Overview
Tradipitant has been used in trials studying the treatment and prevention of Eczema, Pruritus, Gastroparesis, Chronic Pruritus, and Atopic Dermatitis, among others.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Report on Tradipitant (DB12580): Clinical Development, Efficacy, and Regulatory Landscape of a Novel Neurokinin-1 Receptor Antagonist
Executive Summary
Tradipitant is an orally bioavailable, centrally-acting, investigational small molecule drug that functions as a selective neurokinin-1 (NK-1) receptor antagonist.[1] By blocking the action of the neuropeptide Substance P, Tradipitant has been developed to address a range of conditions where this pathway is implicated, including nausea, vomiting, and pruritus. The clinical development of Tradipitant, currently stewarded by Vanda Pharmaceuticals, presents a bifurcated narrative of clear success in one indication and significant challenges in others, making it a compelling case study in modern drug development and regulatory science.
The drug's development program for motion sickness has yielded unequivocally positive results. Multiple Phase III clinical trials have consistently demonstrated that Tradipitant, at doses of 85 mg and 170 mg, provides statistically robust and clinically meaningful prevention of vomiting associated with motion sickness under real-world conditions.[2] Supported by this strong evidence, a New Drug Application (NDA) has been accepted for review by the U.S. Food and Drug Administration (FDA), positioning Tradipitant for a probable first market approval.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/20 | Phase 3 | Recruiting | |||
2025/02/03 | Phase 2 | Recruiting | |||
2023/11/18 | Phase 3 | Recruiting | |||
2023/06/15 | Phase 3 | Completed | |||
2022/12/16 | Phase 2 | ENROLLING_BY_INVITATION | Xiao Jing (Iris) Wang | ||
2021/04/19 | Phase 1 | Completed | |||
2020/07/17 | N/A | AVAILABLE | |||
2020/03/31 | Phase 3 | Completed | |||
2020/03/30 | Phase 3 | ENROLLING_BY_INVITATION | |||
2019/10/28 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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