NDAINJECTIONINJECTABLEPriority Review
Approved
Jun 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
AMICAR (aminocaproic acid) by KalVista Pharmaceuticals is clinical pharmacology the fibrinolysis-inhibitory effects of amicar appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity. Approved for anemia. First approved in 1964.
Drug data last refreshed 10h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMICAR (aminocaproic acid) is a fibrinolysis inhibitor approved since 1964 that works by blocking plasminogen activators and reducing antiplasmin activity. It is indicated for anemia and administered via injection to prevent excessive bleeding by stabilizing blood clots. The drug has a short 2-hour half-life and is primarily renally eliminated.
$0.060MPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with minimal Part D volume (24 claims, $60K annual spending), indicating a heavily mature, niche-market product with limited team expansion opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY The fibrinolysis-inhibitory effects of AMICAR appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity. In adults, oral absorption appears to be a zero-order process with an absorption rate of 5.2 g/hr. The…
Indications (1)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.