NCT06010693 is a Phase 3 clinical trial of Daridorexant in Insomnia Disorder, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd..

Who is sponsoring NCT06010693?

NCT06010693 is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd..

What drugs are being tested in NCT06010693?

Interventions in NCT06010693: Daridorexant, Placebo.

What condition does NCT06010693 study?

NCT06010693 studies Insomnia Disorder.

Is NCT06010693 still recruiting?

NCT06010693 is currently completed. Last updated 30 October 2024.

Last reviewed 2024-10-30 · How we verify

NCT06010693

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Daridorexant in Chinese Patients With Insomnia Disorder

Completed Phase 3 Last updated 30 October 2024

What this trial tests

Phase 3 trial testing Daridorexant in Insomnia Disorder in 206 participants. Completed in 10 May 2024.

Timeline

28 August 2023

Primary endpoint
12 April 2024

10 May 2024

Quick facts

Lead sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	206
Start date	28 August 2023
Primary completion	12 April 2024
Estimated completion	10 May 2024
Sites	33 locations across China

Drugs / interventions tested

Daridorexant (DARIDOREXANT) — full drug profile →
Placebo

Conditions studied

Insomnia Disorder — all drugs for Insomnia Disorder →

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Insomnia Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to assess the efficacy and safety of 50 mg daridorexant in adult and elderly chinese patients with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters .

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and safety of daridorexant in Chinese patients with insomnia disorder: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial.
Huang Z, Wang H, Zhang B, Li C, et al · · 2025 · cited 1× · PMID 40557879 · DOI 10.1093/sleep/zsaf170

Verify or expand the search:

Other trials of Daridorexant

Trials testing the same drug.

NCT07028697 — A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder · Phase 3 · completed
NCT06326723 — Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects · Phase 1 · completed
NCT05597020 — A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia · Phase 4 · completed
NCT05632393 — A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women · Phase 1 · completed
NCT05480475 — A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Dabigatran and R · Phase 1 · completed

Other recruiting trials for Insomnia Disorder

Currently open trials in the same condition.

NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia · NA · recruiting
NCT06626048 — Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study · NA · active not recruiting
NCT06669507 — The Sleep Clinic Outcome and Practice Study · NA · recruiting
NCT06335784 — Mental Imagery and Targeted Memory Reactivation in Insomnia · NA · recruiting
NCT05924425 — Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease · Phase 4 · recruiting

Other Jiangsu Simcere Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07345364 — A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics · Phase 1 · not yet recruiting
NCT07357610 — An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healt · Phase 1 · recruiting
NCT07175233 — A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis · Phase 2 · not yet recruiting
NCT06686745 — Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors · Phase 1 · recruiting
NCT06680921 — A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Brea · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06010693 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jiangsu Simcere Pharmaceutical Co., Ltd.
Last refreshed: 30 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06010693.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing