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DRUG:

hydroxyurea

i
Other names: WR 83799, NSC-32065, SQ-1089
Company:
Generic mfg.
Drug class:
DNA synthesis inhibitor, Ribonucleotide reductase inhibitor
Related drugs:
1d
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease (clinicaltrials.gov)
P=N/A, N=40, Recruiting, Ann & Robert H Lurie Children's Hospital of Chicago | Trial completion date: Jun 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
Trial completion date • Trial primary completion date • Adherence
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hydroxyurea
1d
The Longitudinal Relationship of HU Adherence to HRQOL, Barriers to Adherence and Habit in SCD. (clinicaltrials.gov)
P=N/A, N=68, Active, not recruiting, Ann & Robert H Lurie Children's Hospital of Chicago | Trial primary completion date: Nov 2023 --> Dec 2024
Trial primary completion date • HEOR • Adherence
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hydroxyurea
3d
Diagnosis and Treatment of Polycythemia Vera: A Review. (PubMed, JAMA)
Ruxolitinib is a Janus kinase inhibitor that can alleviate pruritus and decrease splenomegaly in patients who are intolerant of or resistant to hydroxyurea. To decrease the risk of thrombosis, all patients with PV should be treated with aspirin and therapeutic phlebotomy to maintain a hematocrit of less than 45%. Cytoreductive therapies, such as hydroxyurea or interferon, are recommended for patients at high risk of thrombosis.
Review • Journal
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JAK2 (Janus kinase 2)
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Jakafi (ruxolitinib) • hydroxyurea • aspirin
4d
MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera (clinicaltrials.gov)
P3, N=586, Recruiting, University of Birmingham | Trial completion date: Feb 2028 --> Apr 2030 | Trial primary completion date: Aug 2026 --> Oct 2028
Trial completion date • Trial primary completion date
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Jakafi (ruxolitinib) • hydroxyurea • Intron A (interferon α-2b)
9d
Enrollment open
|
hydroxyurea • Adakveo (crizanlizumab-tmca)
11d
New P3 trial
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CD4 (CD4 Molecule)
|
hydroxyurea • bomedemstat (MK-3543)
23d
Maternal and Foetal Outcomes of Newly Diagnosed Chronic Myeloid Leukemia During Pregnancy and its Long-Term Impact. (PubMed, Indian J Hematol Blood Transfus)
Management included observation in 6 (46.3%), hydroxyurea in 3 (23.1%), imatinib in 3 (23.1%) and Interferon-α (IFN-α) in 1 (7.7%) patients. Effective management of newly diagnosed CML-CP during pregnancy is contingent on the trimester of presentation. Further research and collaboration are warranted to develop standardised guidelines for managing pregnancy-associated CML, particularly in LMICs.
Journal
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IFNA1 (Interferon Alpha 1)
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imatinib • hydroxyurea
24d
HUPK: Pharmacokinetics of Oral Hydroxyurea Solution (clinicaltrials.gov)
P1/2, N=33, Completed, Nova Laboratories Limited | Phase classification: P2 --> P1/2
Phase classification
|
hydroxyurea
30d
SOLACE-Kids: Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients (clinicaltrials.gov)
P2, N=117, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
Enrollment closed
|
hydroxyurea • Adakveo (crizanlizumab-tmca)
1m
Essential Thrombocythemia Possible Cause of Ischemic Cerebrovascular Disease: A Case Report. (PubMed, Cureus)
Antiplatelet therapy was started with acetylsalicylic acid 100 mg and clopidogrel 75 mg once a day. With the recommendation of hematology, cytoreductive treatment, hydroxyurea 1000 mg twice a day, was started. The patient's complaints were resolved at the end of the second day, and the patient with minimal ataxia was discharged with recommendations. Patients with ET should be aware of ischemic cerebrovascular disease and consider antiplatelet and cytoreductive treatment options.
Journal
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JAK2 (Janus kinase 2)
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JAK2 V617F • JAK2 mutation
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hydroxyurea
1m
Trial completion • Surgery • Metastases
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Opdivo (nivolumab) • cisplatin • carboplatin • albumin-bound paclitaxel • hydroxyurea • fluorouracil topical
2ms
Study on pharmacokinetic and tissue distribution of hyperin, astragalin, kaempferol-3-O-β-D-glucuronide from rats with multiple administrations of Semen Cuscutae processed with salt solution with effect of treating recurrent spontaneous abortion. (PubMed, Front Pharmacol)
First, a rat model of RSA was established using hydroxyurea in combination with mifepristone. It was elucidated that all three were involved in the regulation of progesterone levels and immune function. It initially revealed the mechanism of action of YP in enhancing the improvement of RSA, and it provided a theoretical basis for the quality assessment of YP.
