RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia)

Structure/Sequence

Molecular FormulaC23H25F5N2O4S

InChIKeyKVMGAIOTUIGROS-AZUAARDMSA-N

CAS Registry2460722-04-5

Clinical Trials associated with Oveporexton

NCT07363720

/ Active, not recruitingPhase 3

A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial 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 assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.

Start Date29 Jan 2026

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT06505031

/ 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 Date08 Oct 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 (oveporexton) 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 (oveporexton) 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 (oveporexton) 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 (oveporexton).

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

24 Sep 2026·NEW ENGLAND JOURNAL OF MEDICINE

Oveporexton for Narcolepsy Type 1 — Results from Two Phase 3 Trials

Article

Author: Khatami, Ramin ; Mignot, Emmanuel ; Zhan, Shuqin ; del Rio Villegas, Rafael ; Kadali, Harisha ; von Rosenstiel, Philipp ; Sum-Ping, Oliver ; Yao, Baiyun ; von Hehn, Christian ; Faessel, Helene ; Buntinx, Erik ; Neuwirth, Rachel ; Du, Yeting ; Abraham, Anson ; Lammers, Gert Jan ; Iranzo, Alex ; Nilsen, Kristian Bernhard ; Sheikh, Sarah ; Corser, Bruce ; Barateau, Lucie ; Schmidt, Markus H. ; Antczak, Jakub ; Hsiao, Samuel ; Dauvilliers, Yves ; Sivam, Sheila ; Hang, Yaming ; Arnulf, Isabelle ; Tanaka, Shinichiro ; Pizza, Fabio ; Koundourakis, Elena ; Naylor, Melissa ; Olsson, Tina ; Lederer, Katharina ; Etherton, Mark R. ; Rogers, Raquel ; Taniguchi, Mitsutaka ; Cai, Alice ; Plazzi, Giuseppe

BACKGROUND:

Narcolepsy type 1 is characterized by excessive daytime sleepiness, cataplexy, disrupted sleep, sleep paralysis, and hypnagogic or hypnopompic hallucinations. Oveporexton (TAK-861), an oral orexin receptor 2-selective agonist, reduced symptoms of narcolepsy type 1 in a previous phase 2 trial.

METHODS:

We conducted two phase 3, randomized, placebo-controlled trials evaluating the efficacy and safety of oveporexton over a period of 12 weeks. Participants 16 to 70 years of age with narcolepsy type 1 were randomly assigned in a 3:3:2 ratio to receive twice-daily oveporexton (1 mg or 2 mg) or placebo in the First Light trial and in a 2:1 ratio to receive twice-daily oveporexton (2 mg) or placebo in the Radiant Light trial. The primary end point was the change from baseline to week 12 in mean sleep latency (the ability to stay awake under soporific conditions) on the Maintenance of Wakefulness Test (MWT; range, 0 to 40 minutes; normal, ≥20). Key secondary end points included the change from baseline to week 12 in the Epworth Sleepiness Scale (ESS) total score (range, 0 to 24; normal, ≤10) and the weekly cataplexy rate at week 12.

RESULTS:

A total of 168 participants were enrolled in the First Light trial and 105 in the Radiant Light trial. Mean changes from baseline to week 12 in mean sleep latency on the MWT ranged from 14.3 to 19.8 minutes with oveporexton, as compared with -0.4 to -0.8 minutes with placebo (adjusted P<0.001 for all comparisons vs. placebo). Mean changes in the ESS total score ranged from -9.7 to -11.8 with oveporexton, as compared with -1.5 to -1.7 with placebo (adjusted P<0.001 for all comparisons vs. placebo). Median percent reductions in the weekly cataplexy rate ranged from 79.0 to 88.8% with oveporexton, as compared with 27.7 to 39.1% with placebo (adjusted P<0.001 for all comparisons vs. placebo). Adverse events occurred in 86 to 89% of the participants with oveporexton, as compared with 43 to 54% with placebo; the most common adverse events were increased urinary frequency and transient insomnia, which occurred in a majority of participants receiving oveporexton.

