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FDA approves Vanda Pharmaceuticals’ motion sickness drug Nereus

The approval marks the first new pharmacologic treatment in motion sickness in over four decades.

Robert Barrie December 31 2025

The US Food and Drug Administration (FDA) has approved Vanda Pharmaceuticals’ Nereus (tradipitant) for the prevention of vomiting induced by motion.

Nereus, taken as an oral capsule, is a new option to those who suffer from motion sickness, becoming the first pharmacological-based therapy to win the agency’s greenlight in this indication in over four decades. The US-based pharma company aims to launch the drug in the coming months.

Up to 78 million adults in the US are estimated to be affected by motion sickness, with symptoms usually presenting during transport in cars, planes, and boats. It arises from a sensory conflict between the eyes, inner ear, and proprioceptors. The mixed neural signals result in disorientation and nausea mediated by a chemical called substance P. Nereus works by inhibiting NK-1 receptors – the target of substance P.

The FDA based its decision on three pivotal clinical trials, two of which were Phase III real-word studies conducted on boats. Nereus significantly reduced the incidence of vomiting compared to placebo.

Vanda’s CEO Mihael Polymeropoulos said: "For the first time in over 40 years, patients have access to a novel therapy grounded in modern neuropharmacology, offering effective prevention without the limitations of existing options.”

Many patients administer over-the-counter pills and patches to counteract motion sickness, though prescription therapies are needed for recurrent and more severe symptoms. Viatris’ scopolamine patch, known under the brand name Transderm Scop, is one such prescription medicine. The FDA first approved scopolamine in 1979, with the drug now a central pillar of the motion sickness treatment space. Defender Pharmaceuticals hoped to enter the market with a nasal gel version of scopolamine, though the FDA rejected the candidate in January 2024.

Vanda is already eyeing further indications for tradipitant. The drug is in the regulatory stage for gastroparesis, a chronic disorder characterised by delayed gastric emptying and persistent nausea and vomiting. The FDA rejected Vanda’s application for tradipitant in gastroparesis in September 2024, citing a lack of substantial evidence of effectiveness and safety.

Tradipitant is also in clinical development for the prevention of nausea and vomiting induced by glucagon like peptide receptor agonists (GLP-1RAs) – a drug class that has boomed in popularity in the diabetes and weight loss sectors. In November 2025, the company announced positive results from a Phase II study.

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