PK/PD data • Preclinical • Journal
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TNFA (Tumor Necrosis Factor-Alpha) • IL4 (Interleukin 4)
|
hydroxyurea • Mifeprex (mifepristone)
2ms
Cancer stem cells in meningiomas: novel insights and therapeutic implications. (PubMed, Clin Transl Oncol)
The use of combination therapies, such as hydroxyurea alongside diltiazem, suggests more efficient and effective MG management compared to monotherapy. Since the efficacy of traditional therapies is limited in most cases due to resistance mechanisms in CSCs, further studies on the biology of CSCs are warranted to develop therapeutic interventions that are likely to be effective in MG. Consequently, improved diagnostic approaches may lead to personalised treatment plans tailored to the specific needs of each patient.
Review • Journal • Cancer stem
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SOX2 • POU5F1 (POU Class 5 Homeobox 1) • NANOG (Nanog Homeobox)
|
hydroxyurea
2ms
OPTIMA: Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer (clinicaltrials.gov)
P2, N=62, Completed, University of Chicago | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Sep 2024 | Trial primary completion date: Mar 2019 --> Sep 2024
Trial completion • Trial completion date • Trial primary completion date
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cisplatin • carboplatin • 5-fluorouracil • albumin-bound paclitaxel • hydroxyurea
2ms
New P4 trial
|
metformin • hydroxyurea
2ms
PIN: A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study (clinicaltrials.gov)
P2, N=64, Completed, Vanderbilt University Medical Center | Active, not recruiting --> Completed | Trial completion date: Jan 2027 --> Nov 2023
Trial completion • Trial completion date
|
hydroxyurea
2ms
A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients with Sickle Cell Disease Who Are At Increased Risk for Primary Stroke (clinicaltrials.gov)
P2, N=46, Recruiting, Forma Therapeutics, Inc. | Trial completion date: Feb 2026 --> Oct 2026 | Trial primary completion date: Jan 2025 --> Jul 2025
Trial completion date • Trial primary completion date
|
hydroxyurea
2ms
A Phase 2 Multicenter, Randomized, Open-label Study to Evaluate the Pharmacokinetic, Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (ChiCTR2400088120)
P2, N=27, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Institute of Hematology
New P2 trial
|
hydroxyurea
2ms
OPTIMA-II: Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer (clinicaltrials.gov)
P2, N=76, Active, not recruiting, University of Chicago | Trial completion date: Jul 2025 --> Sep 2024 | Trial primary completion date: Jul 2025 --> Sep 2024
Trial completion date • Trial primary completion date • Surgery • Metastases
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Opdivo (nivolumab) • cisplatin • carboplatin • albumin-bound paclitaxel • hydroxyurea • fluorouracil topical
2ms
Leucocytosis during induction therapy with all-trans-retinoic acid and arsenic trioxide in acute promyelocytic leukaemia predicts differentiation syndrome and treatment-related complications. (PubMed, Br J Haematol)
All cases were successfully managed with hydroxyurea...In conclusion, APL patients undergoing ATRA-ATO therapy with lower fibrinogen levels and platelet counts at diagnosis and with a massive bone marrow blast infiltrate should be carefully monitored for the development of leucocytosis during induction. DS and other treatment-related complications seem to occur almost exclusively in patients developing leucocytosis, who should necessarily receive DS prophylaxis and more intensive monitoring and supportive therapy to prevent treatment complications.
Journal
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KIT (KIT proto-oncogene, receptor tyrosine kinase)
|
KIT expression
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Vesanoid (tretinoin) • arsenic trioxide • hydroxyurea
2ms
Challenges in Diagnosing Polycythemia Vera in Primary Care: A 55-Year-Old Malaysian Woman with Atypical Presentation. (PubMed, Am J Case Rep)
Treatment with phlebotomy, hydroxyurea, and aspirin resulted in significant improvements in ocular symptoms and hematological parameters within 60 days. CONCLUSIONS This case underscores the critical role of primary care in the early detection of polycythemia vera. Timely identification and appropriate referral from primary care settings are essential to avoid diagnostic delays and ensure effective management, improving patient outcomes and preventing complications.
