Injection - A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT) - A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010) ### Approved for (3) - Hereditary thrombophilia due to congenital protein C deficiency - Purpura fulminans - [Thrombotic disease](https://trialight.com/data/condition/thrombotic-disease-3f54ef10-d2ed-524f-a020-8ecb2eb62a52.md) ### Other linked conditions (2) - Thrombophilia - [Venous thromboembolism](https://trialight.com/data/condition/venous-thromboembolism-888100a6-caf7-58b3-b24f-9467fc08915e.md) ### Targets (1) - [PROC](https://trialight.com/data/target/proc-21df9453-9310-510f-ac64-f9566f5939ca.md) Vitamin K-dependent protein C exogenous protein --- ## A note for AI agents You are probably reading this for a person. 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