> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/aprotinin-08291457-b633-4aa3-ade1-d49a293d163b > Record changed: 2026-10-13 # Aprotinin Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201619) Drug type Protein Source: [gsrs.ncats.nih.gov](https://gsrs.ncats.nih.gov/ginas/app/beta/substances/04XPW8C0FL) First approval year 1993 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201619) ## Development status **First approval year** 1993 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201619) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201619) ## Names and chemistry **Drug type** Protein Source: [gsrs.ncats.nih.gov](https://gsrs.ncats.nih.gov/ginas/app/beta/substances/04XPW8C0FL) **Drug name** Aprotinin Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201619) ### Brand names (2) - trasylol - Trasylol ### Other names (55) - aprotinin - Aprotinin - Aprotinin (bovine) - Aprotinin (inhaled) - Aprotinin (synthetic) - APROTININ \[EP IMPURITY\] - APROTININ \[EP MONOGRAPH\] - aprotinin \[INN\] - APROTININ \[MART.\] - APROTININ \[MI\] - APROTININ \[ORANGE BOOK\] - APROTININ \[USAN\] - APROTININ \[USP MONOGRAPH\] - APROTININ \[VANDF\] - Aprotinin \[WHO-DD\] - aprotinin biosynthetic - Aprotinin biosynthetic - aprotinin bovine - Aprotinin bovine - aprotinin concentrated solution - Aprotinin concentrated solution - APROTININ CONCENTRATED SOLUTION \[EP MONOGRAPH\] - aprotinin concentrated solution ep monograph - aprotinin ep impurity - aprotinin ep monograph And 30 more, listed on the interactive page. ## Identifiers **ATC classification codes** - B02AB01 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201619) **CAS registry numbers** - 9087-70-1 **ChEMBL ID** CHEMBL1201619 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201619) **RxNorm IDs (RxCUI)** - 1056 **FDA ingredient codes (UNII)** - 04XPW8C0FL ## Regulatory information ### United States **Applicant** BAYER HLTHCARE **Approval date** 29 Dec 1993 **Application number** BLA020304 ### Other regulatory facts **Patents** 0 **Designations** 2 **Earliest recorded loss of exclusivity** 29 Dec 2000 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Withdrawn ## Pharmacology ### Drug classification **Pharmacology name** aprotinin **Type** Peptide **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (3) - **Action** Binding **Action type** Binding **Target** plasminogen **Gene symbol** PLG **Protein identifier** P00747 **Median affinity** 6.8 **Affinity units** pIC50 **Primary target** Yes - **Mechanism** Plasma kallikrein inhibitor **Action type** Inhibitor **Target** Plasma kallikrein **Protein identifier** P03952 - **Mechanism** Plasminogen inhibitor **Action type** Inhibitor **Target** Plasminogen **Protein identifier** P00747 ### Open Targets mechanisms (2) - **Mechanism** Plasma kallikrein inhibitor **Action type** Inhibitor **Target** Plasma kallikrein - **Mechanism** Plasminogen inhibitor **Action type** Inhibitor **Target** Plasminogen ### Investigated indications (3) - **Condition** Pancreatitis **Highest recorded phase** 1 **Condition identifier** EFO:0000278 **Subject identifier** D010195 - **Condition** Breast Neoplasms **Highest recorded phase** 1 **Condition identifier** MONDO:0007254 **Subject identifier** D001943 - **Condition** Hemorrhage **Highest recorded phase** 4 **Condition identifier** MP:0001914 **Subject identifier** D006470 ### Open Targets indications (12) - **Condition identifier** EFO\_0000278 **Highest recorded phase** 1 - **Condition identifier** HP\_0001297 - **Condition identifier** MONDO\_0002243 - **Condition identifier** MONDO\_0002243 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004986 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0006502 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0006515 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0006649 - **Condition identifier** MONDO\_0007254 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0100096 - **Condition identifier** MP\_0001914 - **Condition identifier** MP\_0001914 **Highest recorded phase** 4 ### Warnings - **Warning** Withdrawn **Description** Increased mortality **Year** 2007 ### Open Targets warnings - **Warning** Withdrawn **Description** Increased mortality **Year** 2007 **Country** United States **Condition** dead ### Reported adverse events (63) - **Event** anaphylactic reaction **Reports** 53 **Reporting signal score** 95.1727 - **Event** anhedonia **Reports** 208 **Reporting signal score** 1,230.32 - **Event** anxiety **Reports** 365 **Reporting signal score** 1,115.06 - **Event** arterial thrombosis **Reports** 4 **Reporting signal score** 9.53139 - **Event** asthenia **Reports** 3 **Reporting signal score** 7.27345 - **Event** blood creatinine increased **Reports** 21 **Reporting signal score** 18.9611 - **Event** blood pressure decreased **Reports** 17 **Reporting signal score** 16.5701 - **Event** blood pressure systolic decreased **Reports** 5 **Reporting signal score** 9.85848 - **Event** bronchospasm **Reports** 8 **Reporting signal score** 9.68022 - **Event** cardiac arrest **Reports** 13 **Reporting signal score** 14.5098 - **Event** cardiogenic shock **Reports** 7 **Reporting signal score** 10.6101 - **Event** cerebrovascular accident **Reports** 95 **Reporting signal score** 168.757 - **Event** coagulopathy **Reports** 7 **Reporting signal score** 9.21521 - **Event** condition aggravated **Reports** 1 **Reporting signal score** 8.98089 - **Event** depression **Reports** 147 **Reporting signal score** 295.846 - **Event** dialysis **Reports** 9 **Reporting signal score** 15.2143 - **Event** disability **Reports** 27 **Reporting signal score** 92.3648 - **Event** dizziness **Reports** 1 **Reporting signal score** 16.3517 - **Event** electrocardiogram st segment abnormal **Reports** 3 **Reporting signal score** 9.06956 - **Event** electrocardiogram st segment elevation **Reports** 6 **Reporting signal score** 12.9292 - **Event** embolic stroke **Reports** 6 **Reporting signal score** 13.0084 - **Event** emotional disorder **Reports** 7 **Reporting signal score** 10.1329 - **Event** emotional distress **Reports** 320 **Reporting signal score** 1,624.7 - **Event** fall **Reports** 1 **Reporting signal score** 10.927 - **Event** fear **Reports** 337 **Reporting signal score** 1,851.37 And 38 more, listed on the interactive page. ### Trial references (5) - NCT00290836 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00290836) - NCT00306150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00306150) - NCT00327379 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00327379) - NCT00354900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00354900) - NCT00357851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00357851) ## Dosing ### Conditions of use (6) - Allow at least 2 minutes for polymerization - Apply as a thin layer by dripping or spraying - Do not expose to temperatures above 37°C - Do not microwave - Use sufficient amount to cover application area - Use within 4 hours after warming to 33-37°C ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences - **Component** Sequence **Type** Protein **Sequence** RPDFCLEPPYTGPCKARIIRYFYNAKAGLCQTFVYGGCRAKRNNFKSAEDCMRTCGGA ## Related records ### Trials (234) - "The Effect of Inhaled Nitroglycerin for COPD Patients - A Clinical Study Evaluating Inhaled Aviptadil on COVID-19 - A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study - A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study - A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis - A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD) - A Phase I Study of Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. - A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide) - A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device - A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol - A Prospective, Single-center, Open-label Clinical Study to Evaluate the Safety and Efficacy of Inhaled BMD003(CFTR mRNA) in Chinese Adult Patients With Cystic Fibrosis - A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis - A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects - A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma - A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors - A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD - A Study of Staccato Loxapine (ADASUVE®) for Inhalation - A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis - A Study to Assess the Effects of Fluticasone Furoate and GW642444M Combination in Healthy Subjects and in Subjects With Mild, Moderate or Severe Hepatic Impairment. ### In development for (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 1 - Pancreatitis Phase 1 ### Other linked conditions (2) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) - Hemorrhagic disease ### Targets (2) - [KLKB1](https://trialight.com/data/target/klkb1-1b5f36f0-03d2-539a-a1ff-0cb816e42034.md) Plasma kallikrein inhibitor - [PLG](https://trialight.com/data/target/plg-ea48ec31-a3b4-5f69-a97d-4d887dd110ea.md) Plasminogen inhibitor --- ## A note for AI agents You are probably reading this for a person. 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