Drugs / Daridorexant
Daridorexant
also known as
ACT-541468 · ACT-541468 HYDROCHLORIDE · ACT-541468A · DARIDOREXANT HYDROCHLORIDE · DEA NO. 2410 · DTX · Nemorexant · Nemorexant hydrochloride · +1 more
Small molecule targets CYP3A4, HCRTR1, HCRTR2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed insomnia 6 milestones | |||||
| Filed | Japan (PMDA) | — | insomnia | 2023-10-31 | “Sosei Heptares Announces Submission of New Drug Application in Japan for Daridorexant (ACT-541468), a Dual Orexin Receptor Antagonist for the Treatment of Insomnia” nxera.life ↗ “has submitted a New Drug Application (“NDA”) to the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”) for the approval of daridorexant” nxera.life ↗ “for insomnia patients in Japan, and a new drug application was submitted in Japan in October 2023.” shionogi.com ↗ |
| Filed | UK (MHRA) | — | insomnia | 2022-05-03 | “a separate application for the use of daridorexant for the same indication has been submitted to the Medicines and Healthcare products Regulatory Agency (MHRA)” idorsia.com ↗ |
| Filed | Other | — | insomnia | 2021-04-20 | “Idorsia has also submitted marketing authorization applications (MAA) to the European Medicines Agency and Swissmedic for daridorexant for the same indication.” idorsia.com ↗ “Daridorexant MAA submitted to Switzerland’s health authority, Swissmedic, in April 2021” idorsia.com ↗ |
| Filed | EU (EMA) | — | insomnia | 2021-03-02 | “Idorsia has also submitted marketing authorization applications (MAA) to the European Medicines Agency and Swissmedic for daridorexant for the same indication.” idorsia.com ↗ “today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for daridorexant” idorsia.com ↗ “Daridorexant marketing authorisation application (MAA) submitted to the European Medicines Agency (EMA) in March 2021” idorsia.com ↗ “The NDA was submitted to the US FDA on January 8, 2021 and the MAA to the European Union EMA on March 2, 2021.” idorsia.com ↗ |
| Filed | US (FDA) | — | insomnia | 2021-01-08 | “Daridorexant new drug application (NDA) submitted to the US FDA in January 2021 and has been accepted for review” idorsia.com ↗ “Daridorexant new drug application (NDA) submitted to the US Food & Drug Administration (FDA) on January 8, 2021” idorsia.com ↗ “A New Drug Application (NDA) for daridorexant was submitted to the US FDA on January 8, 2021,” idorsia.com ↗ “A New Drug Application (NDA) for daridorexant was submitted to the US FDA on January 8, 2021” idorsia.com ↗ “A New Drug Application (NDA) for daridorexant was submitted to the US FDA on January 8, 2021” idorsia.com ↗ |
| Filed | China (NMPA) | — | insomnia | — | “an NDA for Mainland China was submitted in June 2024.” idorsia.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | QUVIVIQ | — | 2024-09-30 | fda.gov ↗ |
| Approved | EU (EMA) | Quviviq | — | 2022-04-29 | europa.eu ↗ |
| Approved | US (FDA) | QUVIVIQ | — | 2022-01-07 | fda.gov ↗ |
Trials 46
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 124 trials · 2 met primary | ||||||
| Phase 1 | NCT06326723 | Sep → Dec 2023 | — | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05877222 | Jun → Aug 2023 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05632393 | Jan → Apr 2023 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05702177 | Jan → Apr 2023 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05480475 | Sep 2022 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05480488 | Aug → Sep 2022 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05458193 | Aug 2022 → Feb 2023 | obstructive sleep apnea syndrome | Idorsia Pharmaceuticals Ltd. | Completed | Met primary |
| Phase 1 | NCT04390334 | May → Jun 2020 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04250506 | Feb → Jul 2020 | — | Idorsia Pharmaceuticals Ltd. | Completed | Met primary |
