An Open-label, Single-dose, Three-period Phase 1 Study to Compare the Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Healthy Subjects Under Fasted Condition

Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.
The objective of the trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules (Lyrica®) and riluzole tablets (Rilutek®) in Chinese healthy adult subjects after single oral administration under fasted condition.

Start Date28 Mar 2025

Sponsor / Collaborator

Beijing Tiantan Hospital

[+1]

NCT06770491

/ RecruitingPhase 1

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profiles of Y-3 in Healthy Adult Volunteers in the United States

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetic profiles of Y-3 in healthy adult volunteers in the United States. The main questions it aims to answer are:
* What the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers?
* If drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers.
Researchers will compare drug Y-3 (40 mg and 60 mg) to a placebo (a look-alike substance that contains no drug) to see what the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers and if drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers.
Participants will:
* Take drug Y-3 (40 mg) or Y-3 (60 mg) or a placebo only once.
* Answer questions regarding your medical history.
* Comply with the study procedures and requests.
* Complete all tests and collections of PK Sampling.
* Must not have any special dietary requirements and be able to consume the food (low-fat) provided by Tranquil Clinical Research during your 4-night stay.
* Must avoid excessive ( > 8 cups per day) caffeine consumption (i.e. coffee or tea) during your time in the study.
* Must not consume any food or beverage rich in grapefruit, papaya, or mango during your time in the study.
* Must not take any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study.
* Must avoid sexual activity or use non-drug contraceptive measures (i.e. condoms) during your time in the study.
* Female participants must not become pregnant while in the study.
* Must not receive any vaccinations during your time in the study.
* Must not donate blood for purposes outside of study procedures during your time in the study.
* Must not drink alcohol during your time in the study.
* Must not smoke during your time in the study.
* Inform your Study Doctor if you no longer wish to participate in the study.

Start Date06 Jan 2025

Sponsor / Collaborator

Neurodawn Pharmaceutical Co., Ltd.

NCT06935682

/ RecruitingPhase 1IIT

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Study to Assess the Safety and Pharmacokinetics of Y-4 Tablets After Single- and Multiple-dose in Healthy Subjects

Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.
The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose.
The secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.

Start Date04 Jan 2025

Sponsor / Collaborator

Beijing Tiantan Hospital

[+1]

100 Clinical Results associated with Neurodawn Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Neurodawn Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Neurodawn Pharmaceutical Co., Ltd.

01 Apr 2024·JAMA Neurology

Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke

Article

Author: Dong, Aiqin ; Li, Shuya ; Liu, Bo ; Sui, Yi ; Sun, Xin ; Shi, Xueying ; Han, Shugen ; Fu, Yu ; Dong, Xueshuang ; Yao, Jinliang ; Tian, Xue ; Yi, Fei ; Ling, Yun ; Tang, Renhong ; Yang, Shibao ; Feng, Xiaofei ; Wei, Yan ; Xia, Xue ; Wen, Guoqiang ; Li, Chuanling ; Fan, Dongsheng ; Deng, Qian ; Guo, Cunju ; Chen, Rong ; Wang, Anxin ; Ren, Jinsheng ; Zhu, Shunwei ; Wang, Zhimin

ImportanceSublingual edaravone dexborneol, which can rapidly diffuse and be absorbed through the oral mucosa after sublingual exposure, is a multitarget brain cytoprotection composed of antioxidant and anti-inflammatory ingredients edaravone and dexborneol.ObjectiveTo investigate the efficacy and safety of sublingual edaravone dexborneol on 90-day functional outcome in patients with acute ischemic stroke (AIS).Design, Setting, and ParticipantsThis was a double-blind, placebo-controlled, multicenter, parallel-group, phase 3 randomized clinical trial conducted from June 28, 2021, to August 10, 2022, with 90-day follow-up. Participants were recruited from 33 centers in China. Patients randomly assigned to treatment groups were aged 18 to 80 years and had a National Institutes of Health Stroke Scale score between 6 and 20, a total motor deficit score of the upper and lower limbs of 2 or greater, a clinically diagnosed AIS symptom within 48 hours, and a modified Rankin Scale (mRS) score of 1 or less before stroke. Patients who did not meet the eligibility criteria or declined to participate were excluded.InterventionPatients were assigned, in a 1:1 ratio, to receive sublingual edaravone dexborneol (edaravone, 30 mg; dexborneol, 6 mg) or placebo (edaravone, 0 mg; dexborneol, 60 μg) twice daily for 14 days and were followed up until 90 days.Main Outcomes and MeasuresThe primary efficacy outcome was the proportion of patients with mRS score of 1 or less on day 90 after randomization.ResultsOf 956 patients, 42 were excluded. A total of 914 patients (median [IQR] age, 64.0 [56.0-70.0] years; 608 male [66.5%]) were randomly allocated to the edaravone dexborneol group (450 [49.2%]) or placebo group (464 [50.8%]). The edaravone dexborneol group showed a significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization compared with the placebo group (290 [64.4%] vs 254 [54.7%]; risk difference, 9.70%; 95% CI, 3.37%-16.03%; odds ratio, 1.50; 95% CI, 1.15-1.95, P = .003). The rate of adverse events was similar between the 2 groups (89.8% [405 of 450] vs 90.1% [418 of 464]).Conclusion and RelevanceAmong patients with AIS within 48 hours, sublingual edaravone dexborneol could improve the proportion of those achieving a favorable functional outcome at 90 days compared with placebo.Trial RegistrationClinicalTrials.gov Identifier: NCT04950920

27 Feb 2024·Stroke and vascular neurology

Efficacy and safety of Y-2 sublingual tablet for patients with acute ischaemic stroke: protocol of a phase III randomised double-blind placebo-controlled multicentre trial.

