Drug · Small Molecule
Hydroxyurea
CI-DRUG-00000671Explore in graph →CHEMBL467 Approved
Regulatory
Approvals (13)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises. XROMI is an antimetabolite indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises. (1) | approved | Dec 23, 2024 | openfda |
| US FDA | — | XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises. XROMI is an antimetabolite indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises. (1) | approved | Apr 4, 2024 | openfda |
| US FDA | — | Efficacy supplement 2021-12-07 (see label) | approved | Dec 7, 2021 | openfda |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 2 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 8 | 7 | 19 | 64 | 13 | CA, US | Dec 7, 1967 | 1994-10 |
| Leukemia | Phase3 | Phase 3 | 3 | 3 | 9 | 17 | 0 | — | — | 1994-10 |
| Malignant Central Nervous System Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 5 | 0 | — | — | 2004-10 |
| Malignant Laryngeal Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 4 | 0 | — |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (65)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00083187 | VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia | completed | Phase 2 | 230 | Vion PharmaceuticalsINDUSTRY | 3 | Jul 18, 2013 | clinicaltrials |
| NCT00004089 | Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Thyroid Cancer | completed | Phase 2 |