A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms and daily life functions; and to learn about the safety of TAK-861.

Start Date07 Nov 2024

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT06470828

/ CompletedPhase 3

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861.

Start Date02 Jul 2024

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Oveporexton

100 Translational Medicine associated with Oveporexton

100 Patents (Medical) associated with Oveporexton

Literatures (Medical) associated with Oveporexton

01 Jul 2025·Nature Reviews Neurology

Benefits of oveporexton in narcolepsy type 1

Article

Author: Wood, Heather

15 May 2025·NEW ENGLAND JOURNAL OF MEDICINE

Oveporexton, an Oral Orexin Receptor 2–Selective Agonist, in Narcolepsy Type 1

Article

Author: Sheikh, Sarah ; Mignot, Emmanuel ; Khatami, Ramin ; Abraham, Anson ; Kadali, Harisha ; Dauvilliers, Yves ; von Hehn, Christian ; Taniguchi, Mitsutaka ; Tanaka, Shinichiro ; Hang, Yaming ; Neuwirth, Rachel ; von Rosenstiel, Philipp ; Plazzi, Giuseppe ; Swick, Todd J. ; Olsson, Tina ; del Río Villegas, Rafael ; Stukalin, Ellie ; Naylor, Melissa ; Wang, Hao ; Lamberton, Marta ; Cai, Alice ; Lammers, Gert Jan

BACKGROUND:

Narcolepsy type 1 is a disorder of hypersomnolence caused by a loss of orexin neurons, which results in low orexin levels in the brain.

METHODS:

In this phase 2, randomized, placebo-controlled trial, participants with narcolepsy type 1 received once- or twice-daily oveporexton (TAK-861), an oral orexin receptor 2-selective agonist, or placebo. The primary end point was the mean change from baseline to week 8 in average sleep latency (the time it takes to fall asleep) on the Maintenance of Wakefulness Test (MWT) (range, 0 to 40 minutes; normal, ≥20). Secondary end points included the change from baseline to week 8 in the Epworth Sleepiness Scale (ESS) total score (range, 0 to 24; normal, ≤10), the weekly cataplexy rate at week 8, and the occurrence of adverse events.

RESULTS:

A total of 90 participants received oveporexton (0.5 mg twice daily, 23 participants; 2 mg twice daily, 21 participants; 2 mg followed by 5 mg daily, 23 participants; and 7 mg once daily, 23 participants), and 22 received placebo. The mean changes from baseline to week 8 in average sleep latency on the MWT were 12.5, 23.5, 25.4, 15.0, and -1.2 minutes, respectively (adjusted P≤0.001 for all comparisons vs. placebo). The mean changes in the ESS total score at week 8 were -8.9, -13.8, -12.8, -11.3, and -2.5, respectively (adjusted P≤0.004 for all comparisons vs. placebo). The weekly incidence of cataplexy at week 8 was 4.24, 3.14, 2.48, 5.89, and 8.76, respectively (adjusted P<0.05 for 2 mg twice daily and 2 mg followed by 5 mg daily vs. placebo). The most common adverse events associated with oveporexton were insomnia (in 48% of the participants; most cases resolved within 1 week), urinary urgency (in 33%), and urinary frequency (in 32%), without any hepatotoxic effects.

CONCLUSIONS:

In this phase 2 trial involving participants with narcolepsy type 1, oveporexton significantly improved measures of wakefulness, sleepiness, and cataplexy over a period of 8 weeks. (Funded by Takeda Development Center Americas; TAK-861-2001 ClinicalTrials.gov number, NCT05687903.).

Scientific Reports

TAK-861, a potent, orally available orexin receptor 2-selective agonist, produces wakefulness in monkeys and improves narcolepsy-like phenotypes in mouse models

Article

Author: Monjo, Taku ; Koike, Tatsuki ; Yamada, Ryuji ; Kimura, Haruhide ; Hiyoshi, Tetsuaki ; Terada, Michiko ; Mitsukawa, Kayo ; Ando, Tatsuya ; Nakakariya, Masanori ; Kajita, Yuichi

Abstract:

Narcolepsy type 1 (NT1) is associated with severe loss of orexin neurons and characterized by symptoms including excessive daytime sleepiness and cataplexy. Current medications indicated for NT1 often show limited efficacy, not addressing the full spectrum of symptoms, demonstrating a need for novel drugs. We discovered a parenteral orexin receptor 2 (OX2R) agonist, danavorexton, and an orally available OX2R agonist, TAK-994; both improving NT1 phenotypes in mouse models and individuals with NT1. However, danavorexton has limited oral availability and TAK-994 has a risk of off-target liver toxicity. To avoid off-target-based adverse events, a highly potent molecule with low effective dose is preferred. Here, we show that a novel OX2R-selective agonist, TAK-861 [N-{(2S,3R)-4,4-Difluoro-1-(2-hydroxy-2-methylpropanoyl)-2-[(2,3′,5′-trifluoro[1,1′-biphenyl]-3-yl)methyl]pyrrolidin-3-yl}ethanesulfonamide], activates OX2R with a half-maximal effective concentration of 2.5 nM and promotes wakefulness at 1 mg/kg in mice and monkeys, suggesting ~ tenfold higher potency and lower effective dosage than TAK-994. Similar to TAK-994, TAK-861 substantially ameliorates wakefulness fragmentation and cataplexy-like episodes in orexin/ataxin-3 and orexin-tTA;TetO DTA mice (NT1 mouse models). Compared with modafinil, TAK-861 induces highly correlated brain-wide neuronal activation in orexin-tTA;TetO DTA mice, suggesting efficient wake-promoting effects. Thus, TAK-861 has potential as an effective treatment for individuals with hypersomnia disorders including narcolepsy, potentially with a favorable safety profile.

News (Medical) associated with Oveporexton

30 Jul 2025

·www.businesswire.com

Takeda Announces First-Quarter FY2025 Results With Significant Late-Stage Pipeline Progression

OSAKA, Japan--(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first quarter of fiscal year 2025 (three months ended June 30, 2025), with generic erosion of VYVANSE significantly impacting revenue and Core Operating Profit in line with company expectations for the quarter. The company expects these impacts to moderate in future quarters. Takeda also achieved several important milestones in its R&D pipeline, reinforcing its long-term growth trajectory and underscoring its commitment to delivering sustainable value through innovation. Most notably, both Phase 3 studies of oveporexton successfully met all primary and secondary endpoints, demonstrating statistically significant improvements across doses. These results reinforce the potential of oveporexton to transform the standard of care in narcolepsy type 1. In addition, Takeda received U.S. FDA approval for GAMMAGARD® LIQUID ERC and European Commission (EC) approval for ADCETRIS® in new indications and presented promising clinical data for rusfertide at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session. These developments underscore the strength of Takeda’s late-stage pipeline and its potential to drive future growth. Takeda chief financial officer, Milano Furuta, commented: “The impact of VYVANSE generic erosion on Takeda’s FY2025 Q1 results was very significant, but consistent with our expectations, and there is no change to our full-year outlook announced in May. “Our late-stage pipeline continues to advance with the announcement in July of positive results from two pivotal Phase 3 studies for oveporexton in narcolepsy type 1, with both studies meeting all primary and secondary endpoints. These results represent a significant scientific milestone, and we are very excited about the potential for our late-stage pipeline to deliver value to the patients we serve and to position Takeda for sustainable growth.” FINANCIAL HIGHLIGHTS for FY2025 Q1 Ended June 30, 2025 (Billion yen, except percentages and per share amounts) FY2025 Q1 FY2024 Q1 vs. PRIOR YEAR (Actual % change) Revenue 1,106.7 1,208.0 -8.4% Operating Profit 184.6 166.3 +11.0% Net Profit 124.2 95.2 +30.4% EPS (Yen) 79 61 +30.8% Operating Cash Flow 215.4 170.3 +26.5% Adjusted Free Cash Flow (Non-IFRS) 190.1 23.7 +703.6% Core (Non-IFRS) (Billion yen, except percentages and per share amounts) FY2025 Q1 FY2024 Q1 vs. PRIOR YEAR (Actual % change) vs. PRIOR YEAR (CER % change) Revenue 1,106.7 1,208.0 -8.4% -3.7% Operating Profit 321.8 382.3 -15.8 % -11.9% Margin 29.1% 31.6% -2.6 pp ― Net Profit 237.0 276.8 -14.4% -10.3% EPS (Yen) 151 176 -14.1% -10.0% FY2025 Outlook (unchanged from May 2025) (Billion yen, except percentages and per share amounts) FY2025 FORECAST FY2025 MANAGEMENT GUIDANCE Core Change at CER (Non-IFRS) Revenue 4,530.0 --- Core Revenue (Non-IFRS) 4,530.0 Broadly flat Operating Profit 475.0 --- Core Operating Profit (Non-IFRS) 1,140.0 Broadly flat Net Profit 228.0 --- EPS (Yen) 145 --- Core EPS (Yen) (Non-IFRS) 485 Broadly flat Adjusted Free Cash Flow (Non-IFRS) 750.0-850.0 --- Annual Dividend per Share (Yen) 200 --- Additional Information About Takeda’s FY2025 Q1 Results For more details about Takeda’s FY2025 Q1 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2025 Q1 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/). About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com. Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/or at www.sec.gov.Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Financial information and Non-IFRS Measures Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”). This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2025 Q1 investor presentation (available at www.takeda.com/investors). Peak Sales and PTRS Estimates References in this press release to peak revenue potential ranges are estimates that have not been adjusted for probability of technical and regulatory success (PTRS) and should not be considered a forecast or target. These peak revenue potential ranges represent Takeda’s assessments of various possible future commercial scenarios that may or may not occur. References in this press release to PTRS are to internal estimates of Takeda regarding the likelihood of obtaining regulatory approval for a particular product in a particular indication. These estimates reflect the subjective judgment of responsible Takeda personnel and have been approved by Takeda’s Portfolio Review Committee for use in internal planning. Medical information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Please refer to slide 6 of Takeda’s FY2025 Q1 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.

