Vanda Pharmaceuticals Announces FDA Approval of NEREUS™ (tradipitant) for the Prevention of Vomiting Induced by Motion: A Historic Scientific Milestone in the Prevention of Motion Sickness

Rhea-AI Summary

Vanda Pharmaceuticals (Nasdaq: VNDA) announced FDA approval of NEREUS™ (tradipitant) for the prevention of vomiting induced by motion on Dec 30, 2025. The approval is the first new pharmacologic motion‑sickness treatment in over 40 years and is supported by three pivotal trials. In Motion Syros (n=365) vomiting was 18.3–19.5% with NEREUS™ vs 44.3% placebo (p<0.0001); in Motion Serifos (n=316) vomiting was 10.4–18.3% vs 37.7% placebo (p≤0.0014), showing >50–70% risk reductions. NEREUS™ showed consistent vomiting reductions and a favorable acute safety profile. Vanda expects to launch NEREUS™ "in the coming months" and plans further development in gastroparesis and GLP‑1 agonist–induced nausea/vomiting.

Positive

• FDA approval for prevention of motion‑induced vomiting (Dec 30, 2025)
• Motion Syros: vomiting 18.3–19.5% with NEREUS™ vs 44.3% placebo (p<0.0001)
• Motion Serifos: vomiting 10.4–18.3% with NEREUS™ vs 37.7% placebo (p≤0.0014)
• Consistent risk reduction across pivotal program (>50–70% reported)
• Favorable acute safety profile consistent with trial results

Negative

• Approval is limited to prevention of vomiting, not broadly to nausea
• Commercial launch timing vague: planned "in the coming months" without a specific date

News Market Reaction

-2.36% 9.7x vol

42 alerts

-2.36% News Effect

+39.6% Peak in 25 hr 21 min

-$14M Valuation Impact

$567M Market Cap

9.7x Rel. Volume

On the day this news was published, VNDA declined 2.36%, reflecting a moderate negative market reaction. Argus tracked a peak move of +39.6% during that session. Our momentum scanner triggered 42 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $14M from the company's valuation, bringing the market cap to $567M at that time. Trading volume was exceptionally heavy at 9.7x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Motion Syros sample size: 365 patients (n=365) Motion Syros vomiting rates: 18.3–19.5% vs 44.3% placebo Motion Serifos sample size: 316 patients (n=316) +5 more

8 metrics

Motion Syros sample size 365 patients (n=365) Phase 3 boat provocation trial in motion sickness

Motion Syros vomiting rates 18.3–19.5% vs 44.3% placebo Incidence of vomiting with NEREUS vs placebo (p<0.0001)

Motion Serifos sample size 316 patients (n=316) Second pivotal Phase 3 boat study

Motion Serifos vomiting rates 10.4–18.3% vs 37.7% placebo Vomiting incidence with NEREUS vs placebo (p≤0.0014)

Severe motion sickness prevalence 5–15% of population Estimated share with severe, recurrent symptoms

US adults affected 65–78 million people Estimated number experiencing motion sickness symptoms

Q3 2025 net product sales $56.3 million Quarterly sales vs $47.7 million a year ago

Q3 2025 net loss $22.6 million Quarterly net loss, or $0.38 per share

Market Reality Check

Price: $6.09 Vol: Volume 1,480,899 vs 20-da...

normal vol

$6.09 Last Close

Volume Volume 1,480,899 vs 20-day average 1,533,662 (relative volume 0.97x) shows no unusual activity. normal

Technical Price $7.03 is trading above 200-day MA at $4.82, near the 52-week high of $7.47.

Peers on Argus

VNDA slipped 2.36% despite FDA approval, while key biotech peers were mixed: OME...

1 Down

VNDA slipped 2.36% despite FDA approval, while key biotech peers were mixed: OMER up 2.35%, others like LXEO and TNXP down. Peer momentum data show only one scanned peer moving down, suggesting a VNDA-specific reaction rather than a broad sector move.

Historical Context

5 past events · Latest: Dec 15 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 15	BLA submission	Positive	+6.4%	Imsidolimab BLA for GPP with positive Phase 3 data and priority review request.
Dec 11	Conference participation	Neutral	-2.2%	Announcement of J.P. Morgan Healthcare Conference presentation schedule.
Dec 04	Clinical hold lifted	Positive	-0.8%	FDA lifted partial hold on tradipitant motion sickness protocol and confirmed PDUFA date.
Nov 28	Regulatory update	Positive	+1.1%	Expedited re-review of tradipitant clinical hold and confirmation of PDUFA target date.
Nov 17	Clinical results	Positive	+1.1%	Positive topline tradipitant data preventing GLP‑1 agonist–induced nausea/vomiting.

