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    DRUG CLASS:

    Selective androgen receptor modulator

    Related drugs:
    5ms
    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)
    12ms
    Phase 1/2 Study to Evaluate Vosilasarm (EP0062) as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer (clinicaltrials.gov)
    P1/2, N=60, Recruiting, Ellipses Pharma | N=128 --> 60 | Trial completion date: Mar 2025 --> Nov 2026 | Trial primary completion date: Dec 2024 --> Nov 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    everolimus • Orserdu (elacestrant) • vosilasarm (EP0062)
    1year
    Delayed Mandibular Hematoma Following Selective Androgen Receptor Modulator (SARM) Usage. (PubMed, J Craniofac Surg)
    This case presents a delayed hematoma following treatment for maxillary hypoplasia. Our findings indicate that the patients' usage of SARMs is responsible for the postoperative complications.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    over1year
    Polypharmacological profiling across protein target families and cellular pathways using the multiplexed cell-based assay platform safetyProfiler reveals efficacy, potency and side effects of drugs. (PubMed, Biomed Pharmacother)
    For example, the neuroleptics clozapine, paliperidone, and risperidone potently inhibited primary targets DRD2 and HTR2A as well as cAMP and calcium pathways...Additionally, precise potency data for LY2452473, an androgen receptor antagonist, that completed a phase 2 clinical trial for prostate cancer, are presented. The non-selective kinase inhibitor staurosporine was observed to potently inactivate the two RTKs EGFR and ERBB4 as well as MAPK signaling, while eliciting stress-related cAMP responses. Our findings underscore the value of comprehensive profiling in elucidating the pharmacological properties of established and novel therapeutics, thereby facilitating the development of novel multi-target drugs with enhanced efficacy and selectivity.
    Journal • Adverse events
    |
    EGFR (Epidermal growth factor receptor) • ERBB4 (erb-b2 receptor tyrosine kinase 4) • DRD2 (Dopamine Receptor D2) • HTR2A (5-Hydroxytryptamine Receptor 2A)
    |
    OPK 88004
    over1year
    Identification of biomarkers of response and the mechanism of action of a selective androgen receptor modulator in estrogen receptor-positive breast cancer patient-derived xenografts (EORTC-NCI-AACR 2024)
    Adding the CDK4/6 inhibitor palbociclib enhanced the antitumor activity of EP0062 or fulvestrant in ESR1-mutant models but not in HER2-enriched or PTEN-mutant PDX models...EP0062 triggers an E2F1 downmodulation which mediates a potent antiproliferative activity. For EP0062-resistant tumors that remain ER-driven, the addition of palbociclib displays a potent antitumor effect.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AR (Androgen receptor) • FOXA1 (Forkhead Box A1) • HDAC2 (Histone deacetylase 2) • GATA3 (GATA binding protein 3) • E2F1 (E2F transcription factor 1)
    |
    ER positive • PIK3CA mutation • PTEN mutation • ESR1 mutation • AR expression • ER expression • GATA3 mutation
    |
    MSK-IMPACT
    |
    Ibrance (palbociclib) • fulvestrant • vosilasarm (EP0062) • Undisclosed CDK4/6 inhibitor
    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)
    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, Recruiting, Veru Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Ostarine (enobosarm)
    almost2years
    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)