VERU
further on pipeline
Oncology program:
The Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin.
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), and which has been granted Fast Track designation by the FDA.
Enrolling 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). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly is supplying Verzenio® (abemaciclib).
Planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR < 40% expression (third-line metastatic setting).
Veru’s late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.
Current studies on these drugs include:
Enrolling Phase 3 VERACITY study 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 to treat hot flashes in men with advanced prostate cancer undergoing androgen deprivation therapy.
Commercial sexual health program, Urev, has 2 FDA approved products:
ENTADFI™ (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia.
FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally. |
