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| «123456» |
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Daridorexant Does Not Impair Respiratory Function in Patients with Mild/Moderate Obstructive Sleep Apnea Irrespective of Severity () - May 17, 2021 - Abstract #SLEEP2021SLEEP_604;
Treatment differences for any of the evaluated endpoints did not significantly correlate with AHI at baseline as a marker of OSA severity (r2 ≤ 0.09). Conclusion Daridorexant can safely be administered to patients with mild/moderate OSA as treatment differences for respiratory-related endpoints were not of statistical significance and independent of disease severity in the studied population.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Absence of Withdrawal Symptoms and Rebound Insomnia Upon Discontinuation of Daridorexant in Patients with Insomnia () - May 17, 2021 - Abstract #SLEEP2021SLEEP_595;
P3
Mean WASO and LPS values (min) decreased from baseline to placebo run-out (WASO Trial-1: 25mg, -8.6±55.5; 50mg, -2.5±52.4; placebo, -20.4±45.8; Trial-2: 10mg, -11.6±58.3; 25mg, -5.1±57.9; placebo, -26.2±53.5; LPS Trial-1: 25mg, -17.2±56.7; 50mg, -15.0±55.8; placebo, -27.8±47.2; Trial-2: 10mg, -17.3±67.2; 25mg, -10.3±67.3; placebo, -18.3±63.8) while sTST values (min) increased (Trial-1: 25mg, 43.3±53.8; 50mg, 42.9±59.6; placebo, 42.3±52.7; Trial-2: 10mg, 43.3±52.9; 25mg, 46.8±55.4; placebo, 42.3±53.8) indicating absence of rebound effects. Conclusion Treatment with daridorexant for up to 3-months was not associated with any evidence of drug withdrawal or rebound insomnia upon abrupt discontinuation, indicating no safety concerns for patients should treatment be stopped.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Daridorexant is Safe and Improves Both Sleep and Daytime Functioning in Elderly Patients with Insomnia () - May 17, 2021 - Abstract #SLEEP2021SLEEP_594;
P3
Conclusion Daridorexant is efficacious in the elderly population for improvements in sleep and daytime functioning. No safety concerns in this vulnerable population were identified at either dose.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Daridorexant Improves Total Sleep Time (TST) in Insomnia Patients Without Altering the Proportion of Sleep Stages () - May 17, 2021 - Abstract #SLEEP2021SLEEP_591;
P3
Data for 25mg were consistent between trials. Conclusion Daridorexant at any dose, and each more than placebo, increased TST in a dose-dependent manner without affecting the proportion of all sleep stages in patients with insomnia.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] A benefit-risk assessment of daridorexant for the treatment of insomnia using patient preference data from two phase 3 trials () - May 17, 2021 - Abstract #SLEEP2021SLEEP_590;
Daridorexant 50 mg and 25 mg were found to be significantly preferred over placebo, suggesting a positive benefit-risk balance of both doses. Overall, the preference data allowed for an innovative interpretation of the trial data from patients’ perspective.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Effect of the dual orexin receptor antagonist (DORA) daridorexant on behaviour upon awakening in rats and dogs () - May 17, 2021 - Abstract #SLEEP2021SLEEP_331;
Conclusion The type of sleep promoted by daridorexant is surmountable in rats and dogs and similar to physiological sleep. It allows animals to easily wake up, to behave normally without motor impairment and to respond efficiently to the environmental conditions.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Daridorexant: A dual, equipotent, and insurmountable antagonist of both orexin-1 and orexin-2 receptors () - May 17, 2021 - Abstract #SLEEP2021SLEEP_295;
Conclusion Daridorexant displays the desired target interaction profile of a dual, equipotent, and insurmountable antagonist of both OX1R and OX2R, which ensures equally efficient inhibition of both arousal-/wake-promoting receptor subtypes. Daridorexant′s on-target residence times are long enough to cause insurmountable inhibition, but short enough to avoid pharmacodynamic effects after drug elimination.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Daridorexant, a dual orexin receptor antagonist, improves age-related insomnia in rats () - May 17, 2021 - Abstract #SLEEP2021SLEEP_232;
Conclusion In rats, an insomnia-like phenotype, characterized by reduced non-REM sleep time, develops with age. Daridorexant improves this phenotype and its effect is maintained upon repeated administration over three weeks.
