Kyzatrex Health Canada approval

[Funkybeats]

Has anyone seen any updates on Kyzatrex approval by Health Canada? All I can find is approval was expected by the end of 2025 Q2 and we are closing in on Q4

 

[madman]

Has anyone seen any updates on Kyzatrex approval by Health Canada? All I can find is approval was expected by the end of 2025 Q2 and we are closing in on Q4

Long process here.

If it is approved than it will most likely be available 2026.

Thread 'Marius Pharmaceuticals Submits KYZATREX® (oral TU) CIII Capsules for Approval to Health Canada'

Jul 30, 2024

It was just a matter of time!

F**king A!

Looks like they may have beat out Verity Pharmaceuticals oral Tlando for dibs on the Canadian market!




RALEIGH, N.C., July 30, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company focused on developing innovative therapies for Testosterone Deficiency, is pleased to announce the submission of its New Drug Submission (NDS) for KYZATREX® (testosterone undecanoate) CIII capsules to Health Canada for approval. This submission marks the company’s first international filing, with an anticipated...

• madman
• oral t; kyzatrex; hypogonadism; trt; canada
• Replies: 5
• Forum: Testosterone and Men's Health Articles

• 

 

[madman]

Oral Tlando may come out ahead here.

Either way we will have 2 options for the newer oral TU formulations!

Thread 'Lipocine Announces Filing of New Drug Submission for TLANDO® in Canada'

Jun 10, 2025

It's coming!

Lipocine Announces Filing of New Drug Submission for TLANDO® in Canada

New Drug Submission filed by Lipocine's licensing partner Verity Pharma Over 700,000 total prescriptions written annually for testosterone replacement therapy (TRT) in Canada, representing large...

ir.lipocine.com

• New Drug Submission filed by Lipocine's licensing partner Verity Pharma
• Over 700,000 total prescriptions written annually for testosterone replacement therapy (TRT) in Canada, representing large commercial opportunity

SALT LAKE CITY, June 9, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced...

• madman
• hypogonadism; canada; oral-t/tlando
• Replies: 3
• Forum: Testosterone and Men's Health Articles

 

[madman]

At the 81st Annual Meeting of the Canadian Urological Association (CUA) Dr. Yafi briefly mentions that oral Tlando should be available in 2026 but nothing regarding Kyzatrex.

There is no titration needed with oral Tlando as it is a fixed dose 225 mg BID.

Thread 'State-of-the-Art Lecture: Updates on testosterone replacement therapy CUA 2025'

Aug 3, 2025

Nelson's house.....you know where it's at!

Conclusions

• madman
• hypogonadism/loh; trt; testosterone; guidelines
• Replies: 14
• Forum: Testosterone and Men's Health Articles

• 

Oral TU (Jatenzo/Tlando/Kyzatrex)

23:29-28:34

 

[Funkybeats]

At the 81st Annual Meeting of the Canadian Urological Association (CUA) Dr. Yafi briefly mentions that oral Tlando should be available in 2026 but nothing regarding Kyzatrex.

There is no titration needed with oral Tlando as it is a fixed dose 225 mg BID.

Thread 'State-of-the-Art Lecture: Updates on testosterone replacement therapy CUA 2025'

Aug 3, 2025

Nelson's house.....you know where it's at!

Conclusions

• madman
• hypogonadism/loh; trt; testosterone; guidelines
• Replies: 14
• Forum: Testosterone and Men's Health Articles

• 

Oral TU (Jatenzo/Tlando/Kyzatrex)

23:29-28:34
View attachment 52816

Do we understand the mechanism as to why the oral delivery methods do not result in the same rise in HCT as the IM injection pathway?

 

[madman]

Do we understand the mechanism as to why the oral delivery methods do not result in the same rise in HCT as the IM injection pathway?

It comes down to the PK as the daily peaks are short-lived followed by much lower T levels returning close to or even baseline.

Your 2 daily peaks are short-lived and more importantly T levels are not high/very high 24/7.

