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16 Diseases |  |
1 Trial |
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1 Trial |  |
40 News |  |
- | velusetrag (TD-5108) / Innoviva
Preclinical, Journal: The 5HT4R agonist velusetrag efficacy on neuropathic chronic intestinal pseudo-obstruction in PrP-SCA7-92Q transgenic mice. (Pubmed Central) - Aug 14, 2024
We demonstrated that the PrP-SCA7-92Q Tg line, a model originally developed to mimic spinocerebellar ataxia, is suitable to study CIPO pathology and can be useful in establishing new therapeutic strategies, such as in the case of velusetrag. Our results suggest that velusetrag is a promising compound to treat patients affected by CIPO or intestinal dysmotility disease.
- velusetrag (TD-5108) / Innoviva
SAFETY AND EFFICACY OF VELUSETRAG IN CHRONIC INTESTINAL PSEUDO-OBSTRUCTION: A PHASE II PROOF-OF-CONCEPT STUDY (Poster Stage 1) - Jul 18, 2024 - Abstract #UEGW2024UEGW_1778;
VEL was also well-tolerated and safe, with no serious drug-related adverse event reported.VelusetragPlaceboNumber of pseudo-obstructive episodes012012During treatment periodn (%)27 (90.00)2 (6.67)1 (3.33)23 (76.67)7 (23.33)0During wash-out periodn (%)30 (100.00)0029 (96.67)1 (3.33)0Bristol scale class at pre-treatmentConstipation (Total: 4) Normal (Total: 3) Diarrhea (Total: 16)Total (Total: 23)Constipation (Total: 3)Normal (Total: 3)Diarrhea (Total: 17)Total (Total: 23)Bristol scale class at end of treatmentConstipation n (%)00003 (100.00)02 (11.76)5 (21.74)Normal n (%)4 (100.00)1 (33.33)1 (6.25)6 (26.09)02 (66.67)2 (11.76)4 (17.39)Diarrhea n (%)02 (66.67)15 (93.75)17 (73.91)01 (33.33)13 (76.47)14 (60.87)Tab. 1: Number of pseudo-obstructive episodes (30 evaluable pairs) and stool consistency (23 evaluable pairs) by treatment.
- velusetrag (TD-5108) / Innoviva
SAFETY AND EFFICACY OF VELUSETRAG IN CHRONIC INTESTINAL PSEUDO-OBSTRUCTION: PHASE II PROOF-OF-CONCEPT STUDY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5206;
No cardiovascular adverse reactions or serious treatment emergent adverse events were observed in both treatment groups. Conclusion VEL was well-tolerated and resulted in the decrease of number of pseudo-obstructive episodes and of constipation severity, two main clinical features of CIPO.
- || felcisetrag (TAK-954) / Theravance Biopharma, Resolor (prucalopride) / J&J, Takeda, velusetrag (TD-5108) / Innoviva
Retrospective data, Review, Journal: Safety and Efficacy of Highly Selective 5-Hydroxytryptamine Receptor 4 Agonists for Diabetic and Idiopathic Gastroparesis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (Pubmed Central) - Feb 8, 2024
While the overall adverse effect profile is deemed acceptable, larger studies with extended follow-up periods are needed to investigate rare and/or serious adverse events. Moreover, future high-quality RCTs comparing the efficacy and safety of these novel agents with currently available agents are essential to further validate these findings.
- felcisetrag (TAK-954) / Theravance Biopharma, Resolor (prucalopride) / J&J, Takeda, velusetrag (TD-5108) / Innoviva
Safety and Efficacy of Highly Selective 5-HT4 Agonist (Velusetrag, Felcisetrag, Prucalopride) for Diabetic/Idiopathic Gastroparesis - Systematic Review and Meta-Analysis of Randomized Controlled Trials (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_2433;
Pooled GE time was also significantly better with 5-HT4 agonists (mean difference: 2.534, [1.695, 3.373], p< 0.05). Pooled rates of total adverse events were greater with 5-HT4 agonists (mean difference: 6.975, [1.042, 46.684], p< 0.05).
