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Tradipitant

Phase 3

Atopic Dermatitis | Small molecule | Dermatology |Vanda Pharmaceuticals Inc.|Last Updated: Apr 20, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment543
FDA Designations
No designations recorded
Clinical trial landscape

Tradipitant · 13 trials · 10 indications

Phase 3 8Phase 2 3Phase 1 2
NCT07446439A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist UseNausea and Vomiting
RECRUITING280 Analytics
NCT06836557Open Label Safety Study of Tradipitant in Idiopathic and Diabetic GastroparesisIdiopathic Gastroparesis
RECRUITING100 Analytics
NCT05903924Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion SicknessMotion Sickness
COMPLETED316 Analytics
NCT06138613Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion SicknessMotion Sickness
ACTIVE NOT_RECRUITING705 Analytics
NCT04327661Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion SicknessMotion Sickness
COMPLETED366 Analytics
NCT04326426ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 InfectionCoronavirus Infection
ENROLLING BY_INVITATION300 Analytics
NCT04028492Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic GastroparesisIdiopathic Gastroparesis
COMPLETED992 Analytics
NCT03568331Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)Atopic Dermatitis
COMPLETED375 Analytics
PHASE3RECRUITING
A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use
Nausea and VomitingUnlock trial analytics
PHASE3RECRUITING
Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis
Idiopathic GastroparesisUnlock trial analytics
PHASE3COMPLETED
Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness
Motion SicknessUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness
Motion SicknessUnlock trial analytics
PHASE3COMPLETED
Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Motion SicknessUnlock trial analytics
PHASE3ENROLLING BY_INVITATION
ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection
Coronavirus InfectionUnlock trial analytics
PHASE3COMPLETED
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
Idiopathic GastroparesisUnlock trial analytics
PHASE3COMPLETED
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)
Atopic DermatitisUnlock trial analytics
Study Endpoints
Primary Endpoints
Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary.
1 week

A questionnaire called the Nausea Vomiting Daily Diary (NV-DD) will be completed once a day, which will be used to collect data for this endpoint. The NV-DD asks participants to record their vomiting frequency in a 24-hour period.

Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS
12 weeks

AEs will be coded using the MedDRA coding dictionary. An AE is defined as any untoward medical occurrence in a clinical investigation subject that does not necessarily have causal relationship with treatment. AEs will further be categorized by severity, relationship to study medication, and action taken. All AEs will be presented in data listings for subjects. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a semi-structured clinical interview designed to systematically assess and track suicidal adverse events (behavior and ideation) throughout different settings including clinical trials. Results from the C-SSRS will be listed for each subject. These data will also be summarized for all subjects for suicidal ideation events, suicidal behaviors, and completed suicides.

Number of participants with changes in vital signs identified as Clinically Notable Abnormal values
12 weeks

Vital sign measurements include oral temperature (C), respiratory rate, semi-supine blood pressure (systolic and diastolic) (mmHg) and semi-supine heart rate (bpm). Criteria for identifying vital signs as Potentially Clinically Notable Abnormalities are based on the Guidelines for the Division of Neuropharmacological Drug Products. Data from vital signs will be listed, clinically notable values will be flagged, and other information collected will be listed. Data will also be summarized using mean change from first study visit and proportion of subjects with values outside the normal range, and values that were clinically notable.

Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate
12 weeks

Variables include PR (ms), QRS (ms), QTc (ms), and Heart Rate (bpm). Note: ms = millisecond; bpm = beats per minute

Number of participants with Clinically Notable Abnormal laboratory values
12 weeks

Laboratory data will be summarized by presenting the proportions of patients with clinically notable abnormalities as follows: shift tables, first study visit to most extreme post-treatment value, using normal ranges; summary statistics of raw data and change from first study visit values (means, medians, standard deviations, ranges). Criteria for identifying laboratory values as Potentially Clinically Notable Abnormalities are based on the FDA's Guidelines for the Division of Neuropharmacological Drug Products.

Prevention of Vomiting Measured by Vomiting Assessment (VA)
1 day

Prevention of vomiting measured by Vomiting Assessment (VA) score. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited.

Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs).
through study completion, approximately 1 year

Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, and ECGs.

Time to improvement on a 7-point ordinal scale as compared to baseline
14 days or discharge
Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
12 weeks

A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).

Reduction of Worst Itch in Atopic Dermatitis
8 weeks

Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours \[0=No Itch, 10=Worst Itch Imaginable\].

The Most Severe Motion Sickness Severity During Vehicle Travel
1 day

As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement

Percentage of Vomiting
1 day

Defined as subjects ever vomited (MSSS=6) or terminated early due to severity during the vehicle travel. As measured by the Motion Sickness Severity Scale (NRS 0-6).

Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score
56 days

Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm).

Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
9 Days

Fasting Gastric volume

Accommodation Volume as Measured by SPECT
9 Days

Gastric Accommodation post 300mL Ensure

Satiation Expressed as Volume to Fullness as Measured by Satiation Test
9 Days
Gastric Emptying Half-time of Solids as Measured by Scintigraphy
9 Days

Gastric Emptying Solids, T50%, Min

Midazolam Area Under the Curve (AUC)
Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Midazolam time to maximal plasma concentration (Tmax)
Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Midazolam maximal plasma concentration (Cmax)
Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Secondary Endpoints
Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week.
1 week
To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 1 week.
1 week
To evaluate the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo GroupPLACEBO_COMPARATORTreatment with placebo BID for approximately 2 weeks
Tradipitant GroupEXPERIMENTALTreatment with tradipitant BID for approximately 2 weeks
Open Label TradipitantEXPERIMENTALOral Capsule
Tradipitant High DoseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Tradipitant Low DoseEXPERIMENTAL -
Tradipitant Dose AEXPERIMENTAL"See Drug"
Tradipitant Dose BEXPERIMENTAL"See Drug"
TradipitantEXPERIMENTALTradipitant 85 mg PO BID
Interventions
NameTypeDescription
TradipitantDRUGOral Capsule
PlaceboDRUGOral Capsule
Open Label TradipitantDRUGBID
MidazolamDRUGsubstrate for drug-drug interaction assessment
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: * Body Mass Index ≥ 25 and \< 40 kg/m\^2 * No serious medical problems or chronic diseases, specifically no type I or type II diabetes Exclusion Criteria: * Another disorder that contributes to gastrointestinal symptoms * History of intolerance and/or hypersensitivity to NK-1 ...

Countries:United StatesBelgiumGermanySwitzerland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07446439Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT06836557primaryCompletionDate: changed
LOWMay 26, 2026NCT04326426primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT06138613primaryCompletionDate: changed
LOWMay 24, 2026NCT06836557studyFirstPostDate: changed
LOWMay 24, 2026NCT07446439studyFirstPostDate: changed
LOWMay 24, 2026NCT04326426studyFirstPostDate: changed
LOWMay 24, 2026NCT06138613studyFirstPostDate: changed