This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.

Start Date21 Nov 2024

Sponsor / Collaborator

Idorsia Pharmaceuticals Ltd.

[+1]

NCT06630390 / Enrolling by invitationPhase 2IIT

Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery

The goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. The main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events.
Participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.

Start Date11 Nov 2024

Sponsor / Collaborator

University of Rochester

NCT06311864 / RecruitingNot Applicable

Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada

The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia.

Start Date20 Jun 2024

Sponsor / Collaborator

Peripharm, Inc.

[+1]

100 Clinical Results associated with Daridorexant hydrochloride

100 Translational Medicine associated with Daridorexant hydrochloride

100 Patents (Medical) associated with Daridorexant hydrochloride

174

Literatures (Medical) associated with Daridorexant hydrochloride

01 Dec 2024·Journal of sleep research

Early experience with the new DORA daridorexant in patients with insomnia disorder and comorbid mental disturbances: Results of a naturalistic study with 3 months follow‐up

Article

Author: Gemignani, Angelo ; Perugi, Giulio ; Alfi, Gaspare ; Grenno, Giovanna ; Pini, Stefano ; Presta, Silvio ; Gurrieri, Riccardo ; Miniati, Mario ; Palagini, Laura ; Gambini, Matteo ; Caruso, Valerio ; Annuzzi, Eric ; Trivella, Marco

Summary:

Insomnia disorder may affect mental health, increasing suicidal risk. Targeting insomnia is crucial in the clinical practice. Sixty‐six consecutive patients with insomnia disorder according with the DSM‐5‐TR criteria were treated with the dual orexin receptor antagonist, daridorexant 50 mg. Baseline (T0), 1 month (T1) and 3 month (T2) evaluations were performed. Insomnia severity (Insomnia Severity Index), mood, anxiety symptoms and suicidal risk (Beck Depression Inventory‐II, Young Mania Rating Scale, Self‐Reported Anxiety Scale, Suicidal Ideation Scale), dysfunctional insomnia‐cognitive factors and pre‐sleep arousal (Dysfunctional Beliefs About Sleep, Pre‐Sleep Arousal Scale) were evaluated. The final sample included 66 patients (n = 36, 54% females, mean age 60 ± 13.6 years). Most of them, 64%, suffered from insomnia disorder comorbid with unipolar/bipolar depression, anxiety disorders and substance use disorders. Repeated ANOVA analyses showed that Insomnia Severity Index, Dysfunctional Beliefs About Sleep and Pre‐Sleep Arousal Scale total score decreased across time (F = 68.818, p < 0.001; F = 47.561, p < 0.001; F = 28.142, p < 0.001, respectively). Similarly, Beck Depression Inventory‐II, Self‐Reported Anxiety Scale, Young Mania Rating Scale, and Suicidal Ideation Scale significantly decreased over time (p < 0.001). Predictors of insomnia remission (Insomnia Severity Index < 8) at T1 were improvement of Insomnia Severity Index at T1 (F = 60.205, p < 0.001), and improvement of Dysfunctional Beliefs About Sleep at T1 (F = 4.432, p = 0.041). Insomnia remission at T2 was best predicted by improvement of Dysfunctional Beliefs About Sleep at T2 (F = 3.993, p = 0.023). Multiple‐regression models showed that clinical improvement of Beck Depression Inventory‐II was best predicted by improvement in Dysfunctional Beliefs About Sleep at T1 and T2, manic symptoms by Insomnia Severity Index at T2, anxiety symptoms by Dysfunctional Beliefs About Sleep, Insomnia Severity Index and somatic Pre‐Sleep Arousal Scale at T1 and T2. With the caution of a naturalistic design, early experience with daridorexant showed that by targeting insomnia it may be possible to improve not only insomnia symptoms but also comorbid symptoms.

08 Nov 2024·Sleep

Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder: a pooled post hoc analysis of two randomized phase 3 clinical studies

Article

Author: Dauvilliers, Yves ; Sadeghi, Kolia ; Donoghue, Jacob ; Scammell, Thomas E ; Little, David ; Djonlagic, Ina ; Datta, Alexandre N ; Olivieri, Antonio ; Di Marco, Tobias ; Hubbard, Jeffrey ; Parrino, Liborio ; Krystal, Andrew ; Zammit, Gary ; Puryear, Corey B ; Hajak, Göran

Abstract:

Study Objectives:

Post hoc analysis to evaluate the effect of daridorexant on sleep architecture in people with insomnia, focusing on features associated with hyperarousal.

Methods:

We studied sleep architecture in adults with chronic insomnia disorder from two randomized phase 3 clinical studies (Clinicaltrials.gov: NCT03545191 and NCT03575104) investigating 3 months of daridorexant treatment (placebo, daridorexant 25 mg, daridorexant 50 mg). We analyzed sleep–wake transition probabilities, EEG spectra, and sleep spindle properties including density, dispersion, and slow oscillation phase coupling. The wake EEG similarity index (WESI) was determined using a machine learning algorithm analyzing the spectral profile of the EEG.

Results:

At month 3, daridorexant 50 mg decreased wake-to-wake transition probabilities (p < .05) and increased the probability of transitions from wake-to-N1 (p < .05), N2 (p < .05), and REM sleep (p < .05), as well as from N1-to-N2 (p < .05) compared to baseline and placebo. Daridorexant 50 mg decreased relative beta power during wake (p = .011) and N1 (p < .001) compared to baseline and placebo. During the wake, relative alpha power decreased (p < .001) and relative delta power increased (p < .001) compared to placebo. Daridorexant did not alter EEG spectra bands in N2, N3, and REM stages or in sleep spindle activity. Daridorexant decreased the WESI score during wake compared to baseline (p = .004). Effects with 50 mg were consistent between months 1 and 3 and less pronounced with 25 mg.

Conclusions:

Daridorexant reduced EEG features associated with hyperarousal as indicated by reduced wake-to-wake transition probabilities and enhanced spectral features associated with drowsiness and sleep during wake and N1.

Clinical Trials:

ClinicalTrials.gov NCT03545191: study to assess the efficacy and safety of ACT-541468 (daridorexant) in adult and elderly participants with insomnia disorder. URL: Study Details | study to assess the efficacy and safety of ACT-541468 (daridorexant) in adult and elderly participants with insomnia disorder | ClinicalTrials.gov ClinicalTrials.gov NCT03575104:study to assess the efficacy and safety of ACT-541468 (daridorexant) in adult and elderly participants who experience difficulties sleeping. URL: study details | study to assess the efficacy and safety of ACT-541468 (daridorexant) in adult and elderly participants who experience difficulties sleeping | ClinicalTrials.gov

01 Nov 2024·DRUGS

Orexin Receptor Antagonists for the Prevention and Treatment of Alzheimer’s Disease and Associated Sleep Disorders

Review

Author: Carpi, Matteo ; Liguori, Claudio ; Mercuri, Nicola Biagio

Orexins/hypocretins are neuropeptides produced by the hypothalamic neurons, binding two G-protein coupled receptors (orexin 1 and orexin 2 receptors) and playing a critical role in regulating arousal, wakefulness, and various physiological functions. Given the high prevalence of sleep disturbances in Alzheimer's disease (AD) and their reported involvement in AD pathophysiology, the orexin system is hypothesized to contribute to the disease pathogenesis. Specifically, recent evidence suggests that orexin's influence may extend beyond sleep regulation, potentially affecting amyloid-β and tau pathologies. Dual orexin receptor antagonists (DORAs), namely suvorexant, lemborexant, and daridorexant, demonstrated efficacy in treating chronic insomnia disorder across diverse clinical populations. Considering their stabilizing effects on sleep parameters and emerging evidence of a possible neuroprotective role, these agents represent a promising strategy for AD management. This leading article reviews the potential use of orexin receptor antagonists in AD, particularly focusing on their effect in modulating disease-associated sleep disturbances and clinical outcomes. Overall, clinical studies support the use of DORAs to enhance sleep quality in patients with AD with comorbid sleep and circadian sleep-wake rhythm disorders. Preliminary results also suggest that these compounds might influence AD pathology, potentially affecting disease progression. Conversely, research on selective orexin receptor antagonists in AD is currently limited. Further investigation is needed to explore orexin antagonism not only as a symptomatic treatment for sleep disturbances, but also for its broader implications in modifying AD neurodegeneration, emphasizing mechanisms of action and long-term outcomes.

