Wednesday, July 8, 2026

Drug profile · INN

hydroxyurea

hydroxyurea (HYDROXYUREA) is a ribonucleoside-diphosphate reductase rr1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 1
Pipeline programs 5
News articles 0
Drug details — hydroxyurea
US status
approved
Class
Route
ORAL
Patents
1
Programs
5
Data quality
0.84

Quick answer

hydroxyurea (HYDROXYUREA) is a ribonucleoside-diphosphate reductase rr1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN hydroxyurea
Brand HYDROXYUREA
Mechanism Ribonucleoside-diphosphate reductase RR1 inhibitor
Target Ribonucleoside-diphosphate reductase RR1
Route ORAL
Formulation CAPSULE

Mechanism of action

Ribonucleoside-diphosphate reductase RR1 inhibitor

Primary target: Ribonucleoside-diphosphate reductase RR1

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. MK-3543-006 Phase 3 · MSD Merck Sharp · Essential Thrombocythemia patients who have an inadequate re
  2. Hydroxyurea Phase 2 · Sana Biotechnology · Thalassemia, Beta
  3. NN7533-4470 Phase 2 · NovoThirteen · Sickle cell disease
  4. SIKLOS PAEDIATRIC 50mg dispersible tablets Phase 2 · theravia · Sickle Cell Disease
  5. Hydroxyurea Unknown · United Therapeutics Europe · Thrombocythemia

Related & competitor drugs

  1. hydroxycarbamide Antineoplastic and immunomodulating agents (L01)

Related patents

  1. US 6573300

    Hydroxyurea treatment for spinal muscular atrophy

    Expires Mon May 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is hydroxyurea?

hydroxyurea (HYDROXYUREA) is a ribonucleoside-diphosphate reductase rr1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for hydroxyurea?

HYDROXYUREA is a marketed brand name for hydroxyurea. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of hydroxyurea?

hydroxyurea has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.