The Thetis Study: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tradipitant on Nausea and Vomiting After GLP-1R Agonist Administration in Healthy Overweight or Obese Volunteers

The goal of this study is to measure the effects of using Tradipitant to treat nausea and vomiting induced by GLP-1R agonist use in adults with class I or class II obesity, or adults who are overweight with at least one weight-related condition. The study is placebo-controlled with two treatment arms.

Start Date27 Mar 2026

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT06804603

/ CompletedPhase 2

A Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Nausea and Vomiting After GLP-1R Agonist Administration in Healthy Overweight Class I or Class II Obese Volunteers

The goal of this study is to measure the effects of using Tradipitant after GLP-1R agonist use on nausea and vomiting in healthy overweight, class I, or class II obese volunteers. The study is placebo-controlled with two treatment arms.

Start Date25 Feb 2025

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT06836557

/ CompletedPhase 3

A Multicenter, Open Label, 3-Month Safety Study With Tradipitant in Patients With Idiopathic or Diabetic Gastroparesis

This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.

Start Date09 Jan 2024

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

100 Clinical Results associated with Tradipitant

100 Translational Medicine associated with Tradipitant

100 Patents (Medical) associated with Tradipitant

Literatures (Medical) associated with Tradipitant

01 Jul 2026·AMERICAN JOURNAL OF THERAPEUTICS

Tradipitant: A Novel Neurokinin-1 Receptor Antagonist for Motion Sickness

Review

Author: Dima, Lorena ; Junker, Julia ; Willett, Kristine C. ; Andreescu, Oana ; Nguyen, Timothy ; Daly, Laura R.

Background::

Motion sickness affects millions of people with common symptoms, including nausea and vomiting. Medications used for management of motion sickness since 1870 predominately have anticholinergics and antihistamines properties. For the past 40 years, there have been no advances in medication options for motion sickness until recently, a novel agent, tradipidant received the Food and Drug Administration approval for symptoms related to motion sickness.

Mechanism of Action, Pharmacodynamics, and Pharmacokinetics::

Tradipitant is a selective neurokinin-1 (NK-1) receptor antagonist, blocking the actions of substance P, a neurotransmitter from the tachykinin family. It has high affinity for NK-1 receptors that are present throughout the emetic pathway. The 4 major metabolites of this drug (ie, M2, M3, M4, and M8) have shown a similar affinity to the NK-1 receptor as the parent drug. Pharmacokinetic data have revealed that tradipitant absorption is delayed when administered with food. The volume of distribution is 1956 L and is highly plasma protein bound (∼96%). The half-life is 34 hours. Tradipitant is predominately metabolized by CYP450-mediated pathways and through glucuronidation. Approximately 80% of excretion of tradipitant occurs in the feces.

Clinical Trials::

Two phase 3 pivotal trials, Motion Syros (N = 365) and Motion Serifos (N = 316), randomized, double-blinded, placebo-controled, showed significant efficacy for tradipitant in preventing vomiting associated with motion sickness. In Motion Syros, tradipitant groups experienced significantly lower incidences of vomiting than placebo (170 mg tradipitant = 18.3%, 85 mg tradipitant = 19.5%, placebo = 44.3%). In Motion Serifos, 10.4% of the 170-mg tradipitant group and 18.3% of the 85-mg tradipitant group experienced vomiting, compared with 37.7% of the placebo group ( P = 0.00002 and P = 0.0014, respectively). The results of the 2 trials validated tradipitant as an effective NK-1 receptor antagonist for motion sickness prevention. The drug was well tolerated with a favorable safety profile and no serious adverse events.

Therapeutic Advance::

Tradipitant works by blocking the NK-1 receptors found in the emetic pathway and it has been proven in pivotal trials effective for prevention of vomiting due to motion sickness. It reduces motion sickness symptoms in 2 phase 3 trials and offers a revolutionary new treatment option for people who experience motion sickness.