News (Medical) associated with Daridorexant hydrochloride

20 Dec 2024

·www.globenewswire.com

Idorsia provides update on the exclusive negotiations for the global rights to aprocitentan

Ad hoc announcement pursuant to Art. 53 LR Company announces delay to the targeted timeline for signing a binding agreementCompany in discussions with bondholders to restructure the company’s outstanding debt and extend the operational cash runway Allschwil, Switzerland – December 20, 2024Idorsia Ltd (SIX: IDIA) today provided an update on the ongoing exclusive negotiations for the global rights to aprocitentan. On November 27, 2024, the company announced that it had entered exclusive negotiations with an undisclosed party for global rights to aprocitentan that resulted in an exclusivity fee of USD 35 million paid in early December. At that time, the company was targeting signing an agreement before the end of 2024 and closing in early 2025, with more details to be shared should a final agreement be signed. In addition, the company announced plans to streamline its business to reduce costs and restructure its outstanding debt. Idorsia believes signing will not be achieved in 2024. Negotiations with the undisclosed party continue, however the company cannot guarantee that an agreement can be reached. As a result, the company is considering options to extend the company’s operational cash runway to bridge to a potential binding offer, as well as all strategic options. André C. Muller, CEO of Idorsia, commented: “Signing the agreement for aprocitentan is a crucial first step to ensure the future of Idorsia. Based on our current liquidity forecasts, there are additional prerequisites to allow the company to continue to operate, which include the completion of the recently announced company restructuring; the restructuring of the company’s outstanding debt, including the 2025 and 2028 convertible bonds; and raising additional funding. As a result of these constraints and the delay to the completion of the aprocitentan agreement, we are also considering all strategic options beyond a deal for aprocitentan.” Convertible Bond restructuringThe company has issued two convertible bonds which rank pari-passu, the first with a nominal value of CHF 200 million and a conversion price of CHF 6.00 per Idorsia share, maturing on January 17, 2025 (CB 2025), the second with a nominal value of CHF 600 million and a conversion price of CHF 31.54, maturing on August 4, 2028, although investors may request redemption of the bonds as of August 4, 2026 (CB 2028). Given the near-term maturity and the inability of the company to repay the bonds at this time, an extension to the CB 2025 is required whatever the outcome of the ongoing negotiation regarding the rights to aprocitentan. The company is in discussions with certain holders of the CB 2025 and the CB 2028 to amend the terms of both instruments following an extension of the CB 2025. Company restructuringFollowing a consultation process with employee representatives at headquarters a reduction of approximately 250 positions globally is anticipated. The company has already begun the implementation of the restructuring and expects the cost reduction to be largely effective by Q2 2025. Additional fundingIdorsia expects to close 2024 with cash of at least CHF 70 million including the USD 35 million exclusivity fee. The company could end 2024 with cash of around CHF 100 million, should an additional deal close in the coming days. Should the potential agreement for the rights to aprocitentan conclude in a timely manner, in-line with the upfront payment anticipated in the non-binding offer, and subject to the CB 2025 restructuring, Idorsia would be funded until mid-2025. The company is diligently seeking additional funding of at least CHF 200 million to extend its operational cash runway into at least 2026. Updated guidance for 2024For 2024 – excluding unforeseen events and broadly in-line with previously issued guidance – the company expects QUVIVIQ net sales of around CHF 55 million, SG&A expenses of around CHF 265 million, R&D expense of around CHF 130 million for Idorsia-led pipeline assets, leading to non-GAAP operating expenses around CHF 400 million. This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 350 million. The company expects a US GAAP operating loss for 2024 of around CHF 260 million which includes a one-off benefit of CHF 125 million from the agreement with Viatris on selatogrel and cenerimod and an estimated restructuring charge of CHF 10 million. Guidance for 2024 in CHF million* Idorsia-led business Partner-led business Global BusinessREVENUE 55 50 105COGS -10 -30 -40SG&A OPEX -265 – -265R&D OPEX -130 0 -130Non-GAAP EBIT -350 20 -330D&A -30 – -30SBC -15 – -15Other -10 125 115US-GAAP EBIT -405 145 -260 *Excluding unforeseen events Notes to the editor About the 2025 convertible bondOn July 17, 2018, Idorsia raised CHF 200 million through the issuance of convertible bonds to fund the Phase 3 development of aprocitentan, clazosentan, lucerastat and daridorexant, as well as the early-stage and preclinical pipeline. The bonds initially had a term of six years, maturing on July 17, 2024. On May 6, 2024, a bondholders’ meeting approved modifications to the terms of the convertible bonds to, among others, amend the conversion price to CHF 6.00 per Idorsia share (from CHF 33.95) and extend the maturity date by six months to January 17, 2025. About the 2028 convertible bondOn August 4, 2021, Idorsia raised CHF 600 million through the issuance of convertible bonds to support the commercial product launches in several key markets and to fund the further development of the late-stage pipeline. The bonds have a conversion price of CHF 31.54 and a term of seven years, maturing on August 4, 2028. Investors may request redemption of the bonds as of the 5th anniversary of the settlement date. About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contactAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 (0)58 844 10 10investor.relations@idorsia.commedia.relations@idorsia.com www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

