A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial Investigating the Effect of 4 Weeks Bi-daily Dosing of XEN-D0501 on Blood Glucose Reduction as add-on to Metformin in Patients With Diabetes

This is a randomised, double-blind, placebo-controlled, parallel-group trial investigating the effect of 4 weeks bi-daily dosing of XEN-D0501 on blood glucose reduction as add-on to metformin in patients with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.

开始日期2019-02-25

申办/合作机构

Pila Pharma AB

[+1]

EUCTR2018-001880-22-LT / Not yet recruiting临床2期

A randomised, double-blind, placebo-controlled, parallel-group trial investigating the effect of 4 weeks bi-daily dosing of XEN-D0501 on blood glucose reduction as add-on to metformin in patients with diabetes type 2

开始日期2018-08-23

申办/合作机构

Pila Pharma AB

NCT03278158 / Completed临床2期

A Single-dose Dose Escalation Trial in a Randomised, Single-blind, Placebo-controlled Group-comparison Design to Investigate the Safety and Tolerability of XEN-D0501 in Patients With Diabetes Mellitus Type 2

This is a single-dose dose escalation trial in a randomised, single-blind, placebo-controlled group-comparison design to investigate the safety and tolerability of XEN-D0501 in subjects with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.

开始日期2017-09-18

申办/合作机构

Pila Pharma AB

100 项与 XEN-D0501 相关的临床结果

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100 项与 XEN-D0501 相关的转化医学

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100 项与 XEN-D0501 相关的专利（医药）

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项与 XEN-D0501 相关的文献（医药）

2017-11-15·American Journal of Respiratory and Critical Care Medicine

XEN-D0501, a Novel Transient Receptor Potential Vanilloid 1 Antagonist, Does Not Reduce Cough in Patients with Refractory Cough

Article

作者: Badri, Huda ; Holt, Kimberley ; McGarvey, Lorcan ; Birrell, Mark A. ; Smith, Jaclyn A. ; Maher, Sarah A. ; Wortley, Michael A. ; Satia, Imran ; Belvisi, Maria G. ; Round, Patrick ; Ford, John

RATIONALEHeightened cough responses to inhaled capsaicin, a transient receptor potential vanilloid 1 (TRPV1) agonist, are characteristic of patients with chronic cough. However, previously, a TRPV1 antagonist (SB-705498) failed to improve spontaneous cough frequency in these patients, despite small reductions in capsaicin-evoked cough.OBJECTIVESXEN-D0501 (a potent TRPV1 antagonist) was compared with SB-705498 in preclinical studies to establish whether an improved efficacy profile would support a further clinical trial of XEN-D0501 in refractory chronic cough.METHODSXEN-D0501 and SB-705498 were profiled against capsaicin in a sensory nerve activation assay and in vivo potency established against capsaicin-induced cough in the guinea pig. Twenty patients with refractory chronic cough participated in a double-blind, randomized, placebo-controlled crossover study evaluating the effect of 14 days of XEN-D0501 (oral, 4 mg twice daily) versus placebo on awake cough frequency (primary outcome), capsaicin-evoked cough, and patient-reported outcomes.MEASUREMENTS AND MAIN RESULTSXEN-D0501 was more efficacious and 1,000-fold more potent than SB-705498 at inhibiting capsaicin-induced depolarization of guinea pig and human isolated vagus nerve. In vivo XEN-D0501 completely inhibited capsaicin-induced cough, whereas 100 times more SB-705498 was required to achieve the same effect. In patients, XEN-D0501 substantially reduced maximal cough responses to capsaicin (mean change from baseline, XEN-D0501, -19.3 ± 16.4) coughs; placebo, -1.8 ± 5.8 coughs; P < 0.0001), but not spontaneous awake cough frequency (mean change from baseline, XEN-D0501, 6.7 ± 16.9 coughs/h; placebo, 0.4 ± 13.7 coughs/h; P = 0.41).CONCLUSIONSXEN-D0501 demonstrated superior efficacy and potency in preclinical and clinical capsaicin challenge studies; despite this improved pharmacodynamic profile, spontaneous cough frequency did not improve, ruling out TRPV1 as an effective therapeutic target for refractory cough. Clinical trial registered with www.clinicaltrialsregister.eu (2014-000306-36).

100 项与 XEN-D0501 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
膀胱过度活动症	临床2期	-	Xention Ltd.	2011-01-07
红斑性肢痛症	临床前	美国	Pila Pharma AB	2023-11-21
2型糖尿病	药物发现	丹麦	Pila Pharma AB	2017-09-18
慢性咳嗽	药物发现	英国	ario pharma Ltd.	2014-07-01
慢性咳嗽	药物发现	爱尔兰	Xention Ltd.	2014-07-01
慢性咳嗽	药物发现	爱尔兰	ario pharma Ltd.	2014-07-01
慢性咳嗽	药物发现	英国	Xention Ltd.	2014-07-01
慢性阻塞性肺疾病	药物发现	英国	ario pharma Ltd.	2014-02-01
慢性阻塞性肺疾病	药物发现	英国	Xention Ltd.	2014-02-01