Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness

Rhea-AI Summary

Vanda Pharmaceuticals (Nasdaq: VNDA) provided regulatory updates on tradipitant for motion sickness on November 28, 2025.

The FDA is conducting an expedited re-review of a partial clinical hold that limits long-term tradipitant studies; the target completion date was extended from November 26, 2025 to December 5, 2025 at the FDA's request to accommodate CDER personnel and leadership transitions. Separately, the New Drug Application (NDA) review remains on schedule with an unchanged PDUFA target action date of December 30, 2025. The FDA has issued labeling comments and formal labeling discussions with Vanda have begun.

Vanda said it looks forward to potentially delivering the first new pharmacologic treatment for motion sickness in over four decades.

Positive

• NDA review remains on schedule with PDUFA date Dec 30, 2025
• Formal labeling discussions with FDA have commenced

Negative

• Partial clinical hold currently restricts long-term tradipitant studies
• FDA extended expedited re-review target to Dec 5, 2025

Insights

Regulatory Affairs Expert

Regulatory review largely on track; a brief FDA re-review extension adds minimal delay but warrants monitoring.

Vanda has agreed to a short extension of the FDA's expedited re-review of the partial clinical hold on long-term tradipitant studies to December 5, 2025. The extension responds to personnel and leadership changes within CDER and does not alter the collaborative framework terms. Separately, the NDA review continues with an unchanged PDUFA target action date of December 30, 2025, and formal labeling discussions have begun.

The business mechanism is straightforward: a short regulatory timing change may affect study restart planning but does not change the NDA review schedule. The main dependency is the FDA’s re-review outcome on the partial clinical hold; the labeling dialogue is an active milestone but does not imply approval. Key items to watch are the December 5, 2025 completion of the re-review and any FDA statements following labeling discussions ahead of the December 30, 2025 PDUFA action; expect clarity within those narrow timeframes.

• FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of the partial clinical hold on long-term studies
  
  
• Separately, FDA recently issued labeling comments, and labeling discussions have formally begun for the New Drug Application of tradipitant for the prevention of vomiting induced by motion (PDUFA target action date remains December 30, 2025)

WASHINGTON, Nov. 28, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), today announced the following updates regarding tradipitant for motion sickness:

Partial Clinical Hold Re-Review Timeline

Under the collaborative framework announced on October 1, 2025, the U.S. Food and Drug Administration (FDA) is conducting an expedited re-review of the partial clinical hold that currently restricts long-term clinical studies of tradipitant in motion sickness. The original target completion date was November 26, 2025. At the FDA's request, and with Vanda's agreement, the target completion date has been extended to December 5, 2025 to accommodate recent personnel and leadership transitions within the Center for Drug Evaluation and Research (CDER). All other provisions of the collaborative framework remain unchanged.

New Drug Application (NDA) Progress

Separately, review of the NDA for tradipitant for the prevention of vomiting induced by motion continues according to schedule, with an unchanged PDUFA target action date of December 30, 2025. The FDA has recently issued comments on the proposed labeling, and labeling discussions between the FDA and Vanda have now formally commenced. Vanda looks forward to potentially delivering the first new pharmacologic treatment for motion sickness in over four decades.

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 the FDA's re-review of the partial clinical hold on tradipitant, the FDA's continuing review of the tradipitant NDA and the related timeline, the status of the label for tradipitant for the treatment of motion sickness, and the potential commercialization of tradipitant for such indication 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 re-review of the partial clinical hold on tradipitant by December 5, 2025, the FDA's ability to complete its review of the NDA for tradipitant for the treatment of motion sickness by December 30, 2025, the outcome of the labeling discussions between Vanda and the FDA, and the FDA's assessment of the evidence supporting the safety and efficacy of tradipitant for the treatment of motion sickness. 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 U.S. Securities and Exchange Commission, which are available at www.sec.gov.

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.

FAQ

What did Vanda announce about tradipitant and the partial clinical hold (VNDA) on Nov 28, 2025?

Vanda said the FDA is doing an expedited re-review of the partial clinical hold and the target completion date was extended to Dec 5, 2025.

Is the tradipitant NDA review for VNDA still on schedule and what is the PDUFA date?

Yes; the NDA review remains on schedule with an unchanged PDUFA target action date of Dec 30, 2025.

What does the FDA labeling update mean for VNDA tradipitant?

The FDA issued labeling comments and formal labeling discussions with Vanda have now begun, which is a standard step before potential approval.

How long is the FDA re-review extension for the tradipitant partial clinical hold (VNDA)?

The FDA and Vanda agreed to extend the expedited re-review target completion date to Dec 5, 2025 from Nov 26, 2025.

Does the Nov 28, 2025 update change the tradipitant approval timeline for VNDA?

The update extended the re-review of the partial clinical hold to Dec 5, 2025, but the NDA PDUFA date remains Dec 30, 2025.