Financial Statement

19 Dec 2024

·www.globenewswire.com

Nxera Pharma and Shionogi Launch QUVIVIQ™ in Japan for Adults with Insomnia

Tokyo, Japan and Cambridge, UK, 19 December 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – and Shionogi & Co., Ltd. (“Shionogi”) today announce that QUVIVIQ™ (daridorexant) 25 and 50 mg has been launched and is now available in Japan as a new treatment for adults with insomnia. QUVIVIQ™ is an oral Dual Orexin Receptor Antagonist (DORA) for the treatment of insomnia that selectively binds to receptors of the wake-promoting neuropeptide orexin (OX1R and OX2R), inhibiting excessive wakefulness and facilitating the transition to sleep. Nxera Pharma Japan Co., Ltd. (a wholly owned subsidiary of Nxera Pharma) is the approval holder and will be responsible in part for provision of drug product. Shionogi will be solely responsible for distribution and sales activities for QUVIVIQ™ in Japan under the commercial partnership agreement with Nxera Pharma announced on 1 October 2024. For Nxera, reaching this important milestone highlights its ability to develop novel therapeutics for patients in Japan and reinforces its ambition to be a partner of choice for companies looking to develop and commercialize new therapeutics for the Japanese market. As a new pillar, Shionogi is focusing on the 'QOL disease area,' which is less affected by trends. Starting with the launch of QUVIVIQ™, Shionogi is working to strengthen the 'QOL disease area' as a solid pillar. Together, Nxera and Shionogi are committed to deliver QUVIVIQ™ as quickly as possible as a product that has the potential to meet the needs of insomnia patients for a long time to come. –END– Notes to Editors Product Information Product nameQUVIVIQ™ 25 mg, 50 mgNon-proprietary namedaridorexantIndicationInsomniaDosage regimenThe usual adult dosage is 50 mg of daridorexant to be taken orally once daily immediately before bedtime. In addition, depending on the patient's condition, 25 mg can be administered once daily.Date of approval24 September 2024Date of NHI price listing20 November 2024Date of launch19 December 2024Drug priceJPY57.30 per 25 mg tabletJPY90.80 per 50 mg tabletApproval holderNxera Pharma Japan Co., Ltd.DistributorShionogi & Co., Ltd. About QUVIVIQ™QUVIVIQ™ (daridorexant) is a dual orexin receptor antagonist, discovered by Idorsia Pharmaceuticals Ltd, that blocks the binding and activity of the wake-promoting neuropeptides known as orexins. In October 2022, daridorexant achieved positive Phase 3 top-line results in Japanese patients with insomnia and Nxera Pharma Japan has obtained the manufacturing and marketing approval in Japan for QUVIVIQ™ as a treatment for adult patients with insomnia, as of September 24, 2024. Daridorexant is approved in the US, Europe and Canada, and marketed in these territories under the brand name QUVIVIQ™ by Idorsia Pharmaceuticals Ltd. * QUVIVIQ™ is a trademark of Idorsia Ltd. About Insomnia DisorderInsomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep. Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. According to a survey by Japan’s Ministry of Health, Labour and Welfare in 2018, about 20% of Japanese adults struggle to get enough rest from sleep. Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels. The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy. About ShionogiShionogi strives constantly to supply the best possible medicine (healthcare solutions) to protect the health and wellbeing of the patients we serve, and as a united group. We have identified Contributing to a Healthy and Prosperous Life as a material focus. We are committed to creating a society where everyone can lead a longer, more vibrant life, realizing their goals.For more information, please visit https://www.shionogi.com/global/en/ About Nxera PharmaNxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery NxWave™ platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). For more information, please visit www.nxera.life LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma Enquiries: Nxera – Media and Investor RelationsKentaro Tahara, VP Investor Relations and Corporate StrategyShinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life MEDiSTRAVA (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | Nxera@medistrava.com Forward-looking statementsThis press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Drug ApprovalClinical ResultPhase 3License out/in