Article

Author: Tang, Renhong ; Fu, Yu ; Wang, Anxin ; Ren, Jinsheng ; Feng, Xiaofei ; Chen, Rong ; Zhu, Shunwei ; Fan, Dongsheng

BACKGROUND AND PURPOSEClinical studies have demonstrated that edaravone dexborneol can improve the functional outcomes in patients with acute ischaemic stroke (AIS). The present clinical trial aimed at testing the efficacy and safety of Y-2 sublingual tablet on 90-day functional outcome in patients with AIS.METHODS AND DESIGNThis is a randomised, double-blind, placebo-controlled, multicentre, parallel-group trial of Y-2 sublingual tablet on patients with AIS.An estimated 914 patients at age of 18-80 years with AIS within 48 hours after symptom onset from 40 hospitals will be randomly assigned to receive Y-2 sublingual tablet or placebo for 14 days. Patients are at score 6-20 points on National Institutes of Health Stroke Scale (NIHSS) and had a modified Rankin Scale (mRS) ≤1 before this stroke, except mechanical thrombectomy and neuroprotective agents treatment.STUDY OUTCOMESThe primary outcome is the proportion of patients with mRS ≤1 on day 90 after randomisation. Secondary efficacy outcomes include mRS score on day 90, the proportion of patients with mRS ≤2 on day 90; the change of NIHSS score from baseline to day 14 and the proportion of patients with NIHSS score ≤1 at the days 14, 30 and 90.DISCUSSIONThis trial will provide valuable evidence for the efficacy and safety of Y-2 sublingual table for improving 90 days the functional outcomes in patients with AIS.TRIAL REGISTRATION NUMBERNCT04950920.

01 Dec 2023·Stroke and Vascular Neurology

Preclinical evaluation of ZL006-05, a new antistroke drug with fast-onset antidepressant and anxiolytic effects

Article

Author: Wang, Xuan ; Wu, Haiyin ; Chen, Mingyu ; Zhu, Dongya ; Wang, Yilong ; Ren, Jian ; Hua, Yao ; Luo, Chunxia ; Li, Fei ; Song, Yixuan ; Chen, Wei ; Chang, Lei ; Lin, Yuhui ; Shen, Luyao ; Huang, Zhenquan ; Zhou, Ying

BackgroundPoststroke depression and anxiety, independent predictor of poor functional outcomes, are common in the acute phase of stroke. Up to now, there is no fast-onset antidepressive and anxiolytic agents suitable for the management of acute stroke. ZL006-05, a dual-target analgesic we developed, dissociates nitric oxide synthase from postsynaptic density-95 while potentiates α2-containing γ-aminobutyric acid type A receptor. This study aims to determine whether ZL006-05 can be used as an antistroke agent with fast-onset antidepressant and anxiolytic effects.MethodsPhotothrombotic stroke and transient middle cerebral artery occlusion were induced in rats and mice. Infarct size was measured by TTC(2,3,5-Triphenyltetrazolium chloride) staining or Nissl staining. Neurological defects were assessed by four-point scale neurological score or modified Neurological Severity Scores. Grid-walking, cylinder and modified adhesive removal tasks were conducted to assess sensorimotor functions. Spatial learning was assessed using Morris water maze task. Depression and anxiety were induced by unpredictable chronic mild stress. Depressive behaviours were assessed by tail suspension, forced swim and sucrose preference tests. Anxiety behaviours were assessed by novelty-suppressed feeding and elevated plus maze tests. Pharmacokinetics, toxicokinetics and long-term toxicity studies were performed in rats.ResultsAdministration of ZL006-05 in the acute phase of stroke attenuated transient and permanent ischaemic injury and ameliorated long-term functional impairments significantly, with a treatment window of 12 hours after ischemia, and reduced plasminogen activato-induced haemorrhagic transformation. ZL006-05 produced fast-onset antidepressant and anxiolytic effects with onset latency of 1 hour in the normal and CMS mice, had antidepressant and anxiolytic effects in stroke mice. ZL006-05 crossed the blood–brain barrier and distributed into the brain rapidly, and had a high safety profile in toxicokinetics and long-term toxicological studies.ConclusionZL006-05 is a new neuroprotectant with fast-onset antidepressant and anxiolytic effects and has translational properties in terms of efficacy, safety and targeting of clinical issues.

News (Medical) associated with Neurodawn Pharmaceutical Co., Ltd.

