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  1. pharmadog
  2. ›drugs
  3. ›Xromi
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hydroxyurea

Marketedupdated 3mo ago
by Nova Laboratories Ltd
Approved
community read0 votes

indications

investigational
Sickle Cell Disease

all catalysts(0)

nothing on the calendar yet

Trials studying hydroxyurea

  • —Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Veraactive not recruitingn=242
  • phase3Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)recruitingn=300
  • phase4Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictorsterminatedn=76
  • —Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infantsrecruitingn=1,600
  • phase1A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea)recruitingn=27
  • phase1A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patientsnot yet recruitingn=24
  • phase3Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Verarecruitingn=220
  • phase2Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapynot yet recruitingn=70
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Apr 4, 2027
229 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (1)

  • Dec 23, 2041formulationUS 12409156

FDA exclusivities (2)

  • Apr 4, 2031ODE-470Orphan Drug (7y)4.6y
  • Apr 4, 2027NPNP229d

News(1)

  • Second Clinical Scenario - Progressive Disease Despite Hematocrit Control
    Polycythemia vera symptoms like fatigue and aquagenic itching signal active disease; experts urge objective tracking and tailored therapy beyond phlebotomy.
    onclive · 3mo ago
brand
Xromi
generic
hydroxyurea
indication
Sickle Cell Disease With Vaso-Occlusive Crisis
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 39m ago
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