NDAORALCAPSULEPriority Review
Approved
Mar 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AGRYLIN (anagrelide hydrochloride) is an oral small-molecule therapy approved in 1997 for essential thrombocythemia, a myeloproliferative disorder characterized by elevated platelet counts. The drug's mechanism involves suppression of transcription factors (GATA-1 and FOG-1) required for megakaryocyte development, thereby reducing platelet production. It is the only monotherapy indicated specifically for platelet reduction in ET.
$0.232MPart D
LOE ApproachingDeclining
Late-stage product with minimal Part D activity ($232K in 2023) and approaching loss of exclusivity signals potential team rightsizing and transition planning.
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 (8)
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
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
Started Oct 2010
41 enrolled
Essential Thrombocythemia (ET)
Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
Started Oct 2010
53 enrolled
Essential Thrombocythemia (ET)
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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.