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

186

Literatures (Medical) associated with Daridorexant hydrochloride

01 Feb 2025·The American Journal of Geriatric Psychiatry

Efficacy And Safety of Dual Orexin Receptor Antagonist (DORA) For Sleep Disturbance in Patients With Alzheimer's Disease Dementia. A Review Article

Review

Author: Oster, Joel ; Alshiban, Abdulrahman ; Hasoglu, Tuna

INTRODUCTIONThe rising prevalence of Alzheimer's disease (AD) and related dementia worldwide underscores the urgent need for effective interventions, particularly for managing neuropsychiatric symptoms (NPS) such as sleep disturbance. This review explores the emerging role of Dual Orexin Receptor Antagonists (DORA) in addressing sleep disturbance in patients with Alzheimer's disease dementia.METHODSA comprehensive literature search identified four relevant publications between 2014 and 2024, detailing the use of DORA medications, including suvorexant and lemborexant, in patients with Alzheimer's disease.RESULTSFindings suggest that suvorexant may improve total sleep time (TST), wakefulness after sleep onset (WASO), and sleep efficiency (SE) in Alzheimer's patients with insomnia. Lemborexant demonstrated potential in improving circadian rhythm parameters, particularly in patients with irregular sleep-wake rhythm disorder (ISWRD). Safety profiles of DORA medications appeared favorable, with mild to moderate adverse events reported. However, concerns over potential adverse events, such as falls, underscore the need for careful monitoring.CONCLUSIONWhile the evidence suggests promise for DORA medications in addressing sleep disturbance in Alzheimer's disease, limitations in study populations and duration highlight the need for further investigation. Future clinical trials should aim for broader inclusion criteria, encompassing diverse dementia subtypes and severity levels, to enhance generalizability. Additionally, longer-term trials are essential to assess the sustained efficacy and safety of DORA interventions in this vulnerable population.

01 Jan 2025·HIV Medicine

DORA: 48‐week weight and metabolic changes in Black women with HIV, in a phase IIIb switch study from dolutegravir‐ or efavirenz‐ to doravirine‐based first‐line antiretroviral therapy

Article

Author: Sokhela, Simiso ; Möller, Karlien ; Bhaskar, Esther ; Venter, Willem D. F. ; Kruger, Chelsea ; Tom, Noxolo ; Hill, Andrew ; Bosch, Bronwyn ; Chandiwana, Nomathemba ; Macholo, Philadelphia ; Akpomiemie, Godspower ; Manentsa, Ncomeka ; Woods, Joana ; Moorhouse, Michelle

AbstractObjectivesTreatment‐related weight gain and metabolic complications with antiretroviral integrase‐based regimens, especially among Black women, suggest the need for alternative options.MethodsWe conducted a 48‐week, open‐label, single‐arm, single‐centre, phase IIIb switch study to evaluate the tolerability, safety and efficacy of switching from stable efavirenz‐ or dolutegravir‐based antiretroviral therapy to doravirine/lamivudine/tenofovir disoproxil fumarate in Black women.ResultsThe 101 participants enrolled (median age 35 years; interquartile range 31–40) were on efavirenz (n = 46; mean duration on therapy 1.7 years) or dolutegravir‐based (n = 55; mean duration 1.5 years) antiretrovirals at screening. Retention at 48 weeks was 92/101 participants, and viral suppression was >90% throughout the study, with a single case of doravirine resistance (106 M, V108I and H221Y mutations). The mean weight percentage change at week 48 was 4.7% (95% confidence interval [CI] 3.0–6.5; p < 0.001), and the adjusted mean change was 2.7 kg (95% CI 1.50–3.98; p < 0.001); for efavirenz, the percentage change was 5.0% (95% CI 2.9–7.1; p < 0.001), and the adjusted weight gain was 3.5 kg (95% CI 1.93–5.13); for dolutegravir, the percentage change was 4.5% (95% CI 1.8–7.3; p < 0.001), and the adjusted weight gain was 2.1 kg (95% CI 0.26–3.90). Statistically significant decreases in lipid panel percent mean to week 48 included: total cholesterol −8.4% (95% CI −11.3 to −5.5; p < 0.001), triglycerides −10.4% (95% CI −16.4 to −4.4; p < 0.001) and high‐density lipoprotein −14.8% (95% CI −18.5 to −11.2%; p < 0.001), with minor differences when disaggregating the mean percent change in lipids between previous efavirenz/dolutegravir regimens. Adverse events due to doravirine were few and mild.ConclusionsOur findings suggest that a switch to doravirine from efavirenz or dolutegravir is safe and effective in Black women, with significant improvement in lipid profiles, but does not arrest progressive weight gain.