- || velusetrag (TD-5108) / Innoviva
Clinical, P2b data, Journal: A randomized, double-blind, placebo-controlled, phase 2b study of the efficacy and safety of velusetrag in subjects with diabetic or idiopathic gastroparesis. (Pubmed Central) - Mar 21, 2023
P2
Pooled rates of total adverse events were greater with 5-HT4 agonists (mean difference: 6.975, [1.042, 46.684], p< 0.05). Velusetrag treatment was generally well-tolerated and associated with improved GE vs placebo in subjects with diabetic or idiopathic gastroparesis; however, only the lowest dose, velusetrag 5
- || velusetrag (TD-5108) / Innoviva
New P2 trial: Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). (clinicaltrials.gov) - Feb 13, 2023
P2, N=17, Active, not recruiting, Sponsor: Alfasigma S.p.A.
- | Journal: Pharmacotherapeutic advances for chronic idiopathic constipation in adults. (Pubmed Central) - Nov 22, 2022
In addition, relamorelin, a ghrelin agonist, seems promising for accelerating colonic transit...On the other hand, the experience with these new agents is still limited, especially for long-term treatment. Another important point is that these new treatments for chronic idiopathic constipation are not available worldwide and their use could be somewhat limited by their still relatively high cost.
- || bisacodyl / Generic mfg.
Clinical, Review, Journal: Bisacodyl: A review of pharmacology and clinical evidence to guide use in clinical practice in patients with constipation. (Pubmed Central) - Apr 5, 2022
The aim of the current review was to provide an overview of the historic background, structure, function, and mechanism of action of bisacodyl. Additionally, we discuss the important features and studies for bisacodyl to understand its peculiar characteristics and guide its use in clinical practice, but also stimulate research on open questions.
- || Clinical, Journal: Comparative Efficacy of Drugs for the Treatment of Chronic Constipation: Quantitative Information for Medication Guidelines. (Pubmed Central) - Jun 26, 2021
Additionally, we discuss the important features and studies for bisacodyl to understand its peculiar characteristics and guide its use in clinical practice, but also stimulate research on open questions. The data provided in this study may be a valuable supplement to the medication guidelines for the treatment of chronic constipation.
- || velusetrag (TD-5108) / Innoviva
Clinical, P2 data, Journal: Velusetrag accelerates gastric emptying in subjects with gastroparesis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 study. (Pubmed Central) - May 25, 2021
P2
The data provided in this study may be a valuable supplement to the medication guidelines for the treatment of chronic constipation. Velusetrag accelerates GE in subjects with diabetic or idiopathic gastroparesis and is generally well tolerated in this population (Clinicaltrials.gov NCT01718938).
- || Retrospective data, Review, Journal: Efficacy of drugs in chronic idiopathic constipation: a systematic review and network meta-analysis. (Pubmed Central) - May 28, 2020
Prucalopride ranked first at 12 weeks, and many of the included trials recruited patients who previously did not respond to laxatives, suggesting that this drug is likely to be the most efficacious for patients with chronic idiopathic constipation. However, because treatment duration in most trials was 4-12 weeks, the long-term relative efficacy of these drugs is unknown.
- | Resolor (prucalopride) / J&J, Takeda, velusetrag (TD-5108) / Innoviva
Journal: Serotonin 5-HT Receptor Agonists Improve Facilitation of Contextual Fear Extinction in an MPTP-Induced Mouse Model of Parkinson's Disease. (Pubmed Central) - Apr 14, 2020
It is possible that the degeneration of the SNpc DAergic neurons in PD mice affects the SNr GABAergic neurons, and thereafter, the serotonergic neurons in the MnRN, resulting in hippocampal dysfunction. These findings suggest that 5HT4R agonists could be potentially useful as therapeutic drugs for treating cognitive deficits in PD.
- | Review, Journal: New developments in the treatment of gastroparesis and functional dyspepsia. (Pubmed Central) - Oct 24, 2019
Novel approaches under evaluation in these conditions are the fundus relaxing agents acotiamide and buspirone and the antidepressant mirtazapine in FD. For gastroparesis, recently studied agents include the prokinetic ghrelin agonist relamorelin, the prokinetic serotonergic agents velusetrag and prucalopride, the anti-emetic aprepitant and per-endoscopic pyloric myotomy procedures.
