Chemistry:Oveporexton

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Oveporexton (INN; developmental code name TAK-861) is an orexin receptor agonist and wakefulness-promoting agent which is under development for the treatment of narcolepsy (types 1 and 2) and idiopathic hypersomnia.[1][2][3] It is taken by mouth.[1][2]

The drug acts as a selective agonist of the orexin OX2 receptor.[1][2] It has wakefulness-promoting effects in animals, including in rodents and monkeys.[2] In addition, oveporexton has been found to be effective in the treatment of narcolepsy and cataplexy in phase 3 clinical trials in humans.[4][5][6] The drug is a first-in-class medication and targets the root symptomatic cause of narcolepsy (type 1) by remediating the orexin (hypocretin) deficiency that is present in the condition.[7][8][9]

Oveporexton is being developed by Takeda.[1] As of July 2025, it has completed phase 3 clinical trials for treatment of narcolepsy, whereas no recent development has been reported for treatment of idiopathic hypersomnia.[1][5][10] Takeda submitted a New Drug Application (NDA) of oveporexton for the treatment of narcolepsy to the United States Food and Drug Administration (FDA) in February 2026.[1][5] Oveporexton is a follow-on and replacement compound for Takeda's earlier lead drug danavorexton (TAK-925), which is administered intravenously and stopped being developed due to unexpected liver toxicity findings.[10]

See also

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 "Oveporexton". 16 December 2024. https://adisinsight.springer.com/drugs/800063888. 
  2. ↑ 2.0 2.1 2.2 2.3 "TAK-861, a potent, orally available orexin receptor 2-selective agonist, produces wakefulness in monkeys and improves narcolepsy-like phenotypes in mouse models". Scientific Reports 14 (1). September 2024. doi:10.1038/s41598-024-70594-1. PMID 39242684. Bibcode: 2024NatSR..1420838M. 
  3. ↑ "Pharmacological Treatments of Sleep–Wake Disorders: Update 2023". Clinical and Translational Neuroscience 7 (4): 42. 29 November 2023. doi:10.3390/ctn7040042. ISSN 2514-183X. 
  4. ↑ Walters, Jessica (7 October 2025). "Positive Data Presentation on Oveporexton for Narcolepsy". https://www.psychiatrictimes.com/view/positive-data-presentation-on-oveporexton-for-narcolepsy. 
  5. ↑ 5.0 5.1 5.2 Beaney, Abigail (14 July 2025). "Takeda's oral narcolepsy drug shines in two Phase III trials". https://www.clinicaltrialsarena.com/news/takeda-oral-narcolepsy-drug-two-phase-iii-trials/. 
  6. ↑ "Oveporexton, an Oral Orexin Receptor 2-Selective Agonist, in Narcolepsy Type 1". The New England Journal of Medicine 392 (19): 1905–1916. May 2025. doi:10.1056/NEJMoa2405847. PMID 40367374. 
  7. ↑ "Pharmacological options for narcolepsy: are they the way forward?". Expert Rev Neurother 23 (9): 819–834. 2023. doi:10.1080/14737175.2023.2249234. PMID 37585269. 
  8. ↑ Matsuyama, Kanoko (8 September 2025). "Takeda Nears First Therapy for Narcolepsy's Root Cause". https://www.bloomberg.com/news/articles/2025-09-08/takeda-nears-first-therapy-for-narcolepsy-s-root-cause. 
  9. ↑ Vinluan, Frank (9 September 2025). "Takeda Is Waking Up the Narcolepsy Market With First-in-Class Drug, But Alkermes Is on Its Heels". https://medcitynews.com/2025/09/takeda-is-waking-up-the-narcolepsy-market-with-first-in-class-drug-but-alkermes-is-on-its-heels/. 
  10. ↑ 10.0 10.1 "Leading orexin receptor agonist clears phase III for narcolepsy". Nat Rev Drug Discov 24 (9): 655. September 2025. doi:10.1038/d41573-025-00137-4. PMID 40775090. 

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