FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness
Rhea-AI Summary
Vanda Pharmaceuticals (Nasdaq: VNDA) announced that the FDA lifted a partial clinical hold on protocol VP-VLY-686-3403 effective Dec 4, 2025, removing a prior 90-dose limit on tradipitant dosing.
The agency agreed motion sickness is an acute, event-driven condition, eliminating the need for an additional six-month dog toxicity study and allowing Vanda to extend clinical studies of tradipitant. Separately, the company noted the New Drug Application for tradipitant to prevent motion-induced vomiting remains under review with a PDUFA target action date of Dec 30, 2025.
Positive
- Partial clinical hold lifted on protocol VP-VLY-686-3403 (Dec 4, 2025)
- FDA removed requirement for a six-month dog toxicity study
- PDUFA target action date set for Dec 30, 2025
Negative
- NDA decision remains pending with regulatory risk until Dec 30, 2025
- Protocol previously limited to 90 doses while under partial hold
News Market Reaction – VNDA
In the Dec 5 session, VNDA gained 3.65%, reflecting a moderate positive market reaction. Argus tracked a peak move of +8.8% during that session. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Nov 28 | Regulatory update | Positive | +1.1% | FDA extended expedited re-review of partial clinical hold; PDUFA date unchanged. |
| Nov 17 | Clinical results | Positive | +1.1% | Tradipitant reduced GLP-1–induced vomiting with statistically significant efficacy. |
| Nov 05 | Conference participation | Neutral | -0.7% | Announcement of participation and presentation timing at a healthcare conference. |
| Oct 29 | Earnings and pipeline | Negative | -3.0% | Q3 loss, lowered 2025 revenue and cash guidance, plus multiple regulatory milestones. |
| Oct 22 | Earnings notice | Neutral | +0.9% | Scheduled Q3 2025 earnings release and conference call details. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent VNDA news has generally been followed by modest price moves that align with the tone of announcements, including positive clinical/regulatory updates and mixed financial results.
Over the last few months, VNDA has focused on tradipitant and broader pipeline and financial milestones. On Nov 28, the company highlighted the FDA’s expedited re-review of a partial clinical hold and confirmed the Dec 30, 2025 PDUFA date. Earlier, on Nov 17, tradipitant showed positive results in GLP-1–induced nausea and vomiting. Q3 2025 results on Oct 29 combined higher sales with a net loss and updated guidance. Today’s FDA decision on lifting the partial hold fits into this ongoing regulatory trajectory for tradipitant.
Key Terms
partial clinical hold regulatory
protocol VP-VLY-686-3403 technical
CDER regulatory
acute, self-limiting physiologic response medical
New Drug Application regulatory
PDUFA target action date regulatory
event-driven therapy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
The lift followed Vanda's formal dispute resolution request and an expedited re-review conducted by CDER leadership under the collaborative framework established between Vanda and the FDA in October 2025.
The FDA agreed with Vanda's position that motion sickness is an acute, self-limiting physiologic response rather than a chronic or chronic-intermittent condition. The Agency therefore concluded that the use of tradipitant in motion sickness represents an acute, event-driven therapy, eliminating the need for an additional six-month dog toxicity study and rendering the partial clinical hold unnecessary.
This decision allows Vanda to extend clinical studies of tradipitant in motion sickness. Separately, the ongoing review of the pending, fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track, with a PDUFA target action date of December 30, 2025, positioning tradipitant as potentially the first new pharmacologic treatment for motion sickness in over 40 years.
"The swift and favorable resolution of this issue highlights the effectiveness of our collaborative framework with the FDA," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "We thank the Agency for its thorough and expedited scientific review and look forward to continued constructive dialogue."
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.
About Tradipitant
Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for a variety of indications, including gastroparesis, motion sickness, and the prevention of nausea and vomiting induced by GLP-1 receptor agonists.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not limited to statements regarding Vanda's further clinical development plans for tradipitant, Vanda's pursuit of FDA approval of tradipitant for the prevention of vomiting induced by motion, the potential commercialization of tradipitant for such indication, and Vanda's future interactions with the FDA are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to complete its review of the NDA for tradipitant for the prevention of vomiting induced by motion by December 30, 2025, the FDA's assessment of the evidence supporting the safety and efficacy of tradipitant for the prevention of vomiting induced by motion, and the ability of the FDA and Vanda to continue to work together collaboratively. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
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SOURCE Vanda Pharmaceuticals Inc.