NDAORALTABLET
Approved
Dec 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
SIKLOS (hydroxyurea) by Theravia. Approved for antimetabolite [epc]. First approved in 2017.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SIKLOS is an oral antimetabolite tablet containing hydroxyurea, approved in December 2017 for sickle cell disease. It works by inhibiting ribonucleotide reductase, reducing hemolysis and vaso-occlusive crises. The drug represents a foundational cytotoxic approach to managing chronic hemolytic anemias.
$0.742MPart D
PeakModest Part D spend of $742K on 628 claims signals a niche, mature product with stable but limited commercial volume; brand team likely lean with focus on clinical differentiation and patient retention.
Mechanism of Action
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
A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Siklos® in Healthy Volunteers
Started Aug 2021
28 enrolled
Healthy Volunteers
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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.