Clinical ResultFinancial StatementPhase 3Drug ApprovalASCO

21 Jul 2025

·endpoints.news

Alkermes gets a mid-stage narcolepsy hit, but trails Takeda in R&D race

Alkermes’ narcolepsy therapy improved the ability of patients in a mid-stage trial to stay awake, the company said Monday. And while a Phase 3 program is on the cards, it said this might not happen in the immediate timeframe. The pill, named alixorexton, met the Phase 2 trial’s primary endpoint, with narcolepsy patients who took the drug once a day for six weeks having statistically significant, clinically meaningful and dose-dependent improvements from baseline in mean sleep latency over placebo (p<0.0001 at all doses). The study, called Vibrance-1, signed up 92 subjects with the type 1 form of narcolepsy (NT1). Patients with both types of narcolepsy struggle to stay awake during the day, but NT1 patients also have sudden bouts of muscle weakness, called cataplexy. Around 20% of narcolepsy cases are type 1. Sleep latency was measured using a process called the Maintenance of Wakefulness Test (MWT). Patients lie down in a dark, quiet room every two hours for eight hours, and the time it takes for them to fall asleep is measured. Healthy people can stay awake for at least 20 minutes on average; narcolepsy patients are out for less than five. NT1 patients given alixorexton, previously referred to as ALKS 2680, achieved “normative wakefulness,” meaning they were able to stay awake for those 20 minutes. The actual figures for the patients’ time remaining awake, split by dose, have not yet been released. All doses beat placebo on excessive daytime sleepiness, as measured on the Epworth Sleepiness Scale. When it came to testing alixorexton’s effects on muscle weakness, however, only the middle 6 mg dose improved weekly cataplexy rates to a statistically significant degree. “We think that’s more of a methodological issue in Phase 2, because typically cataplexy rates would correlate with all these other positive directions,” Alkermes CEO Richard Pops told Endpoints News . He said the company would focus on “tuning out” this variability in Phase 3 trials. Improvements in narcolepsy symptom severity, cognitive complaints and fatigue were also seen in Vibrance-1, and there were no serious treatment-emergent adverse events. Full data from the trial will come at the World Sleep meeting in Singapore in September, Alkermes said. Alixorexton is an orexin 2 receptor agonist and shares its mechanism with Takeda’s oveporexton, which last week became the first drug in this class to succeed in a Phase 3 test. Analysts are predicting that Takeda could have a blockbuster on its hands. Pops said that Alkermes was planning a three-month-long Phase 3 trial in NT1, similar to what the FDA had requested for Takeda’s Phase 3 trial of oveporexton. But pivotal trials will not start yet, Pops said. Alixorexton is also in Phase 2 studies in narcolepsy type 2 and another type of sleeping disorder called idiopathic hypersomnia. Alkermes will wait for the NT2 trial to read out this autumn. “Then we’ll sit down with FDA with those data and finalize the design of Phase 3. So it’s a little too early to say when we’ll launch Phase 3, but we’ll be moving as fast as we can now with these data,” he said. Pops says he is encouraged by Takeda’s success. “Our overall view is that both we and Takeda are blazing new ground here,” he said. “We’re quite excited to see Takeda’s positive data, reinforcing the idea that orexin 2 receptor agonists can be used safely on a consistent basis, and really drive profound clinical effects for patients with narcolepsy — that’s a really good thing.” He said that the two meds were “quite different, and have been from the outset.” Takeda’s pill is given twice a day, while Alkermes’ is once a day. He said Takeda was mainly focused on NT1, whereas Alkermes is looking at NT2 and idiopathic hypersomnia. (Takeda is investigating other orexin 2 receptor agonists for idiopathic hypersomnia and narcolepsy type 2.) “We feel like they’re an effective pioneer in the space. We’re right behind with a drug with a bit broader spectrum of potential activity,” Pops said.

