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

/ CompletedPhase 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

/ Enrolling by invitationNot 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

116

Literatures (Medical) associated with Daridorexant hydrochloride

01 May 2025·ALCOHOL

Effects of daridorexant on rest/wake activity patterns and drinking in adult rats exposed to chronic ethanol vapor in adolescence

Article

Author: Amodeo, L R ; Ehlers, C L ; Benedict, J ; Wills, D N

Disturbance in sleep and activity rhythms are significant health risks associated with alcohol use during adolescence. Many investigators support the theory of a reciprocal relationship between disrupted circadian rhythms, sleep patterns, and alcohol usage. However, in human studies it is difficult to disentangle other factors (i.e. lifestyle, psychiatric, genetic) when determining what is causal in the relationship between substance use and sleep/activity disruptions. To this end, we used an animal model of adolescent alcohol exposure whereby male and female Wistar rats are exposed to 5 weeks of intermittent alcohol vapor during adolescence (P22-P57). Five days after ethanol vapor rats were allowed to select to drink alcohol or water in a two-bottle choice procedure for a period of 5 h, 4 days a week for 6 weeks. Activity data was collected using a "Fitbit-like" device during vapor exposure, during acute withdrawal, and after 3 weeks of protracted withdrawal. Significant changes in rest/wake activity and circadian measures were seen during 24-h withdrawal and after 3 weeks of withdrawal. Four weeks following withdrawal, the effects of the dual orexin antagonist, Daridorexant, (DAX 30 mg, 100 mg, or vehicle control), on alcohol drinking and rest and activity rhythms were assessed over a 24 h period. Both daridorexant doses led to changes in circadian measures and rest/wake activity patterns. These results showed that daridorexant reduced activity, but it did not improve rest quality as measured by the mean inactive episode duration and inactive fragmentation ratio. Additionally, we did not find a significant difference in drinking behavior in animals treated with the orexin antagonist. Thus, it appears that data from this animal model do not support the use of this drug to improve adolescent alcohol-induced sleep disturbance and/or to decrease alcohol drinking.

01 Mar 2025·JOURNAL OF PSYCHOPHARMACOLOGY

Nighttime safety of daridorexant: Evaluation of responsiveness to an external noise stimulus, postural stability, walking, and cognitive function

Article

Author: Zuiker, Rob ; Koopmans, Ingrid ; Dingemanse, Jasper ; Lemoine, Vincent ; Magliocca, Massimo ; Muehlan, Clemens ; Vaillant, Cedric

Background::

Daridorexant is a dual orexin receptor antagonist approved for the treatment of chronic insomnia disorder.

Aims::

Investigate the auditory awakening threshold (AAT), postural stability, and cognitive function during the night following evening administration of daridorexant 25 and 50 mg.

Methods::

Double-blind, placebo-controlled, randomized, 3-way (placebo, 25, 50 mg) crossover study in 36 healthy male and female nonelderly adult and elderly subjects (1:1 sex/age ratio). Four hours after bedtime administration, the AAT was determined, followed by investigation of the main pharmacodynamic endpoint nocturnal postural stability (body sway) as well as functional mobility using the Timed Up and Go (TUG) test, and cognitive function/memory using the Visual Verbal Learning Test (VVLT).

Results::

All 36 subjects completed the study. The average AAT was approximately 60 dB across treatments, i.e., there were no differences between daridorexant and placebo. Daridorexant marginally increased body sway by approximately 22%, while it had no clinically meaningful effect on the time to complete the TUG test (⩽1 s increase), and the VVLT (immediate and delayed number of correctly recalled words) showed minimal and clinically not meaningful differences of up to one word, all compared to placebo. Delayed word recognition was not different from placebo. The increase in body sway in the overall population was driven by nonelderly adults, as effects in elderly subjects were similar to placebo.

Conclusions::

Following bedtime administration, daridorexant maintained the ability to awaken to an external noise stimulus in the middle of the night, allowing subjects to function safely.

ClinicalTrials.gov Identifier::

NCT05702177.

01 Mar 2025·INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY

The potential use of daridorexant in eating disorders: beyond the treatment of insomnia?

Review

Author: Affaticati, Letizia M. ; Colmegna, Fabrizia ; Clerici, Massimo ; Caldiroli, Alice ; Dakanalis, Antonios ; La Tegola, Davide ; Capuzzi, Enrico ; Buoli, Massimiliano

A strong interplay exists between sleep and dietary habits, and sleep disturbances have been repeatedly documented in individuals with eating disorders (EDs). The orexin system – implicated in sleep regulation, energy homeostasis, and food reward - may represent a mechanist link between sleep alterations and disordered eating behaviors. Daridorexant is a dual orexin receptor antagonist (DORA) recently approved for the treatment of insomnia, with demonstrated efficacy and tolerability. Owing to its action on orexin neurons, the compound represents an intriguing option for addressing both sleep-related and core symptoms of EDs. By inhibiting motor hyperactivity, daridorexant may reduce excessive physical exercise in individuals with anorexia nervosa (AN) restricting type. Additionally, the compound may exert anti-binge effects, suggesting broad applicability in binge ED, bulimia nervosa, and binge/purging AN. In this framework, daridorexant emerges as a promising therapeutic option, offering a multifaceted approach to improving circadian rhythms, energy balance, and overall quality of life in individuals with diverse ED subtypes.

