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Assessing Male Reproductive Toxicity during Drug Development

Mario Sousa, Carolina Ferreira, Ana Rabaca and Rosália Sa

Pharmaceutical development is a crucial research field that attends to the population healthcare needs, comprising several preclinical and clinical steps before the approval of a new compound. Interestingly, the lack of efficacy and toxicity are known major failure causes during pharmaceutical drug development. Toxicity screening is therefore a mandatory procedure during pharmaceutical development. Renal and hepatic toxicity are the most common toxicity matters encountered during the development of new compounds. Nonetheless, the male reproductive system may also be a target for drug toxicity. However, developmental and reproductive toxicology testing is rarely performed both in pre-clinical and clinical trial phases. As a result, there are several risks for human fertility brought on by putative toxic chemical compounds. As there is a low incidence of reproductive and testicular toxicity (TT) found at the early stages of pharmaceutical development, several companies devote the majority of research investments to more frequent areas of occurrence. Such prioritization has resulted in scarce rigorous efforts aimed at improving detection methods to understand the causes of TT. Pharmaceutical companies should include comprehensive studies and more precise methods for TT evaluation when developing new pharmacological drugs, and should focus on the effects of the new chemical compound on male’s reproductive functions.