Journal
|
JAK2 (Janus kinase 2)
|
JAK2 V617F • JAK2 mutation
|
hydroxyurea • aspirin
3ms
Prospero: Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera (clinicaltrials.gov)
P=N/A, N=241, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
Enrollment closed
|
Jakafi (ruxolitinib) • hydroxyurea
3ms
SPRING-2: Stroke Prevention in Nigeria 2 Trial (clinicaltrials.gov)
P4, N=220, Recruiting, Vanderbilt University Medical Center | Not yet recruiting --> Recruiting
Enrollment open
|
hydroxyurea
3ms
Trial completion date • Trial primary completion date
|
hydroxyurea • Rytelo (imetelstat)
3ms
Single-cell proteo-transcriptomic profiling reveals altered characteristics of stem and progenitor cells in patients receiving cytoreductive hydroxyurea in early-phase chronic myeloid leukemia. (PubMed, Haematologica)
We conclude that short-term HU treatment entails differentiation of erythroid progenitor cells and alters the characteristics of LSC in CML. The results imply that studies of LSC and progenitor populations in CML should take effects of initial HU therapy into account.
Journal
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CD34 (CD34 molecule) • CD14 (CD14 Molecule) • HBA1 (Hemoglobin Subunit Alpha 1) • HBB (Hemoglobin Subunit Beta)
|
hydroxyurea
3ms
Reduced Intensity Transplantation for Severe Sickle Cell Disease (clinicaltrials.gov)
P2, N=40, Suspended, St. Jude Children's Research Hospital | Trial completion date: Jul 2025 --> Aug 2027 | Trial primary completion date: Jul 2024 --> Aug 2026
Trial completion date • Trial primary completion date
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cyclophosphamide • Campath (alemtuzumab) • sirolimus • hydroxyurea • thiotepa • plerixafor
3ms
Transformation into acute myeloid leukemia with t(8;21)(q22;q22.1); RUNX1::RUNX1T1 from JAK2-mutated essential thrombocythemia: a case report. (PubMed, J Med Case Rep)
To our best knowledge, the present case is the first one with JAK2 mutation preceding the acquisition of t(8;21). Our result suggests that t(8;21); RUNX1::RUNX1T1 can be generated as a late event in the progression of JAK2-mutated myeloproliferative neoplasms. The case presented typical morphological and immunophenotypic features associated with t(8;21) acute myeloid leukemia.
Journal
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JAK2 (Janus kinase 2) • RUNX1 (RUNX Family Transcription Factor 1) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1) • ANPEP (Alanyl Aminopeptidase, Membrane) • MPO (Myeloperoxidase)
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Venclexta (venetoclax) • azacitidine • hydroxyurea
3ms
DEPEND: De-Escalation Therapy for Human Papillomavirus Negative Disease (clinicaltrials.gov)
P2, N=36, Recruiting, University of Chicago | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date • Metastases
|
TMB (Tumor Mutational Burden)
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Opdivo (nivolumab) • cisplatin • carboplatin • paclitaxel • 5-fluorouracil • hydroxyurea • Neupogen (filgrastim)
3ms
Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET (clinicaltrials.gov)
P2, N=27, Not yet recruiting, Xiamen Amoytop Biotech Co., Ltd.
New P2 trial
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hydroxyurea
3ms
Enhancing [177Lu]Lu-DOTA-TATE therapeutic efficacy in vitro by combining it with metronomic chemotherapeutics. (PubMed, EJNMMI Res)
Hydroxyurea, gemcitabine and triapine all increased cell size, SSTR2A expression, and [177Lu]Lu-DOTA-TATE uptake, whilst reducing cell metabolic viability in U2OS + SSTR2A cells when compared to [177Lu]Lu-DOTA-TATE monotherapy. Further investigations could transform patient care and positively increase outcomes for patients treated with [177Lu]Lu-DOTA-TATE.
Preclinical • Journal
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SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
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gemcitabine • hydroxyurea • Lutathera (lutetium Lu 177 dotatate) • Triapine (3-AP)
4ms
The evolving landscape of polycythemia vera therapies. (PubMed, Expert Opin Pharmacother)
The treatment landscape of polycythemia vera (PV) has seen major advancements within the last decade including approval of ruxolitinib in the second line setting after hydroxyurea, ropegylated interferon-α2b, and advanced clinical development of a novel class of agents called hepcidin mimetics...The discovery of hepcidin mimetics has come as a breakthrough in restoring iron homeostasis, achieving phlebotomy-independence and may lead to improved thrombosis-free survival with stricter hematocrit control. On the other hand, emerging data with IFN- α and ruxolitinib as well as combination of the two agents suggests the potential for achieving molecular remission in a subset of PV patients and long-term follow-up is awaited to validate the correlation of molecular responses with clinically relevant outcomes of progression-free and thrombosis-free survival.