01 Jan 2025·Journal of Clinical Sleep Medicine

Effect of graduated drug therapy for moderate-to-severe chronic insomnia on the severity of disease: an observational study in Germany

Article

Author: Rosenblum, Lisa ; Toncar, Theresa ; Fietze, Ingo ; Boer, Jolijn ; Stange, Arne

STUDY OBJECTIVESSevere chronic insomnia is a common sleep disorder that is mostly persistent and needs to be treated. Pharmacologic treatment options and guidelines are sparse, particularly for long-term treatment. Our study aimed to investigate a graduated therapy scheme for moderate-to-severe chronic insomnia in practice, considering the effects on self-reported sleep quality and quality of life.METHODSPatients with moderate-to-severe chronic insomnia were given appropriate medication according to a graduated therapy scheme, ranging from l-tryptophan (as the first choice, least potent) to Z-drugs and combination therapies (as the last option, most potent). Each step of the graduated therapy scheme was tested for at least 4 weeks. Data related to sleep and quality of life were collected in questionnaire form (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Beck Depression Inventory, second edition, and Short Form 36 Health Survey) at baseline and during the course of the treatment after 1, 3, 6, 9, and 12 months.RESULTSOf 86 eligible patients, 60.5% started treatment with l-tryptophan and 8.1% with melatonin. After 3 months, 12.5% were still taking l-tryptophan and 12.5% were taking melatonin. There was a significant decrease in mean Insomnia Severity Index, Pittsburgh Sleep Quality Index, Beck Depression Inventory, second edition, and Short Form 36 Health Survey scores after 3 months of treatment for all patients in the study (n = 64). After 6 months, 22.2% were still taking l-tryptophan, melatonin, or agomelatine, and the remainder had switched to more potent drugs such as antidepressants, hypnotics, daridorexant, or combination therapies.CONCLUSIONSA significant number of patients already responded favorably to mild sleep medications, whereas others demonstrated a need for more potent treatments. Ongoing monitoring will evaluate the long-term effectiveness of both approaches.CLINICAL TRIAL REGISTRATIONRegistry: German Clinical Trials Register; Name: Schlafqualität und Lebensqualität mit einer medikamentösen Langzeittherapie bei moderater bis schwerer Insomnie; URL: https://drks.de/search/de/trial/DRKS00033175; Identifier: DRKS00033175.CITATIONBoer J, Toncar T, Stange A, Rosenblum L, Fietze I. Effect of graduated drug therapy for moderate-to-severe chronic insomnia on the severity of disease: an observational study in Germany. J Clin Sleep Med. 2025;21(1):33-45.

News (Medical) associated with Daridorexant hydrochloride

14 Jan 2025

·www.idorsia.com

Idorsia publishes an invitation to a bondholder meeting

Ad hoc announcement pursuant to Art. 53 LR A bondholder meeting will take place on February 25, 2025, to vote on proposals to amend the terms of the outstanding convertible bonds maturing on January 17, 2025, including an extension of the maturity by at least six months Allschwil, Switzerland – January 14, 2025 Idorsia Ltd (SIX: IDIA) today announced that it has published an invitation to a bondholder meeting for holders of its outstanding convertible bond (ISIN: CH0426820350) (the Bonds or CB 2025) with a nominal value of CHF 200 million and a conversion price of CHF 6.00 per Idorsia share, maturing on January 17, 2025. At the meeting, the company will propose changing the current terms of the Bonds to avoid short-term liquidity constraints in connection with the redemption of the Bonds. Upon the publication of the invitation, the obligations under the CB 2025 are stayed in accordance with article 1166 of the Swiss Code of Obligations. For this reason, the CB 2025 will not be repaid on January 17, 2025, and accordingly no interest payment will be made on January 17, 2025. Bondholders can access the invitation to the bondholder meeting scheduled for February 25, 2025, at the following link: www.idorsia.com/CB2025. Terms of the resolution, a financial status report, and additional information about the meeting will be set out in a supplement to the invitation, that will be published at least 10 days before the meeting date. Notes to the editor About the 2025 convertible bond The CHF 200 million convertible bonds issued in 2018 (ISIN CH0426820350) 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 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). For further information, please contact Andrew C. Weiss Senior Vice President, Head of Investor Relations & Corporate Communications Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.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

