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 Date25 Feb 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

/ RecruitingPhase 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 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).

11 Jul 2024·JOURNAL OF MEDICINAL CHEMISTRY

Occurrence of “Natural Selection” in Successful Small Molecule Drug Discovery

Article

Author: Waldmann, Herbert ; Zdrazil, Barbara ; Leeson, Paul D. ; Heinzke, A. Lina ; Pahl, Axel ; Leach, Andrew R. ; Young, Robert J.

Published compounds from ChEMBL version 32 are used to seek evidence for the occurrence of "natural selection" in drug discovery. Three measures of natural product (NP) character were applied, to compare time- and target-matched compounds reaching the clinic (clinical compounds in phase 1-3 development and approved drugs) with background compounds (reference compounds). Pseudo-NPs (PNPs), containing NP fragments combined in ways inaccessible by nature, are increasing over time, reaching 67% of clinical compounds first disclosed since 2010. PNPs are 54% more likely to be found in post-2008 clinical versus reference compounds. The majority of target classes show increased clinical compound NP character versus their reference compounds. Only 176 NP fragments appear in >1000 clinical compounds published since 2008, yet these make up on average 63% of the clinical compound's core scaffolds. There is untapped potential awaiting exploitation, by applying nature's building blocks─"natural intelligence"─to drug design.

09 Apr 2024·NEUROLOGY

Tradipitant Effective in the Reduction of Vomiting Associated with Motion Sickness Across Varied Sea Conditions (S3.003)

Article

Author: Birznieks, Gunther ; Kiely, Leah ; Polymeropoulos, Christos ; Goldberg, Abigail ; Xiao, Changfu ; Polymeropoulos, Mihael ; Mourad, Raina ; Bushman, Margaret ; Polymeropoulos, Vasilios ; Miller, Cameron ; Sutherland, Elizabeth ; Pham, Nikolas ; Morgan, Dane ; Davis, Tanner

OBJECTIVE:

The Motion Syros study was a multicenter, randomized, double-blind placebo-controlled study to evaluate the efficacy and safety of tradipitant for motion sickness.

BACKGROUND:

Motion sickness is a common disorder affecting approximately 30% of travelers under usual circumstances. The sensory mismatch theory postulates that motion sickness is induced by a discordance between the visual, vestibular, and kinesthetic systems, leading to a constellation of symptoms including nausea and vomiting. Substance P activates NK1 receptors in the nucleus tractus solitarius inducing a cascade of symptoms. Tradipitant is a novel NK1 receptor antagonist being studied for the treatment of nausea and vomiting associated with motion sickness.

DESIGN/METHODS:

The Motion Syros study was a multicenter, randomized, double-blind, placebo-controlled study where 365 participants embarked on boat trips under varied sea conditions and received tradipitant 170 mg, tradipitant 85 mg, or placebo. Participants evaluated their symptoms at thirty-minute intervals during the expedition.

RESULTS:

Participants on tradipitant 170 mg or 85 mg had a significantly lower incidence of vomiting as compared to those on placebo across all boat trips (tradipitant 170 mg = 18.3%, tradipitant 85mg = 19.5%, placebo = 44.3%, p < .0001 for both dose comparisons against placebo, n = 365). A range of wave heights was represented across the various boat trips, eliciting variable degrees of severity of motion sickness and differing responses to tradipitant.

CONCLUSIONS:

Tradipitant has been confirmed to be effective in the reduction of vomiting associated with motion sickness across varied sea conditions with a range of wave heights. Motion sickness remains a significant unmet medical need, given existing treatments' limitations in alleviating symptoms and their frequent adverse effects. Disclosure: Dr. Polymeropoulos has received personal compensation for serving as an employee of Vanda Pharmaceuticals. An immediate family member of Dr. Polymeropoulos has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Vanda. Dr. Polymeropoulos has stock in Vanda. Miss Bushman has received personal compensation for serving as an employee of Vanda Pharmaceuticals. Miss Bushman has stock in Vanda Pharmaceuticals. Mr. Morgan has stock in Vanda Pharmaceuticals. Ms. Sutherland has received personal compensation for serving as an employee of Vanda Pharmaceuticals. Ms. Sutherland has stock in Vanda Pharmaceuticals. Mr. Davis has received personal compensation for serving as an employee of Vanda Pharmaceuticals, Inc.. Mr. Davis has stock in Vanda Pharmaceuticals, Inc.. Mr. Pham has received personal compensation for serving as an employee of Vanda Pharmaceuticals. Mr. Pham has stock in Vanda Pharmaceuticals. Miss Kiely has received personal compensation for serving as an employee of Vanda Pharmaceuticals Inc.. Miss Kiely has stock in Vanda Pharmaceuticals Inc.. Ms. Goldberg has received personal compensation for serving as an employee of Vanda Pharmaceuticals Inc. Ms. Goldberg has stock in Vanda Pharmaceuticals Inc. Miss Mourad has received personal compensation for serving as an employee of Vanda Pharmaceuticals Inc.. Miss Mourad has stock in Vanda Pharmaceuticals Inc.. Miss Miller has received personal compensation for serving as an employee of Vanda Pharmaceuticals . Miss Miller has stock in Vanda Pharmaceuticals. Dr. Xiao has received personal compensation for serving as an employee of Vanda pharma. Dr. Xiao has stock in Vanda pharma. Dr. Polymeropoulos has received personal compensation for serving as an employee of Vanda Pharmaceuticals Inc. An immediate family member of Dr. Polymeropoulos has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Vanda Pharmaceuticals Inc. Dr. Polymeropoulos has stock in Vanda Pharmaceuticals Inc. Mr. Birznieks has received personal compensation for serving as an employee of Vanda Pharmaceuticals. Dr. Polymeropoulos has received personal compensation for serving as an employee of Vanda Pharmaceuticals. Dr. Polymeropoulos has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Vanda Pharmaceuticals .

News (Medical) associated with Tradipitant

26 Feb 2026

·www.prnewswire.com

Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis

Feb. 25, 2026 -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026. GPP is a rare, chronic, life-threatening autoinflammatory skin disorder characterized by sudden flares of widespread pustules, erythema, and systemic symptoms such as fever and fatigue. The pathogenesis of GPP is increasingly understood through its genetic characterization (OMIM #614204), and its molecular etiology is mainly attributed to excessive activity of the interleukin-36 (IL-36) pathway.1 The majority of GPP cases for which a causal single gene defect has been identified are caused by various consequential genetic variants in the IL36RN gene, encoding the IL-36 receptor antagonist (IL-36Ra).2,3,4 Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is believed to achieve its therapeutic effects in GPP where IL-36 signaling is unbalanced. If approved, imsidolimab