Pattern Detected

Recent VNDA news, especially positive regulatory and clinical updates, has generally led to modestly positive price moves, with occasional divergences on regulatory decisions.

Recent Company History

Over the last months, Vanda has built a steady regulatory and clinical narrative. On Nov 17, 2025, positive tradipitant data in GLP‑1–induced nausea coincided with a 1.15% gain. Subsequent regulatory updates on tradipitant’s motion sickness program around the Dec 30, 2025 PDUFA date brought small moves between about -0.85% and 1.13%. A BLA submission for imsidolimab on Dec 15, 2025 led to a stronger 6.42% rise. Today’s FDA approval fits a pattern of important milestones sometimes met with only modest or even negative immediate reactions.

Market Pulse Summary

This announcement details FDA approval of NEREUS™, supported by three pivotal trials showing substan...

Analysis

This announcement details FDA approval of NEREUS™, supported by three pivotal trials showing substantial vomiting reduction versus placebo and a favorable safety profile. Historical news flow highlights an active regulatory agenda, including BLA and NDA submissions and prior tradipitant interactions with FDA. Investors may focus on how Vanda converts this milestone, given prior reports of higher sales but continued losses and cash outflows. Key items to watch include launch timing, uptake in the sizeable motion sickness population, and progress in related tradipitant indications.

Key Terms

neurokinin-1 (NK-1) receptor antagonist, NK-1 receptors, Phase 3, pivotal clinical trials, +4 more

8 terms

neurokinin-1 (NK-1) receptor antagonist medical

"NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention"

A neurokinin-1 (NK-1) receptor antagonist is a type of drug that blocks a specific protein on nerve cells that normally responds to a signaling molecule called substance P; imagine it as putting a cap on a lock so that the key (substance P) can’t turn it. Investors watch these drugs because they can prevent or reduce symptoms like severe nausea, vomiting, or certain pain and mood-related conditions, making clinical trial results, approvals, and patent position key value drivers for companies developing them.

NK-1 receptors medical

"activation of NK-1 receptors in the central nervous system, leading to nausea and vomiting."

NK-1 receptors are protein 'locks' on the surface of certain nerve and immune cells that bind a natural signaling molecule called substance P; when that lock is turned it can trigger nausea, pain, inflammation and other body responses. Investors care because drugs that block these receptors act like keys that prevent those signals, making them valuable targets for treatments (for example anti-nausea or pain drugs) and their success in trials or approvals can drive a company's clinical and commercial prospects.

Phase 3 medical

"three pivotal clinical trials—two Phase 3 real-world provocation studies conducted on boats"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

pivotal clinical trials medical

"The efficacy of NEREUS™ is supported by robust data from three pivotal clinical trials"

Pivotal clinical trials are the late-stage studies designed to show whether a drug or medical product works and is safe enough for regulators to decide on approval. Think of them as the final exam for a medicine: passing provides the evidence needed to bring the product to market, which can unlock future sales and dramatically affect a company’s valuation, while failing can sharply reduce expected revenue and investor confidence.

gastroparesis medical

"Vanda is advancing tradipitant in clinical development for gastroparesis, a chronic disorder"

Gastroparesis is a disorder in which the stomach’s muscles or the nerves that control them stop moving food through the digestive tract at a normal pace — imagine a conveyor belt in a factory that slows or stalls, causing nausea, vomiting, bloating and poor nutrient absorption. Investors track it because it creates a sustained market for drugs, devices and procedures, influences clinical trial and regulatory risk, and can drive recurring healthcare costs and reimbursement decisions that affect company revenues.

GLP-1 receptor agonists medical

"for the prevention of nausea and vomiting induced by GLP-1 receptor agonists—a common side"

GLP-1 receptor agonists are medicines that mimic a natural gut hormone to lower blood sugar and reduce appetite, often used to treat diabetes and obesity. Investors care because these drugs can drive large prescription sales, face strict regulatory approval and patent timelines, and their safety, pricing, or label changes can meaningfully affect a drug maker’s revenue much like a bestselling product or a recalled item would impact any company’s financial outlook.

placebo medical

"vomiting incidence was 18.3–19.5% with NEREUS™ versus 44.3% with placebo (p<0.0001)."

