Vanda tradipitant update: FDA re-review extends to Dec. 5, 2025
Decision brief
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Vanda Pharmaceuticals controversy now centers on tradipitant’s regulatory timeline and the next catalyst set. The FDA and Vanda agreed to extend the expedited re-review of the partial clinical hold to Dec. 5, 2025, while multiple tradipitant studies remain active or recruiting.
The Vanda Pharmaceuticals controversy around tradipitant shifted from dispute to decisions in late 2025. FDA extended an expedited hold re-review to Dec. 5, 2025, then lifted the partial clinical hold, and approved NEREUS (tradipitant) for motion-induced vomiting on Dec. 30, 2025.
Contents10 sections
Key Takeaways
- Nov. 26 → Dec. 5, 2025: FDA/Vanda extended the expedited re-review of the partial clinical hold.
- Dec. 4, 2025: FDA lifted the hold on protocol VP-VLY-686-3403 (90-dose cap removed).
- Dec. 30, 2025: FDA approved NEREUS (tradipitant) for prevention of vomiting induced by motion.
- Gastroparesis remains a separate dispute track after a 2024 complete response letter.
Why did the Vanda Pharmaceuticals controversy center on Dec. 5?
Under an October 2025 collaborative framework, FDA ran an expedited re-review of the partial clinical hold on long-term tradipitant studies in motion sickness. The first target date was Nov. 26, 2025.
FDA then asked for more time. Vanda agreed to move the target to Dec. 5, 2025. That date became the near-term catalyst many headlines tracked.
Source: PR Newswire regulatory update.
What happened when FDA finished the re-review?
On Dec. 4, 2025, Vanda said FDA lifted the partial clinical hold on protocol VP-VLY-686-3403. The hold had limited the protocol to a maximum of 90 doses.
FDA agreed motion sickness use is acute and event-driven, not a chronic therapy that required an extra six-month dog toxicity study. That decision reopened longer clinical study designs.
Primary wire: PR Newswire — FDA lifts partial clinical hold.
Did the Dec. 30 PDUFA date deliver approval?
Yes. On Dec. 30, 2025, FDA approved NEREUS (tradipitant), an oral NK-1 receptor antagonist, for prevention of vomiting induced by motion in adults. Vanda called it the first new pharmacologic motion-sickness treatment in more than 40 years.
The company filed the approval announcement with the SEC as an 8-K exhibit. Labeling discussions had already begun while the NDA review stayed on the Dec. 30, 2025 PDUFA target.
Approval source: PR Newswire — NEREUS FDA approval.
How does the gastroparesis track differ?
Motion-sickness approval does not resolve the gastroparesis NDA dispute. FDA issued a complete response letter for tradipitant in gastroparesis in 2024. Federal Register notice later outlined a proposed refusal path and hearing opportunity.
Teams should keep those files separate from the motion-sickness approval narrative.
- Motion sickness: NDA approved Dec. 30, 2025 (NEREUS)
- Gastroparesis: CRL / hearing track remains distinct
- Other development: GLP-1–related nausea/vomiting studies remain investigational
Clinical and regulatory timeline
- Oct. 2025 — collaborative framework announced
- Nov. 26, 2025 — original re-review target
- Dec. 5, 2025 — extended re-review target
- Dec. 4, 2025 — partial clinical hold lifted (company announcement date)
- Dec. 30, 2025 — NEREUS approval / PDUFA action
What remains unproven
Approval for motion-induced vomiting does not prove benefit in gastroparesis or GLP-1 nausea. Commercial uptake, pricing, and 2026 launch metrics were not settled in the December wires cited here.
Litigation tone around the Vanda Pharmaceuticals controversy can change after each FDA letter. Always re-check the latest SEC 8-K before diligence calls.
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Frequently Asked Questions
What was the Dec. 5, 2025 FDA re-review about?
FDA asked, and Vanda agreed, to extend an expedited re-review of the partial clinical hold on long-term tradipitant motion-sickness studies from Nov. 26, 2025 to Dec. 5, 2025 under their collaborative framework.
Did FDA lift the tradipitant partial clinical hold?
Yes. On Dec. 4, 2025, Vanda announced FDA lifted the partial clinical hold on protocol VP-VLY-686-3403 that had capped dosing at 90 doses, after CDER leadership completed the expedited re-review.
Is NEREUS (tradipitant) FDA-approved?
Yes. On Dec. 30, 2025, FDA approved NEREUS (tradipitant) for prevention of vomiting induced by motion in adults, per Vanda’s PR Newswire announcement and related SEC 8-K.
Primary Sources
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