01 Jun 2026·DRUGS

Tradipitant: First Approval

Review

Author: Lee, Arnold

Tradipitant (NEREUS™) is a small molecule neurokinin-1 (NK-1) receptor antagonist being developed by Vanda Pharmaceuticals. NK-1 receptor activation and substance P release in the central nervous system leads to nausea and vomiting symptoms associated with motion sickness. Tradipitant received its first approval in the USA in December 2025 for the prevention of vomiting induced by motion in adults, and is also being developed for the treatment of gastroparesis and prevention of vomiting induced by GLP-1 receptor agonists. In phase III trials, tradipitant reduced the incidence of vomiting associated with motion sickness. This article summarizes the milestones in the development of tradipitant leading to this first approval for the prevention of vomiting induced by motion in adults.

01 Dec 2024·Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial

Article

Author: Caleigh Kupersmith ; Darby Madonick ; Michael Camilleri ; Paula Moszczynski ; Mihael H. Polymeropoulos ; Anthony Lembo ; Changfu Xiao ; Michaela Fisher ; Sandra Smieszek ; Jesse L. Carlin ; Christos Polymeropoulos ; Gunther Birznieks

BACKGROUND:

Neurokinin receptor 1 antagonists are effective in reducing nausea and vomiting in chemotherapy-induced emesis. We investigated the safety and efficacy of tradipitant, a neurokinin receptor 1 antagonist, in patients with idiopathic and diabetic gastroparesis.

METHODS:

A total of 201 adults with gastroparesis were randomly assigned to oral tradipitant 85 mg (n = 102) or placebo (n = 99) twice daily for 12 weeks. Symptoms were assessed by a daily symptom dairy, Gastroparesis Cardinal Symptom Index scores, and other patient-reported questionnaires. Blood levels were monitored for an exposure-response analysis. The primary outcome was change from baseline to week 12 in average nausea severity, measured by daily symptom diary.

RESULTS:

The intention-to-treat (ITT) population did not meet the prespecified primary endpoint at week 12 (difference in nausea severity change drug vs placebo; P = .741) or prespecified secondary endpoints. Post hoc analyses were performed to control for drug exposure, rescue medications, and baseline severity inflation. Subjects with high blood levels of tradipitant significantly improved average nausea severity beginning at early time points (weeks 2-4). In post hoc sensitivity analyses, tradipitant treatment demonstrated strengthened effects, with statistically significant improvements in nausea at week 12.

CONCLUSIONS:

Although tradipitant did not reach significance in the ITT population, a pharmacokinetic exposure-response analysis demonstrated significant effects with adequate tradipitant exposure. When accounting for confounding factors such as baseline severity inflation and rescue medication, a statistically significant effect was also observed. These findings suggest that tradipitant has potential as a treatment for the symptom of nausea in gastroparesis. (ClincialTrials.gov, Number: NCT04028492).

News (Medical) associated with Tradipitant

19 Oct 2026

·www.biospace.com

Vanda freezes Novartis-originated social anxiety program after late-stage disappointment

