RU58841 Made it into Phase II clinical studies, Results Here

[Bryan]

With Glaxosmsmith pushing Dutasterid into the marked (is it phase III already??) Any topical solution (unless it's OTC and/or REALLY cheap) would need REMARKABLE results to take a stand in a marked where finasteride 1mg soon loses its patent (prices will drop), and dutasteride soon hits the shelves.

Glaxo isn't pushing dutasteride into the market -- at least, not in the USA. They've stated clearly and unequivocally that they're not going for FDA approval of dutasteride as an anti-male pattern baldness treatment.

 

[Bryan]

Bryan, ''Where on earth'' did you get the idea that Glaxo was not seeking FDA approval for Dutasteride as a treatment for Androgenetic Alopecia?

I got it from Glaxo. They announced sometime around the time that Avodart first became available that they had decided not to pursue an indication for it for the treatment of male pattern baldness! You're not even aware of that?? This is something that's been discussed on all the hairloss sites ever since.

Glaxo has submitted Dutasteride for a clinical trial for androgenetic alopecia treatment, the trial started in 2010 and is ongoing. currently Dutasteride is being clinically tested VS. Finasteride VS. Placebo, to evaluate its safety and efficacy, as a treatment for Androgenetic Alopecia. If the clinical trial is successfull, it may become available as a prescription treatment for AA.

Yes, but very likely not in the USA! Haven't you noticed that an earlier trial (from a year or two ago) that's been discussed on hairloss sites was done in Korea, and this new one you're talking about is being done in South American countries like Argentina, Chile, and Peru, and also Japan, Taiwan, the Philippines, and Thailand? It seems obvious to me that Glaxo is doing these foreign trials just for the purpose of getting doctors everywhere (maybe even the USA) to use it off-label for treating male pattern baldness. I've never seen any indication in all these years that Glaxo has ever changed their minds about not getting FDA approval for it for that specific purpose.

 

[Bryan]

You have not? The current clinical trial clearly states that the purpose of the trial, is to evaluate the safety and efficacy of Dutasteride as a treatment for Androgenetic Alopecia.

Yes. To get doctors to prescribe it off-label. Considering the amount of $$$ it takes to get FDA approval for anything (even a new indication for an established drug), it seems like a reasonable strategy on the part of Glaxo.

I am aware of Glaxo's original stance, but it's clear that they have changed their point of view. I seriously doubt that they would go to the trouble and exspense of seeking approval from a clinical trial, if they were not intending to market it as a treatment for Andogenetic Alopecia. It simply would not be worth it, merely to increase off lable use.

I'll believe that ONLY if they officially announce their intention to do it, or if some credible "inside" source claims it to be true. Otherwise, I'm not going to put any faith in the simple fact that Glaxo has decided to do a couple foreign studies of dutasteride for male pattern baldness.

 

[Ende]

It seems like I prepared a solution with less than 50 mg a day with the broken scale, because 50 mg a day with the new scale gave me worse side effects.

I believe that the 5% solution was 25 mg.

 

[Bryan]

Only time will tell, but I would put my money on them bringing it to market, within the next 4-10 years...

Don't put TOO much of your money on it. Don't bet the farm on it!

 

[Bryan]

I think their only "market strategy" is to get doctors (American doctors, anyway) to prescribe it off-label. Time will tell if that assumption is correct.

 

[Todd]

I think their only "market strategy" is to get doctors (American doctors, anyway) to prescribe it off-label. Time will tell if that assumption is correct.

IMO that would be a brilliant marked strategy; seing as their results would be better than finasteride, but since it's prescribed off- label no new patent or FDA approval has to be made. This way, in the eventuality of any lasting side- effects, or teratogenecity, the responsibility would lie with the doctor and not the company.

But, this is probably just a short term strategy; if the phase 3 results are good, it would be stupid not to marked dutasteride as a hair- loss drug; seing as it's effect apparently is greater than finasteride.

(Either that or they will "pull a Merck"- different dose, same compound, new patent= MONEY)

 

[captain_que]

Could we keep this thread with RU...? What are the chances of any stable compound with RU in it being produced any time soon...?

 

[Ende]

Could we keep this thread with RU...? What are the chances of any stable compound with RU in it being produced any time soon...?

Prostrakan, who owns the patent, hasn't been working with PSK3841 (RU58841) for a long time. Who knows what happens if they discover how valuable it really is. I don't think they're aware of the problems related to Propecia, and how many who gets affected by sexual side effects and quit treatment in fear of PFS, and how many who are reluctant to use Propecia because of the risk. PSK3841 would probably replace Rogaine and Propecia. The drug is similar to CB-03-01, which is at least 4 years away. Prostrakan could probably own the market by then.

Rapid degradation hasn't been proved; it's just a roumor.

 

[blaze]

Could we keep this thread with RU...? What are the chances of any stable compound with RU in it being produced any time soon...?

Prostrakan, who owns the patent, hasn't been working with PSK3841 (RU58841) for a long time. Who knows what happens if they discover how valuable it really is. I don't think they're aware of the problems related to Propecia, and how many who gets affected by sexual side effects and quit treatment in fear of PFS, and how many who are reluctant to use Propecia because of the risk. PSK3841 would probably replace Rogaine and Propecia. The drug is similar to CB-03-01, which is at least 4 years away. Prostrakan could probably own the market by then.

Rapid degradation hasn't been proved; it's just a roumor.

Rapid degradation? What exactly do you mean?

Are you referring to the half life of RU in the body being short and it rapidly degradating?

 

[Ende]

That the drug is only active for so long, once it's mixed in a solution.

 

[blaze]

AHH OK.

 

[thinincrown]

As many of you know RU58841 was developed in France by Dr. Sewaya of the Roussel Uclaf Corporation.

Where on earth did you get the idea that T. Battmann (AKA Bruce Wayne) and his colleagues (AKA Robin & Batgirl) did?

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cracking me up w/ that one finasteride ....