5-7 years to start human trials IF FDA lets them! Grab a chair this is going to take awhile..
The pace of research is slow because a treatment that may be effective in a mouse model can't move directly to a human clinical trial.
On average, preclinical research takes five to seven years and costs several million dollars to complete, according to FasterCures (a nonprofit organization dedicated to increasing the speed of drug discovery across all therapeutic areas). Once this work is done, the drug developer can apply to the FDA for approval to start clinical trials by submitting an investigational new drug application (IND). If the IND is approved, the developer is cleared to start clinical trials.
These trials take another five to seven years to complete (and many more millions of dollars), before the developer can ask the FDA for approval to bring a drug to market.
On average, it takes a drug about 12 years to get from discovery to market, and it costs about $1.8 billion per drug that works. Only about one drug in 10,000 actually makes it. However, due to the rigorous processes of preclinical research, about one in five drugs that get an IND eventually make it through trials.
A lot of work goes into the time between discovering that a drug works in a mouse and testing that drug in a clinical trial. This is not “lost” time. It is time spent ensuring that the drug has the best possible chance of having an effect on the disease and the lowest possible chance of causing harm. This work is termed “preclinical research,” and it encompasses an array of steps. Even the most efficient and lucky of drug developers take a minimum of two years to get through this process.
Although frustrating, these steps are necessary to getting a safe and effective drug to patients. The developers must do toxicology studies to show the U.S. Food and Drug Administration (FDA) that the drug is relatively safe; they must show that the drug is likely to be effective; and they must determine how to administer the drug and how much to give.
Furthermore, curing a mouse is not the same thing as curing a person. Animal models of a disease are just that — models. For example, the SOD1 mouse for amyotrophic lateral sclerosis (ALS) is a good model of one inherited form of ALS. But it’s unclear how well the SOD1 mouse mimics the more-common uninherited (sporadic) form of ALS, making it quite possible that a treatment that works in the SOD1 mouse will not work in those with sporadic ALS.