iStock, nurlankani While Oppenheimer doesn’t see the Phase 3 stumble of VQW-765 as highly detrimental to Vanda Pharmaceuticals, the analyst nevertheless believes the stakes are now higher for the company’s planned Q4 readout for Nereus in GLP-1-induced vomiting. Vanda Pharmaceuticals is suspending the development of a social anxiety drug licensed from Novartis after the drug showed no significant benefit in a late-stage study. The investigational drug, called VQW-765, failed to significantly ease distress versus placebo in patients with social anxiety disorder during a social stress test, according to an announcement on Wednesday. The analysis focused on female participants, for whom the drug was previously found to be more effective. “This was a clean miss, not a near miss,” Oppenheimer analysts told investors in a Wednesday note. Vanda has decided to put the VQW-765 program on hold “pending further analysis of the full dataset,” the biotech said. The Phase 3 study, called VP-VQW-765-3201 , enrolled 546 adults with social anxiety disorder deemed to have elevated anxiety levels at baseline, as measured by validated scales. After receiving either VQW-765 or placebo, participants were asked to go through a standardized social stress test that requires them to prepare and deliver a presentation to a panel. The study’s primary outcome was distress and nervousness during the stress test in female participants, assessed using a self-reported tool, according to Vanda’s release. VQW-765 is a small-molecule partial agonist of the alpha 7 nicotinic acetylcholine receptor, the activation of which could help alleviate symptoms of anxiety and depression. Vanda picked up the drug candidate in a December 2014 settlement agreement with Novartis regarding certain disputes over the antipsychotic drug Fanapt. Alongside a $25 million equity investment, the pharma granted Vanda an exclusive worldwide license to VQW-765, which at the time was called AQW051. Phase 2 data published in July 2025 showed that patients on VQW-765 experienced lower self-reported anxiety during a standard social stress test, though the drug’s effect in the overall study population fell short of statistical significance. Stratifying by sex, results showed that VQW-765 was more effective in females, in whom the anxiety-easing effect was significant; VQW-765’s benefits in males remained non-significant. “We are disappointed that Study 3201 did not confirm the earlier Phase II findings for VQW-765 in patients with social anxiety disorder,” Vanda CEO Mihael Polymeropoulos said in a prepared statement on Wednesday. Analysts at Oppenheimer do not expect the Phase 3 miss to be highly detrimental to Vanda. VQW-765 “sat only in our bull case, so there is no change to our estimates” for the biopharma, the firm said. Oppenheimer continues to rate the biotech at outperform, suggesting it expects Vanda to deliver high returns for investors. Still, the VQW-765 pause is likely to add “pressure to the rest of the portfolio,” Oppenheimer said. Two of the three late-stage readouts the firm was keeping tabs on have already dropped, the analysts noted. The first came in September, when Hetlioz met the primary endpoint of helping patients to fall asleep faster in a Phase 3 study of delayed sleep-wake phase disorder. The second was VQW-765, a “negative” for Vanda, according to Oppenheimer. The third late-stage readout that the analysts have their eye on is for Nereus—also known as tradipitant—an oral motion-sickness drug that received approval in late December 2025. Vanda is now testing Nereus for GLP-1-induced vomiting. The biotech launched a Phase 3 trial in April, with topline data slated for the fourth quarter. Phase 2 data reported in November last year showed that tradipitant significantly lowered the proportion of patients with vomiting—the trial’s primary endpoint—as compared to placebo. The study involved 116 patients who were pretreated with tradipitant or placebo before being given a 1-mg injection of Novo’s Wegovy. Aside from the trio of late-stage readouts, Oppenheimer said Vanda’s “near-term story” will also now depend on launch execution for the schizophrenia and bipolar I disorder drug Bysanti, which notched regulatory clearance in February, and the FDA’s verdict for Quimilza in generalized pustular psoriasis expected by mid- December .

Phase 2Phase 3License out/inClinical Result

22 Aug 2026

·www.prnewswire.com

NEREUS™ Sponsored No. 47 IndyCar Ready for Historic Freedom 250 Grand Prix in Washington, D.C.

