^
    4ms
    Assessing the selective impact of histone modifying drugs on adenoid cystic carcinoma cells and their stem cell counterparts. (PubMed, BMC Cancer)
    These findings demonstrate that CSCs and non‑CSCs respond differently to epigenetic modulation, suggesting that personalized combination therapies targeting both subpopulations may be necessary to improve treatment outcomes for ACC. Although these targeted therapies are still in the early stages of investigation, our study provides a promising pre-clinical foundation for the development of effective, personalized therapeutic strategies for this challenging malignancy.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Duvyzat (givinostat) • GSK343
    6ms
    Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function (clinicaltrials.gov)
    P1, N=24, Recruiting, Italfarmaco | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Duvyzat (givinostat)
    7ms
    Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study (clinicaltrials.gov)
    P2/3, N=206, Active, not recruiting, Italfarmaco | Enrolling by invitation --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2029 | Trial primary completion date: Dec 2025 --> Dec 2029
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Duvyzat (givinostat)
    10ms
    Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old (clinicaltrials.gov)
    P2, N=18, Recruiting, Italfarmaco | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Duvyzat (givinostat)
    11ms
    Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old (clinicaltrials.gov)
    P2, N=18, Not yet recruiting, Italfarmaco
    New P2 trial
    |
    Duvyzat (givinostat)
    11ms
    Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity (clinicaltrials.gov)
    P1, N=26, Completed, Italfarmaco | N=54 --> 26
    Enrollment change
    |
    Duvyzat (givinostat)
    12ms
    Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Italfarmaco
    New P1 trial
    |
    Duvyzat (givinostat)
    over1year
    Synergistic drug interactions of the histone deacetylase inhibitor givinostat (ITF2357) in CRLF2-rearranged pediatric B-cell precursor acute lymphoblastic leukemia identified by high-throughput drug screening. (PubMed, Heliyon)
    The combinations with trametinib (MEKi) or venetoclax (BCL2i) were found to be the most effective and with the greatest synergy across three metrics (ZIP, HAS, Bliss). Finally, we described givinostat-induced modifications in gene expression of MAPK and BCL-2 family members, supporting the observed synergistic interactions. Overall, our study represents a model of drug repurposing strategy using HTP screening for identifying synergistic, efficient, and safe drug combinations.
    Journal • IO biomarker • Epigenetic controller
    |
    BCL2 (B-cell CLL/lymphoma 2) • CRLF2 (Cytokine Receptor Like Factor 2)
    |
    Venclexta (venetoclax) • Mekinist (trametinib) • Duvyzat (givinostat)
    over1year
    Histone deacetylase inhibition mitigates fibrosis-driven disease progression in recessive dystrophic epidermolysis bullosa. (PubMed, Br J Dermatol)
    Dysregulated histone acetylation contributes to RDEB pathogenesis by facilitating the progression of fibrosis. Repurposing of HDACi could be considered for disease-modifying treatments of RDEB.
    Journal • Epigenetic controller
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    Duvyzat (givinostat)
    over1year
    Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Italfarmaco | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    JAK2 (Janus kinase 2)
    |
    Duvyzat (givinostat)
    over1year
    GIV-IN PV: Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera (clinicaltrials.gov)
    P3, N=220, Recruiting, Italfarmaco | Not yet recruiting --> Recruiting
    Enrollment open
    |
    JAK2 V617F
    |
    hydroxyurea • Duvyzat (givinostat)
    almost2years
    ULYSSES: Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy (clinicaltrials.gov)
    P3, N=138, Recruiting, Italfarmaco | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Duvyzat (givinostat)