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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SIKLOS (hydroxyurea) is an oral antimetabolite small molecule approved in 2017 for sickle cell disease and multiple hematologic malignancies and solid tumors. It works by inhibiting ribonucleotide reductase to block DNA synthesis, making S-phase cells vulnerable to radiation and preventing DNA repair in damaged cells. The drug treats a broad spectrum of conditions from hemolytic anemias to acute leukemias and head-and-neck cancers.
$0.742MPart D
PeakSIKLOS is in peak commercial lifecycle with modest Part D spending ($742K in 2023), indicating a niche market positioning that requires focused commercial execution rather than mass-market scaling.
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.