VNDA

Tradipitant

Gastroparesis

Stage (next event)

Expected Date

NDA Filing

2021

Catalyst Info & Data Links

TITLE: Tradipitant for Gastroparesis- NDA Filing

  • ClinicalTrial.gov (NCT04028492) Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis


WHAT IS THE CATALYST EVENT?


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • 2021


PRIOR DATA/EVENTS

PRESS RELEASE

POSTERS

Mechanism of Action

MECHANISM OF ACTION / RATIONALE

  • Tradipitant is an orally bioavailable, centrally-acting, selective, neurokinin 1 receptor (NK1-receptor; NK1R; NK-1R) antagonist with potential anti-emetic, anti-pruritic and anti-inflammatory activities. Upon oral administration, tradipitant competitively binds to and blocks the activity of the NK1R in the central nervous system (CNS), thereby inhibiting the binding of the endogenous ligand and neuropeptide, substance P (SP; neurokinin-1; NK1). This inhibits SP/NK1-mediated signal transduction and may prevent both SP-induced emesis and pruritis. In addition, inhibition of SP/NK1R signaling also reduces neurogenic inflammation which is triggered by the release of neuropeptides, such as substance P, from nerve cells. NK1R is a G protein-coupled receptor (GPCR) that preferentially binds to SP, a neuropeptide secreted by neuronal cells and inflammatory cells (Learn more - National Library of Medicine)

MARKET

  • ~5 million people in the United States have gastroparesis, many remain undiagnosed (learn more)


Updated by HC

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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