Development

Development sees the drug candidate enter clinical testing in humans. This usually takes five to seven years to complete and has several phases:

Phase I

The safety and tolerability of the drug is assessed. The drug is tested in healthy human volunteers, starting at a very low dose which is eventually increased to a dose expected to be effective in patients.

Phase II

The dosing and safety of the drug are investigated. The drug is tested in a small number of patients and the effect on the target disease is evaluated.

Phase III

Drug efficacy and safety are investigated in statistically robust, unbiased studies which usually include several hundred patients in several countries.

Following a successful outcome of phase III studies, the drug may obtain a marketing authorisation.

In all phases, we investigate the effects of the drug and how it interacts with normal physiological processes. We build knowledge on how the drug is absorbed, distributed, metabolised and excreted by the body. This is valuable data for documenting the clinical efficacy and safety.