NDAORALCAPSULEPriority Review
Approved
Dec 1967
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
DROXIA (hydroxyurea) by Viatris is known. First approved in 1967.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DROXIA (hydroxyurea) is an oral antimetabolite approved in 1967 for sickle cell anemia that works by inhibiting DNA synthesis through ribonucleotide reductase inhibition. It increases fetal hemoglobin levels, decreases neutrophils, and improves red blood cell deformability to reduce vaso-occlusive crises in patients with SCA.
$0.113BPart D
LOE ApproachingWith LOE approaching and only 2,471 annual Part D claims, this mature generic asset faces declining commercial opportunities and likely smaller team support.
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
Worked on DROXIA at Viatris? Share your interview experience or compensation data (+7 days Pro)
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.