- velusetrag (TD-5108) / Innoviva
EFFICACY OF VELUSETRAG TREATMENT IN PATIENTS WITH IDIOPATHIC GASTROPARESIS: SUBGROUP ANALYSIS OF A PHASE 2B STUDY (B3) - Aug 18, 2019 - Abstract #UEGW2019UEGW_2057;
VEL treatment for 12 weeks reduced gastroparesis symptoms, with greatest effect for the 5-mg dose; demonstrated gastroprokinetic activity at all doses; and was well tolerated in patients with idiopathic gastroparesis. Future phase 3 studies will further evaluate VEL efficacy in this population.
- |||| velusetrag (TD-5108) / Innoviva
Clinical, P2b data: Results from 12 week phase 2b study presented by Dr. Braden Kuo in the NGM plenary session #DDW19 suggests Velusetrag improves gastric emptying and symptoms in patients with diabetic or idiopathic #gastroparesis @ANMSociety @ENSP_mayo @LindaNguyenMD @IFFGD @4GPACT (Twitter) - May 20, 2019
- |||| velusetrag (TD-5108) / Innoviva
P2 data: Dr Kuo @MGHMedicine discusses phase 2 study of velusetrag @theravance for treatment of #gastroparesis (#diabetes and idiopathic): effective and well tolerated #ddw19 #motility (Twitter) - May 20, 2019
- |||| velusetrag (TD-5108) / Innoviva
Trial completion: The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study (clinicaltrials.gov) - Aug 2, 2017
P2, N=233, Completed, Sponsor: Theravance Biopharma R & D, Inc.
Future phase 3 studies will further evaluate VEL efficacy in this population. Active, not recruiting --> Completed
- ||| velusetrag (TD-5108) / Innoviva
Enrollment closed: The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study (clinicaltrials.gov) - Mar 16, 2017
P2, N=233, Active, not recruiting, Sponsor: Theravance Biopharma R & D, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || velusetrag (TD-5108) / Innoviva
Trial primary completion date: The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study (clinicaltrials.gov) - Dec 14, 2015
P2, N=200, Recruiting, Sponsor: Theravance Biopharma R & D, Inc.
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2015 --> May 2017
- |||| velusetrag (TD-5108) / Innoviva
Enrollment open: The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study (clinicaltrials.gov) - Jan 8, 2015
P2, N=200, Recruiting, Sponsor: Theravance Biopharma R & D, Inc.
Trial primary completion date: Dec 2015 --> May 2017 Not yet recruiting --> Recruiting
- ||||| velusetrag (TD-5108) / Innoviva
New P2 trial: The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study (clinicaltrials.gov) - Oct 17, 2014
P2, N=200, Not yet recruiting, Sponsor: Theravance Biopharma R & D, Inc.
- | velusetrag (TD-5108) / Innoviva
Trial completion, P2 data: Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - Aug 1, 2014
P2, N=34, Completed, Sponsor: Theravance Biopharma Antibiotics, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | velusetrag (TD-5108) / Innoviva
Enrollment closed, P2 data: Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - Nov 7, 2013
P2, N=32, Active, not recruiting, Sponsor: Theravance, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | velusetrag (TD-5108) / Innoviva
New P2 trial, P2 data: Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - Oct 30, 2012
P2, N=32, Active, not recruiting, Sponsor: Theravance, Inc.
- | velusetrag (TD-5108) / Innoviva
Trial completion: Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects (clinicaltrials.gov) - Jan 30, 2012
P1, N=40, Completed, Sponsor: Theravance, Inc.
Recruiting --> Active, not recruiting Recruiting --> Completed
- | velusetrag (TD-5108) / Innoviva
New P1 trial: Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects (clinicaltrials.gov) - Oct 27, 2011
P1, N=40, Completed, Sponsor: Theravance, Inc.