could address a significant unmet medical need in this rare and life-threatening disorder with potential benefits over currently existing treatments. Imsidolimab was studied in global clinical studies conducted in the United States, France, Spain, Poland, Turkey, Malaysia, Thailand, Georgia, Tunisia, Taiwan, and Morocco. In the pivotal efficacy studies GEMINI-1 and GEMINI-2, a single intravenous dose of imsidolimab led to rapid disease clearance, with 53% of patients achieving clear or almost clear skin (GPPPGA 0/1) at Week 4 compared to 13% on placebo. Efficacy was maintained throughout an approximately 2-year maintenance period with monthly doses, and no flares occurred in the active treatment arm. Imsidolimab exhibited a favorable safety profile and demonstrated a low incidence of anti-drug antibodies, which can be a significant advantage over existing treatments. GPP is a rare disorder with prevalence estimates varying widely by region, ranging from approximately 2 to 124 cases per million worldwide (lower in Europe and higher in parts of Asia).5,6 "The acceptance of the BLA filing for imsidolimab marks a critical milestone in our efforts to bring this innovative therapy to patients suffering from GPP," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "Imsidolimab builds on our growing expertise in rare orphan disorders and our anti-inflammatory portfolio. Imsidolimab represents a precision medicine approach targeting a disorder with a known genetic cause using a fully humanized monoclonal antibody against the IL-36 receptor. We look forward to potential FDA approval and leveraging our commercial infrastructure to address this debilitating condition." Vanda celebrates this significant milestone for imsidolimab's acceptance for review by the FDA during Rare Disease Week on Capitol Hill (February 24–26, 2026), as advocates unite to promote innovation and access to treatments for rare orphan diseases like generalized pustular psoriasis. If imsidolimab is approved, it will be the third new drug product approved for Vanda in the past 12 months, following NEREUS™ (tradipitant) and BYSANTI™ (milsaperidone). References Online Mendelian Inheritance in Man, OMIM®. Johns Hopkins University, Baltimore, MD. MIM Number: 614204: 12/16/2020. Available at: https://omim.org/ Marrakchi, S. et al. Interleukin-36–Receptor Antagonist Deficiency and Generalized Pustular Psoriasis. New England Journal of Medicine 365, 620–628 (2011). Sugiura, K. et al. The Majority of Generalized Pustular Psoriasis without Psoriasis Vulgaris Is Caused by Deficiency of Interleukin-36 Receptor Antagonist. Journal of Investigative Dermatology 133, 2514–2521 (2013). Johnston, A. et al. IL-1 and IL-36 are dominant cytokines in generalized pustular psoriasis. Journal of Allergy and Clinical Immunology 140(1), 109–120 (2017). Sachen, K. L. et al. Role of IL-36 cytokines in psoriasis and other inflammatory skin conditions. Cytokine 156, 155897 (2022). Prinz, J. C. et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. Journal of the European Academy of Dermatology and Venereology 37, 256–273 (2022). Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is being developed for GPP, a rare orphan indication. Regulatory and patent exclusivity for imsidolimab is expected to extend into the late 2030s. Vanda holds an exclusive global license for the development and commercialization of imsidolimab from AnaptysBio (Nasdaq: ANAB). 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. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalLicense out/inOrphan Drug

