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Researchers have administered doses hundreds of times higher than typical human protocols without observing toxic effects

It appears to help treat Crohns and Ulcerative Colitis in animal studies

FDA subsequently concluded that evidence supporting TB-500 itself for wound healing remained insufficient

It is not yet FDA-approved to treat hair loss because it was originally developed to treat fungus and yeast infections, and now that the drug has become available widely (and cheaply), there is little money to be made from a new FDA clearance (something that is very expensive to obtain)