P-3074 (polichem Topical Finasteride) Phase Iii Just Ended.

[BalderBaldyBald]

Can you link a source for that ? When i checked i read that 5ar2s are located in the prostate and the skin , which makes sense to me because 5ar2 deficient people have no male pattern baldness ,no body hair/beard and a micropenis , if 5ar2 was expressed everywhere i guess they would have bigger issues

My Bad, you're right, brain tissue don't have type 2

I will also find the paper talking about androgen deprivation on eyes' lacrimal gland, causing dry eyes and eye fatigue, and in the end potentially irrecoverable damages to it

Edit : They recently discovered a type 3, point is, more androgens interaction are still to be discovered

 

[BalderBaldyBald]

That's one example

Androgen support of lacrimal gland function.
https://www.ncbi.nlm.nih.gov/pubmed/9225114

 

[Btg]

That's one example

Androgen support of lacrimal gland function.
https://www.ncbi.nlm.nih.gov/pubmed/9225114

well whatever the case i believe that topical inhibition in the scalp would not result in side effects ,oral use however does

 

[abcdefg]

These are graphs about oral , also the scalp 5ars probably contribute to serum dht so if you inhibit them a drop in serum dht is expected . Some finasteride will definitely reach the prostate , the point is how much

The farther away an organ is in the body from the source the less concentrated it will be when it arrives there. If you dump a dye into a pool its always strongest where it enters, and dilutes as it spreads out. Why would applying a topical to the scalp be any different? Yes, it wont magically disappear, but if it saturates the organs less its still a win right? The prostate wont be saturated the same as when you take orally.
We are just trying to play a game between minimizing sides and maximizing effectiveness. A topical seems it would do better although on the other hand applying a topical is kind of a pain the butt. Which is why Merck went oral finasteride over topical in the first place! Merck asked men if they wanted topical or oral. Guess what won?

 

[Arrade]

The farther away an organ is in the body from the source the less concentrated it will be when it arrives there. If you dump a dye into a pool its always strongest where it enters, and dilutes as it spreads out. Why would applying a topical to the scalp be any different? Yes, it wont magically disappear, but if it saturates the organs less its still a win right?
We are just trying to play a game between minimizing sides and maximizing effectiveness. A topical seems it would do better although on the other hand applying a topical is kind of a pain the butt.

This makes sense. I just want to point out if you're talking about finasteride, it has a very low activation point for a "flat-rate response." Very little in the blood will massively inhibit DHT
My concern with topical actually relates to what you're saying, but that if it goes past the scalp skin the anti androgen interact with the brain in high concentration because of close proximity.
In addition if you ingest something the liver can detoxify it and control its rate of release, but topicals will instantly travel the blood stream uninhibited. Just a concern to keep in mind

 

[Yepesyellow]

I wish there were a little news about this; it’s been nine months since the trial completed and almost five since Almirall noted a positive reading from top line results - they’ve got to be relatively close to publication and filing an NDA...

 

[Dolph]

At this point I assume it had side effects, they would have published results by now if it worked.

 

[tdma]

At this point I assume it had side effects, they would have published results by now if it worked.

Not necessarily, they just might be winning time. We simply don't know.

 

[alibaba92]

At this point I assume it had side effects, they would have published results by now if it worked.

It took them 1 year to release the results. So look forward to March 2019.

 

[Yepesyellow]

At this point I assume it had side effects, they would have published results by now if it worked.

It’s possible but I’d be a little surprised if that were the case; they already noted publicly that initial data from the phase III was positive and it has already been through a phase II trial.

 

[alibaba92]

It’s possible but I’d be a little surprised if that were the case; they already noted publicly that initial data from the phase III was positive and it has already been through a phase II trial.

I wonder where is the data of phase 2 trial ? Did the publish it ?

 

[Yepesyellow]

They must have because there are posts discussing the trial data, folliclethought had quite a decent account of it - that said I don’t have access to the trial data. If I remember, it was found to be as effective as finasteride with only a 30% reduction of dht as opposed to the oral 70%.

