zuclomiphene (VERU-944) / Veru Inc - LARVOL DELTA

Comparison between Amorphous States of the Trans/Cis Isomers of Clomiphene: Similarities and Differences. (PubMed, Mol Pharm) - "Zuclomiphene notably presents more dynamic heterogeneities than its trans counterpart, resulting in drastic differences in secondary and primary relaxations. So far, this study revealed subtle differences between amorphous pairs of trans/cis diastereomers, in contrast to similarities previously observed between pairs of enantiomers."

Journal

Genetic Polymorphisms of Cytochrome P450 2D6 (CYP2D6) Are Associated with Hormonal and Spermatogenic Responses to Enclomiphene Therapy in Infertile Men (AUA 2025) - "INTRODUCTION AND OBJECTIVE: Clomiphene citrate is a mixture of two isomers, zuclomiphene and enclomiphene...Men taking strong CYP2D6 inhibitors (e.g. bupropion, sertraline, fluoxetine) were classified as poor metabolizers... Infertile men who are poor metabolizers or take strong CYP2D6 inhibitors exhibit greater improvements in gonadotropins and sperm concentration when given enclomiphene therapy. This suggests that decreased clearance of enclomiphene in poor metabolizers leads to prolonged drug circulation and enhanced effects."

Infertility

A phase II, dose finding, placebo-controlled, study of zuclomiphene citrate to amerliorate the frequency and severity of hot flashes caused by androgen deprivation in men with advanced prostate cancer. (ASCO-GU 2019) - P2; "Hot flashes are being measured in real time utilizing an electronic data capture device (ePRO) provided to each subject. We anticipate completion of enrollment by the end of 2018 with study results by second quarter of 2019."

Clinical • P2 data

Experimental verification and validation of immune biomarkers based on chromatin regulators in ischemic stroke. (PubMed, Front Genet) - "Molecular docking simulations revealed that mevastatin, WP1066, cladribine, trichostatin A, mequitazine, and zuclomiphene may be potential immunomodulatory drugs for IS. Overall, the results of this study contribute to the identification of CR-related immune therapeutics target in IS and provide an important reference for further research."

Biomarker • Journal • Cardiovascular • Immune Modulation • Inflammation • Ischemic stroke • JAK2 • MLLT3

Veru Announces the Presentation of Updated Data from the Phase 1b/2 Sabizabulin Study in Men with Metastatic Castration Resistant Prostate Cancer at the 2022 ASCO Genitourinary Cancers Symposium (GlobeNewswire) - "Current studies on the two drugs include...Enrolling Phase 3 ARTEST study of enobosarm in androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer with AR ≥ 40% expression (third-line metastatic setting); Planned Q1 2022 Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer with AR ≥ 40% expression (second-line metastatic setting); Planned Q1 2022 Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR < 40% expression (third-line metastatic setting); Enrolling Phase 3 VERACITY in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy; Enrolling Phase 2 dose-finding study of VERU-100 in advanced hormone-sensitive prostate cancer; Planned Phase 2b study of zuclomiphene citrate in men with advanced prostate cancer..."

New P3 trial • Trial status • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • HER2 Negative Breast Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase II, dose finding, placebo-controlled, study of zuclomiphene citrate to amerliorate the frequency and severity of hot flashes caused by androgen deprivation in men with advanced prostate cancer. (ASCO-GU 2019) - P2; "Hot flashes are being measured in real time utilizing an electronic data capture device (ePRO) provided to each subject. We anticipate completion of enrollment by the end of 2018 with study results by second quarter of 2019."

Clinical • P2 data

Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=93; Completed; Sponsor: Veru Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=120; Active, not recruiting; Sponsor: Veru Inc.; Trial primary completion date: Jun 2020 ➔ Feb 2020

Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Enclomiphene citrate: A treatment that maintains fertility in men with secondary hypogonadism. (PubMed, Expert Rev Endocrinol Metab) - "Initial studies demonstrated that enclomiphene maintains the androgenic benefit of clomiphene citrate without the undesirable effects attributable to zuclomiphene. This article reviews the difficulties associated with the FDA approval of a new molecular entity related to the treatment of hypogonadism."

Journal

Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=120; Active, not recruiting; Sponsor: Veru Inc.; Trial completion date: Apr 2020 ➔ Jul 2020

Clinical • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Veru continues strong positive sales momentum in fiscal 2020 first quarter; net revenues increase 66%, gross profit up 57% (GlobeNewswire, Veru Healthcare) - "Completion of VERU-111 Phase 1b Clinical Trial and Initiation of Phase 2 Prostate Cancer Clinical Trial in Q2 FY 2020; Zuclomiphene Expected to Enter Pivotal Phase 3 Clinical Trial for Treating Hot Flashes in Men with Prostate Cancer on ADT Following Planned Meeting with FDA."

New P2 trial • New P3 trial • Trial completion date

Veru says drug reduces hot flashes in men in mid-stage study (SeekingAlpha) - P2, N=120; NCT03646162; Sponsor: Veru Inc; "Veru Inc...says a higher dose of its experimental drug zuclomiphene citrate reduced hot flashes in men with advanced prostate cancer after six weeks of treatment, according to a mid-stage study...Patients taking a 50 mg dosage of the oral treatment had reduced hot flashes after six weeks compared to placebo and the 10 mg dosage, with no serious side effects, the company says....Veru expects to begin a late-stage trial for the drug in H1 2020"

New trial • P2 data

Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Veru Inc.; Active, not recruiting ➔ Recruiting; Trial completion date: Feb 2020 ➔ Jul 2020; Trial primary completion date: Feb 2020 ➔ Jul 2020

Clinical • Enrollment open • Trial completion date • Trial primary completion date

Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=120; Active, not recruiting; Sponsor: Veru Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Veru Inc.; Trial completion date: Sep 2019 ➔ Feb 2020; Trial primary completion date: Jul 2019 ➔ Feb 2020

Clinical • Trial completion date • Trial primary completion date

Veru Reports Strong Fiscal 2019 Second-Quarter Financial Results (GlobeNewswire, Veru Healthcare) - VERU-111: Our oral, next-generation, first-in-class, alpha and beta antitubulin is being evaluated in men who have metastatic prostate cancer and whose disease is resistant to both castration and novel androgen blocking agents (abiraterone or enzalutamide)….The open label Phase 2 clinical study is expected to commence in the Fall of 2019. Oral drugs for advanced prostate cancer, abiraterone and enzalutamide, had over $3 billion in U.S. annual sales in 2018 and $6 billion in 2018 global revenue’ Zuclomiphene Citrate: Enrollment of approximately 100 men in the Phase 2 clinical trial is progressing in approximately 17 clinical sites in the US. Top line results of the study are expected Summer 2019.

Clinical • Clinical data • Commercial

A phase 2, dose finding, placebo-controlled, study of zuclomiphene citrate to alleviate the frequency and severity of hot flashes caused by androgen deprivation in men with advanced prostate cancer (EAU 2019) - No abstract available.

Clinical • P2 data

Veru Announces acceptance of four abstracts for presentation at the Genitourinary Cancer Symposium in February 2019 (GlobeNewswire) - "Three of the presentations will be for VERU-111...for the treatment of advanced prostate cancer which is enrolling in a Phase1b/2 clinical study, and the fourth presentation will be for zuclomiphene citrate (VERU-944), a proprietary oral estrogen receptor agonist drug for the treatment of hot flashes caused by androgen deprivation therapy (ADT) for men with advanced prostate cancer which is currently enrolling in a Phase 2 clinical trial."

P1/2 data • P2 data