- || Clinical, Journal: Clinical pharmacology, efficacy, and safety of orexin receptor antagonists for the treatment of insomnia disorders. (Pubmed Central) - Mar 13, 2021
Further research is needed to demonstrate benefits to patients suffering from insomnia disorder, e.g., with respect to improving not only sleep but also daytime functioning. In addition, ongoing and future research will show whether ORAs may have beneficial effects in patients with various psychiatric and neurodegenerative disorders, including Alzheimer's disease.
- ||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion: Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep (clinicaltrials.gov) - Mar 3, 2021
P3, N=804, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
In addition, ongoing and future research will show whether ORAs may have beneficial effects in patients with various psychiatric and neurodegenerative disorders, including Alzheimer's disease. Active, not recruiting --> Completed
- || daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
Clinical, PK/PD data, Journal: Clinical pharmacology of the dual orexin receptor antagonist ACT-541468 in elderly subjects: Exploration of pharmacokinetics, pharmacodynamics and tolerability following single-dose morning and repeated-dose evening administration. (Pubmed Central) - Feb 4, 2021
P1
ACT-541468 in elderly subjects was well tolerated and pharmacokinetics and pharmacodynamics are compatible with a drug for the treatment of insomnia. Clinicaltrials.gov: NCT02571855.
- || daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
Clinical, PK/PD data, Journal: Pharmacokinetics and Pharmacodynamics of the Dual Orexin Receptor Antagonist Daridorexant in Japanese and Caucasian Subjects. (Pubmed Central) - Dec 17, 2020
Changes in other safety assessments were unremarkable. The PK, PD, and safety profile of daridorexant were similar in Japanese and Caucasian subjects.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Assessment of the Abuse Potential of Daridorexant, a New Dual Orexin Receptor Antagonist for the Treatment of Insomnia Disorder: Data From Preclinical and Clinical Studies () - Sep 30, 2020 - Abstract #ACNP2020ACNP_630;
Among recreational drug users pre-selected based on liking of sedatives, daridorexant exhibited similar drug-liking effects as suvorexant and zolpidem at supratherapeutic doses. At the highest phase-3 dose of 50 mg, daridorexant showed lower effects than both control drugs with respect to the primary and most secondary endpoints.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] The Novel Insomnia Drug Daridorexant Also Reduces Behavioral and Physiological Stress Responses in Rats () - Sep 30, 2020 - Abstract #ACNP2020ACNP_495;
Daridorexant did not reduce panic-like flight reactions induced by ultrasonic danger signals in the rat. The positive impact of decreased wakefulness on attenuating the aversive emotional responses to non-vital environmental stress is discussed.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Daridorexant is Efficacious in Improving Sleep as Well as Daytime Functioning in Insomnia Patients () - Sep 30, 2020 - Abstract #ACNP2020ACNP_160;
P3
Daridorexant significantly improved LPS (50 mg, 25 mg study 1), WASO (50 mg, 25 mg both studies) and sTST (50 mg and 25 mg both studies), and daytime functioning (50 mg). Overall, 50 mg daridorexant appeared to provide more robust efficacy than the lower doses without affecting the safety profile.
- || daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
Clinical, Journal: Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder. (Pubmed Central) - Sep 23, 2020
P2
Daridorexant was well tolerated. Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10-50 mg) in elderly people with insomnia disorder.
- || daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
Clinical, Journal: Daridorexant: A new medication for insomnia in older adults? (Pubmed Central) - Sep 23, 2020
Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10-50 mg) in elderly people with insomnia disorder. No abstract available
- | daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health, Opsumit (macitentan) / Nippon Shinyaku, J&J
Journal: 20 Years of Medicinal Chemistry - Always Look at the Bright Side (of Life). (Pubmed Central) - Sep 23, 2020
[1] Then the discovery of ACT-462206, a dual orexin receptor antagonist for the treatment of insomnia disorder with a serendipitously short story from the screening hit to the drug [2] followed by the identification of daridorexant, another dual orexin receptor antagonist...The measures Idorsia implemented to obtain valuable hits from high-throughput screening (HTS) campaigns are elaborated. [5] Drug discovery is a multi-disciplinary business with unlimited exciting challenges asking for excessive optimism when tackling them in a playful manner.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled, Polysomnography Study to Assess Efficacy and Safety of Daridorexant in Adult and Elderly Insomnia Patients () - Sep 12, 2020 - Abstract #Sleep2020SLEEP_332;
P3
[5] Drug discovery is a multi-disciplinary business with unlimited exciting challenges asking for excessive optimism when tackling them in a playful manner. This study showed that daridorexant improved objective and subjective sleep parameters, and daytime performance using a validated instrument, with an acceptable safety profile.
