[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulations, 25 mg and 50 mg of Daliresan hydrochloride tablets, and the reference formulations, 25 mg and 50 mg of Daliresan hydrochloride tablets, in healthy adult subjects in the fasting state

主要研究目的研究空腹状态下单次口服受试制剂盐酸达利雷生片（规格：25 mg和50 mg；海南先声药业有限公司生产）与参比制剂盐酸达利雷生片（QUVIVIQ®，规格：25 mg和50 mg，Idorsia Pharmaceutical Deutschland GmbH委托Farmea生产）在中国健康成年受试者体内的药代动力学行为，评价空腹状态口服两种制剂的生物等效性。次要研究目的研究受试制剂盐酸达利雷生片和参比制剂盐酸达利雷生片在中国健康成年受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetic behavior of the test preparation Daliresan hydrochloride tablets (specifications: 25 mg and 50 mg; produced by Hainan Xiansheng Pharmaceutical Co., Ltd.) and the reference preparation Daliresan hydrochloride tablets (QUVIVIQ®, specifications: 25 mg and 50 mg, produced by Farmea on behalf of Idorsia Pharmaceutical Deutschland GmbH) in healthy Chinese adult subjects after single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations after oral administration under fasting conditions. Secondary study objectives To study the safety of the test preparation Daliresan hydrochloride tablets and the reference preparation Daliresan hydrochloride tablets in healthy Chinese adult subjects.

Start Date03 Jun 2025

Sponsor / Collaborator

Simcere Pharmaceutical (Hainan) Co. Ltd.

NCT07028697

/ RecruitingPhase 3

A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.

Start Date04 Dec 2024

Sponsor / Collaborator

Nxera Pharma Korea Co. Ltd.

NCT06498128

/ RecruitingNot Applicable

QUVIVIQ® Pregnancy Registry

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]

100 Clinical Results associated with Daridorexant hydrochloride

100 Translational Medicine associated with Daridorexant hydrochloride

100 Patents (Medical) associated with Daridorexant hydrochloride

135

Literatures (Medical) associated with Daridorexant hydrochloride

01 Nov 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery, asymmetric synthesis and biological evaluation of new bisbenzylisoquinoline-orexin receptor antagonists for insomnia treatment

Article

Author: Liu, Shao ; Zhang, Yindi ; Liu, Yufeng ; Wang, Yang ; He, Jia ; Ge, Chengyu ; Jiang, Yueping ; Fang, Jing

The development of new orexin receptor (OXR) antagonists represents a crucial avenue for addressing the urgent need for safe and effective anti-insomnia drugs in clinical practice. Our group discovered neferine, a bisbenzylisoquinoline alkaloid isolated from Nelumbinis Plumula, exhibited a predicted binding affinity for OXR through virtual screening. Herein, we report the asymmetric synthesis of neferine and its isomers using a novel CuBr•Me₂S/picolinic acid-catalyzed arylation method. Biological assay results indicated that (R,S)-neferine demonstrated superior OXR antagonistic activity than suvorexant, with good binding affinities of KD (OX₁R) 0.68 and (OX₂R) 0.81 nM. In vivo pharmacodynamic studies showed that (R,S)-neferine reduced spontaneous activities in mice more effectively than daridorexant and significantly improved sleep in insomnia mice. Furthermore, (R,S)-neferine can restore the significant downregulation of PER1 and PER2, along with the upregulation of BMAL1 caused by insomnia, and decrease the expression of OX₁R and OX₂R, thereby improving core circadian rhythm disorders. (R,S)-neferine carried outstanding pharmacokinetic (F = 63.7 %) and safety profiles (LD50 > 500 mg/kg), no mortality or histopathological changes were observed during the acute toxicity test. Overall, this work highlights the therapeutic potential of the OXR antagonist (R,S)-neferine, providing candidates and viable drug development strategies for the treatment of insomnia.