Phase 3Phase 2Clinical Result

21 Jul 2025

·www.biopharmadive.com

Alkermes narcolepsy drug headed for late-stage testing

A potential multibillion-dollar drug is advancing to late-stage testing now that its developer, Alkermes, has in hand positive results from a smaller study focused on a certain kind of narcolepsy.According to Alkermes, the study found all three doses of its drug under evaluation were significantly better than a placebo at improving scores on a test that places participants in a quiet, dark, peaceful room and monitors how awake and alert they are. Alkermes described the results as clinically meaningful, and said all the drug-treated groups achieved normative wakefulness in this case, taking more than 20 minutes to fall asleep.All doses of the drug, previously dubbed ALKS 2680 and now named alixorexton, were also generally well tolerated. Alkermes said there were no so-called serious treatment-emergent adverse events. Nor were there any treatment-related safety signals seen in participants vital signs, or on liver, kidney and eye exams.The clinical trial specifically enrolled people with narcolepsy type 1, which, along with excessive sleepiness, is characterized by sudden loss in muscle control. Alkermes intends to present more detailed data at a medical meeting in Singapore in September. In the meantime, an extension study in which all participants from the main trial receive alixorexton is still running. So are a couple other experiments assessing the drug in adults with narcolepsy type 2, or a sleep disorder known as idiopathic hypersomnia.Craig Hopkinson, who serves as Alkermes chief medical officer while also leading the companys research and development, said in a statement that his team is moving forward expeditiously to start a global Phase 3 testing of the drug. The fresh data are an important stride forward for the alixorexton program, he said, as well as for Alkermes' broader portfolio of therapies that amplify orexin 2 proteins.These results arrived just a week after Takeda announced its own orexin drug, oveporexton, hit the main goals of two late-stage trials, giving the Japan-based pharmaceutical giant the confidence to plan to file for marketing approval in the U.S. and elsewhere by the end of March.Jefferies analyst Stephen Barker wrote in a note to clients that oveporexton could reach $3 billion in peak yearly sales just as a treatment for narcolepsy Type 1.Trailing Takeda are Alkermes and several other companies, including Eisai, Jazz Pharmaceuticals and Centessa Pharmaceuticals. Theyre each trying to break what Wall Street expects to be a lucrative market, with some estimates holding that between 135,000 and 200,000 people in the U.S. alone have narcolepsy.Johnson & Johnson has an experimental, orexin 2-targeting medicine as well, though its being developed as a therapy for adult and elderly patients who have major depressive disorder with insomnia symptoms.Joseph Thome, an analyst at TD Cowen, last month reported that his team expects annual sales of Alkermes drug to peak at $2 billion. That estimate factors in approvals for both narcolepsy type 1 and 2.Whether Alkermes shareholders will be as bullish remains to be seen. Evercore ISI analyst Umer Raffat wrote that many investors were on the sidelines regarding the companys orexin program ahead of Mondays disclosure.They may still be. Alkermes share price was down by as much as 10% Monday morning, before rebounding somewhat to trade down around 5%. '