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion: Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects (clinicaltrials.gov) - Sep 2, 2020
P1, N=16, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
This study showed that daridorexant improved objective and subjective sleep parameters, and daytime performance using a validated instrument, with an acceptable safety profile. Active, not recruiting --> Completed
- || Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Trial completion: A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects (clinicaltrials.gov) - Sep 2, 2020
P1, N=36, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion: A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant. (clinicaltrials.gov) - Sep 2, 2020
P1, N=24, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Daridorexant, a novel dual orexin receptor antagonist, delivers significant improvement in sleep parameters and daytime function for patients with insomnia disorder (Poster Networking Lounge) - Aug 16, 2020 - Abstract #ESRS2020ESRS_240;
Active, not recruiting --> Completed Daridorexant improved not only objective and subjective sleep parameters, but also daytime function using a validated instrument, while exhibiting an acceptable safety profile.
- ||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Enrollment closed, Enrollment change: Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep (clinicaltrials.gov) - Aug 12, 2020
P3, N=804, Active, not recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
Daridorexant improved not only objective and subjective sleep parameters, but also daytime function using a validated instrument, while exhibiting an acceptable safety profile. Recruiting --> Active, not recruiting | N=1260 --> 804
- || daridorexant (ACT-541468) / Idorsia, Mochida
Clinical, Journal: Multiple-dose clinical pharmacology of ACT-541468, a novel dual orexin receptor antagonist, following repeated-dose morning and evening administration. (Pubmed Central) - Aug 11, 2020
The drug was safe and well tolerated. In conclusion, multiple-dose PK/PD of ACT-541468 were compatible with a drug designated to treat insomnia.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health, Belsomra (suvorexant) / Merck (MSD)
[VIRTUAL] Abuse potential assessment of the novel dual orexin receptor antagonist daridorexant compared to suvorexant and zolpidem in recreational drug users (Poster Area) - Aug 5, 2020 - Abstract #ECNP2020ECNP_366;
At the highest Phase-3 dose of 50 mg, daridorexant exhibited lower abuse potential compared to the schedule IV compounds suvorexant (150 mg) and zolpidem (30 mg), but not at doses of 100 and 150 mg. These data will contribute to the so-called 8-factor analysis of abuse potential according to the applicable FDA guidance.
- | daridorexant (ACT-541468) / Idorsia, Mochida
Journal: Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder. (Pubmed Central) - Aug 4, 2020
P2
Daridorexant induced a dose-dependent reduction in wake time after sleep onset in subjects with insomnia disorder. Clinicaltrials.
- daridorexant (ACT-541468) / Idorsia, Mochida, Syneos Health
[VIRTUAL] Effect of multiple-dose treatment with daridorexant on nighttime respiratory function in patients with mild and moderate obstructive sleep apnea (OSA) (Pre-congress content) - Jul 15, 2020 - Abstract #ERS2020ERS_546;
Overall, no effects on vital signs, ECG, or laboratory variables were detected after daridorexant administration. Our results show that daridorexant does not impair nighttime respiratory function in patients with mild and moderate OSA.
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Enrollment closed: A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant. (clinicaltrials.gov) - Jul 6, 2020
P1, N=24, Active, not recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
Our results show that daridorexant does not impair nighttime respiratory function in patients with mild and moderate OSA. Not yet recruiting --> Active, not recruiting
- | daridorexant (ACT-541468) / Idorsia, Mochida
The daridorexant data aren't perfect, but they're enough for Idorsia $IDIA.SW to file on. Via @evaluatevantage https://t.co/8ZiALM6iYp (Twitter) - Jul 6, 2020
- ||| daridorexant (ACT-541468) / Idorsia, Mochida
.@Idorsia aims for late 2020 filing for #insomnia drug daridorexant, taking on Eisai and Merck & Co https://t.co/P9PhEYMjgI (Twitter) - Jul 6, 2020
- || daridorexant (ACT-541468) / Idorsia, Mochida
...and now the second $IDIA.SW pivotal daridorexant trial in insomnia hits https://t.co/s16Mhl73yq (Twitter) - Jul 6, 2020
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion, Trial completion date, Trial primary completion date: A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment (clinicaltrials.gov) - Jul 2, 2020
P1, N=32, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
Not yet recruiting --> Active, not recruiting Recruiting --> Completed | Trial completion date: Jun 2020 --> Feb 2020 | Trial primary completion date: Jun 2020 --> Feb 2020
- ||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep (clinicaltrials.gov) - Jul 2, 2020
P3, N=924, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
Recruiting --> Completed | Trial completion date: Jun 2020 --> Feb 2020 | Trial primary completion date: Jun 2020 --> Feb 2020 Active, not recruiting --> Completed
- daridorexant (ACT-541468) / Idorsia, Mochida
[VIRTUAL] DARIDOREXANT (ACT-541468), A DUAL OREXIN RECEPTOR ANTAGONIST FOR THE TREATMENT OF INSOMNIA DISORDER: DOUBLE BLIND, RANDOMIZED, PHASE 3 STUDIES FOR EFFICACY AND SAFETY IN ADULT AND ELDERLY PATIENTS () - Jun 29, 2020 - Abstract #Sleep2020SLEEP_188;
P3
Support: Medical writing Randall Watson, (Idorsia). These studies were sponsored by Idorsia Pharmaceuticals Ltd.