01 Sep 2025·PSYCHIATRY RESEARCH

Global burden of insomnia medication-associated suicidality, 1967–2024: A disproportionality analysis of the global pharmacovigilance database

Article

Author: Cho, Hanseul ; Hwang, Jiyoung ; Chung, Eun Kyoung ; Fond, Guillaume ; Yon, Dong Keon ; Kim, Tae Hyeon ; Boyer, Laurent ; Lee, Kyeongmin ; Lee, Suhyun

BACKGROUND:

While insomnia is recognized as a risk factor for suicidality, the potential influence of insomnia medications on this risk requires further investigation.

METHODS:

We utilized the global pharmacovigilance database, to detect pharmacovigilance signal of insomnia medication-related suicidality from 1967 to 2024. The analysis included benzodiazepines, Z-drugs, antidepressants, first-generation H1 antagonists, and dual orexin receptor antagonists for insomnia medications. Multivariable logistic regression models were used to calculate the reporting odds ratio (ROR) and 95 % confidence interval (CI) of suicidality for each medication class, adjusting for age, sex, and reporting region, with melatonin and its receptor agonist as the reference.

RESULTS:

We identified 13,899 reports of suicidality associated with insomnia medications. Benzodiazepines (ROR, 1.78 [95 % CI, 1.62-1.97]), Z-drugs (1.52 [1.40-1.66]), antidepressants (2.08 [1.88-2.31]), and first-generation H1 antagonists (1.59 [1.45-1.73]) showed stronger signal of suicidality compared to melatonin and its receptor agonist. In contrast, dual orexin receptor antagonists (ROR, 0.36 [0.31-0.42]) exhibited a lower signal risk. The melatonin receptor agonist ramelteon (ROR, 0.29 [0.21-0.39]) showed a weaker signal than melatonin. Similarly, dual orexin receptor antagonists suvorexant (ROR, 0.31 [0.26-0.37]), daridorexant (0.20 [0.14-0.29]), and lemborexant (0.24 [0.11-0.51]) significantly lowered the signal risk of suicidality compared to melatonin.

CONCLUSIONS:

Although this disproportionality analysis did not permit causal interpretation, our study highlights significant variations in suicidality signal risk among insomnia medications, with benzodiazepines, Z-drugs, antidepressants, and first-generation H1 antagonists posing stronger signal, and dual orexin receptor antagonists presenting a weaker signal. Given the limitations of pharmacovigilance data, further studies are needed to confirm these findings and guide safer prescribing practices, particularly for individuals at high risk of suicidality.

01 Sep 2025·SLEEP MEDICINE

The putative effects of orexin receptor antagonists on pain and sleep in humans: A systematic review

Review

Author: Morin, Charles M ; Puertas-Cuesta, F Javier ; Sangalli, Linda ; Lavigne, Gilles J ; Herrero Babiloni, Alberto ; Fabbro, Cibele Dal

OBJECTIVE:

Orexin antagonists are newer medications for management of insomnia, a condition frequently associated to chronic pain. This systematic review evaluates the effects of orexin receptor antagonists on pain perception and pain-related outcomes in humans, considering their role in both sleep regulation and pain modulation.

METHODS:

A search was conducted in PubMed, Web of Science, Scopus, CINAHL, PsycINFO, and ClinicalTrials.gov, following PRISMA guidelines. Eligible studies included human participants with acute or chronic pain who received orexin receptor antagonists (e.g., suvorexant, lemborexant, daridorexant, filorexant) with pain intensity, pain thresholds, sleep disturbances, and functional outcomes as primary measures. Risk of bias was assessed using RoB 2 for randomized controlled trials (RCTs) and ROBINS-E for observational studies, while the GRADE approach was applied to assess the overall certainty of evidence.

RESULTS:

Out of 488 identified records, four studies met the inclusion criteria (three RCTs, one observational study), totaling 331 participants. No significant improvements in pain intensity were found, though one study observed increased pain sensitivity thresholds in fibromyalgia patients. Conversely, orexin receptor antagonists consistently improved sleep parameters, including total sleep time and sleep onset latency. Evidence certainty was moderate for RCTs and low for the observational study, with imprecision and publication bias as key concerns.

CONCLUSION:

Orexin receptor antagonists improve sleep, but due to the very limited number of studies and small sample sizes, evidence regarding analgesic effects in humans remains inconclusive. The lack of receptor-selective interventions, short treatment durations, and pain condition variability may contribute to these findings. Future trials should investigate mechanistic analgesic effects, receptor-specific therapies, and explore orexin's role in pain phenotypes.

News (Medical) associated with Daridorexant hydrochloride

30 Jun 2025

·pipelinereview.com

A factory in a lab: Idorsia's breakthrough synthetic glycan vaccine platform validated for the first time in humans

ALLSCHWIL, Switzerland I June 30, 2025 I Idorsia Ltd. (SIX: IDIA) today announced a milestone in the development of its first bacterial vaccine based on the company’s synthetic glycan chemistry platform. The Clostridioides difficile (C. dfficile) vaccine is based on a synthetic glycan mimicking a surface glycan antigen and covers more than 90% of all existing strains of C. difficile bacteria and also targets the spores. Initial data showed that the vaccine is well-tolerated and showed immunogenicity in a Phase 1 study. C. difficile infection C. difficile is a spore-forming and toxin-producing bacterium. It is the leading cause of antibiotic-associated diarrhea in developed countries. It infects the gastrointestinal tract when there is an imbalance in the gut flora, resulting, for example, from the use of antibiotics. C. difficile infection (CDI) symptoms can range from mild diarrhea to pseudomembranous colitis, which in some cases – particularly in the elderly – can lead to death. CDI is a major public health threat, particularly because recurrences are frequent, and is increasing with aging of the population. In the US, C. difficile is estimated to cause almost 400,000 infections each year. One in eleven people over 65 diagnosed with healthcare associated CDI die within one month. C. difficile infections cause more than 25,000 deaths each year in the US alone. CDI places a significant economic burden on the healthcare system. The acute care direct costs of CDI are estimated to be $5–6 billion per year in the US and €3 billion per year in Europe. Standard treatments of CDI are efficacious in clearing primary CDI. However, CDI recurs in up to 25% of treated patients. The C. difficile vaccine identified by Idorsia targets both spores and vegetative C. difficile bacteria and, therefore, could prevent not only colonization but also transmission. Frail patients, elderly persons, persons in nursing homes, on antibiotic treatment, hospitalized, or expected to be hospitalized, could be target population for this prophylactic vaccine. Martine Clozel, MD, Chief Scientific Officer of Idorsia, commented: “There is a huge medical need in older age populations for the prevention of CDI and I am so excited by the breakthrough that Idorsia could bring to the community. The first clinical results of this C. difficile glycoconjugate vaccine are a clinical validation of our revolutionary technology, which transforms biology into chemistry for creating novel vaccines. Our first vaccine could potentially prevent infection, symptoms, recurrences and transmission. We must now find the right partner, who could rapidly advance the development of this promising vaccine but also of our other advanced bacterial vaccines. The technology also has additional potential, for multiple bacterial targets, and then potentially fungal, parasitic and oncological threats.” Idorsia’s vaccine IDOR-1134-2831 is intended to be developed for the prevention of CDI in patients at risk in hospital and community settings, with the potential to eradicate bacteria and spores. A unique approach to vaccination – what is a synthetic glycan vaccine? Pathogenic bacteria like C. difficile express carbohydrates (glycans) on their surface which are recognized by the hosts immune system, leading to the production of glycan specific antibodies. This makes glycans on the surface of pathogens attractive candidates for vaccine development. The synthetic glycan in Idorsia’s C. difficile vaccine is synthesized in a carefully designed chemical process. This transforms a complex biochemical extraction, which is associated with heavy investment, into a purely chemical process driven by medicinal chemistry. Idorsia’s C. difficile synthetic glycan vaccine has the advantage of being stable, immunogenic, fully characterizable and millions of doses can be manufactured in a chemistry lab – limiting manufacturing costs. About the Phase 1 study The Phase 1 clinical pharmacology study is a double-blind, randomized, placebo-controlled, two-part trial to assess the safety, tolerability, and immunogenicity of up to 3 ascending dose levels of the IDOR-1134-2831 vaccine in healthy participants aged < 50. About Idorsia’s vaccine portfolio In addition to the C. difficile vaccine that is in Phase 1 clinical development, Idorsia is also developing synthetic glycan vaccines for infections caused by Klebsiella pneumoniae and Neisseria gonorrhoeae . Notes to the editor About Idorsia Idorsia 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). SOURCE: Idorsia

Phase 1VaccineClinical Result

25 Jun 2025

·www.globenewswire.com

Idorsia launches repurchase offer for its 2025 and 2028 convertible bonds

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – June 25, 2025Idorsia Ltd (SIX: IDIA) today announced the launch of the repurchase offer to the holders of its outstanding CHF 200 million convertible bonds maturing in 2025 (CB 2025; ISIN CH0426820350), and CHF 600 million convertible bonds maturing in 2028 (CB 2028; ISIN CH1128004079) (the Repurchase Offer). The Repurchase Offer is part of a larger holistic restructuring, as announced in a press release on February 26, 2025, and an update published on May 21, 2025. To date, bondholders holding approximately 87.5% of the aggregate nominal value of the CB 2025 and approximately 90.1% of the aggregate nominal value of the CB 2028 have entered a legally binding lockup agreement in support of the holistic restructuring, including the Repurchase Offer. Such bondholders have committed to participating in the Repurchase Offer and to tender their CB 2025 and/or CB 2028 holdings. The main offer period of the Repurchase Offer is expected to start on July 10, 2025, and end at 17:30 hrs CEST on August 7, 2025. The Repurchase Offer is subject to certain offer conditions, as set out in the repurchase notice in relation to the Repurchase Offer (such notice, together with the other Repurchase Offer documentation (if any), the Repurchase Offer Documentation). These include a minimum acceptance rate condition, whereby at least 85% of the total issued nominal value of the CB 2025 and the CB 2028 must be validly tendered by the end of the main offer period of the Repurchase Offer. Bondholders can access the Repurchase Offer Documentation, including further information and instructions at the following link: www.idorsia.com/exchange-offer. Bondholders can participate in the Repurchase Offer and tender their CB 2025 and/or CB 2028 holdings via Kroll Issuer Services Ltd (the Agent) at the following link: https://deals.is.kroll.com/idorsia. Under the same link, eligible bondholders can (i) also participate in the new money facility via our Agent and (ii) find the eligibility criteria for participating in the new money facility. Further details regarding the interaction between participation in the new money facility and the Repurchase Offer can be found in the Repurchase Offer Documentation. Notes to the editor and legal notes 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 contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com Legal Notice and InformationThe above information contains or may contain 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. The information contained in this media release is for information purposes only and does not constitute, or form part of, an offer or invitation to purchase, sell, exchange or issue, or a solicitation of an offer to sell, purchase, exchange or subscribe to, any securities of Idorsia Ltd or Idorsia Investments SARL, including without limitation the CB 2025 and the CB 2028, or any other person, nor shall it form the basis of, or be relied upon in connection with, any contract therefor. This media release is not part of the Repurchase Offer Documentation in relation to the Repurchase Offer. Terms and conditions of the Repurchase Offer have been and/or will be published in the Repurchase Offer Documentation. Holders of CB 2025 and/or CB 2028 are urged to read the Repurchase Offer Documentation, which is and/or will be available at www.idorsia.com/exchange-offer. This media release is not a financial product or investment advice, nor is it a recommendation to acquire, exchange or dispose of securities or accounting, legal or tax advice. It has been prepared without taking into account the objectives, legal, financial or tax situation and needs of individuals. Before making any investment decision, individuals should read the Repurchase Offer Documentation and consider the appropriateness of the information having regard to their own objectives, legal, financial and tax situation and needs and seek legal, tax and other advice as appropriate for their individual needs and jurisdiction. Offer RestrictionsThis media release is only intended for distribution to non-U.S. persons (within the meaning of Regulation S under the U.S. Securities Act of 1933, as amended). This media release is not an offer to tender securities or an offer of securities. The Repurchase Offer is being made on the basis of the Repurchase Offer Documentation only and is subject to the restrictions described therein. The Repurchase Offer is not being made, and will not be made, directly or indirectly in or into, or by use of the mails of, or by any means or instrumentality of interstate or foreign commerce of, or of any facilities of a national securities exchange of, the United States. This includes, but is not limited to, facsimile transmission, electronic mail, telex, telephone, the internet and other forms of electronic communication. Attachment Press Release PDF