 

[BalderBaldyBald]

This makes sense. I just want to point out if you're talking about finasteride, it has a very low activation point for a "flat-rate response." Very little in the blood will massively inhibit DHT
My concern with topical actually relates to what you're saying, but that if it goes past the scalp skin the anti androgen interact with the brain in high concentration because of close proximity.
In addition if you ingest something the liver can detoxify it and control its rate of release, but topicals will instantly travel the blood stream uninhibited. Just a concern to keep in mind

Google Blood Brain Barrier, aka BBB, it's all about molecular weight

 

[Arrade]

Google Blood Brain Barrier, aka BBB, it's all about molecular weight

What is the molecular weight for it?
I'm aware of the concept but don't know the nuances

 

[BalderBaldyBald]

What is the molecular weight for it?
I'm aware of the concept but don't know the nuances

Frankly i don't know, but i will try to find it, i hope it may be harmless, i hate finasteride brain fog

 

[Yepesyellow]

I’m a little hestitant to resurrect this thread needlessly but I noticed that Almirall recently updated their pipeline. P3074 remains a fixture,
which suggests that Almirall are relatively content with the topical’s performance in phase III. What’s sort of interesting is that the update mentions a speculative release date for KX2-391, a drug that is at essentially the exact same stage in the process as P3074. Now, the release date is for Q1 2021 which is later than we’d hope for P3074. I was wondering whether anyone familiar with the process of drug trials and drug approval would be able to weigh-in on whether the speculated real ease for KX2-391 is relevant at all to P3074 or not. Given that they are at the exact same stage in the process I have to wonder, I mean, at that release date we’re really pretty close to Breezula.

https://www.almirall.com/documents/...lish.pdf/79d668fe-fe4f-4ac7-bec3-236f21a55f9f

 

[alibaba92]

I’m a little hestitant to resurrect this thread needlessly but I noticed that Almirall recently updated their pipeline. P3074 remains a fixture,
which suggests that Almirall are relatively content with the topical’s performance in phase III. What’s sort of interesting is that the update mentions a speculative release date for KX2-391, a drug that is at essentially the exact same stage in the process as P3074. Now, the release date is for Q1 2021 which is later than we’d hope for P3074. I was wondering whether anyone familiar with the process of drug trials and drug approval would be able to weigh-in on whether the speculated real ease for KX2-391 is relevant at all to P3074 or not. Given that they are at the exact same stage in the process I have to wonder, I mean, at that release date we’re really pretty close to Breezula.

https://www.almirall.com/documents/...lish.pdf/79d668fe-fe4f-4ac7-bec3-236f21a55f9f

I think, it all depends on the FDA. Thanks to the overwhelmingly reported finasteride side effects on the internet and thanks to the fear-mongers on the forums, maybe FDA will take it seriously this time before approving this "devil" drug once again and further delays are to be expected. Just my guess.

 

[paul1988]

Do you guys think this could be released this year?
On his annual review of thrichology novelties, spanish renowned dermatologist Sergio Vañó, on his 1st point of the article, states -I quote and translate-

[...] Finasteride is an anti-androgen that blocks the formation of dihydrotestosterone through the inhibition of the enzyme 5-alpha-reductase [...]
The news are that through 2019 it'll be commercialized as finasteride 0,25% gel and patients will be able to get in under prescription [...]

(Then the link attached is about the P-3074 clinical trial)

Nothing has been said recentlt about P-3074, but since both the Allergan and Sergio are spanish, he might have some contacts and might have "slipped" the release year.

I personally look forward to the results.
Better efficacy with less systemic absortion would be huge.

 

[Yepesyellow]

I would be a little surprised if it were released this year. I suppose it depends on when they file/ filed for approval. Generally the approval process lasts for between 9 and 12 months, add a month or two for commercialisation. Spring next year is the earliest I would expect a release because there hasn’t been any mention of Almirall filing for approval yet. A release this year would be great though, I’m looking forward to the trial results.

 

[Yepesyellow]

Any updates so far?

Not that I am aware of; they mentioned the product briefly in a presentation from a week ago.

https://www.almirall.com/documents/...2019.pdf/6696d47e-8b3c-4570-bcc8-fbf1174d5bbf

Nothing of any substance in it though. Paul1988’s information is the most recent positive information, but it’s also speculative. They will probably release their yearly report for 2018 in February, hopefully that will say more.