CONCLUSIONS:

Over a period of 12 weeks, oveporexton significantly improved measures of wakefulness, sleepiness, and cataplexy in participants with narcolepsy type 1. Increased urinary frequency and transient insomnia were common side effects. (Funded by Takeda Development Center Americas; the First Light and Radiant Light ClinicalTrials.gov numbers, NCT06470828 and NCT06505031.).

31 Aug 2026·Drug Discoveries and Therapeutics

Oveporexton: The first-in-class orexin receptor 2 (OX2R) agonist approved for treatment of narcolepsy type 1 (NT1)

Review

Author: Sun, Yueyi ; Gao, Jianjun

Narcolepsy type 1 (NT1) is a chronic neurological disorder caused by selective loss of orexin-producing neurons, resulting in unstable sleep-wake regulation and characteristic symptoms including excessive daytime sleepiness (EDS), cataplexy, sleep paralysis, hypnagogic or hypnopompic hallucinations, and disrupted nocturnal sleep. Current treatments mainly provide partial symptomatic relief and do not correct the underlying orexin deficiency, highlighting the need for mechanism-based therapies. Oveporexton (TAK-861), an orally administered selective orexin receptor 2 (OX2R) agonist developed by Takeda Pharmaceuticals, represents the first approved therapy targeting the orexin pathway in NT1. By activating preserved OX2R signaling, oveporexton restores wakefulness regulation and alleviates multiple core symptoms of NT1. Its approval was aided by two global phase 3 trials which demonstrated significant improvements in wakefulness and cataplexy compared with placebo. Although its long-term safety, accessibility, and real-world efficacy need to be evaluated further, oveporexton represents a major advance toward disease mechanism-based treatment for NT1.

01 Feb 2026·JAMA Neurology

Effects of Oveporexton, an Orexin Receptor 2–Selective Agonist, on Cognition in Narcolepsy Type 1

Article

Author: Barateau, Lucie ; Dauvilliers, Yves ; Mignot, Emmanuel ; Scammell, Thomas E. ; Latzman, Robert D. ; Harel, Brian T. ; Pizza, Fabio ; Volfson, Dmitri ; Khachadourian, Vahe ; Tanaka, Shinichiro ; Lammers, Gert Jan ; Plazzi, Giuseppe ; Olsson, Tina ; Naylor, Melissa ; Stukalin, Ellie ; Maruff, Paul

Importance:

Cognitive symptoms negatively impact people with narcolepsy type 1 (NT1). While the effects of orexin receptor 2 (OX2R) agonists have been explored on diagnostic features of the disorder (excessive daytime sleepiness and cataplexy), effects on cognitive symptoms are not characterized.

Objective:

To explore the effects of oveporexton, an oral OX2R-selective agonist, on cognition in people with NT1.

Design, Setting, and Participants:

This is a secondary analysis of the TAK-861-2001 phase 2, 8-week, parallel-group, double-blind, placebo-controlled randomized clinical trial, conducted from January 2023 to December 2023, with a 4-week follow-up period. TAK-861-2001 was a multicenter study conducted in clinical settings. Eligible participants were 18 to 70 years of age, with an International Classification of Sleep Disorders, Third Edition diagnosis of NT1. Data analysis was performed from July 2024 to July 2025.

Interventions:

Participants were randomized 1:1:1:1:1 to twice-daily oral oveporexton or matching placebo, dosed 3 hours apart, in dose groups of 0.5/0.5 mg, 2/2 mg, 2/5 mg, 7 mg/placebo, or placebo/placebo, for 8 weeks.

Main Outcomes and Measures:

Cognitive symptoms were assessed using the Psychomotor Vigilance Task (PVT) for attention, the Continuous Paired Associate Learning (CPAL) test for memory, and the One Back (ONB) test and International Digit Symbol Substitution Test–symbols (IDSST-s) for executive function.