WASHINGTON, Aug. 22, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the NEREUS™ branded No. 47 entry from Rahal Letterman Lanigan Racing, driven by Mick Schumacher, is set to compete this weekend in the inaugural Freedom 250 Grand Prix of Washington, D.C., the first-ever NTT INDYCAR SERIES race on the National Mall. The event, taking place August 22–23, 2026, celebrates America's 250th anniversary with high-speed racing on a 1.7-mile, seven-turn temporary street circuit framed by the Washington Monument, U.S. Capitol, and other iconic landmarks. Practice and qualifying occur Saturday, with the 147-lap, approximately 250-mile race scheduled for Sunday afternoon and broadcast live on FOX. NEREUS™ (tradipitant), the first new U.S. prescription medication approved for the prevention of motion-induced vomiting in 47 years, is the primary sponsor of the No. 47 Honda. The partnership, announced by Vanda, aligns the brand's focus on performance and stability with the demands of IndyCar racing. This weekend marks a home event for the Washington-based company. "Partnering with the No. 47 car perfectly captures this historic moment and our shared commitment to performance under challenging conditions," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda. Fans can follow the No. 47 NEREUS™ IndyCar as Schumacher and Rahal Letterman Lanigan Racing take on this landmark street circuit in the nation's capital. About NEREUS™ (tradipitant) NEREUS™ is an oral NK-1 receptor antagonist FDA-approved for the prevention of vomiting induced by motion in adults. It is the first new pharmacologic treatment approved for this indication in over four decades. 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 and follow us on X @vandapharma. About Rahal Letterman Lanigan Racing Rahal Letterman Lanigan Racing is a championship-winning team competing in the NTT IndyCar Series. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

