AMICAR (aminocaproic acid)
AMICAR is indicated for the treatment of Fibrinolysis; Aplastic Anemia; Abruptio Placentae; Hepatic Cirrhosis; Prostate Cancer; Lung Cancer; Stomach Cancer; Cervical Cancer; Hematuria.
Details
- Status
- Discontinued
- First Approved
- 1964-06-03
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET, SOLUTION
AMICAR Approval History
What AMICAR Treats
9 indicationsAMICAR is approved for 9 conditions since its original approval in 1964. 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
AMICAR 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 AMICAR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AMICAR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AMICAR
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 |
| NCT02030821 results posted | Pro00050108 | Ph 4 | completed | TXA vs. Amicar in Total Knee and Hip Arthroplasty |
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.
AMICAR FDA Label Details
Indications & Usage
FDA Label (PDF)AMICAR is indicated for the treatment of Fibrinolysis; Aplastic Anemia; Abruptio Placentae; Hepatic Cirrhosis; Prostate Cancer; Lung Cancer; Stomach Cancer; Cervical Cancer; Hematuria.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.