23 Jun 2025

·www.globenewswire.com

Idorsia’s QUVIVIQ expands into China as Simcere receives NDA approval – Idorsia and Simcere update their licensing agreement

Ad hoc announcement pursuant to Art. 53 LR Idorsia to receive USD 50 million (an additional USD 30 million) approval milestone payment in return for a reduction in Simcere potential sales milestones and tiered royalty payments. Allschwil, Switzerland – June 23, 2025Idorsia Ltd. (SIX: IDIA) today announced that Simcere Pharmaceuticals Group Ltd (2096.HK, “Simcere”) has received approval for QUVIVIQ® (daridorexant) from the Chinese National Medical Products Administration for the treatment of adult patients with insomnia characterized by difficulty falling asleep and/or maintaining sleep, with no psychotropic drug control labeling. In addition, Idorsia has reached an agreement with Simcere to update the terms of the licensing agreement for QUVIVIQ in China. André C. Muller, Chief Executive Officer of Idorsia, commented:“I want to congratulate everyone at Simcere and the team that supported them from Idorsia. Together they have been able to take our drug from pre-IND, through to local Phase 1 and Phase 3, and then filing, resulting in this approval at an incredible pace of 2.5 years since the signing of the license agreement. I’m very happy as QUVIVIQ becomes a truly global brand, now available to millions of patients in North America, Europe, Japan and China, and we aim to continue this expansion to new territories.” Ren Jinsheng, Chairman and Chief Executive Officer of Simcere, commented:“I echo the congratulations to both teams that have worked diligently together to get this approval. Importantly, the clinical results achieved in both the global and local trials have enabled QUVIVIQ to be approved with no psychotropic drug control labeling in China. We are committed to make QUVIVIQ available to a great number of patients suffering with chronic insomnia.” Under the updated terms of the agreement, Idorsia will receive an approval milestone payment of USD 50 million, commercial milestone payments of up to USD 93 million, and low- to high-single-digit tiered royalties on future net sales. Arno Groenewoud, Chief Financial Officer of Idorsia, commented:“The updated agreement with Simcere allows both companies to streamline the collaboration. The increased milestone payment of USD 50 million in 2025 underscores Simcere's commitment and confidence in the potential of QUVIVIQ, following its significant investment in sealing this approval for Chinese patients and the corresponding launch preparations.” In 2022, Idorsia and Simcere entered into an exclusive licensing agreement for Idorsia’s QUVIVIQ in China. Under the agreement, Simcere has an exclusive right to develop and commercialize QUVIVIQ in the Greater China region (Mainland China, Hong Kong, and Macau). Notes to the editor 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 contactInvestor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.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