News (Medical) associated with Daridorexant hydrochloride

17 Mar 2025

·www.globenewswire.com

Idorsia announces the publication of positive data with daridorexant in patients with chronic insomnia and nocturia

Daridorexant, Idorsia’s dual orexin receptor antagonist, shows consistent efficacy across both insomnia- and nocturia-related endpoints in a placebo-controlled study in patients with chronic insomnia and nocturia In this study, daridorexant was safe and well tolerated, consistent with the well-documented safety profile observed in the Phase 3 studies in chronic insomnia. The data from the Phase 4 study is published in the Journal of Sleep Research On World Sleep Day, Idorsia unites with the World Sleep Society in the call to make sleep health a priority March 14, 2025 Idorsia Ltd (SIX: IDIA) today announced the publication of “A randomized cross-over trial of daridorexant for the treatment of chronic insomnia and nocturia” in the Journal of Sleep Research. The new data provides evidence of the benefit of Idorsia’s dual orexin receptor antagonist, daridorexant (QUVIVIQ™), at a daily dose of 50 mg, in patients aged >=55 years with chronic insomnia and comorbid nocturia, with efficacy data on symptoms of both conditions, improvement in daytime functioning, and a good safety and tolerability profile.1 Chronic insomnia is defined as difficulty initiating and/or maintaining sleep at least three times a week for a minimum of three months and a significant negative impact on daytime functioning. Nocturia is waking during the night due to the need to urinate. Insomnia and nocturia frequently co-exist, particularly in older patients, and each may contribute to poor sleep quality, impaired daytime functioning and low quality of life. Katharina Lederer, MD, Advanced-Sleep-Research GmbH (ASR) in Berlin, Germany, and the coordinating investigator in the study, commented: “In patients needing to frequently visit the bathroom during the night, insomnia is very common and a significant burden for patients. The results that have been generated in this study are remarkable. Not only have we seen consistent efficacy after a short treatment period and across the insomnia measures – including increasing total sleep time and an impressive effect on insomnia severity – but also there was a great effect on their nocturia. What’s more, patients also experienced improved next-day functioning and consequently reported significantly higher satisfaction after treatment with daridorexant versus placebo. I hope that the ability to affect both comorbidities will encourage a more joined-up thinking for specialists of both conditions to adequately treat these patients.” José Emilio Batista, MD, Director of the Urology Department in Teknon Medical Center, Spain, and an investigator in the study, commented: “Many people visit the toilet during the night, go straight back to sleep and think nothing more of it. For these people, it is difficult to understand the impact that nocturia can have. The patients enrolled in this study are waking 3, 4 and sometimes 5 or more times during the night to use the toilet, so quite severe nocturia symptoms. When combined with insomnia, the patients are badly affected by the disruption, with many not able to function well the next day. The results in the study show that the patients are able to sleep longer before the first visit to the toilet and need to go fewer times, these are certainly clinically meaningful results.” In total, 60 patients – equally split between male and female patients – aged 55 or older with insomnia and comorbid nocturia participated in this multi-national, multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over study. The study consisted of 2 treatment periods of 4 weeks each, separated by a 2-3-week washout period. In the study, daridorexant 50 mg significantly improved subjective total sleep time (sTST) from baseline to Week 4 of treatment (primary endpoint) and other measures of sleep and daytime functioning. Insomnia Severity Index (ISI) score was reduced, with one and a half as many patients treated with daridorexant vs placebo improving by ≥6 units, the threshold of clinical relevance. The impact of insomnia on patients’ daytime functioning was measured daily using the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Improvements in sTST, quality and depth of sleep, and daytime functioning were seen as early as Week 1 of treatment and were maintained throughout the treatment period.1 Treatment with daridorexant 50 mg also reduced the number of nocturnal voids (nighttime visits to the toilet) from baseline to Week 4 and improved other nocturia-related symptoms, such as an increase in time to first void. A short time to first void is associated with increased daytime dysfunction and decreased sleep quality, quantity and/or sleep efficiency.1 Daridorexant 50 mg in patients with chronic insomnia and comorbid nocturia was safe and well tolerated1, consistent with the well-documented safety profile observed in the Phase 3 studies in chronic insomnia2. No serious AEs/AEs leading to discontinuation were reported in the study. Importantly, in terms of adverse events of special interest, there were no urinary incontinences, and no falls observed in patients treated with daridorexant.1 Antonio Olivieri, MD, Chief Medical Officer & Head of Global Medical Affairs, commented: “We already have incredibly strong and robust data demonstrating that daridorexant is an effective treatment of insomnia disorder with an optimal duration of action and a well-documented safety profile. Nonetheless, I am very impressed with the study results because here we see that daridorexant has a positive effect on both insomnia and nocturia endpoints. After a short treatment period, patients reported a significant improvement on the quality of their nights’ sleep and importantly, also on their days. I am very proud that Idorsia is leading the way in building evidence on the burden of insomnia and furthering