19 Dec 2024

·www.shionogi.com

SHIONOGI and Nxera Pharma Launch QUVIVIQ in Japan for Adults with Insomnia

OSAKA, Japan, December 19, 2024 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") and Nxera Pharma Co., Ltd.（Head office: Tokyo, Chief Executive Officer: Christopher Cargill, hereafter ”Nxera Pharma”) announced that QUVIVIQ™ (daridorexant) 25 and 50 mg has been launched and is now available in Japan as a new treatment for adults with insomnia. QUVIVIQ™ is an oral Dual Orexin Receptor Antagonist for the treatment of insomnia that selectively binds to receptors of the wake-promoting neuropeptide orexin (OX1R and OX2R), inhibiting excessive wakefulness and facilitating the transition to sleep. Shionogi will be solely responsible for distribution and sales activities for QUVIVIQ™ in Japan under the commercial partnership agreement with Nxera Pharma announced on 1 October 2024. Nxera Pharma Japan Co., Ltd. (a wholly owned subsidiary of Nxera Pharma) is the approval holder and will be responsible in part for provision of drug product1,2. For Nxera, reaching this important milestone highlights its ability to develop novel therapeutics for patients in Japan and reinforces its ambition to be a partner of choice for companies looking to develop and commercialize new therapeutics for the Japanese market. As a new pillar, Shionogi is focusing on the 'QOL disease area,' which is less affected by trends. Starting with the launch of QUVIVIQTM, we are working to strengthen the 'QOL disease area' as a solid pillar Together, Nxera and Shionogi are committed to deliver QUVIVIQ™ as quickly as possible as a product that has the potential to meet the needs of insomnia patients for a long time to come. References 1: Press release on October 1,2024 by Shionogi 2: Press release on October 1,2024 by Nxera Pharma About QUVIVIQTM QUVIVIQ™ (daridorexant) is a dual orexin receptor antagonist, discovered by Idorsia Pharmaceuticals Ltd, that blocks the binding and activity of the wake-promoting neuropeptides known as orexins. In October 2022, daridorexant achieved positive Phase 3 top-line results in Japanese patients with insomnia and Nxera Pharma Japan has obtained the manufacturing and marketing approval in Japan for QUVIVIQTM as a treatment for adult patients with insomnia, as of September 24, 2024*. Daridorexant is approved in the US, Europe and Canada, and marketed in these territories under the brand name QUVIVIQ™ by Idorsia Pharmaceuticals Ltd. * Press release on September 24,2024 by Nxera Pharma About Insomnia Disorder Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep. Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. According to a survey by Japan’s Ministry of Health, Labour and Welfare in 2018, about 20% of Japanese adults struggle to get enough rest from sleep. Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels. The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy. About Shionogi Shionogi strives constantly to supply the best possible medicine (healthcare solutions) to protect the health and wellbeing of the patients we serve, and as a united group. We have identified Contributing to a Healthy and Prosperous Life as a material focus. We are committed to creating a society where everyone can lead a longer, more vibrant life, realizing their goals. For more information, please visit https://www.shionogi.com/global/en/ About Nxera Pharma Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. For more information, please visit www.nxera.life For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.htm Nxera Pharma Website Inquiry Form: https://www.nxera.life/contact

Drug ApprovalClinical ResultPhase 3License out/in

100 Deals associated with Daridorexant hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11886 D11887	Daridorexant hydrochloride	-	DB15031