Clinical ResultPhase 3

100 Deals associated with Oveporexton

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Indication	Highest Phase	Country/Location	Organization	Date
Narcolepsy	Phase 3	Czechia	Takeda Development Center Americas, Inc.	08 Oct 2024
Narcolepsy	Phase 3	Denmark	Takeda Development Center Americas, Inc.	08 Oct 2024
Narcolepsy	Phase 3	Hungary	Takeda Development Center Americas, Inc.	08 Oct 2024
Cataplexy	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	02 Jul 2024
Cataplexy	Phase 3	Japan	Takeda Pharmaceutical Co., Ltd.	02 Jul 2024
Cataplexy	Phase 3	Canada	Takeda Pharmaceutical Co., Ltd.	02 Jul 2024
Cataplexy	Phase 3	France	Takeda Pharmaceutical Co., Ltd.	02 Jul 2024
Cataplexy	Phase 3	Germany	Takeda Pharmaceutical Co., Ltd.	02 Jul 2024
Cataplexy	Phase 3	Italy	Takeda Pharmaceutical Co., Ltd.	02 Jul 2024
Cataplexy	Phase 3	Netherlands	Takeda Pharmaceutical Co., Ltd.	02 Jul 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06470828 \| NCT06505031 (RadiantLight \| TAK-861-3002, PRNewswire) Manual	Phase 3	Narcolepsy	-	TAK-861	jgpzfusdjt(ewataxjtqc) = 相比安慰剂组均取得了具有统计学显著性的改善 dmxtpjfavh (vrtsoqdzml ) Met View more	Positive	16 Jul 2025
				安慰剂
NCT05687903 (TAK-861-2001, BusinessWire \| Pubmed) Manual	Phase 2	Narcolepsy	112	oveporexton twice-daily 0.5/0.5 mg	npdxzmhhkb(lbkrezhxwp) = benhoryaas heqnbuazsj (bhlywitvtq ) View more	Positive	14 May 2025
				oveporexton twice-daily 2/2 mg	npdxzmhhkb(lbkrezhxwp) = hjijxzhhln heqnbuazsj (bhlywitvtq ) View more
NCT05687903 (P12-4.002, AAN2025)	Phase 2	Narcolepsy low cerebrospinal fluid orexin levels	112	TAK-861 0.5mg BID	seauzauncz(foygaeuegt) = qpcieqdgzm awkhrultfu (kuqdihawit )	Positive	07 Apr 2025
				TAK-861 2mg BID	seauzauncz(foygaeuegt) = hnxvmaoztm awkhrultfu (kuqdihawit )
NCT05687903 (TAK-861-2001 \| P12-4.002, CTgov)	Phase 2	Narcolepsy	112	Placebo (Placebo)	wgajqifnjs(dnfcyutzlh) = sohzirqftj orhrwunlle (nalflbtjmq, 2.061) View more	-	09 Jan 2025
				TAK-861 (TAK-861 0.5 mg BID)	wgajqifnjs(dnfcyutzlh) = fgyppgzxfx orhrwunlle (nalflbtjmq, 2.128) View more
NCT05687916 (CTgov)	Phase 2	Narcolepsy	71	Placebo (Placebo)	eldtkrtdkq(caghrerxav) = aaiyschsaf tevlcsbrsb (fenkoodpeq, 2.246) View more	-	09 Jan 2025
				TAK-861 (TAK-861 2 mg and 5 mg)	eldtkrtdkq(caghrerxav) = sdimdabtjj tevlcsbrsb (fenkoodpeq, 2.300) View more
NCT05687903 (TAK-861-2001, NEWS) Manual	Phase 2	Narcolepsy	112	TAK-861	apkjteqfzb(dhghyizctu) = 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. wsyicfjjie (nsururvvth ) View more	Positive	03 Jun 2024
				placebo
WSC2023	Not Applicable	Sleep Disorders, Circadian Rhythm	-	TAK-861 high-dose (HD)	bafnthbuqu(gzbkrocrjx) = reported by 3 (27.3%) subjects on TAK‑861 HD dkhtexffvj (gjgfsgmzjr )	-	23 Oct 2023
				TAK-861 low-dose (LD)

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