the science of sleep.” World Sleep Day Today marks World Sleep Day, a significant annual awareness event within the global sleep community. Sleep is one of the three key pillars of health, alongside healthy diet and exercise, and lays the foundation to our physical, mental, and social well-being. Sleep disorders such as insomnia can lead to a lack of quality, restorative sleep. When people experience problems falling or staying asleep for at least three days a week, for at least three months with significant impact on their daytime activities, their insomnia is defined as chronic. Despite 6-10% of adults living with chronic insomnia, the condition is often not recognized, and the negative impact underestimated. Benjamin Limal, President of Europe and Canada region, commented: “All of us at Idorsia are proud supporters of World Sleep Day, and we are united with the World Sleep Society in the call to action to make sleep health a priority. We support patients, advocates and the medical community in elevating the conversation around sleep and emphasizing the significant, and often hidden, impact chronic sleep disorders have on individuals and society.” To access information and resources for people living with chronic insomnia, including a guide to help discuss symptoms with a doctor, visit World Sleep Day 2025. Daridorexant is Idorsia’s dual orexin receptor antagonist (DORA) which blocks the binding of the wake-promoting orexin neuropeptides. Rather than inducing sleep through broad inhibition of brain activity, daridorexant only blocks the activation of orexin receptors and reduces the overactive wake drive shown in individuals with chronic insomnia. Daridorexant is commercially available as QUVIVIQ in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, France, Sweden, and Japan, and is approved throughout the EU, and in Hong Kong. In total, 60 patients – equally split between male and female patients – aged 55 or older with insomnia and comorbid nocturia participated in this multi-national, multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over study. The study consisted of 2 treatment periods of 4 weeks each, separated by a 2-3-week washout period. The primary objective of the study was to assess the efficacy of daridorexant 50 mg daily on insomnia by measuring subjective total sleep time (sTST) by the Sleep Diary Questionnaire (SDQ). Other sleep-related endpoints included the overall rating of the insomnia severity by the Insomnia Severity Index© (ISI©), and SDQ-derived variables like quality of sleep visual analog scale (VAS), depth of sleep VAS, daytime alertness VAS, daily ability to function VAS, and number of awakenings. The secondary objective was to assess the efficacy of daridorexant on nocturia by evaluating the number of nocturnal voids, the time to the first nocturnal void, each voiding volume (nighttime and daytime) including total volume, lower urinary tract symptoms (LUTS) sub-score using the International Consultation on Incontinence Questionnaire (ICIQ) -MLUTS and -FLUTS for male and female subjects, and quality of life relative to nocturia, assessed by ICIQ Nocturia Quality of Life (ICIQ-NQoL). Other endpoints included a change in daytime functioning (Insomnia Daytime Symptoms and Impacts Questionnaire score, IDSIQ). Other objectives focused on patient’s overall assessment ratings of their condition and symptoms, as well as patients’ safety using various questionnaires. Insomnia is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.3 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. Insomnia is a common problem with a prevalence of approximately 10% worldwide. On this basis, and assuming a US adult population of around 250 million, there are approximately 25 million adults in the US who suffer from insomnia. 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. Idorsia’s research has shown that poor-quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels. The goals of managing insomnia are to improve sleep quality and quantity, as well as daytime functioning. Current recommended treatment of insomnia includes sleep hygiene recommendations, cognitive behavioral therapy and pharmacotherapy. Nocturia is waking during the night due to the need to urinate and is considered clinically relevant if someone needs to urinate at least twice each night. It is one of the main causes of sleep disruption, including frequent awakenings with patients having difficulties returning to sleep.4 Already two or more voids per nights have been associated with significant burden for the patients and were linked to next day impairments. Nocturia is a predictor for insomnia, with an increased number of voids per night associated with worsened sleep quality and quality of life.5,6,7 Insomnia is common in patients suffering from frequent night-time voiding and should be adequately treated. There is a high unmet medical need to identify effective and safe treatments targeting the frequent sleep complaints in this patient population. References Lederer K et al. Journal of Sleep Research. 2025. doi: 10.1111/jsr.70002 Mignot E et al. Lancet Neurol. 2022;21(2):125-139. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed., Text Revision. American Psychiatric Publishing. 2022. Ancoli-Israel S, Bliwise DL, Nørgaard JP. The effect of nocturia on sleep. Sleep Med Rev. 2011;15(2):91-97. doi:10.1016/j.smrv.2010.03.002 Asplund R, Aberg H. Health of the elderly with regard to sleep and nocturnal micturition. Scand J Prim Health Care. 1992 Jun; 10(2):98-104. Bliwise DL, Foley DJ, Vitiello MV, Ansari FP, Ancoli-Israel S, Walsh JK. Nocturia and disturbed sleep in the elderly. Sleep Med. 2009 May; 10(5):540-8. Yu HJ, Chen FY, Huang PC, Chen TH, Chie WC, Liu CY. Impact of nocturia on symptom-specific quality of life among community-dwelling adults aged 40 years and older. Urology. 2006 Apr; 67(4):713-8 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. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug Approval

