A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Acute Anxiety in Patients With Social Anxiety Disorder

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in adults with social anxiety disorder.

Start Date22 Sep 2025

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT04800237

/ CompletedPhase 2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of VQW-765 in Patients With Performance Anxiety

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in male and female participants with performance anxiety.

Start Date23 Feb 2021

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT01730768

/ CompletedPhase 2

A 12 Week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients

This is a study in chronic stable Schizophrenia with the purpose to answer the question of whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well defined chronic stable patient population treated with antipsychotics as standard of care, and thus to support the future development of AQW051 for the treatment of cognitive impairment associated with Schizophrenia (CIAS).

Start Date01 Sep 2012

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with AQW-051

100 Translational Medicine associated with AQW-051

100 Patents (Medical) associated with AQW-051

Literatures (Medical) associated with AQW-051

01 Dec 2025·BRITISH JOURNAL OF PSYCHIATRY

Efficacy and safety of an alpha 7-nicotinic acetylcholine receptor agonist, VQW-765, in subjects with performance anxiety: randomised, double-blind, placebo-controlled trial: commentary, Baldwin et al

Article

Author: Huneke, Nathan T. M. ; Baldwin, David S.

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.

01 Jul 2025·BRITISH JOURNAL OF PSYCHIATRY

Efficacy and safety of an alpha 7-nicotinic acetylcholine receptor agonist, VQW-765, in subjects with performance anxiety: randomised, double-blind, placebo-controlled trial

Article

Author: Polymeropoulos, Mihael H ; Truslow, Sunny O ; Polymeropoulos, Christos M ; Birznieks, Gunther ; Xiao, Changfu ; Wu, Yukun ; Mohrman, Michael A ; He, Yunsheng

Background:

Despite the high prevalence of social and performance anxiety, current treatments do not meet the full needs of patients. Development of novel anxiolytics with rapid onset of action for on-demand treatment of social and performance anxiety is an active area of clinical research.

Aims:

To examine the anxiolytic effect of VQW-765, an α7-nAChR agonist, in subjects with performance anxiety.

Method:

We conducted a randomised, double-blind, placebo-controlled trial of 230 adults with a history of public speaking anxiety. Participants were randomly assigned to receive a single oral dose of 10 mg VQW-765 (n = 116) or placebo (n = 114), followed by a Trier Social Stress Test (TSST). Anxiety levels were assessed by the Subjective Units of Distress Scale (SUDS). Heart rate was monitored during the TSST. Plasma concentration of VQW-765 was measured after the TSST.

Results:

Subjects receiving VQW-765 showed a trend of improvement in intensity of anxiety, as measured by the SUDS, during the performance phase of a TSST compared with placebo (P = 0.1443). Females showed a larger magnitude and significant response to VQW-765 (P = 0.034). The pharmacokinetic/pharmacodynamic analysis observed an inverted U-shaped exposure–response relationship. Subjects in the middle 50% quantiles of VQW-765 plasma concentration showed significant improvement in the SUDS rating compared with placebo (P = 0.033); however, subgroup analysis revealed this was true only for females (P = 0.005). VQW-765 was safe and well tolerated.

Conclusions:

This is the first study showing anxiolytic effect of an α7-nAChR agonist in humans. VQW-765 is a promising candidate to be developed for on-demand treatment of social anxiety disorder.

01 Jan 2025·ACTA Pharmaceutica Sciencia

In silico evaluation of some 7nachr agonists in apical periodontitis: the role of the cholinergic anti-inflammatory pathway

Author: Erdag, Emine ; Sehirli, Ahmet Ozer ; Kirmizi, Dilan ; Aksoy, Umut

Activation of the α7 nicotinic acetylcholine receptor, an important part of the cholinergic anti-inflammatory pathway, is considered a target macromol. in the treatment of many inflammatory disorders.However, there are no mol. studies on the use of α7 nicotinic receptor agonists in apical periodontitis.In this study, we identified some α7 nicotinic acetylcholine receptor agonists that have been previously investigated for use mainly in diseases affecting the central nervous system.The selected ligands were examined in terms of binding affinity and receptor-ligand interactions on α7 nicotinic acetylcholine receptor using the mol. docking method.AutoDock Vina and GROMACS program packages were used in the mol. docking and simulation process.The results showed that B-973B, ABT-107, and GAT107 were the three most effective ligands in receptor binding affinity, resp.This study explored the potential efficacy of α7 nicotinic acetylcholine receptor agonists in addressing apical periodontitis.