13 Jan 2025

·www.idorsia.com

Idorsia to call for a bondholder meeting

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – January 13, 2025 Idorsia Ltd (SIX: IDIA) today announced that – in the coming days – the company intends to publish an invitation to a bondholder meeting for holders of its outstanding convertible bond (ISIN: CH0426820350) (the Bonds or CB 2025) with a nominal value of CHF 200 million and a conversion price of CHF 6.00 per Idorsia share, maturing on January 17, 2025. At the meeting, the company will propose changing the current terms of the Bonds to avoid short-term liquidity constraints in connection with the redemption of the Bonds. On November 27, 2024, the company announced that it had entered exclusive negotiations with an undisclosed party for global rights to aprocitentan. In addition, the company announced plans to streamline its business to reduce costs and restructure its outstanding debt. While the exclusive negotiations continue, the company believes that an agreement will not be reached in the coming weeks and cannot guarantee that an agreement will be reached. Consequently, the company continues to explore all 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, Chief Executive Officer of Idorsia, commented: “Exclusive negotiations with the undisclosed party for global rights to aprocitentan continue, but it is unlikely that an agreement will be reached in the coming weeks. Regardless of the outcome, given the near-term maturity and the inability of the company to repay the bonds at maturity, an extension to the CB 2025 is required, so a bondholder meeting will be called in the coming days. This extension is expected to be a first step in a larger restructuring in which we would amend the terms of both the convertible bonds 2025 and 2028.” Idorsia will call a bondholder meeting in accordance with articles 1164 et seqq. of the Swiss Code of Obligations and will propose to the bondholders to modify the terms of the Bonds to, among others, extend the maturity date. Financial Update Arno Groenewoud, Chief Financial Officer of Idorsia, commented: “We ended 2024 with a cash balance exceeding 100 million Swiss francs thanks, in part, to the sale of daridorexant inventory to Nxera and a royalty monetization transaction for vamorolone with R-Bridge Healthcare Fund. As a result, the company has a cash runway to the end of the first quarter 2025, assuming we are able to extend the maturity of the CB2025.” The guidance for 2024 published in December 2024 remains in place. Notes to the editor About the 2025 convertible bond The CHF 200 million convertible bonds issued in 2018 (ISIN CH0426820350) 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 bond On 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 the agreement with Nxera for daridorexant In 2023, Idorsia out-licensed daridorexant to Nxera Pharma in the Asia-Pacific region (excluding China). QUVIVIQ™ (daridorexant) was approved for the treatment of insomnia in Japan in September 2024 and made available to patients with insomnia in Japan in December 2024. Asia-Pacific region (excluding China): Australia, Brunei, Cambodia, Indonesia, Japan, Laos, Malaysia, Myanmar, New Zealand, Philippines, Singapore, South Korea, Thailand, Taiwan, and Vietnam About the agreement with Santhera for vamorolone In 2020, Idorsia’s license, collaborative development and commercialization agreement with ReveraGen BioPharma in respect of vamorolone was transferred in its entirety to Santhera Pharmaceuticals. Idorsia is entitled to development and sales milestones, as well as low single-digit percentage payments on net sales of vamorolone. In December 2024, Idorsia entered into a royalty monetization agreement for vamorolone with the R-Bridge Healthcare Fund for which it received a USD 30 million payment. As part of the agreement, R-Bridge is entitled to all future vamorolone royalties and milestones up to a certain cap. Once the cap is reached, the entitlement will revert back to Idorsia. About the R-Bridge Healthcare Fund R-Bridge Healthcare Fund is an affiliate of CBC Group, Asia's largest healthcare-dedicated asset management firm with an AUM of $9 billion, headquartered in Singapore with offices in U.S., Asia, and Europe. With a diversified, multi-product strategy, CBC Group is focused on platform-building, buyout, private credit and royalties, and real estate, across the healthcare space, including pharmaceutical, biotech, medical technology, and healthcare services. R-Bridge was founded in 2019 to provide alternative, non-dilutive financing for healthcare companies backed by royalties, revenue interests and other cash flow generated by sales of healthcare products and services in Asia as well as globally, with the intent to generate attractive and non-correlated returns for investors. R-Bridge raised its inaugural fund in 2020 and is currently investing out of its successor fund, RBF II. For further information, please visit www.cbridgecap.com 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). For further information, please contact Andrew C. Weiss Senior Vice President, Head of Investor Relations & Corporate Communications Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.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

