NDAORALCAPSULEPriority Review
Approved
Dec 1967
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
HYDREA (hydroxyurea) by Viatris (2) is known. First approved in 1967.
Drug data last refreshed 20h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYDREA (hydroxyurea) is an oral antimetabolite small molecule approved in 1967 that inhibits DNA synthesis by blocking ribonucleotide reductase. It treats multiple hematologic malignancies and solid tumors, with primary efficacy in sickle cell disease through mechanisms including fetal hemoglobin elevation, neutrophil reduction, and improved red blood cell deformability.
$29KPart D
LOE ApproachingDeclining
HYDREA faces imminent loss of exclusivity with minimal Part D spending ($29K in 2023) and low claim volume (304), signaling a consolidating team focused on legacy product management and generic transition planning.
Mechanism of Action
known. However, various studies support the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein. The mechanisms by which DROXIA produces its beneficial…
Pharmacologic Class:
Antimetabolite
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET
Started Aug 2024
27 enrolled
Essential Thrombocythemia
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Started Jul 2024
300 enrolled
Essential Thrombocythemia
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
Started Dec 2023
340 enrolled
Essential Thrombocythemia
Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa
Started Nov 2023
400 enrolled
Sickle Cell Anemia in ChildrenSickle Cell Disease
Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II )
Started Mar 2021
270 enrolled
Sickle Cell Anemia in Children
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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.