17 Mar 2025

·www.globenewswire.com

US FDA removes REMS requirement for TRYVIO (aprocitentan) – minimizing the burden on the healthcare delivery systems and patients

Ad hoc announcement pursuant to Art. 53 LR FDA confirms that prescribers and pharmacists are no longer expected to interact with the REMS Allschwil, Switzerland – March 17, 2025Idorsia Ltd (SIX: IDIA) today announced that – effective immediately – the US FDA has fully released TRYVIO™ (aprocitentan) from its REMS (Risk Evaluation and Mitigation Strategy) requirement. TRYVIO is Idorsia’s dual endothelin receptor antagonist (ERA) indicated for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs. The US FDA has determined that a REMS is no longer necessary to ensure the benefits of TRYVIO outweigh the risk of embryo-fetal toxicity and that labeling is sufficient for conveying the safety information. The FDA have therefore removed the requirement to minimize the burden on the healthcare delivery system of complying with the REMS. Consequently, Idorsia is also released from the post marketing requirement (PMR) to conduct a worldwide descriptive study that collects prospective and retrospective data in women exposed to TRYVIO during pregnancy and/or lactation as these data are no longer needed. Idorsia no longer has post marketing requirements for TRYVIO. Martine Clozel, Chief Scientific Officer of Idorsia, commented:“As a dual endothelin receptor antagonist (ERA), TRYVIO targets a previously unaddressed but important pathway in systemic hypertension, the endothelin pathway. The FDA decision that a REMS is no longer necessary for TRYVIO reflects the progressive understanding of the risk / benefit of TRYVIO. The decision of the FDA is based on an evaluation of human fetal outcomes after exposure to a drug in the ERA class. This change is very important considering that TRYVIO can be prescribed to a large patient population, who have a high cardiovascular risk and whose hypertension could not be brought under control with the previous classes of medication. This comes on top of the outstanding properties of TRYVIO, the result of over 25 years of optimization in our drug discovery team.” Michael Moye, President and General Manager of Idorsia US, commented:“TRYVIO is the first new antihypertensive working via a new pathway for over 40 years. It is a once-daily tablet, is easy to use for patients and easy to prescribe for physicians. In the absence of clinically relevant drug interactions, it can be safely combined with complex drug regimens and, importantly, can be used by chronic renal failure patients with hypertension without dose modification. On top of existing antihypertensives, aprocitentan has been shown to decrease systolic blood pressure by more than 15 mmHg from baseline at trough, and it is well tolerated over the long term. The release of the REMS is fantastic news as it makes TRYVIO even easier to prescribe. TRYVIO is available to prescribe today, and we are now looking for the best commercial solution to fully launch this important medication that fills a large unmet patient need.” Idorsia will submit revised labeling to the US FDA in accordance with the release of the REMS in the coming weeks. For current information on TRYVIO see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). TRYVIO continues to be commercially available through Walgreens Specialty Pharmacy. For more information visit the following websites: US Healthcare Professionals: www.TRYVIOhcp.com US Patients: www.TRYVIO.com Notes to the editor About aprocitentanAprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan is approved as TRYVIO™ in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. Aprocitentan is approved as JERAYGO™ for the treatment of resistant hypertension in combination with other antihypertensives in the European Union and the UK and marketing authorization applications are under review in Canada, and Switzerland. 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