Drug Approval

05 Aug 2026

·www.prnewswire.com

Vanda Pharmaceuticals Reports Second Quarter 2026 Financial Results

Fanapt® Q2 2026 net product sales increased 23% to $36.0 million; total prescriptions increased 31% Full-year 2026 total revenue guidance of $240-$290 million Cash totaled $170.0 million as of June 30, 2026; expected to fund operations through at least the end of 2027 BYSANTI™ (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia in Q1 2026; commercial launch expected in second half of 2026 Quimilza™ (imsidolimab) BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026 NEREUS™ for prevention of vomiting induced by motion became commercially available in Q2 2026 Results for three Phase III clinical trials expected by end of 2026: NEREUS™ (tradipitant) in vomiting in GLP-1, VQW-765 in social anxiety disorder HETLIOZ® (tasimelteon) in delayed sleep phase disorder WASHINGTON, Aug. 5, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2026. "We are pleased with the continued strong growth of Fanapt and the enthusiastic early response to NEREUS as it becomes available to patients. With BYSANTI approved and on track for launch in the second half of 2026, a December 2026 PDUFA date for Quimilza and multiple late-stage clinical trial results expected before year-end, we believe Vanda is well positioned for meaningful commercial expansion and pipeline value creation," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "As our Phase III programs, launch preparations, and commercial supply manufacturing near completion, we expect operating expenses to begin moderating later this year and more significantly in 2027. Our current resources, together with anticipated product revenues, provide a solid foundation to advance our objectives through at least the end of 2027." Financial Highlights During 2025 and 2026, we have advanced multiple Phase III programs, continued execution on the commercialization of Fanapt® (iloperidone) and PONVORY® (ponesimod) and prepared for the commercial launches, including manufacturing commercial supplies, of NEREUS™ (tradipitant), BYSANTI™ (milsaperidone), and Quimilza™ (imsidolimab). These activities resulted in significantly increased operating expenses in 2025 and 2026. As these activities conclude, Vanda expects operating expenses to begin decreasing by the end of 2026 and more substantially throughout 2027. Based on its current cash position and anticipated revenues, Vanda expects to have sufficient resources to fund operations through at least the end of 2027. Second Quarter of 2026 Total net product sales were $50.5 million in Q2 2026, a 4% decrease compared to $52.6 million in Q2 2025. Total net product sales does not include approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026. Fanapt® net product sales were $36.0 million in Q2 2026, up 23% year-over-year. HETLIOZ® (tasimelteon) net product sales were $5.6 million in Q2 2026, down 66% year-over-year, and do not include orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders will be recognized as revenue in Q3 2026. PONVORY® net product sales were $7.9 million in Q2 2026, up 12% year-over-year. NEREUSTM net product sales were $1.0 million in Q2 2026. NEREUSTM launched commercially in the U.S. in Q2 2026 with the direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Loss before income taxes was $62.4 million in Q2 2026 compared with $34.9 million in Q2 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $170.0 million as of June 30, 2026, representing a decrease to Cash of $32.3 million in Q2 2026. First Six Months of 2026 Total net product sales were $102.2 million in the first six months of 2026 as compared to $102.6 million in the first six months of 2025. Total net product sales does not include approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026. Fanapt® net product sales were $65.5 million in the first six months of 2026, up 24% year-over-year. HETLIOZ® net product sales were $21.5 million in the first six months of 2026, down 42% year-over-year, and do not include orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders will be recognized as revenue in Q3 2026. PONVORY® net product sales were $14.1 million in the first six months of 2026, up 11% year-over-year. NEREUSTM net product sales were $1.0 million in the first six months of 2026. NEREUSTM launched commercially in the U.S. in Q2 2026 with the direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Loss before income taxes was $110.8 million in the first six months of 2026 compared with $72.3 million in the first six months of 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $170.0 million as of June 30, 2026, representing a decrease to Cash of $93.8 million compared to December 31, 2025. Key Commercial Highlights Fanapt® saw continued strong momentum in Q2 2026, with total prescriptions (TRx)1 up 31% and new-to-brand prescriptions (NBRx)1 up 32% versus Q2 2025. Since commercial expansion following the approval of bipolar disorder, Fanapt® has seen significant growth, with TRx1 up 62% and NBRx1 up 300% versus Q2 2024. BYSANTI™ received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia in Q1 2026 and is expected to launch in the second half of 2026. BYSANTI™ is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. In May 2026, the early commercial launch of NEREUS™ was initiated with a direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Key Regulatory & Clinical Development Highlights Upcoming Clinical Milestones Vanda's ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including: The Thetis Phase III study of NEREUS™ for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026. The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected in 2026. The Phase III study of HETLIOZ® in the treatment of delayed sleep phase disorder (DSPD), with results expected in 2026. The Phase III study of BYSANTI™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in the first half of 2027. Other Updates The Biologics License Application (BLA) for Quimilza™ in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026. The results of the pivotal clinical study were published in the April 28, 2026 issue of the New England Journal of Medicine (NEJM) Evidence2. In May 2026, Vanda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation to Quimilza™ for the treatment of GPP. In July 2026, Vanda announced that the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA) had adopted a positive opinion recommending orphan drug designation for Quimilza™ for the treatment of GPP. In July 2026, Vanda announced that the FDA had granted Rare Pediatric Disease Designation to VCA-894A, Vanda's investigational antisense oligonucleotide therapy for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), a rare, serious, and progressive inherited neurological disorder. Vanda continues to progress the FDA formal hearing regarding HETLIOZ® for the treatment of jet lag disorder. The proceeding, a rare administrative hearing process granted after the D.C. Circuit set aside the FDA's prior refusal to approve the application, is advancing according to schedule and is expected to culminate in a five-day hearing before the Administrative Law Judge in December 2026. GAAP Financial Results Net loss was $62.5 million (diluted loss per share of $1.04) in Q2 2026 compared with a net loss of $27.2 million (diluted loss per share of $0.46) in Q2 2025. Net loss was $111.1 million (diluted loss per share of $1.86) in the first six months of 2026 compared with a net loss of $56.7 million (diluted loss per share of $0.96) in the first six months of 2025. 2026 Financial Guidance Vanda is reiterating its 2026 total revenue guidance and expects to achieve the following financial objectives in 2026: Conference Call Vanda has scheduled a conference call for today, Wednesday, August 5, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the second quarter 2026 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 1843107. A replay of the call will be available on Wednesday, August 5, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, August 12, 2026 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 1843107. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). 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 and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2026 Financial Guidance" above and statements regarding Vanda's expectations with respect to its ability to fund its operations through at least the end of 2027; the expected timing of the commercial launch of BYSANTI™ for the treatment of bipolar I disorder and schizophrenia; the anticipated timing of the completion of the FDA's review of the Quimilza™ BLA for the treatment of GPP; Vanda's clinical development plans and expected timelines for NEREUS™ in the prevention of vomiting induced by GLP-1 therapies, VQW-765 in the treatment of adults with social anxiety disorder, HETLIOZ® in the treatment of DSPD, and BYSANTI™ for the treatment of MDD; Vanda's expectations with respect to its commercial expansion and ability to create value from its product pipeline; Vanda's expectations with respect to its operating expense run rate through 2027; the anticipated timing of the commencement of personal promotion of NEREUS™; Vanda's continued pursuit of FDA approval of HETLIOZ® for the treatment of jet lag disorder and Vanda's expectations with respect to the HETLIOZ® evidentiary hearing; and Vanda's expectations with respect to the strength of its business 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 continue to grow its business; Vanda's ability to reduce its operating expenses, conserve cash and generate enough revenue to fund its operations through at least the end of 2027; Vanda's ability to successfully execute the commercial launch of BYSANTI™ for the treatments of bipolar I disorder and schizophrenia in the second half of 2026; the FDA's ability to complete its review of, and reach a decision with respect to, the BLA for Quimilza™ by December 12, 2026; Vanda's ability to continue to advance its late-stage clinical development programs and to obtain regulatory approval for, and successfully commercialize, the late-stage products in development; Vanda's ability to complete the Phase III studies for NEREUS™ in the prevention of vomiting induced by GLP-1 therapies, VQW-765 in the treatment of adults with social anxiety disorder, and HETLIOZ® in the treatment of DSPD and receive the respective study results by the end of 2026; Vanda's ability to complete the Phase III study for BYSANTI™ for the treatment of MDD and receive results in the first half of 2027; Vanda's ability to commence personal promotion of NEREUS™ for the prevention of vomiting induced by motion in 2026; and the outcome of the administrative hearing process for HETLIOZ® for the treatment of jet lag disorder. 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 . 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 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

