Kyzatrex Health Canada approval

Funkybeats · Sunday at 1:16 PM

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 · Sunday at 1:20 PM

Funkybeats said:
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 · Sunday at 1:25 PM

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 · Sunday at 1:41 PM

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

Oral TU (Jatenzo/Tlando/Kyzatrex)

23:29-28:34

Funkybeats · 2025-09-16T11:23:33-0500

madman said:
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?