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A new drug candidate goes through a long research, development and approval process before it lands on the physician's shelf. The overall process is divided into research and development, and the development process is further divided into preclinical stage, phase I, phase II, and phase III. Y's Therapeutics focuses its resources on preclinical to early-stage clinical studies (phase I&II), and seeks collaborative relationships, including out-licensing of product rights and creation of joint ventures, for late-stage development.


Research
The objective of research is to find a possible candidate compound to cure a certain disease with unmet medical needs. The process starts with determining how the disease is caused, and identifying a lead compound that works in curing the disease. The lead compound is then validated and optimized (altered to increase potential efficacy and safety) to choose the best drug candidate for further development.

Preclinical Study
The objective of preclinical study is to check the safety and efficacy of the drug candidate through various laboratory tests and animal tests. Studies to explore the pharmacological action against the target, testing toxicity to determine whether it is safe for humans, and analyzing the stability and pharmacokinetics are all parts of the preclinical study. After conducting these tests and with conviction for further development, an IND (Investigational New Drug) will be filed with the drug administration to start testing the drug candidate with humans.

Clinical Study : Phase I
The objective of phase I clinical study is to test the tolerance of this new drug candidate with humans at various dosages, and studying its absorption, metabolism, and distribution patterns. This test normally involves a minimal number of healthy volunteers to determine the safety profile of the drug candidate. Anti-cancer agents are tested with patient volunteers at this stage.

Clinical Study : Phase II
The objective of phase II clinical study is to test the drug candidate's safety and efficacy with patients with the target disease. The value of the drug candidate gets relatively high when the effectiveness of it is proved through this test (Proof of Concept: PoC). A relatively small number of patient volunteers are enrolled in this clinical trial.

Clinical Study : Phase III
The objective of phase III clinical study is to test the drug candidate with a larger patient population to identify the precise safety and efficacy, and the best way to apply it in real use. If the drug candidate is approved, it will be labeled using data collected from this study. The drug candidate has to be proved superior in some way compared to existing approved drugs. Following the completion of all three clinical studies, the NDA (New Drug Application) will be filed with the drug administration for review and approval.