Veru is a biopharmaceutical company focused on urology and oncology. Veru utilizes FDA’s 505(b)(2) regulatory approval pathway to develop and commercialize drug candidates.

FDA’s 505(b)(2) regulatory approval pathway is designed to allow for potentially expedited regulatory approval based on a previously established safety and efficacy profile of the product. Veru is developing products under the 505(b)(1) pathway as well, which is the traditional new drug application (NDA) pathway. The company is currently developing drug product candidates for benign prostatic hyperplasia (BPH or enlarged prostate), hot flashes associated with prostate cancer hormone treatment, male infertility and novel oral chemotherapy (alpha & beta tubulin inhibitor) for a variety of malignancies, including metastatic prostate, breast and ovarian cancers.



Tamsulosin DRS (tamsulosin HCL extended release for oral suspension), is a proprietary slow release powder-like formulation used for the treatment of enlargement of the prostate…


VERU-944 is an oral drug being developed for the treatment of hot flashes in men caused by prostate cancer hormone therapies.  Hot flashes, also known as vasomotor symptoms…


VERU-111 is a novel oral chemotherapy that targets tubulin for metastatic prostate cancer as well as for other forms of metastatic cancers.


VERU-722 is being developed as the first FDA-approved oral agent for the treatment of male infertility associated with low testosterone.  VERU-722 is a patented, proprietary daily oral…


VERU-112 is a new chemical entity oral drug being developed for treatment of prevention and treatment of gout and Familial Mediterranean Fever.