NDAORALCAPSULEPriority Review
Approved
Mar 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AGRYLIN (anagrelide hydrochloride) is an oral small-molecule capsule approved in 1997 for reducing elevated platelet counts in patients with thrombocythemia. The drug works through platelet-lowering mechanisms, addressing a niche hematologic indication with limited treatment options.
$0.232MPart D
LOE ApproachingModest Medicare spending and declining patient volume signal a mature, niche product with likely downsizing across commercial and medical affairs teams.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Participants
Started Feb 2019
20 enrolled
Healthy Volunteers
Agrylin Drug Use-Result Survey
Started Nov 2014
1,826 enrolled
Essential Thrombocythemia (ET)
Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
Started Mar 2012
60 enrolled
Healthy
A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
Started Jan 2006
150 enrolled
Thrombocythemia, Hemorrhagic
Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
Started May 2005
3,647 enrolled
Thrombocythemia, Essential
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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.