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    DRUG:

    Ostarine (enobosarm)

    i
    Other names: GTx 024, GTx-024, MK-2866, MK 2866, VERU-024, S-22
    Company:
    Veru Inc
    Drug class:
    Selective androgen receptor modulator
    Related drugs:
    29d
    An Update on the Role of Androgens and Androgen Receptor in Triple-Negative Breast Cancer. (PubMed, Cells)
    Increasing interest in AR biology has led to the evaluation of several anti-androgen therapies in AR-positive TNBC, including agents such as enzalutamide, enobosarm, orteronel, bicalutamide, and seviteronel. Although clinical activity has generally been modest, these studies highlight the potential relevance of AR-targeted strategies in selected patient subgroups. This review summarizes current knowledge on androgen and AR signaling in TNBC, integrating molecular mechanisms, preclinical evidence, and clinical studies, and discusses emerging therapeutic strategies aimed at improving patient treatment outcomes.
    Review • Journal
    |
    AR (Androgen receptor)
    |
    AR positive
    |
    enzalutamide • bicalutamide • Ostarine (enobosarm) • orteronel (TAK 700) • seviteronel (KMB-464)
    3ms
    PLATEAU: Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss (clinicaltrials.gov)
    P2, N=200, Recruiting, Veru Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Ostarine (enobosarm)
    3ms
    PLATEAU: Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, Veru Inc.
    New P2 trial
    |
    Ostarine (enobosarm)
    9ms
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=168, Completed, Veru Inc. | Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Aug 2025 | Trial primary completion date: Dec 2024 --> Apr 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Ostarine (enobosarm)
    almost2years
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=150, Active, not recruiting, Veru Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Ostarine (enobosarm)
    almost2years
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=150, Recruiting, Veru Inc. | N=90 --> 150
    Enrollment change
    |
    Ostarine (enobosarm)
    2years
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=90, Recruiting, Veru Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Ostarine (enobosarm)
    over2years
    Phase II Study of GTx024 in Women With Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=22, Terminated, GTx | Completed --> Terminated
    Trial termination • Metastases
    |
    ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • AR positive
    |
    Ostarine (enobosarm)
    over2years
    Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Veru Inc.
    New P2 trial
    |
    Ostarine (enobosarm)
    over2years
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=5, Terminated, Veru Inc. | N=186 --> 5
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Ostarine (enobosarm)
    over2years
    Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=18, Completed, City of Hope Medical Center | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    HER-2 negative • AR positive • ER expression • PGR expression
    |
    Keytruda (pembrolizumab) • Ostarine (enobosarm)
    over2years
    Activity and safety of enobosarm, a novel, oral, selective androgen receptor modulator, in androgen receptor-positive, oestrogen receptor-positive, and HER2-negative advanced breast cancer (Study G200802): a randomised, open-label, multicentre, multinational, parallel design, phase 2 trial. (PubMed, Lancet Oncol)
    Enobosarm has anti-tumour activity in patients with ER-positive, HER2-negative advanced breast cancer, showing that AR activation can result in clinical benefit, supporting further clinical investigation of selective AR activation strategies for the treatment of AR-positive, ER-positive, HER2-negative advanced breast cancer.
    P2 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • AR positive • ER positive + HER-2 negative
    |
    Ostarine (enobosarm)