Catalytic Impact Foundation reposted this
Today, we’re excited to announce the development of TerXT, a combination of novel prodrugs of xanomeline and trospium designed to be long-acting treatments for schizophrenia. Using a novel prodrug approach we’ve been able to overcome inherent pharmacokinetic and physical property limitations of xanomeline and trospium with the goal of creating fixed-dose combinations for daily oral administration as well as long-acting intramuscular injection with multi-month duration. The original combination of xanomeline and trospium has been shown in recent trials to be an effective therapeutic for schizophrenia and is currently undergoing FDA review via the 505(b)(1) pathway. If approved, Terran plans to use the rapid 505(b)(2) approval pathway for our next-generation prodrug forms, potentially enabling market entry approximately five years after the initial xanomeline/trospium approval. This milestone is the result of tireless efforts by over 200 chemists who designed and synthesized 500 prodrugs, which were then tested in 285 in vitro and 365 in vivo studies to select the lead prodrug forms with optimized properties for long-acting administration. Terran has also now received notice of patent claims found to be allowable from the United States Patent and Trademark Office for the composition of matter for the world’s first prodrugs of xanomeline. The development of TerXT represents a major step in Terran’s mission to create effective, accessible, affordable, and patient-friendly neuropsychiatric therapies through innovative drug design and regulatory strategies. Read the press release here: https://bit.ly/4dI3OQy #schizophrenia #mentalhealth #drugdevelopment
So proud and excited for Terran and the difference this will make for patients with schizophrenia!
Incredible news from team Terran, as is tradition!
Wonderful news. Well done
Hats off to the whole Terran Biosciences team !! Big milestones for the industry and huge game changer for patients !! Special thanks to Valhalla Ventures :)
TerXT appears to be a longer-acting competitor to Karuna’s KarXT. Karuna was recently acquired by Bristol-Myers Squibb (BMY) for $14 billion primarily on the strength of KarXT. Hard not to see today’s announcement as major news for we Terran investors. Nice work, Terran Biosciences!
This is huge news! The tireless effort from the Terran Biosciences team should be applauded
Really proud of the team's hard work! Looking forward to delivering improved medicines for patients with schizophrenia.
A major milestone and terrific news for all patients with schizophrenia. Hats off to the whole Terran team 💪🏽
General Partner @ Valhalla Ventures
2moTerXT going to be a game-changer for schizophrenia patients as a longer-acting competitor to BMS’s recently acquired KarXT (via Karuna Therapeutics).