25 Feb 2026

·www.prnewswire.com

Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Opening New Horizons in Psychiatric Innovation

Feb. 20, 2026 -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved BYSANTI™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. BYSANTI™ is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics. In clinical studies BYSANTI™ demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum enabling it to leverage well-established knowledge of efficacy and safety derived from a rich clinical development program and more than 100,000 patient-years of real-world experience with Fanapt® (iloperidone). As such BYSANTI™ represents a novel therapeutic option with a trusted safety profile in the treatment of these serious psychiatric conditions."The BYSANTI™ approval marks a significant step forward, offering patients and providers a reliable new treatment grounded in extensive clinical heritage," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "BYSANTI™ exemplifies a new era of accelerated innovation in drug development that can transform how we address unmet needs in behavioral health." BYSANTI™ is currently being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder in an ongoing clinical study expected to complete by the end of this year. BYSANTI™ (milsaperidone), a new chemical entity, rapidly interconverts to iloperidone, providing dual active molecules that work in tandem by antagonizing dopamine D2, serotonin 5-HT2A, and alpha1-adrenergic receptors to modulate key pathways in these disorders. Its safety profile aligns closely with that established for iloperidone. BYSANTI™'s unique in-class receptor binding profile, featuring strong alpha-adrenergic binding in excess of dopamine and serotonin receptor binding, makes it suitable for further investigation in conditions that include symptoms of hostility, agitation, and hyperarousal. Vanda anticipates commercial availability of BYSANTI™ in Q3 of 2026. BYSANTI™ marketing exclusivity is expected to be protected by regulatory data exclusivity and issued US patents, with the latest expiring in 2044, providing a robust foundation for long-term innovation and patient benefit. BYSANTI™ is the second new drug approval for Vanda in less than 2 months following the approval of NEREUS™ in December of 2025. Bipolar I disorder impacts a significant portion of the roughly 10 million Americans with bipolar disorder, characterized by manic or mixed episodes that require effective symptom management to enhance outcomes.1 Schizophrenia affects approximately 1% of the U.S. adult population (about 2.8 million people), often causing substantial functional impairment, frequent hospitalizations, and diminished quality of life.2345 References Harvard Medical School, 2007. National Comorbidity Survey (NSC). (2017, August 21). Potkin SG, et al. Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S4-S11. doi:10.1097/JCP.0b013e3181692787. Cutler AJ, et al. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S20-S28. doi:10.1097/JCP.0b013e318169278d. Weiden PJ, et al. A Randomized Trial of Iloperidone for Prevention of Relapse in Schizophrenia: The REPRIEVE Study. J Clin Psychopharmacol. 2016;36(4):302-308. doi:10.1097/JCP.0000000000000516. (PMC4982888). Torres R, et al. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024;85(1):23m14966. doi:10.4088/JCP.23m14966. The content above comes from the network. if any infringement, please contact us to modify