Results:

Of 161 eligible individuals screened, 48 did not meet study inclusion criteria, 1 withdrew, and 112 were included in the study. Of 112 participants, mean (SD) age was 34.0 (11.5) years, and 58 participants (51.8%) were female. A total of 112 participants were randomized and received 1 or more doses of oveporexton (0.5/0.5 mg, n = 23; 2/2 mg, n = 21; 2/5 mg, n = 23; 7 mg, n = 23) or placebo (n = 22). Oveporexton improved attention, memory, and executive function over 8 weeks. Least-squares (LS) mean placebo-adjusted changes from baseline were −10.77 (95% CI, −16.74 to −4.79), −9.45 (95% CI, −15.66 to −3.24), −8.60 (95% CI, −14.84 to −2.36), and −8.69 (95% CI, −14.90 to −2.47) PVT lapses with 0.5/0.5 mg, 2/2 mg, 2/5 mg, and 7 mg/placebo doses, respectively. LS mean placebo-adjusted changes were −22.52 (95% CI, −34.95 to −10.10), −16.92 (95% CI, −30.12 to −3.71), −15.51 (95% CI, −28.82 to −2.21), and −17.59 (95% CI, −30.50 to −4.68) for CPAL errors; −0.05 (95% CI, −0.10 to −0.01), −0.07 (95% CI, −0.12 to −0.02), −0.07 (95% CI, −0.12 to −0.02), and −0.05 (95% CI, −0.10 to 0.00) units for ONB log10-transformed performance speed; and 4.72 (95% CI, −1.38 to 10.83), 7.33 (95% CI, 1.06-13.61), 7.85 (95% CI, 1.75-13.95), and 11.82 (95% CI, 5.75-17.89) for IDSST-s correct responses.

Conclusions and Relevance:

In this secondary analysis of the TAK-861-2001 randomized clinial trial, the OX2R agonist oveporexton improved NT1-associated cognitive symptoms in adults.

Trial Registration:

ClinicalTrials.gov Identifier: NCT05687903

News (Medical) associated with Oveporexton

15 Oct 2026

·www.biospace.com

Takeda’s ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 1

− ORZEYFUL is now available in Japan and China following approvals within a month of each other by China’s National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) − Discovered by Takeda scientists in Japan, ORZEYFUL is the lead medicine in Takeda’s orexin franchise, with multiple programs for sleep-wake disorders and conditions where orexin biology plays a role − ORZEYFUL set to launch next month in the U.S., following completion of DEA scheduling; Health Authority submissions underway worldwide OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda ( TSE:4502/NYSE:TAK ) announced today that ORZEYFUL (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. ORZEYFUL is a first-in-class orexin receptor 2 (OX2R) agonist, in tablet form, designed to treat the underlying orexin deficiency associated with NT1. “We’re excited at the potential to fundamentally change how NT1 is managed across Japan and China,” said Giles Platford, president, International, Takeda. “We’ve heard from patients how ORZEYFUL has improved their daily functioning and quality of life, enormously meaningful outcomes for a condition known to impact many aspects of a person’s life, including work, education and social interactions.” 1,2,3,4,5 NT1 is a chronic, rare neurological disease driven by orexin deficiency. People experience a range of symptoms including excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, sleep paralysis, hallucinations and cognitive symptoms. Many patients experience challenges that may affect their quality of life and limit their independence. People with narcolepsy have approximately twice the rate of healthcare resource utilization compared with controls, including more frequent emergency department visits, hospitalizations, outpatient appointments and physician consultations. 6,7,8 ORZEYFUL is the first therapy designed to restore orexin signaling and address the biological cause of NT1. This mechanism represents a potential paradigm shift from symptom management to a disease-targeted treatment. Landmark Phase 3 studies in people with NT1 demonstrated ORZEYFUL improved the full range of NT1 symptoms and quality of life compared with placebo 9 . Results showed consistent, clinically meaningful and statistically significant improvements with ORZEYFUL compared to placebo in wakefulness, sleepiness, cataplexy, disease severity and quality of life measures (p-values of <0.001) across doses over 12 weeks. These improvements were observed at the earliest assessed timepoint for each measure and were sustained throughout the duration of the studies. ORZEYFUL was generally well-tolerated with a safety pro across clinical studies to date. The most common side effects include insomnia, urinary urgency, urinary frequency and excessive saliva. About ORZEYFUL (Oveporexton) ORZEYFUL (oveporexton) is an oral orexin receptor 2 (OX2R) agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency associated with narcolepsy type 1 (NT1). By activating OX2Rs, ORZEYFUL promotes wakefulness and reduces abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy (sudden and temporary loss of muscle tone), and address a range of daytime and nighttime symptoms as evaluated in clinical studies and consistent with the approved label. About Takeda's Orexin Franchise Takeda is the leader in orexin science with a tailored portfolio of investigational orexin agonists in pre-clinical and clinical stages for multiple-sleep wake disorders and other indications where orexin plays a role including respiration, mood and metabolism. Oveporexton is the lead orexin receptor 2 (OX2R) agonist in Takeda’s orexin franchise and has been approved by regulatory bodies in China for the treatment of narcolepsy type 1(NT1) in adolescents aged 16 and older and adults as well as in the United States and Japan for adults with NT1. The company is also investigating other oral orexin agonists, including TAK-360 for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), as well as TAK-495. 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 . Takeda 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 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. Takeda 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 drug pricing, 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: or at . 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. Takeda 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. References Plazzi G, Dauvilliers Y, Pizza F, et al. Effect of the Oral Orexin Receptor 2 Agonist Oveporexton (TAK-861) on Functional Impacts of Narcolepsy Type 1: Results from Two Phase 3 Studies. Presented at: SLEEP 2026; 14-17 June 2026; Baltimore, MD. Pizza F, Dauvilliers Y, Del Rio Villegas R, et al. Oveporexton (TAK-861) Improves Cognitive Symptoms in Patients with Narcolepsy Type 1: Results from Two Randomized, Placebo-controlled Phase 3 Trials. Presented at: SLEEP 2026; 14-17 June 2026; Baltimore, MD. Barateau L, Gong Y, Dauvilliers Y, et al. Effects of Treatment with Oveporexton, an Orexin Receptor 2 Agonist, on Sleep in People with Narcolepsy Type 1: Phase 3 Results. Presented at: SLEEP 2026; 14-17 June 2026; Baltimore, MD. Maski K, Steinhart E, Williams D, et al. Listening to the patient voice in narcolepsy: diagnostic delay, disease burden, and treatment efficacy. J Clin Sleep Med. 2017;13(3):419-425. Flores NM, Villa KF, Black J, et al. The humanistic and economic burden of narcolepsy. J Clin Sleep Med. 2016;12(03):401-407. Thorpy MJ and Hiller G. The medical and economic burden of narcolepsy: implications for managed care. Am Health Drug Benefits. 2017;10(5):233-241. Jennum P, Ibsen R, Petersen ER, et al. Health, social, and economic consequences of narcolepsy: a controlled national study evaluating the societal effect on patients and their partners. Sleep Med. 2012;13(8):1086–93. Black J, Reaven NL, Funk SE, et al. The Burden of Narcolepsy Disease (BOND) study: health-care utilization and cost findings. Sleep Med. 2014 May;15(5):522–9. Dauvilliers Y, Mignot E, Antczak J, et al. Oveporexton for Narcolepsy Type 1: Results from Two Phase 3 Trials. New England Journal of Medicine 2026. Contacts Investor Relations Christopher O’Reilly takeda.ir.contact@takeda.com Japanese Media Tsuyoshi Tada toiawase_kouhou@takeda.co.jp International Media Hannah Badri Media_relations@takeda.com

Phase 3Clinical ResultDrug Approval

21 Sep 2026

·firstwordpharma.com

Alkermes makes argument for orexin expansion into ADHD

Early data for Alkermes' oral orexin 2 receptor (OX2R) agonist throws weight behind the theory that the modality can benefit patients with a range of neurological conditions, not just narcolepsy. The drugmaker said Monday that ALKS 7290 is the first in its class to meaningfully improve symptoms of attention-deficit hyperactivity disorder (ADHD) in adults. The data were disclosed as the company's more advanced OX2R agonist, alixorexton, is nearing Phase III readouts in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Even if the candidate succeeds in NT1, however, it still lags behind Takeda's own oral OX2R agonist Orzeyful (oveporexton), approved by the FDA in August for the indication (see – Physician Views Results: Clinician feedback strongly suggests Takeda's Orzeyful is a game-changer for narcolepsy and Spotlight On: Takeda breaks new ground with narcolepsy approval as Alkermes and Eli Lilly wait in slipstream).While alixorexton might not be first to market in narcolepsy, it helped lay the groundwork for exploring OX2R agonism in ADHD. The candidate met its primary endpoints in a pair of Phase II trials for narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). As part of a detailed June readout from the NT2 trial that included findings on exploratory measures beyond wakefulness, Alkermes said alixorexton achieved a meaningful improvement on patient-reported outcomes focused on cognition and fatigue. That result, Evercore ISI analyst Umer Raffat said at the time, "bodes very well for the big indications beyond narcolepsy," including ADHD, Alzheimer's disease and other dementias (see – Spotlight On: Alkermes' NT2 data boost case for broad potential of orexins and KOL Views Q&A: Solid but unspectacular data for Alkermes’ alixorexton set NT2 benchmark for orexins).From moderate to mild illness The latest data backing a broader exploration of orexin in neurological conditions were generated in a Phase I trial of ALKS 7290 that enrolled 88 healthy volunteers and 50 adults with ADHD. The safety portion of the study established that ALKS 7290 was generally well tolerated, with the maximum tolerated dose not reached. The most common treatment-emergent adverse events were insomnia, pollakiuria, dizziness, change in sustained attention, micturition urgency and constipation, and the candidate avoided any "clinically significant" hepatic, renal or cardio safety signals.The oral OX2R agonist also demonstrated clinically meaningful results on a pair of exploratory ADHD measures, the Adult ADHD Investigator Symptom Rating Scale (AISRS) and Clinical Global Impression-Severity Scale (CGI-S). Participants with ADHD were randomised to receive a two-week in-patient treatment course of 20 mg or 50 mg ALKS 7290 daily, or placebo, following a two-week washout of existing ADHD medications.At day 14, patients receiving low- and high-dose ALKS 7290 achieved median reductions from baseline in AISRS total scores of 14 points and 19 points, respectively. According to Alkermes, improvements were seen as early as day 6, when the first post-baseline AISRS assessment was conducted. The same quick-response timeline was true when symptoms were measured with CGI-S, which also showed improvements as early as day 6. By day 14, the 20-mg and 50-mg dose groups saw median reductions from baseline in CGI-S scores of 1 and 2, respectively, which represent "a shift in disease severity from markedly or moderately ill to mildly ill," Alkermes said. The data "support our strategy to explore the potential of orexin biology beyond hypersomnolence disorders," said Craig Hopkinson, the company's chief medical officer and EVP of R&D. "This exploratory, first-in-patient study was designed to provide early insights into the potential of orexin 2 receptor agonism as a novel treatment for adults with ADHD, and we are excited to see the emerging clinical profile of ALKS 7290."Alkermes already has a Phase II trial underway of ALKS 7290 in patients with ADHD, expected to enrol 312 participants.

Clinical ResultPhase 2Drug ApprovalPhase 3Phase 1

10 Sep 2026

·firstwordpharma.com

Takeda's R&D head Andy Plump to retire after back-to-back approvals

Now that two key therapies have crossed the regulatory finish line — and with a third on the home stretch — Andy Plump has put in his retirement notice at Takeda. After more than a decade with the Japanese drugmaker, Plump is set to step down from his position as president of R&D in June 2027, at which time he will also exit Takeda's board. Once the company selects a new R&D leader, Plump will work closely with them for a smooth transition. Plump joined Takeda in 2015 as chief medical and scientific officer. He then transitioned to the R&D position in late 2018, where he has worked to expand Takeda's portfolio to include rare diseases.Pipeline achievementsAccording to Takeda, as R&D president, Plump "orchestrated a multi-year strategic and cultural transformation of R&D." In particular, he helped shepherd the development of two drugs that each won FDA approval last month. The oral orexin receptor 2 agonist Orzeyful (oveporexton) was greenlit to treat narcolepsy type 1 in adults, making it the first medicine approved to treat the disorder's full range of symptoms rather than targeting them individually (see – Spotlight On: Takeda breaks new ground with narcolepsy approval as Alkermes and Eli Lilly wait in slipstream).US neurologists are upbeat about Orzeyful, with more than 80% of respondents to a recent FirstWord poll signalling that the therapy will significantly enhance the overall treatment of narcolepsy type 1 (see – Physician Views Results: Clinician feedback strongly suggests Takeda's Orzeyful is a game-changer for narcolepsy).Takeda also received a nod for Mimrylo (rusfertide) to treat adults with polycythemia vera (PV), the first hepcidin mimetic cleared to treat the rare blood disorder (see – Spotlight On: Takeda scores PV breakthrough but could find old habits die hard).And a third programme is showing promise. Takeda reported in June that its oral TYK2 inhibitor zasocitinib outperformed Bristol Myers Squibb's Sotyktu (deucravacitinib) in a head-to-head Phase III psoriasis study. The pharma plans to submit a filing with the FDA and other regulators starting this fiscal year (see – KOL Views Q&A: Label and access will dictate threat level of Takeda's zasocitinib to J&J's Icotyde in psoriasis)."Under his leadership, Takeda’s pipeline was rebuilt with an innovative therapeutic area focus and we now have a robust late-stage pipeline which has delivered three transformative medicines that we are poised to launch in the coming months," said Takeda Representative Director, President & CEO Julie Kim.

Phase 3Executive ChangeDrug ApprovalBiosimilarNDA

100 Deals associated with Oveporexton

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KEGG	Wiki	ATC	Drug Bank
D13223	-	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cataplexy	United States	Takeda Pharmaceuticals U.S.A., Inc.	05 Aug 2026
Narcolepsy	China	Takeda Pharmaceuticals U.S.A., Inc.	21 Jul 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nervous System Diseases	NDA/BLA	Canada	Takeda Canada, Inc.	01 Jul 2026
Primary Hypersomnia	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	05 Apr 2023
Primary Hypersomnia	Phase 3	Japan	Takeda Pharmaceutical Co., Ltd.	05 Apr 2023
Primary Hypersomnia	Phase 3	Australia	Takeda Pharmaceutical Co., Ltd.	05 Apr 2023
Primary Hypersomnia	Phase 3	Finland	Takeda Pharmaceutical Co., Ltd.	05 Apr 2023
Primary Hypersomnia	Phase 3	France	Takeda Pharmaceutical Co., Ltd.	05 Apr 2023
Primary Hypersomnia	Phase 3	Germany	Takeda Pharmaceutical Co., Ltd.	05 Apr 2023
Primary Hypersomnia	Phase 3	Italy	Takeda Pharmaceutical Co., Ltd.	05 Apr 2023
Primary Hypersomnia	Phase 3	Netherlands	Takeda Pharmaceutical Co., Ltd.	05 Apr 2023
Primary Hypersomnia	Phase 3	Norway	Takeda Pharmaceutical Co., Ltd.	05 Apr 2023

