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pdufa.bio

Tradipitant

Updated ยทnext FDA decision on the calendar

Tradipitant is a Vanda Pharmaceuticals Inc. program. Its next catalyst is a Readout in Sep 2027. 1 FDA decision on record below. Every date links its source.

VNDA catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Tradipitant is marketed as NEREUS (tradipitant); the events below include those tracked under the brand name. Sponsor: Vanda Pharmaceuticals Inc. (VNDA). We track 2 catalyst events for this program: 1 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Dec 30, 2025 ✓ ApprovedVNDAReadout · Sep 2027VNDA

Questions

When is Tradipitant's next FDA decision or readout?

The next tracked catalyst for Tradipitant is a Readout in Sep 2027.

What happened at Tradipitant's most recent FDA decision?

On Dec 30, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Tradipitant?

Vanda Pharmaceuticals Inc. (VNDA).

Has Tradipitant been approved by the FDA?

Yes. The FDA approved an application for Tradipitant on Dec 30, 2025; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.