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	US	Idorsia Pharmaceuticals Ltd.	07 Jan 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Sleep	NDA/BLA	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	16 Jul 2024
Sleep	NDA/BLA	CN	Farmea	16 Jul 2024
Sleep	NDA/BLA	CN	Idorsia Pharmaceuticals Deutschland GmbH	16 Jul 2024
Sleep Apnea, Obstructive	Phase 1	DE	Idorsia Pharmaceuticals Ltd.	14 Mar 2019
Pulmonary Disease, Chronic Obstructive	Phase 1	DE	Idorsia Pharmaceuticals Ltd.	15 Nov 2018
Liver Diseases	Phase 1	CH	Idorsia Pharmaceuticals Ltd.	26 Feb 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05702177 (Pubmed \| J Psychopharmacol)	Phase 1	-	36	Daridorexant 25 mg	hwopkkoqnc(rmzabxltrl) = jtsndhxpmt cltugvthwt (offwpaymuw ) View more	Positive	06 Dec 2024
				Daridorexant 50 mg	hwopkkoqnc(rmzabxltrl) = tcjjsykbxu cltugvthwt (offwpaymuw ) View more
EAN2024	Not Applicable	Sleep Initiation and Maintenance Disorders	23	Daridorexant	gfpckxglvr(vkhxetaxsh) = Questionnaire scores indicated a clinically meaningful reduction: IDSIQ- cognitive domain by 10 fqjzmciuvr (csxdqjlrxr ) View more	Positive	28 Jun 2024
NCT05480488 (Pubmed) Manual	Phase 1	-	18	midazolamant 50 mwarfarin	khhhqcrqtk(zuelclktrn) = jfqpypvivo jxpytfqslc (qzszljwneg ) View more	Positive	13 Mar 2024
				daridorexantmgmidazolamwarfarin	khhhqcrqtk(zuelclktrn) = klzaxfxgac jxpytfqslc (qzszljwneg ) View more
NCT03545191 (Phase 3 trial, WSC2023)	Phase 3	Sleep Initiation and Maintenance Disorders \| Sleep Apnea, Obstructive	930	Daridorexant 50 mg	lxigokvcda(xfrpiupbbo) = Two participants discontinued study treatment due to AEs (both in placebo) rbnzaiqdfs (qtpobukayq ) View more	Positive	22 Oct 2023
				Placebo
NCT03575104 \| NCT03545191 (Phase 3 studies, WSC2023)	Phase 3	Sleep Initiation and Maintenance Disorders	-	Daridorexant 50 mg	fjltpimqvf(quohyxbiys) = necdneujle btxvjyfqdc (yyqfjdtxzh ) View more	Positive	22 Oct 2023
NCT03679884 (Pubmed) Manual	Phase 3	Sleep Initiation and Maintenance Disorders	804	Daridorexant	htgpolevuo(dlqvsnhnni) = Overall incidence of treatment-emergent adverse events was similar across groups (35-40%). udeknoleab (cwodphfhsy ) View more	Positive	09 Dec 2022
				Placebo
NCT03545191 (Pubmed)	Phase 3	Sleep Initiation and Maintenance Disorders	930	Daridorexant 50 mg	lpwszgpfaq(ankjtbbvcb) = no cases of cataplexy rvdnlnplea (bgocuqktyg ) View more	-	13 Sep 2022
				Daridorexant 25 mg
NCT03575104 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders \| Sleep	924	Daridorexant (Daridorexant 10 mg)	fgqfkoqkid(rqfodtgbkt) = bbbycjmvxa imbgxiflvg (ytbaqtlknv, nfoynryqgu - vdtfwfomeu) View more	-	25 Mar 2022
				Daridorexant (Daridorexant 25 mg)	fgqfkoqkid(rqfodtgbkt) = extjpwisrk imbgxiflvg (ytbaqtlknv, besbpnguvb - dvcchbjoin) View more
NCT03545191 (Phase 3 trial \| NCT03679884 \| ###DELETE \| phase-3, CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders	930	Daridorexant 25 mg (Daridorexant 25 mg)	xglahcawxc(gmxmjejgpd) = fmtnbcqaqf dvysrsslhu (zhalkmzpvn, ominuoowts - mctclbgczn) View more	-	25 Mar 2022
				Daridorexant 50 mg (Daridorexant 50 mg)	xglahcawxc(gmxmjejgpd) = ftdxmbgtlw dvysrsslhu (zhalkmzpvn, hinlgahexf - qmnmjmtcos) View more
Phase 3 program (WSC2022)	Phase 3	Sleep Initiation and Maintenance Disorders	-	Daridorexant 25 mg	vpydmomumy(scuewrvkmd) = gsvmprevbr tmriemypjh (itmlmpzfgy, 56.7) View more	Positive	11 Mar 2022
				Daridorexant 50 mg	vpydmomumy(scuewrvkmd) = hglweulczh tmriemypjh (itmlmpzfgy, 55.8) View more

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