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06470828 \| NCT06505031 (First Light, Pubmed \| N Engl J Med)	Phase 3	Narcolepsy	273	Oveporexton 1 mg	cbrhyhrcyf(uawoanzemc) = unrklijwnb wydorogryj (hpbtykqbxg ) View more	Positive	24 Sep 2026
				Oveporexton 2 mg	cbrhyhrcyf(uawoanzemc) = efwicjuabj wydorogryj (hpbtykqbxg ) View more
NCT06470828 (FirstLight \| The First Light \| First Light \| TAK-861-3001, CTgov)	Phase 3	Narcolepsy \| Cataplexy	168	Placebo (Placebo)	icgugzqanx(cgzgagkdto) = ubpchluopv msepfapeyh (czncetgrie, 1.502) View more	-	31 Aug 2026
				Oveporexton (OVE 1 mg BID)	icgugzqanx(cgzgagkdto) = qjqbapqunl msepfapeyh (czncetgrie, 1.284) View more
NCT06505031 (TAK-861-3002 \| RadiantLight, CTgov)	Phase 3	Narcolepsy \| Cataplexy	105	Placebo	byprziqkrd(drwltzhdzl) = buysuvucsu jttmuwkvgp (ufiedzsfqd, 1.529) View more	-	16 Jul 2026
AAN2026	Phase 3	-	168	Oveporexton 1mg/1mg	mxcnfitzvb(pigssnvfuy) = qpzjnsymod fipelxfmoa (pfmtwcjnkg, -9.87 to -6.13) View more	Positive	25 Apr 2026
				Oveporexton 2mg/2mg	mxcnfitzvb(pigssnvfuy) = ybsmmmwhqa fipelxfmoa (pfmtwcjnkg, -11.59 to -7.90) View more
NCT06470828 \| NCT06505031 (RadiantLight \| TAK-861-3002, Company_Website) Manual	Phase 3	Narcolepsy	273	安慰剂	-	Positive	08 Sep 2025
				Oveporexton	ktwnrganpn(ehxafzlsoi) = bxoskjjkof sggjgqklij (weqiopocix ) Met
NCT06470828 \| NCT06505031 (RadiantLight \| TAK-861-3002, PRNewswire) Manual	Phase 3	Narcolepsy	-	TAK-861	gglxrmkriu(bfjqnddtod) = 相比安慰剂组均取得了具有统计学显著性的改善 kuoijifhsx (ikdgngclwm ) 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	gvmtnxtuvm(jaizfnrkac) = fhptlqnyxo yxsohwfziy (xpnxyhbljg ) View more	Positive	14 May 2025
				oveporexton twice-daily 2/2 mg	gvmtnxtuvm(jaizfnrkac) = fllrpnbbwf yxsohwfziy (xpnxyhbljg ) View more
NCT05687903 (P12-4.002, AAN2025)	Phase 2	Narcolepsy low cerebrospinal fluid orexin levels	112	TAK-861 0.5mg BID	unnfdrycbb(wtoiaogcin) = iotsoevpaj janwgjjalg (lrelkaeslw )	Positive	07 Apr 2025
				TAK-861 2mg BID	unnfdrycbb(wtoiaogcin) = dslrwzntyo janwgjjalg (lrelkaeslw )
NCT05687903 (TAK-861-2001 \| First Light \| P12-4.002, CTgov)	Phase 2	Narcolepsy	112	Placebo (Placebo)	zezxqrfqqn(kvbptwtwos) = gdrkqmjxpg hdypvidpve (uftkjxapug, 2.061) View more	-	09 Jan 2025
				TAK-861 (TAK-861 0.5 mg BID)	zezxqrfqqn(kvbptwtwos) = cobuzahuzc hdypvidpve (uftkjxapug, 2.128) View more
NCT05687916 (CTgov)	Phase 2	Narcolepsy	71	Placebo (Placebo)	ppsvsigwos(tyyfiqqrrp) = dszpagajvi gapxgutpaw (udrjsqdvdc, 2.246) View more	-	09 Jan 2025
				TAK-861 (TAK-861 2 mg and 5 mg)	ppsvsigwos(tyyfiqqrrp) = pcvckhkooa gapxgutpaw (udrjsqdvdc, 2.300) View more

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