tradipitant (VLY-686) / Vanda 
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 2 Diseases   5 Trials   5 Trials   115 News 


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  • ||||||||||  tradipitant (VLY-686) / Vanda
    MOTION SERIFOS: TRADIPITANT EFFECTIVE IN THE PREVENTION OF VOMITING IN MOTION SICKNESS DURING SEA TRAVEL (Strauss 2) -  Sep 23, 2024 - Abstract #UEGW2024UEGW_3681;    
    Tradipitant could be of significant utility for motion sickness affected travelers in both civilian and military settings across air, land, and sea. Given the adverse effects and incomplete efficacy of currently available therapies, there remains a need for a novel efficacious therapeutic with a desirable tolerability profile.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Exposure-Response Analysis of Open Label Tradipitant in Idiopathic and Diabetic Gastroparesis in Study VP-VLY-686-3301 (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_5561;    
    Given the adverse effects and incomplete efficacy of currently available therapies, there remains a need for a novel efficacious therapeutic with a desirable tolerability profile. Patients in the High PK subgroup had statistically improved nausea severity at Week 12 compared to the Low PK subgroup (-1.19 vs. -0.78, respectively; p< 0.0001), including at baseline nausea severity scores of ?2 (-1.61 vs. -0.98, respectively; p< 0.0001) and ?2.5 (-1.77 vs.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Open Label Efficacy Analysis of Tradipitant in Idiopathic and Diabetic Gastroparesis (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_5560;    
    Patients improved the average nausea score significantly from baseline after 12 weeks tradipitant (improvement of -1.01 vs 2.14 at baseline, p< 0.0001). A significant improvement was also seen in the percent of nausea free days (an addition of 51.76% of days for tradipitant vs. 19.62% at baseline, p< 0.0001).
  • ||||||||||  tradipitant (VLY-686) / Vanda
    EXPOSURE-RESPONSE ANALYSIS OF OPEN LABEL TRADIPITANT IN IDIOPATHIC GASTROPARESIS IN STUDY VP-VLY-686-3301 (Science Lounge) -  Jul 18, 2024 - Abstract #UEGW2024UEGW_1069;    
    A significant exposure response was seen in idiopathic gastroparesis patients receiving open label tradipitant for 12 weeks. Patients with higher blood levels of tradipitant significantly improved in average nausea severity and in endpoints measuring overall gastroparesis symptoms compared to subjects with low drug blood levels.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    OPEN LABEL EFFICACY ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS (Science Lounge) -  Jul 18, 2024 - Abstract #UEGW2024UEGW_1068;    
    Tradipitant demonstrated statistically significant improvement from baseline in average nausea severity and percentage of nausea-free days in this 12 week open label study in both idiopathic and diabetic gastroparesis subjects. Additionally, a strong exposure response in nausea improvement was observed when comparing subjects with high drug exposure vs low drug exposure.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Biomarker, Enrollment open:  Tradipitant for Functional Dyspepsia (clinicaltrials.gov) -  Apr 8, 2024   
    P2,  N=60, Enrolling by invitation, 
    Recruiting --> Completed | Phase classification: P1 --> P1/2 Not yet recruiting --> Enrolling by invitation
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Trial completion date, Trial primary completion date:  Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness (clinicaltrials.gov) -  Mar 21, 2024   
    P3,  N=500, Recruiting, 
    Unknown status --> Completed | Trial completion date: Sep 2020 --> Apr 2023 | Trial primary completion date: Aug 2020 --> Apr 2023 Trial completion date: Jul 2024 --> Apr 2025 | Trial primary completion date: Jul 2024 --> Apr 2025
  • ||||||||||  tradipitant (VLY-686) / Vanda
    OPEN LABEL EFFICACY ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS (Hall A, Poster Hall - Walter E. Washington Convention Center) -  Mar 14, 2024 - Abstract #DDW2024DDW_5177;    
    Discussion : Tradipitant demonstrated statistically significant improvement from baseline in average nausea severity and percentage of nausea-free days in this 12 week open label study in both idiopathic and diabetic gastroparesis subjects. Additionally, a strong exposure response in nausea improvement was observed when comparing subjects with high drug exposure vs low drug exposure.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    TRADIPITANT EFFECTIVE IN THE REDUCTION OF VOMITING ASSOCIATED WITH MOTION SICKNESS ACROSS VARIED SEA CONDITIONS (Hall A, Poster Hall - Walter E. Washington Convention Center) -  Mar 14, 2024 - Abstract #DDW2024DDW_2950;    
    Tradipitant has been confirmed to be effective in the reduction of vomiting associated with motion sickness across varied sea conditions with a range of wave heights. Motion sickness remains a significant unmet medical need, given existing treatments' limitations in alleviating symptoms and their frequent adverse effects.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Enrollment change, Trial completion date, Trial primary completion date:  VP-VLY-686-3301: Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis (clinicaltrials.gov) -  Mar 12, 2024   
