Pharma-Grade Enclomiphene now available

[Marco N Cognito]

For those interested, the struggle to find a U.S-based pharma grade supplier is now over. Tailor Made Compounding Pharmacy now offers it and licensed physicians can prescribe it: Box

If anyone is already using it, please give us details, specifically, if it is nothing more than clomiphene (Clomid) minus the zuclomiphene (the estrogenic isomer) or if it actually produces results comparable to frank TRT.

 

[txmx]

Anyone with Defy using Enclomiphene?

 

[seppuku]

For those interested, the struggle to find a U.S-based pharma grade supplier is now over. Tailor Made Compounding Pharmacy now offers it and licensed physicians can prescribe it: Box

If anyone is already using it, please give us details, specifically, if it is nothing more than clomiphene (Clomid) minus the zuclomiphene (the estrogenic isomer) or if it actually produces results comparable to frank TRT.

The picture in the link you posted says "Enclomiphene, aromatase inhibitor" - surely that's not right, it's a serm like regular clomid isn't it?

 

[txmx]

Good catch, seppuku. I guess the pharmacy tech writer doesn't understand how a SERM works vs an AI, since they talk SERM in the text description.
If enclomiphene were to actually work as we all wished it would be a TRT game-changer.

 

[Cataceous]

Anyone with Defy using Enclomiphene?

I've asked if they're willing to prescribe it and am waiting for an answer.

 

[Dr Justin Saya MD]

I've asked if they're willing to prescribe it and am waiting for an answer.

Unfortunately no. As we know it is going through the arduous FDA approval process, but Repros has rights to it. Anyone dispensing (or less likely prescribing) could end up with liability if Repros and/or the FDA discovers.

 

[Dr Justin Saya MD]

Of note Repros is now a subsidiary of Allergan.

 

[txmx]

Is Allergan/Repros even actively pursuing FDA approval of Enclomiphene on a current basis anymore, or are they letting it quietly die? I know Repros ended up selling out for a pittance, generating shareholder lawsuits in the process.
Maybe instead of pursuing FDA approval, they sit back and let unauthorized distribution occur, just to see if Enclomiphene is a real product with real benefits. If so, they swoop in and sue, if not, they have saved their FDA approval time and resources?

 

[Cataceous]

I just got off the phone with Blake at Tailor Made Compounding. He insists that their enclomifene offering is legal and above-board. He also says they just had a thorough FDA inspection less than two months ago. I wouldn't say that he totally clarified why they don't run afoul of Repros, but one possible explanation is that the Repros patents involve claims of treatment for specific conditions, which they are not making. In any case, as the OP said, if your doctor will prescribe it then you can now obtain pharmaceutical-grade enclomifene.

 

[Cataceous]

Unfortunately no. As we know it is going through the arduous FDA approval process, but Repros has rights to it. Anyone dispensing (or less likely prescribing) could end up with liability if Repros and/or the FDA discovers.

I'm trying to understand what distinctions there are between enclomifene and something like ipamorelin. Helsinn Therapeutics holds various patents to ipamorelin uses, which seem analogous to the ones Repros holds on enclomifene. Helsinn Therapeutics got through a phase II clinical trial, and Repros got hung up at the phase III stage.

 

[ghce]

Unfortunately no. As we know it is going through the arduous FDA approval process, but Repros has rights to it. Anyone dispensing (or less likely prescribing) could end up with liability if Repros and/or the FDA discovers.

I thought that the FDA process had been abandoned? is it really still actively being processed?

 

[Dr Justin Saya MD]

Drug rights with or without FDA approval is a complex legal arena. Anyhow, the pharmacy assumes most liability when it comes to drug rights, whereas prescribing practitioner assumes liability for any adverse reactions (particularly without FDA approval).

I’m having my team look into the supplier of the raw ingredients they are sourcing for the enclomiphene. This is important to know.

 

[ghce]

I will be interested to see as currently I am on Clomid but upping my dose is a little difficult as the estrogenic effects kick in pretty quickly when I try doubling my dose.

 

[Marco N Cognito]

Drug rights with or without FDA approval is a complex legal arena. Anyhow, the pharmacy assumes most liability when it comes to drug rights, whereas prescribing practitioner assumes liability for any adverse reactions (particularly without FDA approval).

I’m having my team look into the supplier of the raw ingredients they are sourcing for the enclomiphene. This is important to know.

Any updates on this yet on your end? Regardless of the availability/sourcing issues, my main concern would be whether we can assume that enclomiphene is essentially nothing more than clomiphene minus the zuclomiphene - - or if it will actually produce the subjective benefits comparable to frank TRT. My sense is it won't. Peak Testosterone's Lee Myer piece seems to sum it up well: Testosterone Therapy and Androxal
Thoughts?

 

[Cataceous]

... my main concern would be whether we can assume that enclomiphene is essentially nothing more than clomiphene minus the zuclomiphene ...

I think this is significant on its own, given that zuclomiphene may be preventing a decent fraction of guys from using Clomid. When I read how suppressive zuclomiphene is it's almost surprising that Clomid works at all: "... zuclomifene is antigonadotropic due to activation of the ER and is able to reduce testosterone levels in men to near-castrate levels."[1] And that's without even getting into its much longer half-life.

Additionally, there are some reports of guys successfully using Clomid with TRT, thus not needing hCG. Pure enclomiphene might be even better for this job.

 

[Dr Justin Saya MD]

Any updates on this yet on your end? Regardless of the availability/sourcing issues, my main concern would be whether we can assume that enclomiphene is essentially nothing more than clomiphene minus the zuclomiphene - - or if it will actually produce the subjective benefits comparable to frank TRT. My sense is it won't. Peak Testosterone's Lee Myer piece seems to sum it up well: Testosterone Therapy and Androxal
Thoughts?

Sourced from Australia, but specifics beyond that were not disclosed to my team.

 

[Marco N Cognito]

Doing a trial of enclomiphene first and running labs every month or so might be the best way to evaluate before giving up and jumping over to TRT. Thoughts?

 

[txmx]

I suspect several of us who respond/responded well to low-dose clomiphene, at least numbers-wise if not subjectively, would like to give enclomiphene a try.

 

[ghce]

I suspect several of us who respond/responded well to low-dose clomiphene, at least numbers-wise if not subjectively, would like to give enclomiphene a try.

Absolutely

 

[Cataceous]

... prescribing practitioner assumes liability for any adverse reactions (particularly without FDA approval).
...

On this point, it's hard to envision someone arguing successfully that he was harmed by enclomiphene, but would not have been harmed by Clomid.