Drug ApprovalLicense out/in

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

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.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep	NDA/BLA	CN	Idorsia Pharmaceuticals Deutschland GmbH	16 Jul 2024
Sleep	NDA/BLA	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	16 Jul 2024
Sleep	NDA/BLA	CN	Farmea	16 Jul 2024
Sleep Apnea, Obstructive	Phase 1	DE	Idorsia Pharmaceuticals Ltd.	14 Mar 2019
Pulmonary Disease, Chronic Obstructive	Discovery	DE	Idorsia Pharmaceuticals Ltd.	15 Nov 2018
Sleep Initiation and Maintenance Disorders	Discovery	KR	Idorsia Pharmaceuticals Ltd.	29 May 2018
Liver Diseases	Discovery	CH	Idorsia Pharmaceuticals Ltd.	26 Feb 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05702177 (Pubmed \| J Psychopharmacol)	Phase 1	-	36	Daridorexant 25 mg	(axxorfxmwl) = bsvlastqyc eiptahfvur (xqjlpdnrti ) View more	Positive	06 Dec 2024
				Daridorexant 50 mg	(axxorfxmwl) = okmtxbgiwg eiptahfvur (xqjlpdnrti ) View more
EAN2024	Not Applicable	Sleep Initiation and Maintenance Disorders	23	Daridorexant	etvwthfdhh(qhuonrfowy) = Questionnaire scores indicated a clinically meaningful reduction: IDSIQ- cognitive domain by 10 dhrjjwouho (lwslgxhonf ) View more	Positive	28 Jun 2024
NCT05480488 (Pubmed) Manual	Phase 1	-	18	midazolamant 50 mwarfarin	(rdfhkozype) = itxjhbnrbw ejtzjxyhve (sbwxcpxacz ) View more	Positive	13 Mar 2024
				daridorexantmgmidazolamwarfarin	(rdfhkozype) = wevcwkgony ejtzjxyhve (sbwxcpxacz ) View more
NCT03575104 \| NCT03545191 (Phase 3 studies, WSC2023)	Phase 3	Sleep Initiation and Maintenance Disorders	-	Daridorexant 50 mg	rqnfsofpvm(lmfqaqwwcq) = nmhuajmmoi kibhugefus (fdvizpjaak ) View more	Positive	22 Oct 2023
NCT03545191 (Phase 3 trial, WSC2023)	Phase 3	Sleep Initiation and Maintenance Disorders \| Sleep Apnea, Obstructive	930	Daridorexant 50 mg	hldxawvxak(mjuwcmbcrc) = Two participants discontinued study treatment due to AEs (both in placebo) jrcvnhvqdg (vkezhnrzdx ) View more	Positive	22 Oct 2023
				Placebo
NCT03679884 (Pubmed) Manual	Phase 3	Sleep Initiation and Maintenance Disorders	804	Daridorexant	(bhjxwyhkcm) = Overall incidence of treatment-emergent adverse events was similar across groups (35-40%). qkkzxvcfos (ufwxxmrwqk ) View more	Positive	09 Dec 2022
				Placebo
NCT03545191 (Pubmed)	Phase 3	Sleep Initiation and Maintenance Disorders	930	Daridorexant 50 mg	yhhnvlphss(fdmnmspkyy) = no cases of cataplexy vfpxjwvzze (kswyxqhyer ) View more	-	13 Sep 2022
				Daridorexant 25 mg
NCT03545191 (Phase 3 trial \| NCT03679884 \| ###DELETE \| phase-3, CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders	930	Daridorexant 25 mg (Daridorexant 25 mg)	ekwbutkhjh(trxyssrova) = ybvcyphixf vrxbohavul (dcvyuhjqik, lvlyanfimz - tsymrkrizm) View more	-	25 Mar 2022
				Daridorexant 50 mg (Daridorexant 50 mg)	ekwbutkhjh(trxyssrova) = mjczjgnczh vrxbohavul (dcvyuhjqik, ghniheuiyr - niumxzshhr) View more
NCT03575104 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders \| Sleep	924	Daridorexant (Daridorexant 10 mg)	vsccrbmzqe(hhdqyjtfwq) = tmgaxrhgtw uwxdqzhjyg (bfjjxykrdl, gghwfyvpyu - gsbxrmnqld) View more	-	25 Mar 2022
				Daridorexant (Daridorexant 25 mg)	vsccrbmzqe(hhdqyjtfwq) = fuuveuocjv uwxdqzhjyg (bfjjxykrdl, nbumaegmly - aaizhrjfli) View more
NCT03575104 \| NCT03545191 (Phase 3 program, WSC2022)	Phase 3	Sleep Initiation and Maintenance Disorders	-	Daridorexant 25 mg	(eybprqlipf) = ewxyrtbwiy eabavhaqdn (uhzilevibz, 56.7) View more	Positive	11 Mar 2022
				Daridorexant 50 mg	(eybprqlipf) = abmxruvala eabavhaqdn (uhzilevibz, 55.8) View more

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