A pill that could outsell Viagra: New testosterone Rx drug

[BigTex]

So this is an oral testosterone undecanoate.

 

[Systemlord]

There are already signs of the logical decline of Jatenzo:

Jatenzo patents will be sold and someone else will take over all without disruption of supply. No one is going to take Jatenzo off the market if one is trying to sell a patent.

 

[Systemlord]

Actually the maker of Jatenzo is already bankrupt, not because their pills do not work but because they do not understand what would be a reasonable market price for their pills:

The problem was the maker of Jatenzo launched the product at the start of the pandemic.

 

[sammmy]

No, the problem is they tried to repackage oral TU, known from the 70s, as the next best thing after sliced bed, to justify the insanely inflated price, while there is an effective and way cheaper competition - injectable and transdermal testosterone.

The pandemic has nothing to do with their bankruptcy - men needing TRT didn't decrease in number because of COVID.

 

[sammmy]

So this is an oral testosterone undecanoate.

Yes it is oral TU in an oil/emulsifier vehicle. Nothing new or Earth shattering. The only benefit to the public is that they did absorption studies but it was quite stupid of them to try to sell it for $1000/month.
I hope the next company that comes with the similar idea will be more reasonable.

 

[BigTex]

I have actually had my best blood work doing TU doing 750mg every 30 days. I am strongly considering switching back from test cyp. I will wait until I see my blood work Monday.

 

[WhatSayYou89]

I’m usually not one to jump on newly released medications until I see how others have faired on it, however after 3 years of no progress with the regular trt methods, I’m strongly considering this.

Price doesn’t look to bad considering that labwork and doctors visits are included with the monthly price.

Thank you for posting this.

 

[WhatSayYou89]

Tried to edit my previous post but said 30 minutes had past and wouldn’t let me, adding it here.

Any clue if the method of how this drugs works is by signaling to the testes to make more testosterone or does the pill itself just basically elevate the testosterone levels without going through the testicles?

If it’s just making the testes work harder wouldn’t that be similar to how hcg works? I aromatize to much on hcg so if that’s the case I would think that would rule this out.

If it’s the later then would it shut you down to where you end up running into the same issue with current trt methods of needing to backfill hormone pathways?

I know this is a new drug but just seeing what some of you might think of how this works.

 

[sammmy]

Jatenzo is just testosterone (ester) in oil. It is not a new drug, the manufacturer just pretends it is. It gives you testosterone by intestinal absorption, it does not make your testes produce more and will make your natural testosterone production shut down.

 

[Systemlord]

Jatenzo is just testosterone (ester) in oil. It is not a new drug, the manufacturer just pretends it is.

Jatenzo has a patent on the delivery system by which testosterone is absorbed.

 

[sammmy]

Jatenzo "patented delivery" is not very original and there will be a lot of litigations amongst these companies making new oral TU formulations because they are all based on some sort of oil and the emulsifier hydrogenated castor oil. It's like patenting water with sugar and then claiming no-one can later patent water with brown sugar.

Andriol (the first formula from the 70's): hydrogenated castor oil, propylene glycol monolaureate.

Jatenzo: oleic acid and borage oil, hydrogenated castor oil (Cremophor RH 40).

Kyzatrex: Vitamin E, phytosterol esters, polyoxyl 40 hydrogenated castor oil, propylene glycol monolaurate.

Tilandro: ascorbyl palmitate, glyceryl monolinoleate, polyethylene glycol 8000, and polyoxyl 40 hydrogenated castor oil.

I think Jatenzo and Kyzatrex were already in litigation.

 

[WhatSayYou89]

Jatenzo "patented delivery" is not very original and there will be a lot of litigations amongst these companies making new oral TU formulations because they are all based on some sort of oil and the emulsifier hydrogenated castor oil. It's like patenting water with sugar and then claiming no-one can later patent water with brown sugar.

Andriol (the first formula from the 70's): hydrogenated castor oil, propylene glycol monolaureate.

Jatenzo: oleic acid and borage oil, hydrogenated castor oil (Cremophor RH 40).

Kyzatrex: Vitamin E, phytosterol esters, polyoxyl 40 hydrogenated castor oil, propylene glycol monolaurate.

Tilandro: ascorbyl palmitate, glyceryl monolinoleate, polyethylene glycol 8000, and polyoxyl 40 hydrogenated castor oil.

I think Jatenzo and Kyzatrex were already in litigation.

Ah ok, I was referring to Kyzatrex, the one that releases this month.

Bummer thought, this might be something different that would be a way of increasing testosterone without shutting down natural production and the host of problems that come along with that.

 

[madman]

Tried to edit my previous post but said 30 minutes had past and wouldn’t let me, adding it here.

Any clue if the method of how this drugs works is by signaling to the testes to make more testosterone or does the pill itself just basically elevate the testosterone levels without going through the testicles?

If it’s just making the testes work harder wouldn’t that be similar to how hcg works? I aromatize to much on hcg so if that’s the case I would think that would rule this out.

