FDA Begins Expedited Re review of Tradipitant Clinical Hold, Timeline Updated
Vanda Pharmaceuticals said on November 28, 2025 that the Food and Drug Administration has launched an expedited re review of the partial clinical hold that had been restricting long term studies of tradipitant for motion sickness. The company told investors and trial stakeholders that an updated target completion date was included in its statement reproduced in an RTTNews market brief, and it will continue working with regulators to address outstanding questions.
Vanda Pharmaceuticals announced on November 28, 2025 that the U.S. Food and Drug Administration is conducting an expedited re review of a partial clinical hold that has limited long term trials of tradipitant, an investigational therapy for motion sickness. The notice, framed as an update to investors and trial stakeholders, was reproduced in an RTTNews market brief published the same day. Vanda said the re review includes an updated target completion date and that the company will continue to engage with regulators to respond to the agency’s questions.
The partial clinical hold had curtailed the company’s ability to collect extended safety and efficacy data in participants receiving tradipitant over prolonged periods, a constraint that has implications for both regulatory assessment and patient communities awaiting new therapeutic options. By initiating an expedited re review, the FDA appears to be prioritizing a resolution, though the agency and Vanda have not released additional detail about the specific regulatory concerns or the revised completion timeline included in the company statement.
Clinical holds are a principal tool for the FDA to ensure participant safety and data integrity in clinical research. When they affect long term studies, they can slow the accumulation of evidence needed to evaluate whether a drug is safe for ongoing or chronic use, a distinction that matters for people whose work, travel or medical conditions expose them to repeated motion sickness. Patients, caregivers and clinicians who had anticipated expanded access to investigational therapies may face continued uncertainty while regulators and sponsors reconcile outstanding issues.
The update also underscores the dual pressures that accompany clinical development for small companies. Trial stakeholders include not only potential future patients but also research sites, investigators and investors who have a financial interest in timelines and outcomes. Vanda’s market brief notification to investors and trial partners was intended to signal active engagement with the agency and to provide an interim timeline, while acknowledging unresolved questions that must be addressed before long term trials can fully resume.
Beyond this immediate case, the episode highlights broader public health and policy considerations. Regulatory oversight protects participants, but prolonged holds can exacerbate inequities when marginalized communities are under represented in halted trials and when alternative treatments are less accessible. Ensuring transparent, timely communication between regulators, sponsors and affected communities is essential to maintain trust and to prioritize research that addresses diverse patient needs.
As of November 29, 2025, stakeholders will be watching for the FDA’s conclusion of the expedited re review and for Vanda to disclose the specifics of the updated target completion date published in the RTTNews brief. The outcome will determine whether long term studies of tradipitant can proceed and will shape the evidence available to regulators, clinicians and patients considering the potential role of this therapy in managing motion sickness.