| Phase 1 | NCT04024332 | Sep 2019 → Aug 2020 | impaired renal function disease | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03907215 | Apr → Jun 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03892902 | Mar → Oct 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03765294 | Mar → Nov 2019 | obstructive sleep apnea syndrome | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03799978 | Mar 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03646864 | Nov 2018 → Sep 2019 | chronic obstructive pulmonary disease | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03657355 | Sep 2018 → Aug 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03609775 | Aug → Oct 2018 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03713242 | Feb 2018 → Feb 2020 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03339752 | Oct → Dec 2017 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03101189 | Mar → Apr 2017 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03017495 | Jan → Feb 2017 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02571855 | Oct 2015 → Feb 2016 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02526888 | Sep → Nov 2015 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02919319 | Feb → May 2015 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 210 trials · 2 met primary | ||||||
| Phase 2 | NCT07532252 | Jan 2027 → Aug 2030 expected | alcohol-related disorders | Johns Hopkins University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07701928 | Sep 2026 → Dec 2030 expected | alcohol dependence, insomnia | Sterling McPherson | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07217912 | Oct 2025 → Nov 2027 expected | delirium | University of Rochester | Recruiting | No outcome recorded |
| Phase 2 | NCT07213349 | Oct 2025 → Dec 2028 expected | Alzheimer disease | Douglas Mental Health University Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06630390 | Nov 2024 → Feb 2025 | delirium | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT05422612 | Nov 2023 → Jul 2028 | post-traumatic stress disorder | Global Coalition for Adaptive Research | Suspended | No outcome recorded |
| Phase 2 | NCT05948540 | Nov 2023 → Apr 2028 | post-traumatic stress disorder | Global Coalition for Adaptive Research | Suspended | No outcome recorded |
| Phase 2 | NCT05423717 | Sep 2022 → Jan 2026 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02841709 | Nov 2016 → May 2017 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | Met primary |
| Phase 2 | NCT02839200 | Oct 2016 → Apr 2017 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | Met primary |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT07843329 | Sep 2026 → Nov 2027 expected | insomnia | Idorsia Pharmaceuticals Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07028697 | Dec 2024 → Sep 2025 | insomnia | Nxera Pharma Korea Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06010693 | Aug 2023 → Apr 2024 | insomnia | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03679884 | Oct 2018 → Feb 2021 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03545191 | Jun 2018 → Jan 2020 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | Met primary |
| Phase 3 | NCT03575104 | May 2018 → Apr 2020 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | Mixed |
| Phase 45 trials · 1 met primary | ||||||
| Phase 4 | NCT07830303 | Sep 2026 → Feb 2029 expected | cirrhosis of liver, hepatic encephalopathy, sleep disorder | Wang Fengmei | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07555743 | Apr 2026 → Apr 2027 expected | insomnia, major depressive disorder | Bellvitge Biomedical Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07267559 | Oct 2025 → Sep 2026 overdue | cognitive disorder | University of Oxford | Recruiting | No outcome recorded |
| Phase 4 | NCT05924425 | Mar 2024 → May 2027 expected | Alzheimer disease, insomnia | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 4 | NCT05597020 | Feb 2023 → Apr 2024 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT07743931 | Sep 2026 → Sep 2028 expected | insomnia, obstructive sleep apnea syndrome | University Hospital, Grenoble | Recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT07136415 Comparator | Feb 2026 → Feb 2031 expected | insomnia | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07328594 Comparator | Feb 2026 → Mar 2027 expected | insomnia, nicotine dependence | Legacy Health System | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 47
| Date | Issuer | Release |
|---|---|---|