Drug Approval

11 Feb 2026

·www.prnewswire.com

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results

Full year 2025 Fanapt® net product sales increased by 24% to $117.3 million compared to full year 2024 Full year 2025 total revenues increased by 9% to $216.1 million compared to full year 2024 NEREUS™ (tradipitant) approved for the prevention of vomiting induced by motion Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026 WASHINGTON, Feb. 11, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2025. "2025 showed strong momentum at Vanda, led by Fanapt, with net product sales up 24% to $117.3 million, driven by a 28% rise in total prescriptions and 149% surge in new-to-brand prescriptions - reflecting accelerating growth in schizophrenia and bipolar I disorder. We await the FDA decision on the Bysanti (milsaperidone) NDA by the February 21, 2026 PDUFA date, which would expand our psychiatry franchise in the global antipsychotic category. This category had a total addressable market estimated at approximately $20 billion in 2025," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "The FDA approval of NEREUS (tradipitant) is a landmark - the first new oral therapy for motion-induced vomiting prevention in over 40 years - targeting a large addressable population of roughly 65–78 million U.S. adults experiencing symptoms, with tens of millions seeking relief annually. We are preparing for the NEREUS commercial launch and plan to start a Phase III program in the first half of 2026 for its use in preventing vomiting from GLP-1 analogs," continued Dr. Polymeropoulos. "We submitted the imsidolimab BLA in Q4 2025 for generalized pustular psoriasis, a rare orphan condition. With our current franchise - Fanapt, HETLIOZ, HETLIOZ LQ, and PONVORY - we expect 2026 total revenues of $230 to $260 million from these marketed products alone, providing a solid baseline. We look forward to continued growth from this portfolio, with further contributions from the NEREUS launch and potential approvals of Bysanti and imsidolimab." Financial Highlights Fourth Quarter of 2025 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $57.2 million in the fourth quarter of 2025, an 8% increase compared to $53.2 million in the fourth quarter of 2024. Fanapt® net product sales were $33.2 million in the fourth quarter of 2025, a 25% increase compared to $26.6 million in the fourth quarter of 2024. HETLIOZ® net product sales were $16.4 million in the fourth quarter of 2025, an 18% decrease compared to $20.0 million in the fourth quarter of 2024. PONVORY® net product sales were $7.6 million in the fourth quarter of 2025, a 17% increase compared to $6.5 million in the fourth quarter of 2024. Loss before income taxes was $38.0 million in the fourth quarter of 2025 compared to a loss before income taxes of $6.5 million in the fourth quarter of 2024. Provision for income taxes was $103.2 million in the fourth quarter of 2025 compared to a benefit for income taxes of $1.6 million in the fourth quarter of 2024. The provision for income taxes in the fourth quarter of 2025 includes the impact of the recording of a valuation allowance of $113.7 million against all of Vanda's deferred tax assets, which is a non-cash charge. Cash, cash equivalents and marketable securities (Cash) was $263.8 million as of December 31, 2025, representing a decrease to Cash of $29.9 million compared to September 30, 2025. Full Year 2025 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $216.1 million for the full year 2025, a 9% increase compared to $198.8 million for the full year 2024. Fanapt® net product sales were $117.3 million for the full year 2025, a 24% increase compared to $94.3 million for the full year 2024. HETLIOZ® net product sales were $71.4 million for the full year 2025, a 7% decrease compared to $76.7 million for the full year 2024. PONVORY® net product sales were $27.4 million for the full year 2025, a 2% decrease compared to $27.8 million for the full year 2024. Loss before income taxes was $138.6 million for the full year 2025 compared to a loss before income taxes of $22.9 million for the full year 2024. Provision for income taxes was $81.8 million for the full year 2025 compared to a benefit for income taxes of $4.0 million for the full year 2024. The provision for income taxes for the full year 2025 includes the impact of the recording of a valuation allowance of $113.7 million against all of Vanda's deferred tax assets, which is a non-cash charge. Cash was $263.8 million as of December 31, 2025, representing a decrease to Cash of $110.8 million compared to December 31, 2024. Key Operational Highlights – Commercial Fanapt® experienced significant growth, with total prescriptions (TRx)1 increasing by 36% and Fanapt® net product sales increasing by 25% in the fourth quarter of 2025 as compared to the fourth quarter of 2024. Fanapt® total prescriptions increased by 28% and Fanapt® net product sales increased by 24% for the full year 2025 as compared to the full year 2024. New to brand prescriptions (NBRx)1 increased by 108% in the fourth quarter of 2025 as compared to the fourth quarter of 2024 and increased by 149% for the full year 2025 as compared to the full year 2024. During 2025, Vanda's direct-to-consumer campaign, launched in the first quarter, continued to drive meaningful gains in brand awareness for the company and its products, Fanapt® and PONVORY®. The Company maintained strategic investments in its commercial infrastructure, including increased brand visibility through targeted sponsorships, with the goal of supporting long-term market leadership and future commercial launches. Fanapt® performance remains the focus of Vanda's commercial initiatives and encourages us to continue to invest in this differentiated medicine, and, if approved, the franchise-extending launch of Bysanti™. Key Operational Highlights – Regulatory & Clinical Development 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. Bysanti™ (milsaperidone) New Drug Application (NDA) for bipolar I disorder and schizophrenia is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2026. A Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is enrolling patients and results are expected in 2026. Vanda announced positive results of a clinical study of NEREUSTM in the prevention of vomiting induced by a GLP-1 analog, Wegovy® (semaglutide). A Phase III clinical program is anticipated to be initiated in the first half of 2026. Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) was submitted to the FDA in the fourth quarter of 2025. A Phase III study of VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, in the treatment of adults with social anxiety disorder has been initiated and study results are expected by the end of 2026. The Phase III study of the long acting injectable (LAI) formulation of iloperidone in the treatment of schizophrenia in relapse-prevention is enrolling patients. A clinical study of the LAI formulation of iloperidone in people with treatment-resistant hypertension is ongoing and Vanda is enrolling patients. On January 8, 2026, Vanda announced that it had received a decision letter from the FDA Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in the current form. This letter followed CDER's re-review of the jet lag sNDA under Vanda's collaborative framework agreement with the FDA. Vanda has requested that the FDA Commissioner resume hearing proceedings. GAAP Financial Results Net loss was $141.2 million in the fourth quarter of 2025 compared to net loss of $4.9 million in the fourth quarter of 2024. Diluted net loss per share was $2.39 in the fourth quarter of 2025 compared to diluted net loss per share of $0.08 in the fourth quarter of 2024. Net loss was $220.5 million for the full year 2025 compared to net loss of $18.9 million for the full year 2024. Diluted net loss per share was $3.74 for the full year 2025 compared to diluted net loss per share of $0.33 for the full year 2024. Provision for Income Taxes - One-Time, Non-Cash Charge Impact In the fourth quarter of 2025, Vanda determined that it is not more-likely-than-not that it will realize its existing net deferred tax assets, having reviewed both positive and negative evidence as well as expectations of future taxable income, and recorded a valuation allowance against all its deferred tax assets. As a result, the fourth quarter of 2025 provision for income taxes includes a one-time, non-cash income tax charge of $113.7 million. Excluding this one-time non-cash tax charge, our full year 2025: Effective tax rate would have increased to 23%, compared to the reported effective tax rate of negative 59%. Net loss would have decreased to $106.8 million, compared to the reported net loss of $220.5 million. Diluted net loss per share would have decreased to $1.81, compared to the reported diluted net loss per share of $3.74. Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information." 2026 Financial Guidance Due to the recent and upcoming regulatory and commercial milestones, Vanda's 2026 financial guidance is limited to revenue guidance for currently commercialized products which includes Fanapt®, HETLIOZ® and PONVORY®. Vanda expects to achieve the following financial objectives in 2026. Conference Call Vanda has scheduled a conference call for today, Wednesday, February 11, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 2025 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 8728050. A replay of the call will be available on Wednesday, February 11, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, February 18, 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 8728050. 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 Non-GAAP Financial Information Vanda believes that the above Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda's business and reflect how it manages the business internally and sets operational goals. The Non-GAAP effective tax rate, Non-GAAP net loss and Non-GAAP dilutive EPS exclude the one-time, non-cash valuation allowance income tax charge. Vanda believes that excluding the impact of this one-time, non-cash charge better reflects the recurring economic characteristics of its business, as well as Vanda's use of financial resources and its long-term performance. These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies because all companies may not calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies. The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda's financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial information in connection with its GAAP financial information. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure. 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 plans for pursuit of FDA approval of BysantiTM for the treatments of bipolar I disorder and schizophrenia and imsidolimab for the treatment of GPP, and the related timelines and prospects for approval; Vanda's commercial launch plans for NEREUSTM for the prevention of vomiting induced by motion; the prevalence of motion-induced vomiting in the U.S. and the number of people seeking relief each year; the goals, focus and expected results of Vanda's commercial infrastructure investment strategy; Vanda's clinical development plans and expected timelines for BysantiTM for the treatment of MDD, NEREUSTM in the prevention of vomiting induced by Wegovy®, the long acting injectable formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension and VQW-765 in the treatment of adults with social anxiety disorder; Vanda's plans to continue its pursuit of FDA approval of HETLIOZ® for the treatment of jet lag disorder; 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; the FDA's ability to complete its reviews of, and reach decisions with respect to, the NDA for Bysanti™ by February 21, 2026; Vanda's ability to obtain regulatory approval of imsidolimab for the treatment of GPP; Vanda's ability to successfully execute the commercial launch of NEREUSTM; the accuracy of the estimates of the prevalence of motion-induced vomiting in the U.S. and the number of people seeking relief each year; Vanda's ability to achieve long-term market leadership and execute new commercial launches through its commercial infrastructure investments; Vanda's ability to complete the clinical study for BysantiTM for the treatment of MDD and receive results in 2026; Vanda's ability to initiate the clinical program for NEREUSTM in the prevention of vomiting induced by Wegovy® in the first half of 2026; Vanda's ability to complete enrollment of patients in the clinical studies for the LAI formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension; Vanda's ability to complete the clinical study for VQW-765 in the treatment of adults with social anxiety disorder and receive results by the end of 2026; and the FDA's willingness to resume hearing proceedings on 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 3NDAFinancial StatementDrug ApprovalClinical Result