21 Feb 2024

·www.prnewswire.com

Findings of a Phase III Clinical Study of Sanbexin® Sublingual Tablets Published in JAMA

NANJING, China, Feb. 20, 2024 /PRNewswire/ -- On February 19, 2024, the Journal of American Medical Association•Neurology (JAMA NEUROLOGY, IF: 29.0) published online the key findings of a phase III clinical study (NCT04950920) (the "TASTE-SL Study") investigating Sanbexin® (a combination of edaravone and dexborneol) sublingual tablets for the treatment of acute ischemic stroke (the "AIS"). The findings indicate that Sanbexin® sublingual tablets has substantially enhanced neurological functions and independence in daily living activities among AIS patients following the treatment. Continue Reading JAMA-Neurology paper published online Feb.19 TASTE-SL study design TASTE-SL study primary end point Sanbexin® sublingual tablets is an innovative drug jointly developed by Simcere Pharmaceutical Group Ltd. ("Simcere") and Neurodawn Pharmaceutical Co., Ltd. ("Neurodawn"). The Sanbexin® sublingual tablets is expected to become a sequential therapy with Simcere's marketed Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) and allow patients to receive a complete course of treatment both in and outside of the hospital. On June 28, 2023, the New Drug Application (NDA) of the Sanbexin® sublingual tablets was accepted by the National Medical Products Administration of China (the "NMPA"). The first indication is for the improvement of neurological symptoms, activities of daily living, and functional disabilities caused by AIS. Sanbexin® sublingual tablet offers a novel approach to stroke treatment, leveraging the power of edaravone and dexborneol. The two active ingredients dissolve quickly under the tongue and are rapidly absorbed into the bloodstream via the sublingual venous plexus, providing unparalleled anti-inflammatory and free radical scavenging capabilities. By minimizing the cascading damage caused by AIS and protecting brain cells, this innovative formulation has the potential to expand treatment options and improve patient compliance. With its innovative sublingual delivery system, Sanbexin® is poised to revolutionize stroke care. The TASTE-SL study, published in JAMA Neurology, is a Phase III clinical trial that evaluated the safety and efficacy of Sanbexin® sublingual tablets in AIA patients. This multi-center, randomized, double-blind, placebo-controlled study enrolled 914 AIS patients within 48 hours of onset at 33 research sites in China from June 28, 2021, to August 10, 2022. Of these, 450 patients in the Sanbexin® sublingual tablets group received 36mg dose of sublingual edaravone dexborneol (edaravone 30mg, dexborneol 6mg) twice a day for 14 consecutive days), while 464 patients in the placebo group received a sublingual placebo (edaravone 0mg, dexborneol 60μg) twice a day for 14 consecutive days. The findings from the clinical trial suggest that the Sanbexin® sublingual tablets offer significant benefits for the treatment of AIS. The study, which included 302 patients, showed that those taking Sanbexin® sublingual tablets had a higher proportion of good functional outcomes (mRS score 0-1) on day 90 post-randomization compared to the placebo group: – 64.4% vs. 54.7%. The odds ratio was 1.50 (95% CI 1.15-1.95, p=0.003). Subgroup analyses of different demographic and clinical characteristics revealed consistent improvements in neurological function for the Sanbexin® sublingual tablet, regardless of age (≤65 or >65), gender, time from stroke onset to treatment (≤24 hours or >24 hours), presence of hypertension, hyperlipemia, diabetes, heart disease, or renal dysfunction. The Sanbexin® sublingual tablets demonstrated a favorable safety profile, with comparable rates of adverse events (AEs) and treatment-related AEs within 90 days between the two groups. This data strengthens Sanbexin® sublingual tablets' position as an effective and well-tolerated treatment option for AIS patients. Prof. Wang Yongjun, President of Beijing Tiantan Hospital of Capital Medical University, said, "In the field of stroke treatment, the continued exploration of brain cell protection therapy is beginning to show promise. Following the TASTE study, which validated the clinical benefit of edaravone dexamethasone injection, the TASTE-SL study further confirmed the efficacy and safety of the sublingual dosage form in the AIS population, and a more convenient way of administering the drug is expected to push the brain cell protection to home treatment." Prof. Fan Dongsheng from the Peking University Third Hospital said, "Sanbexin® sublingual tablets is effective in improving neurological function recovery and independent living ability of ischemic stroke patients after treatment and apply to a variety of treatment scenarios. This Phase III study of Sanbexin® sublingual tablet also provides a high-quality evidence-based basis for clinical brain cell protection, which provides a strong guarantee for stroke treatment." SOURCE Simcere Pharmaceutical Group Limited

Phase 3Clinical Result

100 Deals associated with Neurodawn Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 16 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

NDA/BLA

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Edaravone/Dexborneol ( CPT1A x PRDX1 )	Acute Ischemic Stroke More	NDA/BLA
Y-3 ( GABAA receptor x PSD95 x nNOS )	Depressive Disorder More	Phase 3
Mecripyrine Hydrochloride ( ACHE )	Alzheimer Disease More	Phase 2
Cilostazol/Decanol ( PDE3 )	occlusions More	Phase 2
Pregabalin/Riluzole ( CACNA2D1 x CACNA2D2 x SCNA )	-	Phase 1

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