| 2026-08-11 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia acknowledges the DEA proposal to reclassify dual orexin receptor antagonists to the lowest schedule – Schedule V idorsia.com ↗
Idorsia Ltd (SIX: IDIA) announces that the US Drug Enforcement Administration (DEA) will publish a proposed rule to reclassify dual orexin receptor antagonists (DORAs) from Schedule IV to Schedule V under the Controlled Substances Act (CSA). |
| 2026-04-28 | Idorsia Pharmaceuticals Ltd. | Results Idorsia reports strong Q1 2026 performance with 74% QUVIVIQ sales growth year-on-year idorsia.com ↗
Outstanding Phase 2 results in children: statistically significant dose-dependent response on total sleep time with clinically meaningful improvements across multiple sleep measures in children with insomnia disorder, with especially pronounced efficacy in those with co-morbid neurodevelopmental disorders. |
| 2026-04-14 | Nxera Pharma UK Limited | Regulatory Nxera Pharma’s QUVIVIQ (daridorexant) 25mg and 50mg Receives Approval in Taiwan for the Treatment of Insomnia nxera.life ↗ |
| 2026-04-14 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2026-03-30 | Idorsia Pharmaceuticals Ltd. | Results Idorsia’s daridorexant delivers outstanding results in a Phase 2 study in children with insomnia disorder idorsia.com ↗
Phase 2 results show a statistically significant dose-dependent response on total sleep time with clinically meaningful improvements across multiple sleep measures in children with insomnia disorder, with especially pronounced efficacy in those with co-morbid neurodevelopmental disorders |
| 2026-03-04 | Nxera Pharma UK Limited | Regulatory Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea nxera.life ↗
Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea |
| 2026-03-04 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2026-01-19 | Nxera Pharma UK Limited | Results Nxera Pharma Reports Positive Results From Phase 3 Trial of Daridorexant in South Korea nxera.life ↗
Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that positive top-line results were obtained from a Phase 3 study conducted in South Korea evaluating daridorexant 50 mg in adult and elderly patients with insomnia. |
| 2026-01-19 | Nxera Pharma UK Limited | Results Other nxera.life ↗
本試験結果は、主要評価項目および副次評価項目のいずれの項目も達成しました。 |
| 2026-01-05 | Idorsia Pharmaceuticals Ltd. | Results Idorsia’s daridorexant in women during menopausal transition age with insomnia idorsia.com ↗
New analysis of a Phase 3 study of daridorexant shows that 50 mg improved both sleep and daytime functioning compared to placebo in women during menopausal transition age |
| 2025-11-17 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere to Start Producing Swiss Insomnia Drug in China, Building Manufacturing Capabilities for Global Supply simcere.com ↗
We have already submitted our application to the NMPA for locally manufacturing the drug in Hainan, |
| 2025-10-31 | Nxera Pharma UK Limited | Regulatory Nxera Pharma Receives a Manufacturing Approval Partial Amendment Regarding the Addition of a Manufacturing Site in Asia for QUVIVIQ® 25 and 50 mg nxera.life ↗ |
| 2025-09-10 | Idorsia Pharmaceuticals Ltd. | Results Idorsia shares new analyses of daridorexant for patients with insomnia at World Sleep 2025 idorsia.com ↗
The real-world data presented with daridorexant in patients with neurological and psychiatric comorbidities are particularly compelling. |
| 2025-09-08 | Idorsia Pharmaceuticals Ltd. | Results Idorsia highlights very low real-world abuse potential of DORA class for insomnia treatment at WSC 2025 idorsia.com ↗
These findings reinforce the favorable safety profile of DORAs such as daridorexant, supporting their role as a modern treatment option with minimal abuse potential. |
| 2025-09-05 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results New Sleep Medication Significantly Improves Multiple Sleep Parameters: Phase III Clinical Data of Daridorexant in China Published in SLEEP simcere.com ↗
This randomized, double-blind, placebo-controlled, multicenter study (NCT06010693) demonstrated that Daridorexant significantly improved multiple insomnia-related parameters, enhancing both sleep quantity and quality without next-morning residual effects. |
| 2025-06-23 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia’s QUVIVIQ expands into China as Simcere receives NDA approval – Idorsia and Simcere update their licensing agreement idorsia.com ↗
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. |
| 2025-06-23 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory QUVIVIQ® - The World’s New Generation Anti-Insomnia Drug – Approved for Launch，Significantly Improves Sleep and Daytime Functioning simcere.com ↗ |
| 2025-04-29 | Idorsia Pharmaceuticals Ltd. | Results New data with daridorexant assessing the transition from night to day in insomnia disorder published in Sleep Medicine idorsia.com ↗
The analysis of the Phase 3 data provides evidence that daridorexant reduces wakefulness throughout the entire night, while decreasing morning sleepiness and improving daytime functioning and alertness in patients with chronic insomnia disorder. |
| 2025-03-14 | Idorsia Pharmaceuticals Ltd. | Results Idorsia announces the publication of positive data with daridorexant in patients with chronic insomnia and nocturia idorsia.com ↗ |
| 2024-09-24 | Mochida Pharmaceutical Company, Ltd. | Regulatory 不眠症治療薬「クービビック錠」の日本における製造販売承認取得のお知らせ mochida.co.jp ↗ |
| 2024-09-24 | Nxera Pharma UK Limited | Regulatory Nxera Pharma Receives Approval of QUVIVIQ (daridorexant) 25 and 50 mg in Japan for the Treatment of Insomnia nxera.life ↗
Nxera Pharma Receives Approval of QUVIVIQ (daridorexant) 25 and 50 mg in Japan for the Treatment of Insomnia |
| 2024-07-25 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory New Drug Application for Novel Anti-Insomnia Drug Quviviq® Accepted simcere.com ↗
On Jul. 16, 2024, Simcere Pharmaceutical (2096.HK) announced that the new drug application for Quviviq ® (daridorexant hydrochloride tablets), an innovative anti-insomnia drug developed in collaboration with Idorsia (Switzerland), has been accepted by the National Medical Products Administration. |
| 2024-06-03 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Phase III Clinical Study of Daridorexant Reached the Primary Endpoint simcere.com ↗
On May 30, 2024, Simcere Pharmaceutical Group Limited (Simcere; 2096.HK) announced that the Chinese Phase III clinical study of Daridorexant Hydrochloride Tablets (Daridorexant), for the treatment of insomnia patients in China, has met the primary study endpoint. |
| 2023-11-10 | Nxera Pharma UK Limited | Regulatory Sosei Heptares Operational Highlights and Consolidated Results for the Third Quarter and First Nine Months of 2023 nxera.life ↗
New Drug Application submitted to the Japanese Pharmaceuticals and Medical Devices Agency for the approval of daridorexant (ACT541468), a novel dual orexin receptor antagonist, for the treatment of adult patients with insomnia |
| 2023-10-31 | Mochida Pharmaceutical Company, Ltd. | Regulatory 不眠症治療薬ダリドレキサントの日本における製造販売承認申請のお知らせ mochida.co.jp ↗ |
| 2023-10-31 | Nxera Pharma UK Limited | Regulatory Sosei Heptares Announces Submission of New Drug Application in Japan for Daridorexant, a Dual Orexin Receptor Antagonist for the Treatment of Insomnia nxera.life ↗
Sosei Heptares Announces Submission of New Drug Application in Japan for Daridorexant (ACT-541468), a Dual Orexin Receptor Antagonist for the Treatment of Insomnia |
| 2023-10-31 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2023-07-21 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory The hypnotics Daridorexant hydrochloride tablets obtained the clinical trial approval issued by the national medical products administration simcere.com ↗
On July 20, 2023, Daridorexant hydrochloride tablets obtained the clinical trial approval issued, which aimed at the treatment of adult insomnia patients with symptoms persisting for at least 3 months and affecting daytime function. |
| 2023-05-18 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Acceptance of IND Application for Simcere's New Anti-insomnia Dual Orexin Receptor Antagonist simcere.com ↗
the investigational new drug (IND) application for the new anti-insomnia drug, daridorexant, jointly developed by Simcere (2096.HK) and Idorsia (Switzerland) has been accepted by the Center for Drug Evaluation (CDE) |
