505(b)(2) NDAs
GenZen is primarily focused on developing 505(b)(2) new drug applications, a regulatory pathway that allows for the development of value-added medicines by relying in part on existing safety and efficacy data. This pathway enables GenZen to:
Improve existing therapies
(e.g., through new dosage forms or delivery methods)
Address new patient populations or indications
Streamline development timelines and reduce cost and risk
505(b)(2) development is central to GenZen’s mission to provide differentiated, clinically meaningful therapies while maintaining a capital-efficient model.