Drug Approval

04 Mar 2025

·www.idorsia.com

Idorsia announces financial results for 2024

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – March 4, 2025Idorsia Ltd (SIX: IDIA) today announced its financial results for 2024. Business highlights 2024 Viatris collaboration: Global research and development collaboration, focused on the development and commercialization of selatogrel and cenerimod entered in March 2024. QUVIVIQ™ (daridorexant): Outstanding launch dynamic in France, and a strong performance in Germany accelerate sales in 2024 – Total Idorsia-led net sales of CHF 61 million in 2024. TRYVIO™ (aprocitentan): Commercially available in the US since October 2024. JERAYGO™ (aprocitentan): Approved in European Union in June 2024 and the UK in January 2025 – marketing authorization application under review in Switzerland and Canada. Subsequent events Restructured convertible bond debt: Tailored approach to remove large debt overhang. New funding: Bondholders to provide CHF 150 million new money facility. Viatris collaboration: Updated agreement removes significant cash requirement for 2025 Financial highlights Net revenue FY 2024 at CHF 113 million. US GAAP operating expenses FY 2024 at CHF 351 million – benefiting from one-off income of CHF 125 million from the Viatris deal – and non-GAAP operating expenses FY 2024 at CHF 427 million. US GAAP operating loss FY 2024 of CHF 232 million and non-GAAP operating loss of CHF 308 million. Guidance for 2025 unforeseen events excluded QUVIVIQ net sales of around CHF 110 million. SG&A expenses of around CHF 210 million, R&D expense of around CHF 100 million, leading to non-GAAP operating expenses of around CHF 325 million. US GAAP loss for global business of around CHF 155 million. André C. Muller, Chief Executive Officer of Idorsia, commented:“We were not able to close the envisaged out-licensing agreement for aprocitentan, but we will now pivot to potential alternative partners. Despite this unexpected setback, we were able to agree a holistic restructuring of our convertible bond debt and secure additional funding for future operations. With so much attention going to the financial situation of the company during the past six months, it’s easy to lose sight of how well the company was performing in other areas. We exceeded our sales target for QUVIVIQ, with a particularly strong performance in France and Germany. Our next potential blockbuster, TRYVIO, was made available for prescription in the US, approved as JERAYGO in the EU and UK, and submitted for review in Switzerland and Canada. We closed a great deal with Viatris for our Phase 3 assets, selatogrel and cenerimod, and we have advanced our early-stage pipeline of potentially first- or best-in-class discoveries. With commercial profitability forecast in 2026, and overall profitability forecast for 2027, we have a lot to be excited about.”Financial results Net revenue of CHF 113 million in 2024 is the result of QUVIVIQ product sales (CHF 61 million), product sales to partners (CHF 47 million), and contract revenues (CHF 5 million). This compares to net revenue of CHF 152 million in 2023, which included CHF 107 million one-off incomes (mainly PIVLAZ sales in Japan and the APAC (ex-China) Nxera deal). Other revenues in 2023 consisted of QUVIVIQ product sales (CHF 31 million), and other contract revenue of CHF 15 million. US GAAP operating expenses in 2024 (CHF 351 million) and 2023 (CHF 409 million) were impacted by one-off incomes of CHF 125 million (Viatris deal) and CHF 298 million (Nxera deal) respectively. Excluding these one-off incomes, US GAAP operating expenses in 2024 amounted to CHF 476 million, decreasing by CHF 231 million compared to 2023 (CHF 707 million), mainly driven by R&D expenses of CHF 144 million decreasing by CHF 150 million compared to 2023 (CHF 294 million), and SG&A expenses of CHF 273 million decreasing by CHF 120 million compared to 2023 (CHF 392 million). US GAAP net loss in 2024 amounted to CHF 264 million (CHF 298 million in 2023). The net loss was favorably impacted by the one-off income related to the Viatris deal (Nxera deal in 2023) and lower operating expenses throughout all functions. The reduction in operating expenses is mainly a result of the restructuring initiative from 2023 which became fully cost effective in 2024 and the Viatris Deal, which relieved the group from Phase 3 development costs related to selatogrel and cenerimod. The US GAAP net loss resulted in a basic net loss per share of CHF 1.45 (basic and diluted) in 2024, compared to a net loss per share of CHF 1.67 (basic and diluted) in 2023. * Idorsia measures, reports, and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance. Non-GAAP net loss in 2024 amounted to CHF 330 million; the difference versus US GAAP net loss was mainly driven by a net gain from the Viatris Deal (CHF 125 million). The non-GAAP net loss resulted in a net loss per share of CHF 1.81 (basic and diluted) in 2024, compared to a net loss per share of CHF 3.04 (basic and diluted) in 2023. Viatris collaborationIn March 2024, Idorsia entered into a global research and development collaboration with Viatris, for the global development and commercialization rights to selatogrel and cenerimod. Idorsia received an upfront payment of USD 350 million (CHF 308 million) with Idorsia obligated to contribute USD 200 million for the development of selatogrel and cenerimod. Idorsia is entitled to potential development and regulatory milestone payments, and certain contingent payments of additional sales milestone payments and tiered royalties in the mid-single to low-double digit percentages on annual net sales. In February 2025, Idorsia reached an agreement with Viatris to update the terms of the collaboration. In exchange for a USD 100 million reduction to Idorsia’s contribution to the development costs due in 2025, Idorsia has agreed to a USD 250 million reduction in future potential regulatory and sales milestone payments, and an expansion of territorial rights to Viatris for cenerimod. The agreed royalties on future sales remain unchanged. Under the updated terms, Idorsia's contribution for the development of selatogrel and cenerimod is reduced to USD 100 million with no commitment in 2025. Idorsia has contributed USD 73 million in 2024 for the performance of development services, and the remaining USD 27 million will be paid in 2026. Restructured convertible bond debt and new funding securedOn February 26, 2025, Idorsia announced that it has reached an agreement with more than two-thirds of the holders of its outstanding convertible bond debt on the main terms of a holistic