| 2023-05-03 | Idorsia Pharmaceuticals Ltd. | Regulatory Health Canada approves QUVIVIQ (daridorexant) for the management of adult patients with insomnia idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced that Health Canada has granted marketing authorization for QUVIVIQ™ (daridorexant) for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, on April 28, 2023. |
| 2022-12-12 | Idorsia Pharmaceuticals Ltd. | Results Long-term safety and tolerability results with daridorexant in patients with insomnia disorder published in CNS Drugs idorsia.com ↗
The improvement in sleep onset, sleep maintenance and daytime functioning seen with 50 mg daridorexant were sustained for up to 12 months. |
| 2022-12-05 | Idorsia Pharmaceuticals Ltd. | Regulatory Swissmedic approves QUVIVIQ (daridorexant) – a first-in-class treatment for chronic insomnia disorder to improve both nighttime symptoms and daytime functioning idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced that Swissmedic has granted marketing authorization for QUVIVIQ™ (daridorexant) for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning. |
| 2022-10-03 | Idorsia Pharmaceuticals Ltd. | Results Idorsia Japan announces positive results with daridorexant in a Phase 3 study of Japanese patients with insomnia idorsia.com ↗
Daridorexant significantly improved sTST from baseline compared to placebo at 28 days (p<0.001 for 50 mg, p=0.042 for 25 mg). |
| 2022-05-03 | Idorsia Pharmaceuticals Ltd. | Regulatory Europe’s first dual orexin receptor antagonist – QUVIVIQ (daridorexant) – granted approval to improve both nighttime symptoms and daytime functioning in adults with chronic insomnia disorder idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced the European Commission (EC) has granted marketing authorization for QUVIVIQ™▼ (daridorexant) for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning. |
| 2022-02-25 | Idorsia Pharmaceuticals Ltd. | Regulatory QUVIVIQ (daridorexant) recommended for approval in Europe as a new treatment for adults with insomnia disorder idorsia.com ↗
Idorsia receives a positive opinion from the Committee for Medicinal Products for Human Use for QUVIVIQ™ (daridorexant) for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning |
| 2022-01-20 | Idorsia Pharmaceuticals Ltd. | Results The Lancet Neurology reports impact of daridorexant on both nighttime symptoms and daytime functioning in adults with insomnia idorsia.com ↗
Daridorexant 25 mg and 50 mg improved sleep outcomes, and daridorexant 50 mg also improved daytime functioning, in people with insomnia disorder, with a favorable safety profile. |
| 2022-01-10 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia presents at the 40th J.P. Morgan Healthcare Conference – Ready for first product launches – QUVIVIQ (daridorexant) approved by the US FDA idorsia.com ↗
The first approval of QUVIVIQ is a pivotal moment for both Idorsia as a company and adults in the US who live with insomnia. |
| 2022-01-10 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has approved QUVIVIQ™ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance1. |
| 2021-03-10 | Idorsia Pharmaceuticals Ltd. | Regulatory FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia’s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia. |
| 2021-03-03 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia submits European marketing authorisation application for daridorexant for the treatment of adult patients with insomnia idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for daridorexant, Idorsia's investigational dual orexin receptor antagonist, for the treatment of adult patients with insomnia. |
| 2021-01-11 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia to debut at the 39th J.P. Morgan Healthcare Conference – Major catalysts expected in the near-term – Daridorexant NDA submitted to the US FDA idorsia.com ↗
Daridorexant new drug application (NDA) submitted to the US Food & Drug Administration (FDA) on January 8, 2021 |
| 2020-08-28 | Idorsia Pharmaceuticals Ltd. | Results Daridorexant Phase 3 results in insomnia presented at SLEEP 2020 idorsia.com ↗