Tmax is achieved 4 hrs post-dose followed by much lower levels returning close to or even baseline 8 hrs later.

Post in thread 'Unmasking Risks: Prevalence of Erythrocytosis Among Men on T-Therapy Across Different Formulations'

Sep 9, 2025

I frequently read comments stating that one of the benefits of transdermal is that it's less likely to push up HCT. Definitely not the case for me. I have more trouble with HCT using cream than anything else. I sometimes wonder what the most important variable is: rapid swings in levels vs. highest level achieved in a given time frame vs. high levels for a certain amount of time?

In any case, high HCT with cream is real.

KRS

If you are using a sensible dose and not pushing your FT too high and we are not just talking peak--->trough here as steady-state levels will have a big...

• madman

 

[Funkybeats]

It comes down to the PK as the daily peaks are short-lived followed by much lower T levels returning close to or even baseline.

Your 2 daily peaks are short-lived and more importantly T levels are not high/very high 24/7.

Tmax is achieved 4 hrs post-dose followed by much lower levels returning close to or even baseline 8 hrs later.





View attachment 52821

Post in thread 'Unmasking Risks: Prevalence of Erythrocytosis Among Men on T-Therapy Across Different Formulations'

Sep 9, 2025

I frequently read comments stating that one of the benefits of transdermal is that it's less likely to push up HCT. Definitely not the case for me. I have more trouble with HCT using cream than anything else. I sometimes wonder what the most important variable is: rapid swings in levels vs. highest level achieved in a given time frame vs. high levels for a certain amount of time?

In any case, high HCT with cream is real.

KRS

If you are using a sensible dose and not pushing your FT too high and we are not just talking peak--->trough here as steady-state levels will have a big...

• madman

I'm looking forward to trying oral T to deal with my high HCT. Right now I've reduced my dose and increased frequency to EOD. Coming down from 57% to 54.9% at first blood test post change. My next draw is at the start of October so I hope to see the trend continue downward. However, my baseline was 50% so I don't know how much lower I will go. Right now HCT is my only out of spec parameter.

 

[madman]

I'm looking forward to trying oral T to deal with my high HCT. Right now I've reduced my dose and increased frequency to EOD. Coming down from 57% to 54.9% at first blood test post change. My next draw is at the start of October so I hope to see the trend continue downward. However, my baseline was 50% so I don't know how much lower I will go. Right now HCT is my only out of spec parameter.

Men with high/end or high HCT at baseline will always struggle when using exogenous T especially injectable T.

Even then most struggling with elevated RBCs, hemoglobin and hematocrit is due to running too high a trough/steady-state FT!

Too many caught up on that more T is better mentality bulls**t!

Always need to be mindful of your injection frequency/where trough FT sits.

FT <5 ng/dL would be considerd low.

FT 5-9 ng/dL would be considered the grey zone where some men may experience symptoms of low-T.

FT 10-15 ng/dL would be healthy.

FT 20-25 ng/dL would be high-end/high!

The majority of men will do well with a trough FT 15-25 ng/dL depending on the injection frequency.

Need to keep in mind that there is a big difference between one running a high-end/high trough FT 20-25 ng/dL injecting daily vs twice-weekly vs once weekly.

Also going to be a big difference in peak--->trough on said protocol!

Many tend to overlook this and gun for a high-end/high trough FT only to end up struggling with sides especilly in the long run.

Just to put this in perspective most healthy young males would be hitting a cFTV 13-15 ng/dL or 10-12 ng/dL tested using the most accurate assay the gold standard Equilibrium Dialysis and this is a short-lived daily peak to boot!

Even if you take those natty outliers in the 95th percentile hitting a high FT 25 ng/dL again this is a short-lived daily peak to boot!

You have guys on T hitting a trough FT 25-30+ ng/dL injecting daily with FT elevated 24/7, EOD as in every 2 days (48 hrs post-injection),twice-weekly as in every 3.5 days (84 hrs post-injection), once weekly as in 7 days post-injection.

You get the point!