restructuring of the bonds and a CHF 150 million new money facility, to alleviate the short- to mid-term debt overhang of CHF 800 million while retaining upside potential of key assets beyond the value of the debt. As part of the holistic restructuring Idorsia will issue up to 27.5 million shares and up to 25.5 million warrants. When complete, the tailored solution secures future operations of Idorsia into 2026. More information can be found in the dedicated press release. Capital increaseIn connection with the holistic restructuring of the convertible bond debt and raising of additional funds, 35 million registered shares with a nominal value of CHF 0.05 each have been created out of capital band and will be listed today, March 4, 2025. Financial guidance for 2025As previously announced, for the Idorsia-led portfolio in 2025, the company expects a continued acceleration of QUVIVIQ with net sales of around CHF 110 million, COGS of around CHF 15 million, SG&A expenses of around CHF 210 million, and R&D expense of around CHF 100 million, leading to non-GAAP operating expenses of around CHF 325 million. This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 215 million and US-GAAP operating loss of around CHF 260 million. The company expects US-GAAP EBIT for the partnered business of around CHF 105 million, mainly driven by the amended deal with Viatris. This would result in a US-GAAP loss for the global business of around CHF 155 million. All amounts exclude unforeseen events and potential revenue related to additional business development activities. Arno Groenewoud, Chief Financial Officer, commented:“I’m pleased that our performance in 2024 exceeded our expectations, with higher QUVIVIQ sales and lower OPEX. The series of initiatives that we announced last week totally changes the financial situation of Idorsia. By relieving the significant debt overhang, removing significant and immediate cash requirements, and securing new funding, Idorsia is able to continue to operate into 2026. We will continue our efforts to maximize QUVIVIQ sales and reduce costs moving forward in order to make the money last.” Liquidity and indebtednessAt the end of 2024, Idorsia’s liquidity amounted to CHF 106 million. *rounding differences may occur Commercial operationsIn 2024, QUVIVIQ™ (daridorexant) in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, France, and Sweden generated total product sales of CHF 61 million. Europe and Canada QUVIVIQ (daridorexant) net sales in 2024 reached CHF 32 million in the EUCAN region, a significant increase from CHF 6.5 million in 2023. In France, QUVIVIQ is reimbursed for moderate and severe chronic insomnia patients after, or as an alternative to, cognitive behavioral therapy for insomnia (CBT-I) since January 2024, and was launched in March 2024 as the first and only pharmacotherapy recommended for the treatment of chronic insomnia. Through a commercial partnership with Menarini in France, Idorsia expanded its commercial reach from specialist prescribers to general practitioners (GPs) in October 2024, which has substantially increased sales quarter on quarter with France being one of the main drivers of sales growth in the EUCAN region. In Germany, QUVIVIQ was launched in November 2022 and is the only sleep medication in Germany that can be prescribed for long-term treatment of chronic insomnia. The progress made in Germany is reflected by the performance of QUVIVIQ on the market, with net sales increasing by 279% in 2024 compared to 2023. In February 2025, Idorsia successfully concluded negotiations for the reimbursement price in Germany. Idorsia is expanding its commercial reach from specialist prescribers to general practitioners (GPs) through a commercial partnership with Berlin-Chemie (a wholly owned subsidiary of the Menarini Group) beginning in early April 2025. In the UK, QUVIVIQ is recommended as first-line pharmaceutical treatment for patients with chronic insomnia, after, or as an alternative to, cognitive behavioral therapy for insomnia (CBT-I). QUVIVIQ was launched in October 2023 at NICE approval. The priority in the UK in 2024 was to secure regional access, and the team has achieved reimbursement throughout 85% of the UK, as well as raising awareness of QUVIVIQ among general practitioners. Increased access and awareness have started to translate into strong demand in the UK. In Canada, after being approved in April 2023, QUVIVIQ was launched in November 2023 to the private market, representing 55% of the Canadian insomnia market. To date, 85% of private Canadian lives are covered. The focus is now on public payers; the company submitted public reimbursement dossiers and expects decisions by the end of 2025. In Switzerland, Italy, Spain, Austria, and Sweden, where we are still negotiating for reimbursement, launches have been very successful despite the out-of-pocket costs for patients, particularly in Switzerland where we see a strong demand. In Italy, we have achieved an expansion of the prescriber base from specialists to now include general practitioners who represent nearly 80% of the total insomnia market. Benjamin Limal, President of Europe and Canada region, commented:“Commercial efforts with QUVIVIQ in the EUCAN region are beginning to translate into promising success. Sales have shown a steady increase since the first launch in November 2022, with a recent acceleration – particularly driven by an outstanding launch in France and a great performance in Germany. This dynamic is expected to continue in the coming months as access expands in key European markets. We are also expanding our commercial reach from specialist prescribers to general practitioners through commercial partnerships such as Menarini in France and Berlin-Chemie in Germany.” For more information about QUVIVIQ in the EU, see the Summary of Product Characteristics. For more information about QUVIVIQ in Switzerland, see the Patient Information and Information for Healthcare Professionals. For more information on the marketing authorization of QUVIVIQ in Canada, see the Product Monograph. United States QUVIVIQ® (daridorexant) net sales in 2024 reached CHF 28.6 million in the US, an increase of 17% compared to 2023. As of the end of 2024, almost 175,000 patients have been treated with QUVIVIQ since launch in the US, over 550,000 prescriptions have been dispensed, and the product has been prescribed by more than 51,000 healthcare professionals. Michael Moye, President and General Manager of Idorsia US, commented:“In the US, we have implemented a change to the commercialization approach for QUVIVIQ with the objective to reduce operating costs