The study demonstrated efficacy of treatment with daridorexant on objective and subjective sleep parameters, and daytime functioning, with no next-morning residual effect. |
| 2020-08-06 | Idorsia Pharmaceuticals Ltd. | Results Idorsia Japan confirms daridorexant dose response in Japanese patients with insomnia – preparation for a local registration program advancing idorsia.com ↗
In addition, daridorexant significantly decreased LPS (latency to persistent sleep) in a dose-dependent manner. |
| 2020-07-06 | Idorsia Pharmaceuticals Ltd. | Results Idorsia announces positive results in the second Phase 3 study of daridorexant idorsia.com ↗
In the second study, daridorexant 25 mg significantly improved sleep maintenance as measured objectively in a sleep lab by polysomnography. |
| 2020-04-20 | Idorsia Pharmaceuticals Ltd. | Results Idorsia announces positive results in the first Phase 3 study of daridorexant with improved overall sleep and daytime performance of patients with insomnia idorsia.com ↗
The study demonstrated efficacy of treatment with daridorexant on objective and subjective sleep parameters and daytime performance with no residual effect in the morning, and no evidence of rebound or withdrawal symptoms upon treatment discontinuation. |
| 2019-06-13 | Idorsia Pharmaceuticals Ltd. | Results Efficacy and safety data with Idorsia's dual orexin receptor antagonist presented at SLEEP 2019 in San Antonio idorsia.com ↗
Treatment with ACT-541468 dose-dependently improved sleep onset and sleep maintenance in adult and elderly patients with insomnia disorder, with significant reductions in LPS (latency to persistent sleep) and WASO (wake after sleep onset), at the time points measured |
| 2017-07-28 | Idorsia Pharmaceuticals Ltd. | Results ACT-541468 (DORA) meets primary endpoint in Phase 2 program in adult and elderly patients with insomnia idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced positive results for the comprehensive Phase 2 program with the dual orexin receptor antagonist ACT-541468 (DORA) in insomnia, with zolpidem as an active reference. |
All press releases naming this drug 87 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Daridorexant | “Daridorexant (ACT-541468) is a potent dual orexin receptor antagonist under development for the treatment of sleep disorders.” PMID 33205362 ↗ Nov 202032“Daridorexant is a dual orexin receptor antagonist in clinical development for insomnia.” PMID 34002356 ↗ May 2021 |
| Known as | ACT-541468 | “The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder.” NCT03575104 ↗19“Daridorexant (ACT-541468) is a potent dual orexin receptor antagonist under development for the treatment of sleep disorders.” PMID 33205362 ↗ Nov 2020 “Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder” NCT03545191 ↗ “Daridorexant (ACT-541468) administered as film-coated tablets for oral use.” NCT04250506 ↗ “a single dose of 50 mg ACT-541468 (Treatment A) on Day 1” NCT03907215 ↗ |
| Known as | ACT-541468 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | ACT-541468A | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | DARIDOREXANT HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | DEA NO. 2410 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | DTX | “sleep medication, daridorexant (DTX), can help decrease drinking in people who have alcohol use disorder (AUD) and insomnia.” NCT07701928 ↗ |
| Known as | Nemorexant | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | Nemorexant hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297590 ↗ |
| Known as | Quviviq | “Daridorexant (brand name Quviviq) is FDA-approved for the treatment of insomnia in adults.” NCT07267559 ↗ |
| Action | Inhibit | “Daridorexant, a dual orexin receptor antagonist, is approved for the treatment of insomnia disorder in adults.” PMID 40660750 ↗ Jul 2025 |
| Modality | Small molecule | — CHEMBL4297590 ↗ |
| Route | Oral | “Oral capsule (25 mg) as single dose” NCT02526888 ↗ |
| Target | CYP3A4 | “Daridorexant at 50 mg is classified as a weak CYP3A4 inhibitor after single- and multiple-dose administration once daily at steady state.” PMID 38472696 ↗ Mar 2024 |
| Target | HCRTR1 | “Orexin receptor 1 antagonist” CHEMBL4297590 ↗ |
| Target | HCRTR2 | “Orexin receptor 2 antagonist” CHEMBL4297590 ↗ |