TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

AMICAR

AMINOCAPROIC ACID
Oncology Approved 1964-06-03
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
4
Indications
--
Phase 3 Trials
3
Priority Reviews
61
Years on Market

Details

Status
Prescription
First Approved
1964-06-03
Routes
ORAL, INJECTION
Dosage Forms
TABLET, SOLUTION, INJECTABLE

Companies

Hikma EPIC PHARMA LLC
Active Ingredient: AMINOCAPROIC ACID

AMICAR Approval History

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What AMICAR Treats

9 indications

AMICAR 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
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

Pro

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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Data Sources

FDA Approval: NDA015197 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.