AMINOCAPROIC ACID · RISING
Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures), and portacaval shunt; hematological disorders such as aplastic anemia; acute and life-threatening abruptio placenta...
Details
- Status
- Prescription
- First Approved
- 1964-06-03
- Routes
- ORAL, INJECTION, Injection
- Dosage Forms
- TABLET, SOLUTION, INJECTABLE, Injectable
Companies
AMINOCAPROIC ACID Approval History
What AMINOCAPROIC ACID Treats
9 indicationsAMINOCAPROIC ACID is approved for 9 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Fibrinolysis
- Aplastic Anemia
- Abruptio Placentae
- Hepatic Cirrhosis
- Prostate Cancer
- Lung Cancer
- Stomach Cancer
- Cervical Cancer
- Hematuria
AMINOCAPROIC ACID Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AMINOCAPROIC ACID's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AMINOCAPROIC ACID treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AMINOCAPROIC ACID
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04814433 results posted | 20-01420 | Ph 4 | terminated | Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation |
| NCT07644923 | 24-01580 | Ph 4 | not yet recruiting | Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
AMINOCAPROIC ACID FDA Label Details
Indications & Usage
FDA Label (PDF)Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures), and portacaval shunt; hematological disorders such as aplastic anemia; acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and c...
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AMICAR
Full clinical data, patents, trials, and competitive landscape for aminocaproic acid.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.