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    DRUG CLASS:

    DNA polymerase inhibitor

    Related drugs:
    23h
    VYSION: VYxeoS Liposomal Italian Observational Study iN the Real Practice (clinicaltrials.gov)
    P=N/A, N=112, Active, not recruiting, Jazz Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    9d
    Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy with CPX-351 in Adult Patients with Newly Diagnosed AML and Intermediate- or Adverse Genetics (clinicaltrials.gov)
    P3, N=882, Recruiting, University of Ulm | Trial completion date: Mar 2024 --> Jun 2027 | Trial primary completion date: Mar 2024 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    17d
    CPX-351 TA-SMP: Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm (clinicaltrials.gov)
    P2, N=42, Completed, French Innovative Leukemia Organisation | Recruiting --> Completed | Trial completion date: Sep 2025 --> Dec 2023
    Trial completion • Trial completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    28d
    A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer (clinicaltrials.gov)
    P1, N=90, Active, not recruiting, Fujifilm Pharmaceuticals U.S.A., Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    liposomal gemcitabine (FF-10832)
    28d
    Lower-intensity CPX-351 plus venetoclax induction for adults with newly diagnosed AML unfit for intensive chemotherapy. (PubMed, Blood Adv)
    This study highlights that lower-intensity therapy of CPX-351 plus venetoclax as induction therapy provides a well-tolerated treatment option in adults with AML deemed unfit for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT04038437.
    Journal • IO biomarker
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    Venclexta (venetoclax) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    1m
    HPTN 083: Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (clinicaltrials.gov)
    P2/3, N=4570, Active, not recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Jul 2024 --> Apr 2025
    Trial completion date
    2ms
    Valacyclovir in Neonatal Herpes Simplex Virus Disease (clinicaltrials.gov)
    P1, N=7, Completed, University of Alabama at Birmingham | Recruiting --> Completed | N=10 --> 7 | Trial completion date: Nov 2025 --> Jul 2024 | Trial primary completion date: Oct 2025 --> Jul 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    valacyclovir
    2ms
    ZEDS: Zoster Eye Disease Study (clinicaltrials.gov)
    P4, N=652, Completed, NYU Langone Health | Active, not recruiting --> Completed
    Trial completion
    |
    valacyclovir
    3ms
    Anti-Inflammatory Immunomodulatory Activity of Valacyclovir on the in Vitro Activated Mammalian Macrophages. (PubMed, Discov Med)
    Valacyclovir has the potential to be utilized in the clinical setting as an anti-viral drug molecule with anti-inflammatory properties. Future studies are needed to further confirm its activities on different immune system cell types.
    Preclinical • Journal • Immunomodulating
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CSF2 (Colony stimulating factor 2)
    |
    valacyclovir
    3ms
    Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1 (clinicaltrials.gov)
    P2, N=54, Recruiting, University of North Carolina, Chapel Hill | Not yet recruiting --> Recruiting
    Enrollment open
    3ms
    CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, University of California, Irvine | Recruiting --> Active, not recruiting | Trial completion date: Sep 2025 --> Jun 2027 | Trial primary completion date: Jun 2024 --> Jun 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    NPM1 (Nucleophosmin 1) • CEBPA (CCAAT Enhancer Binding Protein Alpha)
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation) • Daurismo (glasdegib)
    3ms
    CPX-351 Therapy for MDS After Hypomethylating Agent Failure (clinicaltrials.gov)
    P2, N=4, Terminated, Case Comprehensive Cancer Center | N=25 --> 4 | Recruiting --> Terminated; Slow Accrual
    Enrollment change • Trial termination
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    3ms
    Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes (clinicaltrials.gov)
    P2, N=78, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    RUNX1 (RUNX Family Transcription Factor 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • SRSF2 (Serine and arginine rich splicing factor 2) • BCOR (BCL6 Corepressor) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • STAG2 (Stromal Antigen 2) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation) • pomalidomide
    3ms
    The Women TDF-FTC Benchmark Study (clinicaltrials.gov)
    P2, N=72, Active, not recruiting, University of Washington | Trial primary completion date: Mar 2024 --> Jan 2025
    Trial primary completion date
    4ms
    DOXYVAC: Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP) (clinicaltrials.gov)
    P3, N=556, Completed, ANRS, Emerging Infectious Diseases | Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Apr 2024
    Trial completion • Trial completion date
    4ms
    A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer (clinicaltrials.gov)
    P1, N=90, Recruiting, Fujifilm Pharmaceuticals U.S.A., Inc. | Trial completion date: Mar 2025 --> Jun 2025 | Trial primary completion date: Sep 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    liposomal gemcitabine (FF-10832)
    4ms
    RTIAGS: Reverse Transcriptase Inhibitors in Aicardi Goutières Syndrome (clinicaltrials.gov)
    P1/2, N=34, Not yet recruiting, Children's Hospital of Philadelphia | Trial completion date: Dec 2028 --> Dec 2029 | Trial primary completion date: Dec 2028 --> Dec 2029
    Trial completion date • Trial primary completion date
    |
    ADAR (Adenosine Deaminase RNA Specific) • IFIH1 (Interferon Induced With Helicase C Domain 1) • IFNA1 (Interferon Alpha 1)
    4ms
    CPX-351 as a Novel Approach for the Treatment of Older Patients With AML and MDS (clinicaltrials.gov)
    P2, N=13, Active, not recruiting, Case Comprehensive Cancer Center | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    4ms
    Phase IB/II of CPX-351 for Relapse Prevention in AML (clinicaltrials.gov)
    P1/2, N=24, Recruiting, Georgetown University | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    5ms
    Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML (clinicaltrials.gov)
    P1, N=22, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Aug 2025 --> Nov 2025 | Trial primary completion date: Aug 2024 --> Nov 2024
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    Xospata (gilteritinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    5ms
    CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML (clinicaltrials.gov)
    P1, N=18, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Dec 2024 --> Nov 2025
    Trial primary completion date • Combination therapy
    |
    CD33 (CD33 Molecule)
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    5ms
    The Kampala Women's Bone Study (clinicaltrials.gov)
    P4, N=500, Completed, University of Washington | Trial completion date: Feb 2022 --> Dec 2023 | Trial primary completion date: Feb 2022 --> Dec 2023
    Trial completion date • Trial primary completion date
    5ms
    Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps) (clinicaltrials.gov)
    P3, N=36, Completed, Brigham and Women's Hospital | Active, not recruiting --> Completed
    Trial completion • Adherence
    5ms
    Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    CD33 (CD33 Molecule)
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    6ms
    Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1 (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, University of North Carolina, Chapel Hill
    New P2 trial
    6ms
    SHIPP: Sustainable Healthcenter Implementation PrEP Pilot Study (clinicaltrials.gov)
    P=N/A, N=1420, Completed, Centers for Disease Control and Prevention | Unknown status --> Completed
    Trial completion
    6ms
    Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=268, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Mar 2027 | Trial primary completion date: Sep 2024 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • azacitidine • Vyxeos (cytarabine/daunorubicin liposomal formulation) • Starasid (cytarabine ocfosfate)
    6ms
    Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=18, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2027 --> May 2025 | Trial primary completion date: Feb 2027 --> May 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    6ms
    ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection (clinicaltrials.gov)
    P2, N=32, Completed, Acurx Pharmaceuticals Inc. | Active, not recruiting --> Completed
    Trial completion
    6ms
    Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=18, Recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2024 --> Feb 2027 | Trial primary completion date: May 2024 --> Feb 2027
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    6ms
    INSIGHT: A Cohort for Evaluation of Open-label PrEP Use and PreP Preferences Among African Women (clinicaltrials.gov)
    P=N/A, N=3087, Completed, University of Washington | Active, not recruiting --> Completed | Trial completion date: May 2024 --> Aug 2023
    Trial completion • Trial completion date
    7ms
    NCI-2019-03712: Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms (clinicaltrials.gov)
    P1/2, N=47, Recruiting, Ohio State University Comprehensive Cancer Center | Suspended --> Recruiting
    Enrollment open • Metastases
    |
    Jakafi (ruxolitinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    7ms
    ORAZ-351: Oral Azacitidine Maintenance Post-CPX 351 (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Centre Hospitalier Universitaire de Nice
    New trial
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation) • Onureg (azacitidine oral)
    7ms
    Antiviral: Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening (clinicaltrials.gov)
    P4, N=82, Recruiting, Dow University of Health Sciences
    New P4 trial
    |
    valacyclovir
    8ms
    Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study (clinicaltrials.gov)
    P1/2, N=49, Completed, Hektoen Institute for Medical Research | Unknown status --> Completed | Trial completion date: Nov 2020 --> Nov 2023 | Trial primary completion date: May 2020 --> Nov 2023
    Trial completion • Trial completion date • Trial primary completion date • Adherence
    8ms
    Urinary Viral Spectrum in Patients with Interstitial Cystitis/Bladder Pain Syndrome and the Clinical Efficacy of Valacyclovir Treatment. (PubMed, Biomedicines)
    Urinary EBV was undetectable in any sample after valacyclovir treatment, and the decreases in urinary interleukin (IL)-1β (from 0.66 [0.55-0.82] pg/mL to 0.58 [0.55-0.64] pg/mL, p = 0.0034), IL-8 (from 6.81 [2.38 to 29.1] pg/mL to 4.33 [1.53-11.04] pg/mL, p = 0.0361), IL-10 (from 1.06 [0.94-1.18] pg/mL to 0.92 [0.88-1.02], p = 0.0086), and tumor necrosis factor-α (from 1.61 [1.50-1.72] pg/mL to 1.50 [1.44-1.55] pg/mL, p = 0.0079) were significant. Valacyclovir could relieve bladder pain, eliminate urinary EBV, and reduce bladder inflammation.
    Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL10 (Interleukin 10)
    |
    valacyclovir
    8ms
    PASC: Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2 (clinicaltrials.gov)
    P2, N=60, Recruiting, Bateman Horne Center
    New P2 trial
    |
    celecoxib oral • valacyclovir
    8ms
    CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P2, N=30, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    8ms
    Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps) (clinicaltrials.gov)
    P3, N=36, Active, not recruiting, Brigham and Women's Hospital | Recruiting --> Active, not recruiting | N=60 --> 36
    Enrollment closed • Enrollment change • Adherence
    8ms
    Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum (clinicaltrials.gov)
    P2, N=390, Completed, National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting --> Completed
    Trial completion
    8ms
    A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (clinicaltrials.gov)
    P3, N=1400, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate) • dexrazoxane
    9ms
    NCI-2019-01558: CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (clinicaltrials.gov)
    P1, N=38, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)