If it’s the later then would it shut you down to where you end up running into the same issue with current trt methods of needing to backfill hormone pathways?

I know this is a new drug but just seeing what some of you might think of how this works.

Kyzatrex, Jatenzo, and Tlando are just oral esterified T (testosterone undecanoate) which has been in use in Canada and Europe since the 70s.

Jatenzo was the first to come out in the US followed by Tlando and now as of yesterday Kyzatrex.

Jatenzo (TU) may have a slight advantage over the older formulations due to the TU being formulated into a new proprietary self-emulsifying drug delivery system (SEDDS) formulation.


*SEDDS promotes solubilization and the intestinal lymphatic absorption of lipophilic T esters, thereby reducing first-pass hepatic metabolism

*A proprietary prodrug formulation SEDDS including the active ingredient TU was developed by Clarus Therapeutics Inc (Northbrook, Illinois). Each TU capsule contains 100 mg of T equivalent to 158.3 mg of TU. The TU dose henceforth refers to the T dose equivalent. This T-ester is lipophilic, and the formulation incorporates a complex lipid matrix and an emulsifying agent

*In contrast to the older oil-based formulation of TU Andriol, the current SEDDS formulation uses a unique combination of lipophilic and hydrophilic surfactants to increase the solubility of the lipophilic T ester and promote emulsification in the aqueous environment of the gastrointestinal tract. The elimination half-life of T in response to TU in the SEDDS formulation studied after 28 days of dosing was appreciably longer than has been reported for T alone or for oral TU in other (non-SEDDS) formulations (Sandberg and Slaunwhite, 1956)

*Although there is a paucity of detailed serum T PK data with repeat dosing of Andriol in the literature, recent large studies showed that trough serum T levels after oral TU in oil were near to or lower than the baseline serum T levels in hypogonadal men (Emmelot-Vonk et al, 2008; Legros et al, 2009). And although serum T levels increased after administration of Andriol at the recommended dose of 80 mg twice a day (equivalent to T 50 mg twice a day; Nieschlag et al, 1975; Jungwirth et al, 2007), a significant percentage of hypogonadal men failed to achieve serum T levels in the eugonadal range (Skakkebaek et al, 1981; Gooren, 1994).

*The higher serum T concentrations observed with SEDDS formulation of TU used in this study when compared with Andriol could be due to more T administered in the improved formulation of TU in the SEDDS, or the methods used for quantifying serum T. In earlier publications, serum T was measured by immunoassays after chromatography, whereas the LC-MS/MS used in the present study is more accurate and precise (Taieb et al, 2003; Wang et al, 2004a).

Solid Self-Emulsifying Drug Delivery System (Solid SEDDS) for Testosterone Undecanoate: In Vitro and In Vivo Evaluation

Objective: The current study aimed to investigate the potential of Solid Self-Emulsifying Drug Delivery Systems (solid SEDDS) loaded with Testosterone Undecanoate (TU) (solid TUSEDDS). The solid TU-SEDDS was composed of TU, Medium-Chain Triglycerides (MCT, oil), 2- Chloro-1-(chloromethyl) ethyl...

www.eurekaselect.com

Yes nothing magical but it is the first oral esterified T available in the US to treat hypogonadism.

Oral TU will still have a strong impact on suppressing the HPG axis.

* 70% decrease in LH and FSH from mean baseline values in the oral TU and topical T patients

post #6
https://www.excelmale.com/forum/threads/restoring-fertility-in-men-on-trt-–-what’s-new-what’s-coming.23608/

 

[madman]

Jatenzo "patented delivery" is not very original and there will be a lot of litigations amongst these companies making new oral TU formulations because they are all based on some sort of oil and the emulsifier hydrogenated castor oil. It's like patenting water with sugar and then claiming no-one can later patent water with brown sugar.

Andriol (the first formula from the 70's): hydrogenated castor oil, propylene glycol monolaureate.

Jatenzo: oleic acid and borage oil, hydrogenated castor oil (Cremophor RH 40).

Kyzatrex: Vitamin E, phytosterol esters, polyoxyl 40 hydrogenated castor oil, propylene glycol monolaurate.

Tilandro: ascorbyl palmitate, glyceryl monolinoleate, polyethylene glycol 8000, and polyoxyl 40 hydrogenated castor oil.

I think Jatenzo and Kyzatrex were already in litigation.

Might wanna throw that in there!


Jatenzo

*A proprietary prodrug formulation SEDDS including the active ingredient TU was developed by Clarus Therapeutics Inc (Northbrook, Illinois).

 

[WhatSayYou89]

Kyzatrex, Jatenzo, and Tlando are just oral esterified T (testosterone undecanoate) which has been in use in Canada and Europe since the 70s.

Jatenzo was the first to come out in the US followed by Tlando and now as of yesterday Kyzatrex.

Jatenzo (TU) may have a slight advantage over the older formulations due to the TU being formulated into a new proprietary self-emulsifying drug delivery system (SEDDS) formulation.


