Tradipitant
An investigational treatment for Gastroparesis.
The same compound appears under different names depending on the context. Here is how to identify Tradipitant wherever you encounter it, plus the key facts at a glance.
- Generic name
- Tradipitant
- Development code
- VLY-686
- Drug class
- NK-1 receptor antagonist (anti-nausea)
- Manufacturer
- Vanda Pharmaceuticals
Tradipitant is an anti-nausea medicine from Vanda Pharmaceuticals that the FDA did not approve for gastroparesis in September 2024. The FDA approved it in December 2025, as Nereus, for a different use, preventing vomiting caused by motion.
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How Tradipitant works
Tradipitant blocks the neurokinin-1 (NK-1) receptor, which is involved in the nausea and vomiting reflex.
Mechanism: Neurokinin-1 (NK-1) receptor antagonist
Side effects and safety
Pink Sheet reported that the FDA found not enough efficacy and safety data to approve tradipitant for gastroparesis[2]. Side effects for its approved motion sickness use are listed in the Nereus prescribing information.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Development history
The FDA issued a complete response letter, declining to approve tradipitant for gastroparesis, on September 18, 2024, and then proposed refusing approval. In March 2026 the FDA published its decision on Vanda's request for a hearing on that proposal[1]; Pink Sheet reported the hearing was denied and that Vanda asked a federal appeals court to set the decision aside[2]. Results posted on ClinicalTrials.gov show the Phase 3 trial, NCT04028492 with 979 adults, did not meet its primary nausea endpoint[3]. Separately, the FDA approved tradipitant as Nereus to prevent vomiting induced by motion, which Vanda announced on December 30, 2025[4].
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Common questions about Tradipitant
▸What is Tradipitant?
Tradipitant is an anti-nausea medicine from Vanda Pharmaceuticals that the FDA did not approve for gastroparesis in September 2024. The FDA approved it in December 2025, as Nereus, for a different use, preventing vomiting caused by motion.
▸How does Tradipitant work?
Tradipitant blocks the neurokinin-1 (NK-1) receptor, which is involved in the nausea and vomiting reflex.
▸What are the side effects of Tradipitant?
Pink Sheet reported that the FDA found not enough efficacy and safety data to approve tradipitant for gastroparesis[2]. Side effects for its approved motion sickness use are listed in the Nereus prescribing information.
▸Is Tradipitant FDA approved?
Tradipitant is currently in crl clinical trials for Gastroparesis. It has not yet received FDA approval.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration, Federal Register · 2026-03-31. Notice of Decision on a Hearing Request Regarding a Proposal to Refuse to Approve a New Drug. https://www.federalregister.gov/documents/2026/03/31/2026-06187/notice-of-decision-on-a-hearing-request-regarding-a-proposal-to-refuse-to-approve-a-new-drug
- Pink Sheet (Citeline) · 2026-03-27. US FDA denies tradipitant hearing, says not enough efficacy, safety data for gastroparesis. https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/us-fda-denies-tradipitant-hearing-says-not-enough-efficacy-safety-data-for-gastroparesis-IM4SQ3XXPJCMLAPKX24QACJAYY/
- ClinicalTrials.gov. Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis. https://clinicaltrials.gov/study/NCT04028492
- BioSpace · 2025-12-30. Vanda ends 40-year motion sickness drug drought with FDA approval for Nereus. https://www.biospace.com/fda/vanda-ends-40-year-motion-sickness-drug-drought-with-fda-approval-for-nereus