    P3,  N=900, Recruiting, 
    Motion sickness remains a significant unmet medical need, given existing treatments' limitations in alleviating symptoms and their frequent adverse effects. N=250 --> 900 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Tradipitant Effective in the Reduction of Vomiting Associated with Motion Sickness Across Varied Sea Conditions (Colorado Convention Center | Four Seasons 2/3) -  Mar 8, 2024 - Abstract #AAN2024AAN_2356;    
    Tradipitant has been confirmed to be effective in the reduction of vomiting associated with motion sickness across varied sea conditions with a range of wave heights. Motion sickness remains a significant unmet medical need, given existing treatments' limitations in alleviating symptoms and their frequent adverse effects.
  • ||||||||||  Review, Journal:  An assessment of the effects of neurokinin receptor antagonism against nausea and vomiting: Relative efficacy, sites of action and lessons for future drug development. (Pubmed Central) -  Nov 27, 2023   
    Although NK receptors are present in cerebral nuclei implicated in nausea, and imaging studies show very high receptor occupancy at clinically used doses, the variable or limited ability of NK RAs to inhibit nausea emphasises (a) our inadequate understanding of the mechanisms of nausea and (b) that classification of a drug as an "anti-emetic" may give a false impression of efficacy against nausea versus vomiting. We discuss the potential mechanisms for the differential efficacy of NK RA and the implications for future development of drugs which can effectively treat nausea, an area of unmet clinical need.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Trial completion date, Trial primary completion date:  VP-VLY-686-3301: Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis (clinicaltrials.gov) -  Oct 1, 2023   
    P3,  N=250, Recruiting, 
    We discuss the potential mechanisms for the differential efficacy of NK RA and the implications for future development of drugs which can effectively treat nausea, an area of unmet clinical need. Trial completion date: Sep 2021 --> Dec 2023 | Trial primary completion date: Sep 2021 --> Dec 2023
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Open Label Efficacy Analysis of Tradipitant in Idiopathic and Diabetic Gastroparesis (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_3227;    
    Patients improved the average nausea score significantly from baseline after 12 weeks tradipitant (improvement of -1.06 vs 2.07 at baseline, p< 0.0001). A significant improvement was also seen in the percent of nausea free days (an addition of 32.42% of days for tradipitant vs. 20.19% at baseline, p< 0.0001).
  • ||||||||||  tradipitant (VLY-686) / Vanda
    EFFICACY ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS IN STUDY VP-VLY-686-3301 (South Hall A, Poster Hall - McCormick Place) -  Mar 23, 2023 - Abstract #DDW2023DDW_2608;    
    Significant but similar improvements from baseline for tradipitant and placebo may have masked the true treatment effect size at the primary endpoint of the study of change in nausea severity as measured by daily diary at week 12 leading to no statistically significant difference between treatments. Despite this large placebo effect, tradipitant was shown to be significantly better than placebo in global measures of patient improvement including the Patient Global Impression of Change (PGI-C) and the Overall Patient Benefit (OPB) scales.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    A BASELINE SEVERITY INFLATION ANALYSIS IN STUDY VP-VLY-686-3301 OF TRADIPITANT IN GASTROPARESIS (South Hall A, Poster Hall - McCormick Place) -  Mar 23, 2023 - Abstract #DDW2023DDW_2607;    
    Despite this large placebo effect, tradipitant was shown to be significantly better than placebo in global measures of patient improvement including the Patient Global Impression of Change (PGI-C) and the Overall Patient Benefit (OPB) scales. Tradipitant treatment in the Baseline Severity Inflation Analysis subpopulation resulted in improvements in Nausea, PGI-C, and Overall Patient Benefit Score both the earliest (Week 2) and last (Week 12) timepoints.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Efficacy Analysis of Tradipitant in Idiopathic and Diabetic Gastroparesis in Study VP-VLY-686-3301 (Crown Ballroom) -  Sep 4, 2022 - Abstract #ACG2022ACG_3580;    
    However, in the PGI-C scale, more tradipitant treated patients demonstrated response as compared to placebo both at week 2 (74% v. 58%, p=0.019) and at week 12 (78% v. 66%, p=0.065). Similarly, in the OPB scale, more tradipitant treated patients demonstrated response as compared to placebo both at week 2 (81% v. 62%, p=0.0003) and week 12 (86% v. 71%, p=0.011).