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.	25 Feb 2026
Vomiting	Phase 3	United States	Vanda Pharmaceuticals, Inc.	25 Feb 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


NCT06804603 (VP-VLY-686-2601, PRNewswire) Manual	Phase 2	Drug-induced nausea and vomiting	116	Tradipitant 85 mg	ckqevbbtni(qbiohhtbkg) = abpmapmdpq fciznvkkas (oprqistyzl ) View more	Positive	18 Nov 2025
				Placebo	ckqevbbtni(qbiohhtbkg) = fycnegtohm fciznvkkas (oprqistyzl ) View more
NCT03772340 (CTgov)	Phase 2	Motion Sickness	126	Tradipitant (Tradipitant)	vbpxukhtfh(wtcvauvpzo) = jjdqbxztjt tsviwtxkun (hdmrhlqrqy, 0.238) View more	-	09 May 2025
				Placebo (Placebo)	vbpxukhtfh(wtcvauvpzo) = fvnurpymjx tsviwtxkun (hdmrhlqrqy, 0.239) View more
NCT05903924 (CTgov)	Phase 3	Motion Sickness	316	Tradipitant (Tradipitant High Dose)	uhywskccmx = nlfypbvocx rdoeayacof (kbdzdrzesg, owypybeahb - tvgfejyadl) View more	-	04 Apr 2025
				Tradipitant (Tradipitant Low Dose)	uhywskccmx = ixlekwsvfm rdoeayacof (kbdzdrzesg, eurorsnltn - esyyufwxlo) View more
NCT04327661 (Motion Syros, CTgov)	Phase 3	Motion Sickness	366	Tradipitant (Tradipitant High Dose)	fnkbdzrrbq = iekfgtfkum pxnldlgpib (gnociotkvr, noqgnurvsw - mfraiaxycb) View more	-	11 Dec 2024
				Tradipitant (Tradipitant Low Dose)	fnkbdzrrbq = vjwcrqnnwv pxnldlgpib (gnociotkvr, mqstfdkyre - iudfdojdoj) View more
NCT02651714 (CTgov)	Phase 2	Pruritus \| Dermatitis, Atopic	168	Tradipitant (Tradipitant)	wtohinkryt(tugafuxgkw) = ikeydiirws qzuhyiucyb (edlusgvznk, 3.89) View more	-	13 Jun 2024
				Placebo (Placebo)	wtohinkryt(tugafuxgkw) = xksukxzgjn qzuhyiucyb (edlusgvznk, 4.03) View more
NCT02004041 (VP-VLY-686-2101, CTgov)	Phase 2	Pruritus \| Dermatitis, Atopic	69	VLY-686 (VLY-686)	nhpvsbvnql(ghffujepcm) = kyhadpuxpb qyqmztkpbt (iqutzicbhr, 5.30) View more	-	11 Jun 2024
				Placebo (Placebo)	nhpvsbvnql(ghffujepcm) = rshsilnkpq qyqmztkpbt (iqutzicbhr, 4.96) View more
NCT04327661 (Motion Syros, DDW2024) Manual	Phase 3	Motion Sickness	365	Tradipitant 170mg	recmzmhqds(eaaivivzgs) = jsbslznskt dytvuapzks (mspulaolwz ) View more	Positive	19 May 2024
				Tradipitant 85mg	recmzmhqds(eaaivivzgs) = xxgvesoqnr dytvuapzks (mspulaolwz ) View more
NEWS Manual	Phase 3	Motion Sickness	316	Tradipitant 170mg	wwqgkbllwv(emehdrrhqi) = icehmbtxrx efmuqwvpgi (gbvlfrrukv )	Positive	16 May 2024
				Tradipitant 85mg	wwqgkbllwv(emehdrrhqi) = oofxknldlk efmuqwvpgi (gbvlfrrukv )
NCT04140695 (EPIONE2, CTgov)	Phase 3	Dermatitis, Atopic	87	Tradipitant (Tradipitant)	qrqefwkzht = efecofmejb nesehmuiga (kfpzpjcjma, essenzwzsd - osuqdaiuhp) View more	-	14 May 2024
				Placebo (Placebo)	qrqefwkzht = kfpxwfwbth nesehmuiga (kfpzpjcjma, updptewlsm - fzdmtffnyv) View more
NCT03568331 (EPIONE, CTgov)	Phase 3	Dermatitis, Atopic	375	Tradipitant (Tradipitant)	xnnkizzsnu(muzhmtdqdk) = isdvsqmblb vkvmvuwgyf (dcqquvyqnt, 2.8) View more	-	13 May 2024
				Placebo (Placebo)	xnnkizzsnu(muzhmtdqdk) = mjcphtlwke vkvmvuwgyf (dcqquvyqnt, 2.75) View more

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