News (Medical) associated with AQW-051

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

07 May 2025

·www.prnewswire.com

Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results

Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024 Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024 Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON, May 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2025. Continue Reading Fanapt® TRx and NBRx "Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline. Fanapt commercial growth has accelerated, reaching multi-year highs, with weekly prescriptions surpassing 2,000 at the end of April as an increasing number of prescribers are adding Fanapt to their therapeutic armamentarium," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Our recent new drug application filings for tradipitant and Bysanti are a testament to our productive research and development pipeline. The addition of imsidolimab alongside Ponvory establishes an anti-inflammatory franchise that we believe has significant growth potential. These accomplishments have been possible because of our talented employees, who for the first time surpassed 400 in number, a 22-year high." Financial Highlights Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $50.0 million in the first quarter of 2025, a 5% increase compared to $47.5 million in the first quarter of 2024. Fanapt® net product sales were $23.5 million in the first quarter of 2025, a 14% increase compared to $20.6 million in the first quarter of 2024. HETLIOZ® net product sales were $20.9 million in the first quarter of 2025, a 4% increase compared to $20.1 million in the first quarter of 2024. PONVORY® net product sales were $5.6 million in the first quarter of 2025, a decrease of 18% compared to $6.8 million in the first quarter of 2024. Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. The net loss in the first quarter of 2025 reflects expenses associated with the payment of $15.0 million related to the exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab and increased commercial activities. Cash, cash equivalents and marketable securities (Cash) was $340.9 million as of March 31, 2025, representing a decrease to Cash of $33.7 million compared to December 31, 2024. The decrease to Cash reflects the payment of $15.0 million during the first quarter of 2025 related to the exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab. Key Operational Highlights – Commercial Fanapt® (iloperidone) Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions (TRx)1 increased by approximately 14% and Fanapt® net product sales increased by 14%. Additionally, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by nearly threefold in the same period. Fanapt® total prescriptions (TRx) for the week of April 25, 2025 reached the milestone of 2,000, making Fanapt® one of the fastest growing atypical antipsychotics.1 Vanda has also announced an expansion of its psychiatry sales force to approximately 300 representatives. HETLIOZ® (tasimelteon) Through the first quarter of 2025, HETLIOZ® continues to retain the largest portion of market share despite generic competition for over two years.2 PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. In April 2025, new patient prescriptions reached a new record high since the initiation of Vanda's commercial launch. Vanda has re-enforced the PONVORY® sales leadership team and announced an expansion of its PONVORY® sales force to approximately 40 representatives. Key Operational Highlights – Regulatory & Clinical Development Key Regulatory Milestones Tradipitant New Drug Application (NDA) for motion sickness accepted for filing by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. Fanapt® Marketing Authorization Application (MAA) for bipolar I disorder and schizophrenia submitted to the European Medicines Agency (EMA) in Q4 2024. HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted to the EMA in Q4 2024. Bysanti™ NDA for bipolar I disorder and schizophrenia accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in 2025. Key Clinical Highlights Fanapt® (iloperidone) Schizophrenia: A Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the treatment of schizophrenia in relapse prevention is ongoing. Hypertension: Vanda initiated a study of the Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension and plans to begin enrolling patients soon. Bysanti™ (milsaperidone) The NDA for Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia was accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Exclusivity for Bysanti™, including pending patent applications, could extend into the 2040s. Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona. The Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is ongoing. Results are expected in 2026. HETLIOZ® (tasimelteon) HETLIOZ® clinical programs in pediatric insomnia and delayed sleep phase disorder (DSPD) are ongoing. Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for SMS is pending with the EMA. PONVORY® (ponesimod) Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Tradipitant The NDA for tradipitant for the treatment of motion sickness was accepted for filing by the FDA with a PDUFA target action date of December 30, 2025. In the fourth quarter of 2024, Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide). Results are expected in the third quarter of 2025. Imsidolimab In February 2025, Vanda announced it entered into an exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab (IL-36R antagonist mAb). A BLA for GPP is expected to be submitted to the FDA in 2025. Early-Stage Program Highlights VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate the Phase III program in 2025. The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025. GAAP Financial Results Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. Diluted net loss per share was $0.50 in the first quarter of 2025 compared to diluted net loss per share of $0.07 in the first quarter of 2024. 2025 Financial Guidance Vanda is reiterating its 2025 total revenues guidance and updating its 2025 financial guidance to include year-end 2025 Cash. Vanda expects to achieve the following financial objectives in 2025: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 7, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2025 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 9941754. A replay of the call will be available on Wednesday, May 7, 2025, beginning at 8:30 PM ET and will be accessible until Wednesday, May 14, 2025 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 9941754. 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 Based on blended data analysis 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 "2025 Financial Guidance" above and statements regarding the growth potential of Vanda's anti-inflammatory franchise; Vanda's plans for pursuit of FDA approval of Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia, tradipitant for the treatment of motion sickness, and imsidolimab for the treatment of GPP, and the related timelines; Vanda's plans for pursuit of EMA approval of Fanapt® for the treatment of bipolar I disorder and schizophrenia and HETLIOZ® and HETLIOZ LQ® for the treatment of SMS; Vanda's clinical development plans and expected timelines for Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension, Bysanti™ for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the expected timing of the results of the tradipitant clinical trial for the prevention of vomiting induced by Wegovy; and the potential to extend patent exclusivity for Bysanti™ into the 2040s 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 obtain regulatory approval and execute a successful commercial launch of imsidolimab, and increase PONVORY® revenue; the FDA's ability to complete its reviews of, and reach decisions with respect to, the NDAs for Bysanti™ and tradipitant by their respective PDUFA target action dates; Vanda's ability to complete and submit the BLA for imsidolimab in 2025; Vanda's ability to obtain EMA approval of the MAAs for Fanapt® and HETLIOZ® and HETLIOZ LQ®, Vanda's ability to begin enrolling patients in the Fanapt® LAI study within the specified timeframe; Vanda's ability to complete the Phase III clinical study for Bysanti™ for MDD and receive results in 2026; Vanda's ability to complete the clinical trial of tradipitant for the prevention of vomiting induced by Wegovy and receive results in the third quarter of 2025; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; and Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s. 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. 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Phase 1License out/inDrug ApprovalPhase 3NDA

13 Feb 2025

·www.prnewswire.com

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results

Q4 2024 total revenues of $53.2 million, +17% compared to Q4 2023 Q4 2024 Fanapt® net product sales of $26.6 million, +18% compared to Q4 2023 Full year 2024 total revenues of $198.8 million, +3% compared to full year 2023 Full year 2025 revenue expected to grow to $210 to $250 million Psychiatry portfolio revenue expected to grow to greater than $750 million in 2030 Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024 BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025 HETLIOZ® MAA for Smith-Magenis syndrome submitted in Q4 2024 Tradipitant NDA for motion sickness submitted in Q4 2024 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON, Feb. 13, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2024. "Strong revenue growth for Fanapt is putting us on a significant growth trajectory for 2025 and beyond, supported also by the commercial performance of Hetlioz and Ponvory. The Fanapt long acting injectable program, the NDA for Bysanti for bipolar disorder and schizophrenia along with its development for major depressive disorder have the potential to drive future growth in our psychiatry portfolio for many years to come," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Tradipitant's NDA for motion sickness was filed with a potential approval this year, while we are pursuing approval in gastroparesis and the development of tradipitant to improve tolerability of GLP-1 analog Wegovy. Our anti-inflammatory portfolio, anchored by Ponvory, was strengthened with the addition of imsidolimab from Anaptys, an IL-36 receptor inhibitor for the treatment of generalized pustular psoriasis. We plan to file a BLA later this year while we are exploring registration in Europe and Japan as well as the development of this novel drug for other inflammatory disorders with an unopposed action of the IL-36 system. In 2024 we returned to revenue growth driven by the commercial launches in bipolar disorder and multiple sclerosis and advanced our development pipeline with a number of products at or near marketing applications. All this was achieved by the hard work, ingenuity and efficiency of our organization and its wonderful people." Financial Highlights Fourth Quarter of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $53.2 million in the fourth quarter of 2024, a 17% increase compared to $45.3 million in the fourth quarter of 2023 and a 12% increase compared to $47.7 million in the third quarter of 2024. Fanapt® net product sales were $26.6 million in the fourth quarter of 2024, an 18% increase compared to $22.6 million in the fourth quarter of 2023 and an 11% increase compared to $23.9 million in the third quarter of 2024. HETLIOZ® net product sales were $20.0 million in the fourth quarter of 2024, a 5% decrease compared to $21.1 million in the fourth quarter of 2023 and a 12% increase compared to $17.9 million in the third quarter of 2024. PONVORY® net product sales were $6.5 million in the fourth quarter of 2024, an increase of 11% compared to $5.9 million in the third quarter of 2024. The acquisition of PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company, was completed on December 7, 2023. Net loss was $4.9 million in the fourth quarter of 2024 compared to net loss of $2.4 million in the fourth quarter of 2023 and net loss of $5.3 million in the third quarter of 2024. Cash, cash equivalents and marketable securities (Cash) was $374.6 million as of December 31, 2024, representing a decrease to Cash of $1.6 million compared to September 30, 2024. Full Year 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $198.8 million for the full year 2024, a 3% increase compared to $192.6 million for the full year 2023. Fanapt® net product sales were $94.3 million for the full year 2024, a 4% increase compared to $90.9 million for the full year 2023. HETLIOZ® net product sales were $76.7 million for the full year 2024, a 23% decrease compared to $100.2 million for the full year 2023. The decrease relative to the full year 2023 was the result of continued generic competition in the U.S. PONVORY® net product sales were $27.8 million for the full year 2024. The acquisition of PONVORY® from Janssen was completed on December 7, 2023. Net loss was $18.9 million for the full year 2024, compared to net income of $2.5 million for the full year 2023. Cash was $374.6 million as of December 31, 2024, representing a decrease to Cash of $13.6 million compared to December 31, 2023. Key Operational Highlights Fanapt® (iloperidone) Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the fourth quarter of 2024, as compared to the fourth quarter of 2023, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by over 160% and Fanapt® net product sales increased by 18%. Vanda initiated a Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the fourth quarter of 2024. Vanda plans to initiate a study of the Fanapt® LAI as a once-a-month injectable for the treatment of hypertension to address both treatment resistance and treatment compliance. Vanda submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the fourth quarter of 2024 for Fanapt® for bipolar I disorder and schizophrenia. Bysanti™ (milsaperidone) Vanda expects to submit a New Drug Application (NDA) for Bysanti™ to the U.S. Food and Drug Administration (FDA) for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025. Exclusivity, including pending patent applications, could extend into the 2040s. Vanda initiated a Phase III clinical study for Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD) in the fourth quarter of 2024. Results are expected in 2026. HETLIOZ® (tasimelteon) Vanda has initiated clinical programs for HETLIOZ® in pediatric insomnia and delayed sleep phase disorder (DSPD) and these programs are ongoing. Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome (SMS) is pending with the EMA. PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Tradipitant The NDA for tradipitant for the treatment of motion sickness was submitted to the FDA in the fourth quarter of 2024. Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide), in the fourth quarter of 2024. Vanda has accepted the opportunity for a hearing with the FDA on the approvability of the NDA for tradipitant for the treatment of symptoms of gastroparesis. Imsidolimab In February 2025, Vanda announced it entered into an exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab (IL-36R antagonist mAb). Vanda expects to initiate and complete the technology transfer activities in 2025 and immediately begin preparing the Biologics License Application (BLA) and MAA for generalized pustular psoriasis (GPP) for the US and EU. The imsidolimab BLA for GPP is expected to be submitted to the FDA in 2025. Early-Stage Program Highlights VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate a Phase III program in 2025. The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025. In December 2024, Vanda announced that the FDA has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2,000 Americans. Key Regulatory Milestones Tradipitant NDA for motion sickness submitted in Q4 2024. Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024. HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted in Q4 2024. Bysanti™ NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025. Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025. GAAP Financial Results Net loss was $4.9 million in the fourth quarter of 2024 compared to net loss of $2.4 million in the fourth quarter of 2023. Diluted net loss per share was $0.08 in the fourth quarter of 2024 compared to diluted net loss per share of $0.04 in the fourth quarter of 2023. Net loss was $18.9 million for the full year 2024 compared to net income of $2.5 million for the full year 2023. Diluted net loss per share was $0.33 for the full year 2024 compared to diluted net income per share of $0.04 for the full year 2023. 2025 Financial Guidance and 2030 Revenue Targets Vanda expects to achieve the following financial objectives in 2025: Vanda is providing 2030 revenue targets. For the psychiatry portfolio alone, Vanda is targeting annual revenue in excess of $750 million in 2030, assuming the potential approval of Bysanti™ for the treatments of acute bipolar I disorder and schizophrenia in early 2026, the potential approval of Bysanti™ for the treatment of MDD, and the potential approval of Fanapt® LAI. Vanda is also targeting total annual revenue in excess of $1 billion in 2030. Conference Call Vanda has scheduled a conference call for today, Thursday, February 13, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 2024 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 2881765. A replay of the call will be available on Thursday, February 13, 2025, beginning at 8:30 PM ET and will be accessible until Thursday, February 20, 2025 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 2881765. 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 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 "2025 Financial Guidance and 2030 Revenue Targets" above and the related implied growth of Vanda's business, and statements regarding Vanda's plans for pursuit of FDA approval of BysantiTM for the treatments of acute bipolar I disorder and schizophrenia and imsidolimab for the treatment of GPP, and the related timelines; Vanda's expectations with respect to the growth opportunities for its psychiatry frachise; Vanda's consideration of foreign regulatory approval for imsidolimab and its potential development for other inflammatory disorders; Vanda's clinical development plans and expected timelines for Fanapt® LAI, BysantiTM for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the commercial and therapeutic potential for BysantiTM; the potential to extend patent exclusivity for BysantiTM into the 2040s; the anticipated timing of the initiation and completion of technology transfer activities and the preparation of regulatory filings in the US and EU for imsidolimab; and the prevalence of PV 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 psychiatry portfolio and overall business; the results of Vanda's review of foreign regulatory opportunities for imsidolmab; Vanda's ability to identify additional indications for imsidolimab; Vanda's ability to complete and submit to the FDA the NDA for BysantiTM for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025; Vanda's ability to complete and submit the BLA for imsidolimab for the treatment of GPP in 2025; Vanda's ability to complete the Phase III clinical study for BysantiTM for MDD and receive results in 2026; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; Vanda's ability to complete the clinical development of, obtain regulatory approval for, and successfully commercialize, BysantiTM for the treatments of acute bipolar I disorder, schizophrenia and MDD; Vanda's ability to satisfy the conditions necessary to extend BysantiTM's patent exclusivity into the 2040s; Vanda's ability to initiate and complete the technology transfer activities and prepare the BLA and MAA for imsidolimab in the specified timeframes; and the accuracy of the estimate regarding the prevalence of PV. 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. 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License out/inDrug ApprovalNDAPhase 1Phase 3

100 Deals associated with AQW-051

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Performance Anxiety	Phase 2	United States	Vanda Pharmaceuticals, Inc.	23 Feb 2021
Dyskinesia, Drug-Induced	Phase 2	United States	Novartis Pharmaceuticals Corp.	15 Sep 2011
Dyskinesia, Drug-Induced	Phase 2	France	Novartis Pharmaceuticals Corp.	15 Sep 2011
Dyskinesia, Drug-Induced	Phase 2	Germany	Novartis Pharmaceuticals Corp.	15 Sep 2011
Dyskinesia, Drug-Induced	Phase 2	Italy	Novartis Pharmaceuticals Corp.	15 Sep 2011
Parkinson Disease	Phase 2	United States	Novartis Pharmaceuticals Corp.	15 Sep 2011
Parkinson Disease	Phase 2	France	Novartis Pharmaceuticals Corp.	15 Sep 2011
Parkinson Disease	Phase 2	Germany	Novartis Pharmaceuticals Corp.	15 Sep 2011
Parkinson Disease	Phase 2	Italy	Novartis Pharmaceuticals Corp.	15 Sep 2011
Chronic schizophrenia	Phase 2	United States	Novartis Pharmaceuticals Corp.	01 May 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04800237 (Corporate Publications) Manual	Phase 2	Performance Anxiety	230	AQW-051	ghzzzjqjpz(kfzenjbght) = Participants who received VQW-765 showed numerically lower stress levels compared to those who received placebo. phcjbqxbtk (mctgrcsfjh )	Positive	02 Dec 2022
				Placebo
NCT00825539 (Pubmed \| Prog Neuropsychopharmacol \| Prog Neuropsychopharmacol) Manual	Phase 2	Schizophrenia	60	AQW051 100mg (then placebo)	ivqxyjyzbj(ekduahfwvc) = mqtohsgkyf owsgqyccsa (zisnnzgfmg )	Negative	03 Nov 2016
				Placebo (then AQW051)	-

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