  • ||||||||||  tradipitant (VLY-686) / Vanda
    A BASELINE SEVERITY INFLATION ANALYSIS IN STUDY VP-VLY-686-3301 OF TRADIPITANT IN GASTROPARESIS (Science Lounge) -  Jul 20, 2022 - Abstract #UEGW2022UEGW_2243;    
    Similarly, in the OPB scale, more tradipitant treated patients demonstrated response as compared to placebo both at week 2 (81% v. 62%, p=0.0003) and week 12 (86% v. 71%, p=0.011). Tradipitant treatment in the Baseline Severity Inflation Analysis subpopulation resulted in improvements in Nausea, PGI-C, and Overall Patient Benefit Score both the earliest (Week 2) and last (Week 12) timepoints.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    EFFICACY ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS IN STUDY VP-VLY-686-3301 (Poster Stage 4) -  Jul 20, 2022 - Abstract #UEGW2022UEGW_1306;    
     Significant but similar improvements from baseline for tradipitant and placebo may have masked the true treatment effect size at the primary endpoint of the study of change in nausea severity as measured by daily diary at week 12 leading to no statistically significant difference between treatments. Despite this large placebo effect, tradipitant was shown to be significantly better than placebo in global measures of patient improvement including the Patient Global Impression of Change (PGI-C) and the Overall Patient Benefit (OPB) scales.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    THE ROLE OF M1 TO M2 MACROPHAGE POLARIZATION IN THE ETIOLOGY OF IDIOPATHIC GASTROPARESIS: GWAS PERSPECTIVE (25 - San Diego Convention Center) -  May 7, 2022 - Abstract #DDW2022DDW_6894;    
    We have done a genome-wide association study comparing idiopathic and diabetic cases with controls as well as contrasting idiopathic versus diabetic cases.The samples were obtained from patients with idiopathic and diabetic gastroparesis enrolled in a phase II clinical study (VP-VLY-686-2301)3 and phase III gastroparesis clinical study (VP-VLY-686-3301)...We suggest that macrophage polarization fate could lead to the destruction of the interstitial cells of Cajal which effectively leads to abnormal gastric emptying. The GWAS picture that is emerging implicates novels loci implicated in the pathophysiology of gastroparesis differentiating those of diabetic versus idiopathic etiology.
  • ||||||||||  tradipitant (VLY-686) / Vanda
    Trial completion, Enrollment change:  EPIONE 2: Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2) (clinicaltrials.gov) -  May 4, 2022   
    P3,  N=87, Completed, 
    The GWAS picture that is emerging implicates novels loci implicated in the pathophysiology of gastroparesis differentiating those of diabetic versus idiopathic etiology. Recruiting --> Completed | N=200 --> 87
  • ||||||||||  Clinical, Review, Journal:  Treatments for Childhood Atopic Dermatitis: an Update on Emerging Therapies. (Pubmed Central) -  Dec 18, 2021   
    Several novel topical agents are under clinical investigation for the treatment of AD, including topical phosphodiesterase 4 (PDE4) inhibitors, Janus kinase (JAK) inhibitors, aryl hydrocarbon receptor (AhR) modulating agents, and transient receptor potential vanilloid subfamily member 1 (TRPV1) antagonists. Accompanied by thorough characterization of different phenotype and endotype subsets, the application of precision medicine could provide new prospects for the optimal treatment of AD.