while maintaining the sales. We are still hopeful that descheduling of the dual orexin receptor antagonist (DORA) class can be achieved and the real value of QUVIVIQ in the US market can be unlocked. Our commercialization partner, Syneos Health, has switched to 20 virtual sales reps, operating with a data driven, highly targeted call plan, instead of the around 100 field force sales reps we had before. Syneos is now also executing marketing, focused digital media, data analytics and market access activities in support of the virtual representatives.” For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide). On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food. Following the approval, the US team rapidly established both the REMS program and specialty distribution channel, begun engaging with hypertension experts at major cardiovascular and nephrology congresses, and initiated encouraging discussions with payors, resulting in TRYVIO being made available for prescription in October 2024. Michael concluded:“TRYVIO has been available to prescribe to the millions of patients in the US whose high blood pressure is not adequately controlled by other drugs since October 2024. A detailed US market assessment, campaign and educational approach is now complete, although funding for a field sales force and promotional activities continues to be dependent on a partnership deal. However, we have started to execute a limited launch of TRYVIO in the US in order to maintain and increase the value of a potential out-licensing deal for aprocitentan.” For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Research & DevelopmentOur drug discovery engine has produced innovative drugs with the potential to transform the treatment paradigm in multiple therapeutic areas, including CNS, cardiovascular, and immunological disorders, as well as orphan diseases. The company also has a vaccine platform for the discovery and development of glycoconjugate vaccines to prevent infection. The company has focused its drug discovery efforts, reducing the number of active projects in research and development and preparing some for out-licensing. The prioritization has resulted in a portfolio of assets where Idorsia intends to develop to the next inflection point before partnering, or when feasible and appropriate, developing further ourselves. The company expects new lucerastat data from a kidney biopsy sub-study (to the ongoing Phase 3 open-label extension study) in the second quarter of 2025, with further discussions on the regulatory pathway to follow. The results from a Phase 1 study of our Clostridium difficile infection vaccine are also expected in the coming months. The company will need to further prioritize activities in order to reduce costs and the decisions on which assets to advance will be taken based on the data when available and the results of ongoing out-licensing discussions for early-stage assets. Idorsia-led portfolioThe company will develop each asset to the next inflection point or seek a partner. Further details including the current status of each project in our portfolio can be found in our innovation fact sheet.Idorsia partner-led portfolioFor Idorsia, sophisticated partnerships are a way of gaining strategic access to technologies or products and fully exploiting our discovery engine and clinical pipeline. We seek suitable external project partners to maximize the value of internal innovation. Aprocitentan is an innovative and highly differentiated drug, commercially available in the US and approved in Europe and UK for the millions of patients who are unable to bring their hypertension under control with existing medications. As the first drug to target the endothelin pathway in systemic hypertension, aprocitentan has blockbuster potential in uncontrolled hypertension, particularly for difficult to treat patients with chronic kidney disease and hypertension, and further potential beyond hypertension. The priority remains to partner aprocitentan, having been released from the exclusivity constraint with the undisclosed party, the company will resume discussions with alternative potential partners that recognize the value of aprocitentan. On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. See the commercial operations section above. On June 27, 2024, the European Commission (EC) approved JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control. For more information about JERAYGO in the EU, see the Summary of Product Characteristics. Further details including the current status of each project in our partner-led portfolio can be found in our innovation fact sheet. Human ResourcesIdorsia reduced 249 positions worldwide in 2024, bringing the total number of permanent employees to 689 (2023: 938). Following a consultation process with employee representatives at headquarters in December 2024, a further reduction of approximately 250 positions globally was anticipated. The company has already begun the implementation of the restructuring and expects the cost reduction to be largely effective by Q2 2025. The total number of permanent employees who are not on notice at the end of February 2025 is 552. Financial ReportThe Financial Report 2024 is available at www.idorsia.com/annual-report. Annual ReportIdorsia's Annual Report 2024 – consisting of the Business Report, Governance Report, Compensation Report, Sustainability Report, and Financial Report (already published today) – will be published on March 27, 2025. Note to ShareholdersThe Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31, 2024, will be held on Wednesday, May 28, 2025. Registered shareholders with voting rights individually or jointly representing at least 0.5% of the share capital of the company, being entitled to add items to the agenda of the general meeting of shareholders, are invited to send in proposals, if any, to Idorsia Ltd, attention Corporate Secretary, Hegenheimermattweg 91, CH-4123 Allschwil, to arrive no later than April 11, 2025. Any proposal received after the deadline will be disregarded. In order to vote at the Annual General Meeting, shareholders must be registered in the company's shareholder register by May 19, 2025, at the latest. Results Day CenterInvestor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: www.idorsia.com/results-day-center. Events Publication of the Annual Report 2024 on March 27, 2025 First Quarter 2025 Financial Results reporting on April 30, 2025 Annual General Meeting of Shareholders on May 28, 2025 Half-Year 2025 Financial Results reporting on July 30, 2025 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 Press Release PDF

