Hi Zahra,
I will attempt to answer this question.
To investigate if a currently approved drug can be effective against another disease, one will need to conduct human clinical trials to look at the effects of that drug specifically in the new disease patient population and compare it against gold-standard if available.
And to get the approval to conduct the clinical trial, pre-clinical evidence will be required, and often they come from animal studies.
So the answer is yes, animal studies using models specific to the new disease need to be carried out.
Hope that helps.
Degeneration is such a broad term - can you be more specific ? In the field of adult neuroscience, neurodegeneration can relate to Alzheimers, Huntingtons and Parkinson's (and MANY more!) so we appreciate that it would still be necessary to repeat animal studies to prove efficacy against the mechanism leading to the neurodegeneration.
If the degenerative disorder occurs in a similar patient population (both adults, similar age etc), then you would likely NOT have to do phase 1 safety trials if this has already been well established. However, the use of drugs "Off-Label" is rampant and drugs are being repurposed in new populations everyday by clinicians. This has ethical (and legal) implications though and these should be carefully considered.
I think it depends on what you want to test with your drug. As Bobby said, neurodegeneration is a broad concept, so you need to foucus in a specific desease, because in my opinion the related deseases have many mechanisms in common but many others which have particular biomarkers and specifics targets. If you want to try your durg in other desease, you will have to test this drug again, in better animal models, which be abble to support the new clinical trial.
Yes, you need to validate the effectiveness of your drug in that specific disease. Nevertheless, when going into clinical trials, repurposing of an "old" drug may allow you to speed up the process of getting onto phase II and III.
Yes, you need to validate the effectiveness of your drug in that specific disease. Nevertheless, when going into clinical trials, repurposing of an "old" drug may allow you to speed up the process of getting onto phase II and III.
Thank you for your answers ,i saw the clinical trial on such a drug (in clinicaltrials.gov ) without any animal study, while i could not find any animal study in literature,how it can be possible ?
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