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    DRUG CLASS:

    SIK3 inhibitor

    Related drugs:
    2d
    Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=40, Recruiting, Rhizen Pharmaceuticals SA | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Oct 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    tenalisib (RP6530)
    9ms
    Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=40, Recruiting, Rhizen Pharmaceuticals SA | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    tenalisib (RP6530)
    over1year
    A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgically (clinicaltrials.gov)
    P1/2, N=158, Recruiting, iOmx Therapeutics AG | Phase classification: P1 --> P1/2 | N=30 --> 158 | Trial completion date: May 2025 --> Apr 2026 | Trial primary completion date: Aug 2024 --> Mar 2026
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date
    |
    OMX-0407
    almost2years
    Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=40, Recruiting, Rhizen Pharmaceuticals SA | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    tenalisib (RP6530)
    almost2years
    Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Rhizen Pharmaceuticals SA
    New P2 trial • Metastases
    |
    tenalisib (RP6530)
    over2years
    Safety and efficacy of tenalisib in combination with romidepsin in patients with relapsed/refractory T-cell lymphoma: results from a phase I/II open-label multicenter study. (PubMed, Haematologica)
    Coadministration of tenalisib and romidepsin did not significantly alter the pharmacokinetics of romidepsin. Overall, tenalisib and romidepsin combination demonstrated a favorable safety and efficacy profile supporting its further development for relapsed/refractory TCL.
    Clinical • P1/2 data • Journal • Combination therapy
    |
    Istodax (romidepsin) • tenalisib (RP6530)
    over2years
    Compassionate Use Study of Tenalisib (RP6530) (clinicaltrials.gov)
    P1/2, N=17, Completed, Rhizen Pharmaceuticals SA | Trial primary completion date: Mar 2022 --> Mar 2023
    Trial primary completion date
    |
    tenalisib (RP6530)
    over2years
    Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=40, Completed, Rhizen Pharmaceuticals SA | Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Dec 2022 --> Mar 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    tenalisib (RP6530)
    over2years
    Development of a predictive biomarker signature for the highly potent SIK3 inhibitor OMX-0407 (AACR 2023)
    By screening sensitive and non-sensitive tumor cell lines and PDX models, we identified a response-prediction biomarker signature. In upcoming clinical studies, this predictive biomarker signature will be evaluated for it’s potential to enrich for patients highly responsive to OMX-0407 therapy.
    PD(L)-1 Biomarker • IO biomarker
    |
    AMPK (Protein Kinase AMP-Activated Catalytic Subunit Alpha 1)
    |
    OMX-0407
    3years
    Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL (clinicaltrials.gov)
    P2, N=0, Withdrawn, Rhizen Pharmaceuticals SA | N=40 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    ALK positive
    |
    doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • tenalisib (RP6530)
    over3years
    Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Rhizen Pharmaceuticals SA | Initiation date: May 2022 --> Jan 2023
    Trial initiation date
    |
    ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    ALK positive
    |
    doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • tenalisib (RP6530)
    over3years
    Curcumin-induced antitumor effects on triple-negative breast cancer patient-derived xenograft tumor mice through inhibiting salt-induced kinase-3 protein. (PubMed, J Food Drug Anal)
    For clinical indications, dietary nutrients (such as curcumin) as an adjuvant to chemotherapy should be helpful to TNBC patients because the current trend is to shrink the tumor with preoperative chemotherapy and then perform surgery. In addition, from the perspective of chemoprevention, curcumin has excellent clinical application value.
    Preclinical • Journal
    |
    VIM (Vimentin) • MMP3 (Matrix metallopeptidase 3)