Drug Type Small molecule drug |
Synonyms TAK 861, TAK-861 |
Target |
Action agonists |
Mechanism OX2R agonists(Orexin receptor type 2 agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationBreakthrough Therapy (United States), Breakthrough Therapy (China) |
Molecular FormulaC23H25F5N2O4S |
InChIKeyKVMGAIOTUIGROS-AZUAARDMSA-N |
CAS Registry2460722-04-5 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Narcolepsy | Phase 3 | Czechia | 08 Oct 2024 | |
Narcolepsy | Phase 3 | Denmark | 08 Oct 2024 | |
Narcolepsy | Phase 3 | Hungary | 08 Oct 2024 | |
Cataplexy | Phase 3 | United States | 02 Jul 2024 | |
Cataplexy | Phase 3 | Japan | 02 Jul 2024 | |
Cataplexy | Phase 3 | Canada | 02 Jul 2024 | |
Cataplexy | Phase 3 | France | 02 Jul 2024 | |
Cataplexy | Phase 3 | Germany | 02 Jul 2024 | |
Cataplexy | Phase 3 | Italy | 02 Jul 2024 | |
Cataplexy | Phase 3 | Netherlands | 02 Jul 2024 |
Phase 3 | - | amzczeecsr(whpmhizulq) = 相比安慰剂组均取得了具有统计学显著性的改善 fddjfanmzr (wbkrgbqvjr ) Met View more | Positive | 16 Jul 2025 | |||
安慰剂 | |||||||
Phase 2 | 112 | oveporexton twice-daily 0.5/0.5 mg | gldnidhxbh(aehesdzopm) = fobilfyiik zpnzyhtoqq (wxeziduiqg ) View more | Positive | 14 May 2025 | ||
oveporexton twice-daily 2/2 mg | gldnidhxbh(aehesdzopm) = ogzukbnqpa zpnzyhtoqq (wxeziduiqg ) View more | ||||||
Phase 2 | Narcolepsy low cerebrospinal fluid orexin levels | 112 | ghncvaclvr(igvctlskhs) = anyddrrkwp oxamxduqsc (ecthgthmms ) | Positive | 07 Apr 2025 | ||
ghncvaclvr(igvctlskhs) = ryxbjipmez oxamxduqsc (ecthgthmms ) | |||||||
Phase 2 | 71 | Placebo (Placebo) | lsuvwqbglv(pijdvalfhw) = eoooqsgsor fcowzdnkkl (suqkjniskk, 2.246) View more | - | 09 Jan 2025 | ||
(TAK-861 2 mg and 5 mg) | lsuvwqbglv(pijdvalfhw) = yxixcsjlqs fcowzdnkkl (suqkjniskk, 2.300) View more | ||||||
Phase 2 | 112 | Placebo (Placebo) | ytzolvtmow(iqdcplqcgg) = zyiqbqcrxp qquhgftcrz (iyklvagesh, 2.061) View more | - | 09 Jan 2025 | ||
(TAK-861 0.5 mg BID) | ytzolvtmow(iqdcplqcgg) = gugwezxvpf qquhgftcrz (iyklvagesh, 2.128) View more | ||||||
Phase 2 | 112 | bymueuwrfp(gvrmzvtemn) = The primary endpoint demonstrated statistically significant and clinically meaningful increased sleep latency on the Maintenance of Wakefulness Test (MWT) versus placebo across all doses (LS mean difference versus placebo all p ≤0.001). Improvements were sustained over 8 weeks.
Mean sleep latency ranged from 16.5 minutes for the lowest 0.5mg/0.5mg dose up to 30.7 minutes for the 2mg/5mg dose, compared to just 7 minutes for placebo. nahkwehncg (kgdsyydncm ) View more | Positive | 03 Jun 2024 | |||
placebo | |||||||
Not Applicable | - | TAK-861 high-dose (HD) | lnfxewumti(qnebvlfaxg) = reported by 3 (27.3%) subjects on TAK‑861 HD ftabcyqifn (exvchjbdzx ) | - | 23 Oct 2023 | ||
TAK-861 low-dose (LD) |