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Enrollment closed, Trial completion date, Trial primary completion date: Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects (clinicaltrials.gov) - Jun 28, 2020
P1, N=16, Active, not recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
These studies were sponsored by Idorsia Pharmaceuticals Ltd. Recruiting --> Active, not recruiting | Trial completion date: Feb 2020 --> Jul 2020 | Trial primary completion date: Feb 2020 --> Jul 2020
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
New P1 trial: A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant. (clinicaltrials.gov) - May 14, 2020
P1, N=24, Not yet recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
- || daridorexant (ACT-541468) / Idorsia, Mochida
Idorsia daridorexant low dose (=high dose in 2nd ph2 trial) misses key secondary endpoint, next-day performance, h/t @BertrandBio (Twitter) - Apr 20, 2020
- || daridorexant (ACT-541468) / Idorsia, Mochida
Pretty solid phase 3 data for Idorsia's daridorexant in insomnia, no? https://t.co/QnvlYdPQmN (Twitter) - Apr 20, 2020
- || Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Enrollment closed: A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects (clinicaltrials.gov) - Mar 26, 2020
P1, N=36, Active, not recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
Recruiting --> Active, not recruiting | Trial completion date: Feb 2020 --> Jul 2020 | Trial primary completion date: Feb 2020 --> Jul 2020 Not yet recruiting --> Active, not recruiting
- ||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder (clinicaltrials.gov) - Feb 28, 2020
P3, N=930, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
Not yet recruiting --> Active, not recruiting Active, not recruiting --> Completed
- || Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
New P1 trial: A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects (clinicaltrials.gov) - Jan 30, 2020
P1, N=36, Not yet recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
- ||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Enrollment closed: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep (clinicaltrials.gov) - Jan 23, 2020
P3, N=924, Active, not recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion: A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea (clinicaltrials.gov) - Dec 19, 2019
P1, N=28, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
Recruiting --> Active, not recruiting Recruiting --> Completed
- | nemorexant (ACT-541468) / Idorsia Pharma
P1 data, Journal: Investigating the Metabolism of ACT-541468, Utilizing a Microtracer and Accelerator Mass Spectrometry in The First-in-Humans Trial. (Pubmed Central) - Nov 29, 2019
Recruiting --> Completed In conclusion, ACT-541468 is extensively metabolized predominantly by oxidative transformations.
- ||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Enrollment closed: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder (clinicaltrials.gov) - Nov 20, 2019
P3, N=900, Active, not recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
In conclusion, ACT-541468 is extensively metabolized predominantly by oxidative transformations. Recruiting --> Active, not recruiting
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Enrollment open: Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects (clinicaltrials.gov) - Nov 7, 2019
P1, N=16, Recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion: A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects (clinicaltrials.gov) - Nov 5, 2019
P1, N=56, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
Not yet recruiting --> Recruiting Recruiting --> Completed
- | Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion date, Trial primary completion date: Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep (clinicaltrials.gov) - Oct 15, 2019
P3, N=1260, Recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
Recruiting --> Completed Trial completion date: Sep 2020 --> Mar 2021 | Trial primary completion date: Jul 2020 --> Feb 2021
- | Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Trial completion date, Trial primary completion date: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder (clinicaltrials.gov) - Oct 15, 2019
P3, N=900, Recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
Trial completion date: Sep 2020 --> Mar 2021 | Trial primary completion date: Jul 2020 --> Feb 2021 Trial completion date: Nov 2019 --> Feb 2020 | Trial primary completion date: Oct 2019 --> Jan 2020