*SEDDS promotes solubilization and the intestinal lymphatic absorption of lipophilic T esters, thereby reducing first-pass hepatic metabolism

*A proprietary prodrug formulation SEDDS including the active ingredient TU was developed by Clarus Therapeutics Inc (Northbrook, Illinois). Each TU capsule contains 100 mg of T equivalent to 158.3 mg of TU. The TU dose henceforth refers to the T dose equivalent. This T-ester is lipophilic, and the formulation incorporates a complex lipid matrix and an emulsifying agent

*In contrast to the older oil-based formulation of TU Andriol, the current SEDDS formulation uses a unique combination of lipophilic and hydrophilic surfactants to increase the solubility of the lipophilic T ester and promote emulsification in the aqueous environment of the gastrointestinal tract. The elimination half-life of T in response to TU in the SEDDS formulation studied after 28 days of dosing was appreciably longer than has been reported for T alone or for oral TU in other (non-SEDDS) formulations (Sandberg and Slaunwhite, 1956)

*Although there is a paucity of detailed serum T PK data with repeat dosing of Andriol in the literature, recent large studies showed that trough serum T levels after oral TU in oil were near to or lower than the baseline serum T levels in hypogonadal men (Emmelot-Vonk et al, 2008; Legros et al, 2009). And although serum T levels increased after administration of Andriol at the recommended dose of 80 mg twice a day (equivalent to T 50 mg twice a day; Nieschlag et al, 1975; Jungwirth et al, 2007), a significant percentage of hypogonadal men failed to achieve serum T levels in the eugonadal range (Skakkebaek et al, 1981; Gooren, 1994).

*The higher serum T concentrations observed with SEDDS formulation of TU used in this study when compared with Andriol could be due to more T administered in the improved formulation of TU in the SEDDS, or the methods used for quantifying serum T. In earlier publications, serum T was measured by immunoassays after chromatography, whereas the LC-MS/MS used in the present study is more accurate and precise (Taieb et al, 2003; Wang et al, 2004a).

Solid Self-Emulsifying Drug Delivery System (Solid SEDDS) for Testosterone Undecanoate: In Vitro and In Vivo Evaluation

Objective: The current study aimed to investigate the potential of Solid Self-Emulsifying Drug Delivery Systems (solid SEDDS) loaded with Testosterone Undecanoate (TU) (solid TUSEDDS). The solid TU-SEDDS was composed of TU, Medium-Chain Triglycerides (MCT, oil), 2- Chloro-1-(chloromethyl) ethyl...

www.eurekaselect.com

Yes nothing magical but it is the first oral esterified T available in the US to treat hypogonadism.

Oral TU will still have a strong impact on suppressing the HPG axis.

* 70% decrease in LH and FSH from mean baseline values in the oral TU and topical T patients

post #6
https://www.excelmale.com/forum/threads/restoring-fertility-in-men-on-trt-–-what’s-new-what’s-coming.23608/

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I see, well I guess just first thought for me is the only thing this would offer is just easier use for intake of the testosterone from injections & those who have absorption issues via creams.

Back to the grind of tweaking the trt protocol.

 

[Systemlord]

Back to the grind of tweaking the trt protocol.

I can't tell you enough how easy it is to tweak TRT on Jatenzo, it's only about the dosage and makes dialing in quick and easy compared to injections.

My hormones were only in flux for a couple of days as far as I could tell after dosing changes.

It will be interesting to see everyone else's experience once the price has come down.

 

[madman]

I see, well I guess just first thought for me is the only thing this would offer is just easier use for intake of the testosterone from injections & those who have absorption issues via creams.

Back to the grind of tweaking the trt protocol.

Look over post #9.

PKs.

If you are content with keeping your T levels within the physiological range and dealing with two daily peaks/troughs then no harm in giving it a go!

When it comes to using exogenous T and suppression of the hpta Natesto would be considered the least suppressive due to the short-lived peaks/significant trough times between doses.

Regardless of whether dosing 2-3 times daily, there is a short-lived peak Tmax 40-60 min with long trough times 6-8 hrs between doses.

 

[WhatSayYou89]

Look over post #9.

PKs.

If you are content with keeping your T levels within the physiological range and dealing with two daily peaks/troughs then no harm in giving it a go!

When it comes to using exogenous T and suppression of the hpta
Natesto would be considered the least suppressive due to the short-lived peaks/significant trough times between doses.

Regardless of whether dosing 2-3 times daily, there is a short-lived peak Tmax 40-60 min with long trough times 6-8 hrs between doses.

Read over that post and yeah I’m past the point of reading into numbers to determine where I should be.

Getting on trt just disconnects stuff in my brain. Shuts down any urge for sex, memory becomes hit or miss.

I do get better with weight loss & depression gets better.

The shutting down the neurotransmitter network hormones is something that just kicks my ass and supplementing hcg, DHEA, preg, prog just either makes it worse or short lived benefit.

So maybe if the oral route can help with keeping everything flowing mentally & just boosts testosterone levels some then I believe it would be a good fit for me.

Seen that Natesto name floated around here some, haven’t looked into it. Will check it out.