Vanda Pharma's NEREUS Becomes First New Motion Sickness Drug in 40 Years — Shares Surge 18%

December 31, 2025 · by Fintool Agent

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Vanda Pharmaceuticals+25.46% secured FDA approval for NEREUS (tradipitant) on December 30, 2025 — the first new pharmacologic treatment for motion sickness in over four decades 1. Shares jumped as much as 18% in premarket trading on the news, with the stock touching three-year highs near $8.29 before settling at $7.03 by market close 2.

The approval marks a historic scientific milestone: no new drug for motion sickness had reached the market since the 1980s, leaving patients reliant on scopolamine patches and over-the-counter options like Dramamine 3. More significantly for investors, the approval validates Vanda's NK-1 receptor platform and positions tradipitant as a potential solution for GLP-1-induced nausea — a far larger commercial opportunity tied to the $50 billion obesity drug boom 4.

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Clinical Data: 50-70% Reduction in Vomiting

NEREUS demonstrated robust efficacy across two pivotal Phase 3 trials conducted on boats with patients who had documented histories of motion sickness 1:

The drug works by selectively blocking NK-1 receptors in the central nervous system, targeting the substance P pathway that triggers nausea and vomiting during sensory conflicts 4. This mechanism differs fundamentally from existing treatments: scopolamine patches work through anticholinergic effects and come with side effects like dry mouth and drowsiness, while Dramamine is an antihistamine with sedative properties.

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A Massive Addressable Market

Motion sickness affects approximately 25–30% of adults — roughly 65–78 million people in the United States alone 1. While most cases are mild, an estimated 5–15% of the population experiences severe, recurrent symptoms that significantly impact quality of life 2.

"Sales of tradipitant solely in this indication could exceed $100 million annually at peak in the U.S. alone," said H.C. Wainwright analyst Raghuram Selvaraju 3.

Jefferies is more bullish, raising its price target to $7.50 from $5.00 and projecting NEREUS could be a $100-300 million opportunity 4. The firm notes Vanda plans a patient-centric digital marketing strategy targeting the 2-3 million U.S. patients currently taking Dramamine monthly 5.

The Bigger Opportunity: GLP-1-Induced Nausea

While motion sickness provides a solid commercial foundation, the real excitement lies in tradipitant's potential as an adjunct therapy for GLP-1 drugs like Novo Nordisk's-0.66% Wegovy and Eli Lilly's-0.47% Zepbound.

In a Phase 2 study announced in November 2025, tradipitant cut vomiting by 50% versus placebo in overweight and obese adults receiving Wegovy 6. The results are particularly compelling given that 30-50% of GLP-1 patients discontinue treatment — often due to gastrointestinal side effects before reaching therapeutic doses 7.

The global GLP-1 agonist market exceeded $50 billion through the first nine months of 2025 10. A Phase 3 program for this indication is planned for the first half of 2026 11.

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Stock Performance and Valuation

VNDA shares have rallied significantly in anticipation of the approval, with the stock up approximately 45% year-to-date 1.

With a market cap of approximately $425 million and minimal debt ($10.9M)*, Vanda trades at a fraction of what the GLP-1 nausea opportunity alone could be worth. The company's existing hypercortisolism business generated $56.3 million in Q3 2025 revenue 14, providing a foundation while the NEREUS franchise scales.

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Regulatory History: A Long Road

The approval caps a protracted regulatory journey. The FDA originally placed a partial clinical hold on tradipitant in December 2018, requiring additional six-month chronic toxicity studies in dogs because regulators initially classified motion sickness as a chronic condition 1.

The hold was lifted on December 4, 2025 after the FDA reclassified motion sickness as an acute condition, eliminating the study requirement 2 . This cleared the path for the December 30 approval, meeting the PDUFA target action date 3.

Vanda originally licensed tradipitant from Eli Lilly-0.47% in 2012 4.

Competition and Launch Strategy

NEREUS enters a market with established, inexpensive alternatives:

• Transderm Scop (Viatris-0.72%) — Prescription scopolamine patch
• Bonine (WellSpring Pharmaceutical) — OTC meclizine
• Dramamine (Prestige Consumer Healthcare-0.90%) — OTC dimenhydrinate

Jefferies notes that launch adoption will be sensitive to out-of-pocket costs, as Dramamine is inexpensive 5. However, NEREUS offers a modern mechanism without the sedation issues that plague existing treatments.

Vanda plans to launch ahead of the 2026 summer travel season and will pursue a patient-centric digital marketing strategy rather than building a large prescriber-focused sales force 6.

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What to Watch

1. NEREUS Launch Execution — Pricing, insurance coverage, and early prescription data will be critical signals for the motion sickness franchise in H1 2026

2. GLP-1 Phase 3 Initiation — Vanda expects to begin Phase 3 trials for tradipitant as an adjunct to GLP-1 drugs in the first half of 2026 1

3. Gastroparesis Progress — FDA administrative proceedings regarding the gastroparesis indication resume January 7, 2026 2

4. Cash Runway — With $70 million in cash and ongoing losses, Vanda may need to raise capital to fund the GLP-1 Phase 3 program

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*Values retrieved from S&P Global

Related: Vanda Pharmaceuticals+25.46% · Eli Lilly-0.47% · Novo Nordisk-0.66% · Viatris-0.72% · Prestige Consumer Healthcare-0.90%