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    DRUG:

    Odomzo (sonidegib)

    i
    Other names: LDE225, LDE 225, NVP LDE225, NVP-LDE225, LDE-225, NVPLDE225
    Company:
    Novartis, Sun Pharma
    Drug class:
    Hedgehog cell-signalling pathway inhibitor
    Related drugs:
    7d
    Aberrant Activation of the Hedgehog Pathway in Cutaneous Melanoma: Therapeutic Potential of Pharmacological Inhibitors. (PubMed, Int J Mol Sci)
    Profiling inflammatory mediators revealed significant modulation upon treatment with SMO inhibitors, possibly affecting chemotactic and immune functions. Collectively, these findings provide deeper insight into the role of the Hh pathway in melanoma and support the potential repurposing of Hh inhibitors as therapeutic agents for melanoma.
    Journal
    |
    PTCH1 (Patched 1) • GLI2 (GLI Family Zinc Finger 2)
    |
    Odomzo (sonidegib)
    25d
    Resistance to SMO Inhibitors in Advanced Basal Cell Carcinoma: A Case Highlighting the Role of Molecular Tumor Profiling. (PubMed, Int J Mol Sci)
    Accordingly, current targeted therapies for locally advanced, unresectable, or metastatic BCC focus on SMO inhibition, using orally administered drugs such as vismodegib and sonidegib. To our knowledge, this is the first report documenting a sonidegib resistance mechanism in BCC that is independent of HH pathway mutations. This case highlights the complexity of resistance mechanisms to HH inhibitors and underscores the critical need for comprehensive molecular tumor profiling prior to initiating targeted therapy.
    Journal
    |
    TP53 (Tumor protein P53) • FGFR1 (Fibroblast growth factor receptor 1) • NOTCH1 (Notch 1) • PTCH1 (Patched 1) • SMO (Smoothened Frizzled Class Receptor)
    |
    TP53 mutation
    |
    Erivedge (vismodegib) • Odomzo (sonidegib)
    26d
    An Updated Comprehensive Pharmacovigilance Study of Drug- Induced Breast Cancer Based on FDA Adverse Event Reporting System Data. (PubMed, Curr Med Chem)
    Targeted therapies of lapatinib, fulvestrant, and endocrine agents (letrozole or ribociclib) show disproportionately high AE reporting odds ratios, necessitating vigilant monitoring. HER2-positive BC treatments (trastuzumab) and TNBC agents (sonidegib) exhibit distinct risk profiles, advocating for personalized risk-benefit assessments for BC patients.
    Journal • Adverse events
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • lapatinib • Kisqali (ribociclib) • fulvestrant • letrozole • Odomzo (sonidegib)
    2ms
    SONIB: A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma (clinicaltrials.gov)
    P2, N=16, Completed, Melanoma Institute Australia | Recruiting --> Completed | Trial completion date: Jun 2026 --> Mar 2025 | Trial primary completion date: Jun 2026 --> Mar 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Odomzo (sonidegib) • Zyclara (imiquimod)
    3ms
    SONIB: A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma (clinicaltrials.gov)
    P2, N=20, Recruiting, Melanoma Institute Australia | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Odomzo (sonidegib) • Zyclara (imiquimod)
    3ms
    A case of basal cell nevus syndrome with a SUFU mutation. (PubMed, Dermatol Online J)
    Rarely, this condition is related to a suppressor of fused gene mutation, which occurs downstream from Smoothened, and is unresponsive to Smoothened inhibitors including vismodegib and sonidegib. Genetic testing was negative for patched 1 and patched 2 mutations but positive for a heterozygous suppressor of fused mutation. Patients with basal cell nevus syndrome should be treated with surgical excision, counseled on sun protection, screened and monitored for complications, and treated with vismodegib (if associated with patched 1 mutation) or itraconazole (if associated with suppressor of fused mutation).
    Journal
    |
    PTCH1 (Patched 1) • SUFU (SUFU Negative Regulator Of Hedgehog Signaling)
    |
    Erivedge (vismodegib) • Odomzo (sonidegib) • itraconazole
    3ms
    PersoMed-I: Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (clinicaltrials.gov)
    P2, N=20, Terminated, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: Dec 2025 --> Sep 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Jun 2025; Poor accrual
    Trial completion date • Trial termination • Trial primary completion date
    |
    TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    TP53 wild-type
    |
    cisplatin • vincristine • lomustine • Odomzo (sonidegib)
    4ms
    Sonidegib in Adult Patients With Locally Advanced Basal Cell Carcinoma (laBCC) in China (clinicaltrials.gov)
    P4, N=160, Completed, Jemincare | Active, not recruiting --> Completed
    Trial completion
    |
    Odomzo (sonidegib)
    6ms
    PersoMed-I: Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    TP53 wild-type
    |
    cisplatin • vincristine • lomustine • Odomzo (sonidegib)
    7ms
    BCC-Sonidegib: Dose-Modulated Sonidegib Therapy for Periocular Basal Cell Carcinoma (clinicaltrials.gov)
    P=N/A, N=12, Completed, Federico II University
    New trial
    |
    Odomzo (sonidegib)
    7ms
    NISSO: Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma (clinicaltrials.gov)
    P=N/A, N=323, Completed, Sun Pharmaceutical Industries Limited | Active, not recruiting --> Completed | Trial completion date: Sep 2025 --> Mar 2025
    Trial completion • Trial completion date
    |
    Odomzo (sonidegib)
    8ms
    UF-GI-015: AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=12, Suspended, University of Florida | Recruiting --> Suspended
    Trial suspension
    |
    sorafenib • irinotecan • Odomzo (sonidegib)