Clinical Trials

Numerous clinical trials across various phases evaluate tradipitant for conditions including motion sickness, atopic dermatitis, functional dyspepsia, nausea and vomiting associated with obesity, and idiopathic or diabetic gastroparesis. Sponsored primarily by Vanda Pharmaceuticals alongside academic investigators such as Xiao Jing (Iris) Wang, these studies encompass statuses ranging from active recruitment and invitation-based enrollment to completed protocols and expanded access programs.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06138613 ACTIVE_NOT_RECRUITING
Motion Sickness
Vanda Pharmaceuticals
 2023-02-27 PHASE3
NCT05653310 ENROLLING_BY_INVITATION
Functional Dyspepsia
Xiao Jing (Iris) Wang
 2023-02-09 PHASE2
NCT07446439 RECRUITING
Nausea and Vomiting; Obesity
Vanda Pharmaceuticals
 2026-03-27 PHASE3
NCT06836557 RECRUITING
Idiopathic Gastroparesis; Diabetic Gastroparesis; Gastroparesis
Vanda Pharmaceuticals
 2024-01-09 PHASE3
NCT06804603 COMPLETED
Obesity
Vanda Pharmaceuticals
 2025-02-25 PHASE2
NCT04028492 COMPLETED
Idiopathic Gastroparesis; Diabetic Gastroparesis; Gastroparesis
Vanda Pharmaceuticals
 2019-08-20 PHASE3
NCT05903924 COMPLETED
Motion Sickness
Vanda Pharmaceuticals
 2023-09-09 PHASE3
NCT04327661 COMPLETED
Motion Sickness
Vanda Pharmaceuticals
 2021-11-15 PHASE3
NCT04849559 COMPLETED
Healthy Volunteer
Vanda Pharmaceuticals
 2021-02-01 PHASE1; PHASE2
NCT04140695 TERMINATED
Atopic Dermatitis
Vanda Pharmaceuticals
 2019-10-21 PHASE3
NCT04326426 ENROLLING_BY_INVITATION
Coronavirus Infection
Vanda Pharmaceuticals
 2020-04-13 PHASE3
NCT03568331 COMPLETED
Atopic Dermatitis
Vanda Pharmaceuticals
 2018-07-09 PHASE3
NCT03772340 COMPLETED
Motion Sickness
Vanda Pharmaceuticals
 2018-12-20 PHASE2
NCT02970968 COMPLETED
Gastroparesis
Vanda Pharmaceuticals
 2016-11 PHASE2
NCT02651714 COMPLETED
Atopic Dermatitis
Vanda Pharmaceuticals
 2016-01-19 PHASE2
NCT02621385 COMPLETED
Healthy Volunteers
Vanda Pharmaceuticals
 2015-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-16)

Check the Tradipitant product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tradipitant functions as a selective second-generation antagonist of the neurokinin-1 (NK-1) receptor, competitively inhibiting the binding of endogenous substance P to prevent downstream neurokinin signaling pathways within the central and peripheral nervous systems. By suppressing substance P-mediated signal transduction, this blockade blunts emetic reflex pathways and neurogenic inflammatory cascades, providing clinical relevance in alleviating motion sickness, gastroparesis-associated nausea, and pruritus in clinical trial settings.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.