TLANDO & TLANDO XR - novel oral prodrugs of testosterone

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madman

Super Moderator
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Defy Medical TRT clinic doctor
on Nov 2019:


March 2020:

 
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PIONEERING FOR NEXT-GENERATION ORAL TRT


TLANDO XR is a next-generation, novel ester prodrug of testosterone that uses the patent-protected Lip'ral technology to enhance solubility and improve systemic absorption. Lipocine completed a Phase 2b dose-finding study in hypogonadal men in 2016. The primary objectives of the Phase 2b clinical study were to determine the starting Phase 3 dose of TLANDO XR along with the safety and tolerability of TLANDO XR and its metabolites following oral administration of single and multiple doses in hypogonadal men. The Phase 2b clinical trial was a randomized, open-label, two-period, multi-dose PK study. Results suggested that the primary objectives were met, including identifying the dose expected to be tested in the planned Phase 3 study. A good dose-response relationship was observed over the tested dose range. Additionally, the target Phase 3 dose met primary and secondary endpoints. TLANDO XR was well tolerated with no drug-related severe or serious adverse events reported in the Phase 2b study.
 
Their pipeline chart says the XR version has finished phase 2.
 
@madman, any idea if Tlando XR is currently in phase 3 studies?

Going to be a while!



TLANDO

Tlando was launched by partner Halozyme during the second quarter, which acquired original license holder Antares Pharma in May 2022. Halozyme announced the launch of the product in a June 7th press release and plans to commercialize Tlando along with Antares’ injectable testosterone replacement therapy Xyosted. Halozyme’s orientation as a commercialization company rather than a development company led to the passing of the Tlando XR (LPCN 1111) option. Tlando XR is now available for partnering. Lipocine is working with a contract manufacturer for the scale-up and manufacturing of LPCN 1111 and has completed a technology transfer to this end. Lipocine will not develop the product any further but is seeking a partner to do so and preparing for an efficient handoff with the product ready for clinical trials.
 
When more oral T replacement comes out driving up competition and therefore making it more affordable, pellet therapy will be all but pointless.

The injections will still be king of being more convenient provided you're not on a daily protocol.
 
Last edited:
Beyond Testosterone Book by Nelson Vergel
Tlando appears to be an advantage over Jatenzo in that it does not require dose titration (not sure how this is the case) and fat content has less impact on absorption.

However, when looking at the pharmacokinetic curves, it appears that Tlando reaches peak levels around 6 hours after dosing, compared with two hours for Jatenzo. If you take Tlando at 6AM and 6PM, this would mean you would get a surge around midnight.

It seems wasteful to have those levels while you are sleeping, not to mention potentially disruptive to sleep.
 
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