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

p-value medical

"vomiting incidence was 18.3–19.5% with NEREUS™ versus 44.3% with placebo (p<0.0001)."

A p-value is a number that helps determine how likely it is that a result or pattern happened by chance rather than because of a real effect. For investors, a low p-value suggests that the findings in a study or analysis are probably meaningful and not just random noise—like noticing a pattern in coin flips that’s unlikely to occur by chance. This helps in assessing the reliability of information used to make financial decisions.

AI-generated analysis. Not financial advice.

WASHINGTON, Dec. 30, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement in the understanding and management of this debilitating physiologic response that affects a substantial portion of the population and has long been recognized as a factor affecting military operational readiness.

"This approval underscores the strong scientific evidence in the antiemetic effects of NEREUS™ in motion sickness," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "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. We are proud of this historic milestone and grateful to the Vanda researchers, patients, investigators, and regulators who contributed to this achievement."

The efficacy of NEREUS™ is supported by robust data from three pivotal clinical trials—two Phase 3 real-world provocation studies conducted on boats (Motion Syros and Motion Serifos) and one additional supporting study—with participants who had documented histories of motion sickness. In Motion Syros (n=365), vomiting incidence was 18.3–19.5% with NEREUS™ versus 44.3% with placebo (p<0.0001).¹ In Motion Serifos (n=316), vomiting rates were 10.4–18.3% with NEREUS™ versus 37.7% with placebo (p≤0.0014), representing risk reductions of over 50–70%.² Across the pivotal program, NEREUS™ consistently demonstrated significant reductions in vomiting and a favorable safety profile consistent with acute use.

Motion sickness has been recognized as a critical factor in military operations since World War II, most notably during the D-Day invasion of Normandy in 1944, where severe seasickness impaired the effectiveness of troops, including paratroopers of the 101st Airborne Division deployed in rough Channel crossings and airborne drops. The condition was elevated to a strategic imperative, prompting early research into antiemetic therapies to ensure operational readiness during large-scale troop deployments by sea, air, and land.

Today, motion sickness remains prevalent in civilian life, with approximately 25–30% of adults³—roughly 65–78 million people in the U.S.—experiencing symptoms during common travel modes such as cars, planes, or boats. Globally, up to one-third of individuals are highly susceptible.⁴ While most cases are mild, an estimated 5–15% of the population experiences severe, recurrent symptoms that can significantly impact quality of life. This severe segment comprises two key groups: those whose illness is inadequately controlled by existing therapeutic options, leaving them with persistent debilitating symptoms despite treatment, and those whose illness is so severe that it leads to avoidance of engaging in motion-provoking activities altogether, resulting in altered travel plans, missed opportunities, or complete abstention from certain modes of transportation or experiences. Tens of millions seek pharmacologic treatment annually, primarily through over-the-counter options, though many patients opt for prescription therapies when escalating care. Motion sickness arises from a sensory conflict between visual, vestibular, and proprioceptive inputs, triggering the release of substance P and activation of NK-1 receptors in the central nervous system, leading to nausea and vomiting. NEREUS™'s mechanism of action—potent and selective antagonism of NK-1 receptors—directly addresses this pathway.

The approval of NEREUS™ for the prevention of vomiting induced by motion validates its pharmacological profile and paves the way for further exploration of NK-1 antagonism in related vomit-inducing conditions. Vanda is advancing tradipitant in clinical development for gastroparesis, a chronic disorder characterized by delayed gastric emptying and persistent nausea/vomiting, as well as for the prevention of nausea and vomiting induced by GLP-1 receptor agonists—a common side effect impacting adherence in the rapidly growing obesity and diabetes treatment landscape. 

Vanda anticipates launching NEREUS™ for the prevention of vomiting induced by motion in the coming months and remains committed to expanding its therapeutic potential across indications driven by substance P-mediated pathways.