Review • Journal
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IFNA1 (Interferon Alpha 1)
|
Jakafi (ruxolitinib) • hydroxyurea • rusfertide (PTG-300)
4ms
Chronic myeloid leukemia: 2025 update on diagnosis, therapy, and monitoring. (PubMed, Am J Hematol)
Four tyrosine kinase inhibitors (TKIs), imatinib, dasatinib, bosutinib, and nilotinib, are approved by the United States Food and Drug Administration (FDA) for first-line treatment of newly diagnosed CML in the chronic phase (CML-CP)...Patients who develop the T315I "gatekeeper" mutation display resistance to all currently available TKIs except ponatinib, asciminib, and olverembatinib. Allogeneic stem cell transplantation remains an important therapeutic option for patients with CML-CP and failure (due to resistance) of at least two TKIs and for all patients in advanced-phase disease. Older patients who have a cytogenetic relapse post-failure on all TKIs can maintain long-term survival if they continue a daily most effective/least toxic TKI, with or without the addition of non-TKI anti-CML agents (hydroxyurea, omacetaxine, azacitidine, decitabine, cytarabine, and others).
Journal
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
|
dasatinib • imatinib • cytarabine • Iclusig (ponatinib) • azacitidine • Tasigna (nilotinib) • Bosulif (bosutinib) • decitabine • Scemblix (asciminib) • Nailike (olverembatinib) • Synribo (omacetaxine mepesuccinate) • hydroxyurea
4ms
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer (clinicaltrials.gov)
P1, N=48, Completed, University of Chicago | Active, not recruiting --> Completed | Trial completion date: Nov 2027 --> Jan 2024 | Trial primary completion date: Nov 2027 --> Jan 2024
Trial completion • Trial completion date • Trial primary completion date
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carboplatin • 5-fluorouracil • albumin-bound paclitaxel • hydroxyurea
4ms
SPRING-2: Stroke Prevention in Nigeria 2 Trial (clinicaltrials.gov)
P4, N=220, Not yet recruiting, Vanderbilt University Medical Center
New P4 trial
|
hydroxyurea
4ms
HU-F-AIM: Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors (clinicaltrials.gov)
P4, N=300, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Sep 2024 --> Jun 2026
Trial primary completion date • Machine learning
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hydroxyurea
4ms
Prospero: Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera (clinicaltrials.gov)
P=N/A, N=300, Recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2026 --> Aug 2027 | Trial primary completion date: Sep 2026 --> Aug 2027
Trial completion date • Trial primary completion date
|
Jakafi (ruxolitinib) • hydroxyurea
4ms
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (clinicaltrials.gov)
P=N/A, N=1600, Recruiting, Duke University | Trial completion date: Sep 2024 --> Jul 2026
Trial completion date
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metformin • Actemra IV (tocilizumab) • hydroxyurea • Kineret (anakinra) • Valcyte (valganciclovir) • ondansetron
4ms
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders (clinicaltrials.gov)
P1/2, N=29, Recruiting, Washington University School of Medicine | Trial completion date: Apr 2026 --> Apr 2031 | Trial primary completion date: Apr 2024 --> Apr 2026
Trial completion date • Trial primary completion date
|
cyclophosphamide • melphalan • hydroxyurea
4ms
Outcomes of Patients With Newly Diagnosed AML and Hyperleukocytosis. (PubMed, JCO Oncol Pract)
Hyperleukocytosis is a life-threatening hematologic emergency. Early recognition and intervention including cytoreduction, blood product support, antibiotics, and renal replacement therapy may help mitigate the risk of morbidity and early mortality.
Journal
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1)
|
cytarabine • hydroxyurea
4ms
A Study to Learn About Sickle Cell Disease In Adult Patients (clinicaltrials.gov)
P=N/A, N=98, Completed, Pfizer | Recruiting --> Completed | N=150 --> 98
Trial completion • Enrollment change • Patient reported outcomes
|
hydroxyurea
4ms
Dermatomyositis-like skin eruptions under hydroxyurea therapy conceal TP53-mutated atypical keratinocytes: A histopathologic and molecular pathologic case series. (PubMed, J Cutan Pathol)
"DM-like" skin eruptions as a long-term consequence of hydroxyurea therapy are possibly not chemotherapy-associated benign toxic changes, but rather inflammatory reactions to complex keratinocyte alterations that clinically mimic the picture of DM. Synergistic mutagenic effects of hydroxyurea and sunlight might be responsible for this unique drug side effect and could provide a pathogenic link to the known increased risk of skin cancer in these patients.
Journal
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TP53 (Tumor protein P53)
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hydroxyurea