License out/inDrug Approval

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	United States	Idorsia Pharmaceuticals Ltd.	07 Jan 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Sleep	Phase 3	United States	Idorsia Pharmaceuticals Ltd.	29 May 2018
Sleep	Phase 3	Belgium	Idorsia Pharmaceuticals Ltd.	29 May 2018
Sleep	Phase 3	Bulgaria	Idorsia Pharmaceuticals Ltd.	29 May 2018
Sleep	Phase 3	Canada	Idorsia Pharmaceuticals Ltd.	29 May 2018
Sleep	Phase 3	Czechia	Idorsia Pharmaceuticals Ltd.	29 May 2018
Sleep	Phase 3	Finland	Idorsia Pharmaceuticals Ltd.	29 May 2018
Sleep	Phase 3	France	Idorsia Pharmaceuticals Ltd.	29 May 2018
Sleep	Phase 3	Germany	Idorsia Pharmaceuticals Ltd.	29 May 2018
Sleep	Phase 3	Hungary	Idorsia Pharmaceuticals Ltd.	29 May 2018
Sleep	Phase 3	Sweden	Idorsia Pharmaceuticals Ltd.	29 May 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06630390 (CTgov)	Phase 2	Emergence Delirium \| postoperative cognitive dysfunction	11	Daridorexant 50 mg (Daridorexant)	vkjunjugfw = mynxupiedp uhbaxyggmw (iuyewrzxqu, jrchrtqqps - fngekgauij) View more	-	11 Jul 2025
				Placebo (Placebo)	vkjunjugfw = wmrqajoqrd uhbaxyggmw (iuyewrzxqu, lgjjvzkoqt - qjxcwksdce) View more
NCT03545191 (Pubmed \| Sleep Med)	Phase 3	Sleep Initiation and Maintenance Disorders	930	Daridorexant 50 mg	scchdkbhoc(cmwfcbgakv) = adcxbjpsft vnkpiqhlxi (jxscblyzcm )	Positive	01 Jul 2025
				Daridorexant 25 mg	scchdkbhoc(cmwfcbgakv) = dibcqucgft vnkpiqhlxi (jxscblyzcm )
NCT05597020 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Nocturia	60	Placebo	rbnsngzcsc(emhyjzlbfi) = mkwhglilmv hjgzztkvgd (cwfshvwnwn, zumyvwfrbt - zlpmidzqrn) View more	-	18 Apr 2025
NCT05702177 (Pubmed \| J Psychopharmacol)	Phase 1	-	36	Daridorexant 25 mg	ciubaabfdj(pblgwjgphf) = vjvgmowbhf uvwrhwotsp (hvkhwamfjn ) View more	Positive	06 Dec 2024
				Daridorexant 50 mg	ciubaabfdj(pblgwjgphf) = gzsxhkwfdt uvwrhwotsp (hvkhwamfjn ) View more
EAN2024	Not Applicable	Sleep Initiation and Maintenance Disorders	23	Daridorexant	baeubrciqp(zmsvnpcxgw) = Questionnaire scores indicated a clinically meaningful reduction: IDSIQ- cognitive domain by 10 rnfendkbgh (jbddtggrne ) View more	Positive	28 Jun 2024
NCT05480488 (Pubmed) Manual	Phase 1	-	18	midazolamant 50 mwarfarin	fwkfudjhyk(ikeunkkgfl) = tgdcjwgyzu uvthkuzenl (cgzxcavvsh ) View more	Positive	13 Mar 2024
				daridorexantmgmidazolamwarfarin	fwkfudjhyk(ikeunkkgfl) = ayjhxfwiof uvthkuzenl (cgzxcavvsh ) View more
NCT03545191 (Phase 3 trial, WSC2023)	Phase 3	Sleep Initiation and Maintenance Disorders \| Sleep Apnea, Obstructive	930	Daridorexant 50 mg	kklgjdyote(jppfakwcch) = Two participants discontinued study treatment due to AEs (both in placebo) qyroekhvkt (eqrswmlgoc ) View more	Positive	22 Oct 2023
				Placebo
NCT03575104 \| NCT03545191 (Phase 3 studies, WSC2023)	Phase 3	Sleep Initiation and Maintenance Disorders	-	Daridorexant 50 mg	ykhpjiyxjj(kgteydwuay) = dvrafkcpmh fibzqmmgww (qvxbsbfsil ) View more	Positive	22 Oct 2023
NCT03679884 (Pubmed) Manual	Phase 3	Sleep Initiation and Maintenance Disorders	804	Daridorexant	vsryvwehlk(zwpzuuiuaw) = Overall incidence of treatment-emergent adverse events was similar across groups (35-40%). ilhcbzmcbb (uwwdixpykp ) View more	Positive	09 Dec 2022
				Placebo
NCT03545191 (Pubmed)	Phase 3	Sleep Initiation and Maintenance Disorders	930	Daridorexant 50 mg	qnlozgvajm(pjknkkkwnc) = no cases of cataplexy qiqxxghmsg (evpfgjdrzh ) View more	-	13 Sep 2022
				Daridorexant 25 mg

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