Phase 3Drug ApprovalFinancial StatementOrphan Drug

100 Deals associated with Tradipitant

External Link

KEGG	Wiki	ATC	Drug Bank
D11728	Tradipitant	-	DB12580

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Motion Sickness	United States	Vanda Pharmaceuticals, Inc.	30 Dec 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroparesis	NDA/BLA	United States	Vanda Pharmaceuticals, Inc.	04 Dec 2023
Obesity	Phase 3	United States	Vanda Pharmaceuticals, Inc.	27 Mar 2026
Vomiting	Phase 3	United States	Vanda Pharmaceuticals, Inc.	27 Mar 2026
COVID-19	Phase 3	United States	Vanda Pharmaceuticals, Inc.	13 Apr 2020
Lung Injury	Phase 3	United States	Vanda Pharmaceuticals, Inc.	13 Apr 2020
Diabetic Gastroparesis	Phase 3	United States	Vanda Pharmaceuticals, Inc.	20 Aug 2019
Dermatitis, Atopic	Phase 3	United States	Vanda Pharmaceuticals, Inc.	09 Jul 2018
Pruritus	Phase 2	Germany	Vanda Pharmaceuticals, Inc.	10 Dec 2013
Alcoholism	Phase 2	United States	Eli Lilly & Co.	01 Mar 2006
Anxiety Disorders	Phase 2	United States	Eli Lilly & Co.	01 Mar 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04327661 \| NCT05903924 (Motion Syros, Pubmed \| Am J Ther)	Phase 3	Motion Sickness	681	Tradipitant 170 mg	zkvewwtcld(zimsdiwati) = no serious adverse events lezuqknelp (zirmcjhauq )	Positive	01 Jul 2026
				Tradipitant 85 mg
VP-VLY-686-3301 (DDW2026)	Phase 2	Diabetic Gastroparesis	776	Tradipitant 85 mg	qmptvemngc(nameryxboz) = kwrcixsclp lnizzhlicd (trypzzxbzz ) View more	Positive	02 May 2026
				Tradipitant 85 mg (higher concentration (High PK))	zjzfdhwdaj(vflxjcqrzn) = hwtlomocdd gxmyphobln (tdacjbvmzl )
DDW2026	Not Applicable	Gastroparesis \| Diabetic Gastroparesis	464	NK-1 Receptor Antagonists	lcfvznvbny(atuoafemuq) = ptpmzlszyf hemazdbivn (wtsxjggynb )	Positive	02 May 2026
				Placebo	lcfvznvbny(atuoafemuq) = cdopbcqjhb hemazdbivn (wtsxjggynb )
NCT06804603 (VP-VLY-686-2601, PRNewswire) Manual	Phase 2	Drug-induced nausea and vomiting	116	Tradipitant 85 mg	izncodtydu(eipzqyfaxq) = ldftktfaee uizpmegkaq (yljnlibmxt ) View more	Positive	18 Nov 2025
				Placebo	izncodtydu(eipzqyfaxq) = mqfkrrcnck uizpmegkaq (yljnlibmxt ) View more
NCT03772340 (CTgov)	Phase 2	Motion Sickness	126	Tradipitant (Tradipitant)	gkflrearqr(mbzazyvslx) = dcicimrclk vqdbccqldh (enmshcustj, 0.238) View more	-	09 May 2025
				Placebo (Placebo)	gkflrearqr(mbzazyvslx) = wxeuhqmxsk vqdbccqldh (enmshcustj, 0.239) View more
NCT05903924 (Motion Syros, CTgov)	Phase 3	Motion Sickness	316	Tradipitant (Tradipitant High Dose)	mkjofzamdq = gttbpcvrfu nvyjyqeqnc (oxqqxevzbh, ivqtzckhox - tzrgagormc) View more	-	04 Apr 2025
				Tradipitant (Tradipitant Low Dose)	mkjofzamdq = zpcqdkfnmk nvyjyqeqnc (oxqqxevzbh, exskgfvylm - nuhbjoxmjq) View more
NCT04327661 (Motion Syros, CTgov)	Phase 3	Motion Sickness	366	Tradipitant (Tradipitant High Dose)	bwixwgtlrc = eyajhlqoug juyqiasjfn (amoymnyipa, xiverpypbk - tnvitjyvid) View more	-	11 Dec 2024
				Tradipitant (Tradipitant Low Dose)	bwixwgtlrc = ohpjporljh juyqiasjfn (amoymnyipa, sggrrsewwm - fediqzqahj) View more
NCT02651714 (CTgov)	Phase 2	Pruritus \| Dermatitis, Atopic	168	Tradipitant (Tradipitant)	uzimlgbxfs(ygdkjcjcfz) = yotxcdjwyd zdxsqgykew (iudfrflbum, 3.89) View more	-	13 Jun 2024
				Placebo (Placebo)	uzimlgbxfs(ygdkjcjcfz) = ynldecwimx zdxsqgykew (iudfrflbum, 4.03) View more
NCT02004041 (VP-VLY-686-2101, CTgov)	Phase 2	Pruritus \| Dermatitis, Atopic	69	VLY-686 (VLY-686)	vgemhdobxt(yqflosxyjl) = jdifmlpsjo aubgvgpcbm (alkqgupxoa, 5.30) View more	-	11 Jun 2024
				Placebo (Placebo)	vgemhdobxt(yqflosxyjl) = dbuhajyhgl aubgvgpcbm (alkqgupxoa, 4.96) View more
NCT04327661 (Motion Syros, DDW2024) Manual	Phase 3	Motion Sickness	365	Tradipitant 170mg	iorizgwxrf(hthkxvabgg) = eawmwicafz mthgsnkipq (gugtbgujhq ) View more	Positive	19 May 2024
				Tradipitant 85mg	iorizgwxrf(hthkxvabgg) = lylpwcsubo mthgsnkipq (gugtbgujhq ) View more

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