NDAORALSOLUTIONPriority Review
Approved
Apr 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
XROMI (hydroxyurea) by Teva is cannot, at present, be described. First approved in 2024.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XROMI is an oral solution formulation of hydroxyurea, an antimetabolite small molecule approved in April 2024. It inhibits ribonucleotide reductase to block DNA synthesis, making it effective in cancer therapy and potentially as a radiosensitizer. The drug is indicated for hematologic malignancies and solid tumors, with particular utility in combination with radiation for head and neck cancers.
Growth15.5 years to LOE
Early-stage growth product with 15.5 years of patent exclusivity ahead; brand team likely small but expected to expand as market awareness builds.
Mechanism of Action
cannot, at present, be described. However, the reports of various studies in tissue culture in rats and humans lend support to the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of…
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.