References

1. Polymeropoulos VM, Kiely L, Bushman ML, Sutherland EB, Goldberg AR, Pham AX, Miller CR, Mourad R, Davis TR, Pham NV, Morgan DB, Giles AK, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study. Front Neurol. 2025 Mar 4;16:1550670. doi: 10.3389/fneur.2025.1550670. PMID: 40103934; PMCID: PMC11913704, available here.
2. Vanda Pharmaceuticals Inc., "Vanda Pharmaceuticals Reports Positive Results from a Second Phase III Study of Tradipitant in Motion Sickness" [Press Release], May 16, 2024, available here.
3. Turner M, Griffin MJ. Motion sickness in public road transport: passenger behavior and susceptibility. Ergonomics. 1999: 42: 444-461, available here.
4. Golding, J. F. (2016). "Motion sickness". Neuro-Otology. Handbook of Clinical Neurology. Vol. 137. pp. 371–390. doi:10.1016/B978-0-444-63437-5.00027-3. ISBN 978-0-444-63437-5. ISSN 0072-9752. PMID 27638085, available here.

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 NEREUS™

NEREUS™ (tradipitant) is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. NEREUS™ is approved for the acute prevention of vomiting induced by motion in adults, and is currently in clinical development for a variety of indications, including gastroparesis and the prevention of nausea and vomiting induced by GLP-1 receptor agonists.

INDICATION AND IMPORTANT SAFETY INFORMATION

Indication

NEREUS™ is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated for the prevention of vomiting induced by motion in adults.

Important Safety Information

In placebo-controlled clinical trials, somnolence (6%, 12%) and fatigue (6%, 8%) were adverse reactions reported in subjects who took a single dose of 85 mg or 170 mg NEREUS™, respectively. NEREUS™ may impair the mental and/or physical abilities required for driving a motor vehicle or operating heavy machinery. Concomitant use of other drugs that cause central nervous system depression and strong CYP3A4 inhibitors may increase this effect. If concomitant use is unavoidable, warn patients against driving and other activities requiring complete mental alertness.

Available data from clinical trials with NEREUS™ use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Lactation studies have not been conducted to assess the presence of tradipitant or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Tradipitant has been found to be present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Monitor breastfed infants for somnolence.

The safety and effectiveness of NEREUS™ have not been established in pediatric patients. 

Tradipitant has not been studied in subjects with severe renal impairment (eGFR ≤ 29 mL/min/1.73m2). Avoid use of NEREUS™ in patients with severe renal impairment.

Tradipitant has not been studied in patients with any degree of hepatic impairment (Child-Pugh Class A to C). Avoid NEREUS™ in patients with mild, moderate, or severe hepatic impairment.

CONTRAINDICATIONS

None.

DRUG INTERACTIONS

Tradipitant is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase tradipitant exposure, which may increase the risk of adverse reactions to NEREUS™.

Full Nereus™ Prescribing Information can be found at: https://www.nereus.us.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements in this press release, including, but not limited to statements regarding patient access to NEREUS™, the prevalence of motion sickness, Vanda's further clinical development plans for NEREUS™, Vanda's commercial launch plans for NEREUS™ and the timing thereof, and Vanda's plans to expand the therapeutic potential of NEREUS™ across additional indications driven by substance P-mediated pathways 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, Vanda's ability to successfully execute the commercial launch of NEREUS™ in the coming months, the accuracy of the estimates of the prevalence of motion sickness, Vanda's ability to continue to advance tradipitant in gastroparesis and the prevention of nausea and vomiting induced by GLP-1 receptor agonists, and Vanda's ability to develop NEREUS™ as a safe and effective treatment for additional indications driven by substance P-mediated pathways. 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 (VNDA) announce on Dec 30, 2025 about NEREUS™?

FDA approved NEREUS™ (tradipitant) for prevention of vomiting induced by motion.

How effective was NEREUS™ in the Motion Syros Phase 3 trial (VNDA)?

In Motion Syros (n=365) vomiting was 18.3–19.5% with NEREUS™ vs 44.3% with placebo (p<0.0001).

What were the Motion Serifos Phase 3 results for NEREUS™ (VNDA)?

In Motion Serifos (n=316) vomiting was 10.4–18.3% with NEREUS™ vs 37.7% with placebo (p≤0.0014), a >50–70% risk reduction.

When will Vanda (VNDA) launch NEREUS™ in the U.S.?

Vanda anticipates launching NEREUS™ for motion‑induced vomiting "in the coming months".

Does the FDA approval for NEREUS™ cover nausea and other indications (VNDA)?

The approval specifically covers the prevention of vomiting induced by motion; broader nausea indications are not included.

What additional development plans did Vanda (VNDA) disclose for tradipitant?

Vanda is advancing tradipitant in trials for gastroparesis and for prevention of GLP‑1 agonist–induced nausea/vomiting.