Veru Inc. is an oncology and urology biopharmaceutical company developing novel specialty pharmaceuticals and medicines for the prostate cancer continuum of care. The Veru pipeline includes zuclomiphene citrate (also known as VERU-944, cis-clomiphene) ,VERU-111 (bisindole), and Veru 100. Zuclomiphene citrate is an estrogen receptor agonist being evaluated in a Phase 2 trial to treat hot flashes, a common side effect caused by hormone treatment for men with advanced prostate cancer. VERU-111 is an oral, next-generation, first-in-class selective small molecule that targets and disrupts alpha and beta subunits of microtubules in cells to treat metastatic prostate cancer patients whose disease is resistant to both castration and novel androgen blocking agent therapies. Veru 100 is a 3 month GnRH antagonist administered via small volume subcutaneous injection. The company is also advancing 505 (b)(2) products in its speciality pharmaceutical line. The first product, a combination tablet of Tadalafil and Finasteride (Tad-Fin combination tablet) met FDA requirements for both bioavailability and bioequivalence with an NDA submission scheduled in 2020.