Drug ApprovalVaccinePhase 1License out/inFinancial Statement

100 Deals associated with Daridorexant hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D11886 D11887	Daridorexant hydrochloride	-	DB15031

R&D Status

Approved

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

Developing

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

Clinical Result

Indication

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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	bszitgqldv(qunbwgajml) = jshvwdusiy qzwktaagrn (cepmgdegja ) View more	Positive	06 Dec 2024
				Daridorexant 50 mg	bszitgqldv(qunbwgajml) = exzkeybosr qzwktaagrn (cepmgdegja ) View more
EAN2024	Not Applicable	Sleep Initiation and Maintenance Disorders	23	Daridorexant	taiybtegpc(ctztkbyhgv) = Questionnaire scores indicated a clinically meaningful reduction: IDSIQ- cognitive domain by 10 rvapgzsgav (zvinjqycfl ) View more	Positive	28 Jun 2024
NCT05480488 (Pubmed) Manual	Phase 1	-	18	midazolamant 50 mwarfarin	bnkurefhzn(sgwghdpkpp) = lzcryxumcs qsppnohhgb (gnovsxbcpr ) View more	Positive	13 Mar 2024
				daridorexantmgmidazolamwarfarin	bnkurefhzn(sgwghdpkpp) = bhkyvmuwxc qsppnohhgb (gnovsxbcpr ) View more
NCT03545191 (Phase 3 trial, WSC2023)	Phase 3	Sleep Initiation and Maintenance Disorders \| Sleep Apnea, Obstructive	930	Daridorexant 50 mg	ofxfgmzqsz(ajwwrdgffv) = Two participants discontinued study treatment due to AEs (both in placebo) endtsmnyry (jbsuuhgpfx ) View more	Positive	22 Oct 2023
				Placebo
NCT03575104 \| NCT03545191 (Phase 3 studies, WSC2023)	Phase 3	Sleep Initiation and Maintenance Disorders	-	Daridorexant 50 mg	gycadiabym(btgodaiwiv) = krkahxclle eoprbufezb (dwmzoqtzxo ) View more	Positive	22 Oct 2023
NCT03679884 (Pubmed) Manual	Phase 3	Sleep Initiation and Maintenance Disorders	804	Daridorexant	ljfmdjesxm(fbvurzbqol) = Overall incidence of treatment-emergent adverse events was similar across groups (35-40%). ijricdtsdm (hvpoyadnug ) View more	Positive	09 Dec 2022
				Placebo
NCT03545191 (Pubmed)	Phase 3	Sleep Initiation and Maintenance Disorders	930	Daridorexant 50 mg	pnwpzjiudp(edblefjggf) = no cases of cataplexy fnjaoxbcca (nnybdnloho ) 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)	dxgdqocigo(yvqsalwrct) = fekmvbizxm uotgfxzzxy (bfostrwhty, kffhyipvsd - uygcgusjtc) View more	-	25 Mar 2022
				Daridorexant 50 mg (Daridorexant 50 mg)	dxgdqocigo(yvqsalwrct) = itphfvaobm uotgfxzzxy (bfostrwhty, unvgcfsmuv - wlciprjocx) View more
NCT03575104 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders \| Sleep	924	Daridorexant (Daridorexant 10 mg)	dfynizatka(ozfhegjjub) = kouxlcgrxw igmtzehdjq (rjoiqppbfg, nondjghmfu - numjnxfwwn) View more	-	25 Mar 2022
				Daridorexant (Daridorexant 25 mg)	dfynizatka(ozfhegjjub) = zgkagblgit igmtzehdjq (rjoiqppbfg, ufgcgneesy - nrdxaiejhx) View more
NCT03575104 \| NCT03545191 (Trial-1, Trial-2, WSC2022)	Phase 3	Sleep Initiation and Maintenance Disorders	-	Daridorexant 25 mg	ozrwseujbw(bedxlqhlio) = alpsfoykxh akibdjexsv (jzfhgeukby, 56)	Positive	11 Mar 2022
				Daridorexant 50 mg	ozrwseujbw(bedxlqhlio) = nzeggvoymx akibdjexsv (jzfhgeukby, 53)

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