.
WASHINGTON, Dec. 4, 2025 — Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration has lifted the partial clinical hold on protocol VP‑VLY‑686‑3403. The hold had limited the study to a maximum of 90 doses of the NK‑1 receptor antagonist tradipitant.
The agency’s decision followed Vanda’s formal request for dispute resolution and an expedited re‑evaluation conducted by the Center for Drug Evaluation and Research (CDER) leadership under the collaborative framework the two parties established in October 2025.
FDA reviewers agreed with Vanda’s position that motion sickness is an acute, self‑limiting physiological response rather than a chronic condition. Consequently, the agency classified tradipitant as an event‑driven therapy, eliminating the requirement for a six‑month canine toxicity study and rendering the partial hold unnecessary.
With the hold removed, Vanda can now expand its clinical program for tradipitant in motion‑sickness indications. The company’s pending New Drug Application (NDA) for the prevention of motion‑induced vomiting remains on schedule, with a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 30, 2025. If approved, tradipitant would become the first new pharmacologic treatment for motion sickness in more than four decades.
“The swift and favorable resolution underscores the value of our collaborative framework with the FDA,” said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. “We appreciate the agency’s rigorous yet efficient scientific review and look forward to continued constructive dialogue.”
Business and market implications
Motion sickness affects an estimated 30 % of the global population, generating a market opportunity valued at roughly $1.5 billion annually, according to industry analysts. Tradipitant’s oral dosing regimen and its mechanism—blocking neurokinin‑1 receptors that mediate nausea pathways—could offer a differentiated alternative to existing antihistamine‑ and anticholinergic‑based products, which often cause drowsiness and have limited efficacy.
From a technical perspective, tradipitant’s high selectivity for NK‑1 receptors translates into a favorable safety profile, as demonstrated in prior Phase II studies for gastroparesis and chemotherapy‑induced nausea. The removal of the animal‑toxicity requirement accelerates the timeline for potential commercial launch, shortening the path to revenue generation and enhancing Vanda’s pipeline valuation.
Strategically, successful approval would bolster Vanda’s position as a specialty‑focused biopharma capable of leveraging licensed assets—tradipitant was originally developed by Eli Lilly—to address high‑unmet‑need therapeutic areas. The company may also explore combination strategies, such as pairing tradipitant with GLP‑1 receptor agonists to mitigate nausea associated with weight‑loss treatments, further expanding its addressable market.
About Vanda Pharmaceuticals Inc.
Vanda is a global biopharmaceutical company dedicated to developing and commercializing innovative therapies for underserved medical conditions. The company’s portfolio focuses on neurological and gastro‑intestinal disorders, leveraging both in‑house discovery and strategic licensing.
About Tradipitant
Tradipitant is a neurokinin‑1 (NK‑1) receptor antagonist licensed from Eli Lilly. The molecule is in clinical development for multiple indications, including gastroparesis, motion sickness, and the prevention of nausea and vomiting induced by GLP‑1 receptor agonists.
Cautionary Note Regarding Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties, including Vanda’s expectations regarding clinical development, regulatory timelines, and commercial prospects for tradipitant. Actual results may differ materially due to factors such as the FDA’s review outcomes, competitive dynamics, and the company’s ability to continue its collaborative relationship with regulators. Investors are cautioned to review Vanda’s filings with the U.S. Securities and Exchange Commission for a comprehensive discussion of risk factors.
Source: Vanda Pharmaceuticals Inc.
Original article, Author: Jam. If you wish to reprint this article, please indicate the source:https://aicnbc.com/14062.html
