What are your thoughts on enclomiphene without TRT and do you see it gaining FDA approval anytime soon?

This is very similar to another question so I will copy/paste that answer.

The SERM (clomiphene or enclomiphene) and TRT combo is still experimental and not proven science. The hCG plus TRT is proven and the gold standard for men on TRT who want to maintain fertility.While the there is logic to the theory behind why a SERM like Clomid might work while concurrently on TRT, we have no good studies proving that.

We do know that clomiphene and enclomiphene both have a higher side effect profile than hCG. We also know the both clomiphene and enclomiphene cause shutdown of the body’s production of IGF-1, a hormone which has greater benefit for muscle growth and fat loss than even testosterone.

Basically, our thought is hCG is proven to use while on TRT, and is available with lower side effects. We know some doctors have had trouble sourcing it from reputable FDA approved pharmacies, prompting them to instead prescribe Clomid, though all of AlphaMD’s partnered pharmacies have it available in all states.

So, typically when there is a proven alternative with fewer side effects, newer drugs are not given FDA approval. Since hCG is approved already, and because enclomiphene is still not proven safer or more effective than clomiphene (which is not approved for the purposes of hypogonadism), I doubt enclomiphene meets the stringent criteria to gain FDA approval.

I think there are applications where it can be beneficial without TRT. It is way cheaper than hCG which is a good alternative and more tested. I don't think there will be FDA approval in this application.

Keep in mind FDA approval isn't applicable to many medications used for various reasons. One example is benadryl/diphenhydramine is FDA approved as antihistamine for allergic reactions, but not approved as a sleep aid when it is commonly sold as a sleep aid.