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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, Androgen receptor modulator
    Related drugs:
    3ms
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    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=90, Not yet recruiting, Veru Inc.
    New P2 trial
    |
    Ostarine (enobosarm)
    almost2years
    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)
    almost2years
    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)
    almost2years
    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)
    almost2years
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Suspended, Veru Inc. | Trial completion date: Jan 2024 --> Dec 2025 | Trial primary completion date: Jan 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    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)
    almost2years
    ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=52, Terminated, Veru Inc. | N=210 --> 52 | Active, not recruiting --> Terminated; Business decision
    Enrollment change • Trial termination • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
    |
    ER positive • HER-2 negative • AR positive
    |
    everolimus • exemestane • Ostarine (enobosarm)
    almost2years
    ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=186, Suspended, Veru Inc. | Active, not recruiting --> Suspended | Trial primary completion date: Sep 2023 --> Jan 2024
    Trial suspension • Trial primary completion date • Metastases
    |
    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)