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Hydroxyurea (HU) — Competitive Intelligence Brief
phase 3
Antimetabolite; ribonucleotide reductase inhibitor
Ribonucleotide reductase
Oncology; Hematology
Small molecule
Live · refreshed every 30 min
Target snapshot
Hydroxyurea (HU) (Hydroxyurea (HU)) — Bionoxx Inc.. Hydroxyurea inhibits ribonucleotide reductase, reducing deoxyribonucleotide synthesis and slowing DNA replication in rapidly dividing cells.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Hydroxyurea (HU) TARGET | Hydroxyurea (HU) | Bionoxx Inc. | phase 3 | Antimetabolite; ribonucleotide reductase inhibitor | Ribonucleotide reductase | |
| Gemzar | Gemcitabine Hydrochloride | Accord Hlthcare | marketed | Nucleoside metabolic inhibitor | Ribonucleotide reductase; DNA incorporation | 1996-01-01 |
| HYDROXYUREA | HYDROXYUREA | marketed | Antimetabolite [EPC] | Ribonucleotide reductase | 1967-01-01 | |
| standard dose ARA-C | standard dose ARA-C | National Research Center for Hematology, Russia | marketed | Nucleoside analog antimetabolite | DNA polymerase; ribonucleotide reductase | |
| Gemcitabine Injectable Product | Gemcitabine Injectable Product | Henan Cancer Hospital | marketed | Nucleoside analog antimetabolite | Ribonucleotide reductase; DNA incorporation | |
| Cladribine Tablets | Cladribine Tablets | Keith Edwards, M.D. | marketed | Purine nucleoside analog | Ribonucleotide reductase; DNA incorporation | |
| Platinum + Gemcitabine | Platinum + Gemcitabine | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | marketed | Chemotherapy combination (platinum agent + nucleoside analog) | DNA (platinum crosslinking); ribonucleotide reductase and DNA polymerase (gemcitabine) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
- — Gemzar · 12403086 · Formulation · US
- — Gemzar · 8679094 · Formulation · US
- — Gemzar · 9241948 · Formulation · US
- — Gemzar · 10729823 · Formulation · US
- — Gemzar · 12447241 · Formulation · US
- — HYDROXYUREA · 12409156 · Formulation · US
Sponsor landscape (Antimetabolite; ribonucleotide reductase inhibitor class)
- Assistance Publique - Hôpitaux de Paris · 1 drug in this class
- Bionoxx Inc. · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Hydroxyurea (HU) — Competitive Intelligence Brief. https://druglandscape.com/ci/hydroxyurea-hu. Accessed 2026-05-14.
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