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.

CTIS2023-503802-35-00

/ RecruitingPhase 3

A MULTICENTER OPEN LABEL 3 MONTH SAFETY STUDY WITH TRADIPITANT IN PATIENTS WITH IDIOPATHIC OR DIABETIC GASTROPARESIS - VP-VLY-686-3304

Start Date09 Jan 2024

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

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: Zdrazil, Barbara ; Waldmann, Herbert ; 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

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

23 Apr 2025

·www.fiercebiotech.com

Vanda sues FDA over hearing delay as agency points to mass layoffs, other litigation with the biopharma

“CDER is still evaluating the impact the RIF may have on CDER’s immediate operations,\" the federal department said in an April 14 letter to Vanda.\n Vanda Pharmaceuticals is suing the FDA again, this time alleging the agency is unlawfully delaying a hearing to discuss the rejection of the biotech\'s stomach disorder drug last year.The FDA has asked the commissioner’s office to set a hearing by mid-September 2025 for Vanda\'s request, which was prompted by a complete response letter (CRL). In a letter to the biotech last week, the agency cited multiple reasons for the delay—including the company’s numerous ongoing legal cases with the agency, plus the recent mass federal layoffs.Vanda has filed a lawsuit against the federal agency for the \"unlawful delay\" that is currently pending in Washington, D.C., courts, a Vanda spokesperson told Fierce. The drug at the heart of the dispute is tradipitant, an investigational NK-1R antagonist that the FDA rejected as a gastroparesis treatment in September 2024. At the time, Vanda CEO Mihael Polymeropoulos, M.D., argued that the CRL generally disregarded the evidence the company had provided to support the application.In a late-stage study (PDF), tradipitant was shown to be no better than placebo at reducing the severity of nausea across 12 weeks of treatment, but Vanda identified a baseline imbalance of rescue medication use between the treatment arms and some poor compliance with the study drug as a potential cause for the miss. When excluding patients that Vanda deemed to be confounders, the company argued that the study had actually hit its primary endpoint.After receiving the rejection, the FDA provided Vanda with a notice for the opportunity for a hearing on Jan. 7, 2025—well past the statutory deadline, according to Vanda\'s spokesperson.Despite the delay, Vanda accepted the FDA’s offer on Jan. 27 and submitted the requested information on March 17, the spokesperson told Fierce.Vanda contends it accepted the hearing offer within the required timeframe, and based on its understanding of FDA procedures, believes the agency is obligated to hold the hearing within 120 days of the notice. According to Vanda, that timeline would mean the hearing should be scheduled on or before May 7, 2025. The FDA confirmed receipt of the submitted information on March 17 in an April 14 letter sent to Vanda from G. Matthew Warren, director of the FDA’s Office of Scientific Integrity. Warren wrote that CDER is working to thoroughly review Vanda’s submission and asked the FDA commissioner to issue a scheduling order in which CDER responds to Vanda’s request no later than Sept. 12.The FDA department cited several reasons for the proposed September deadline, with the first being that Vanda’s request for a summary judgment or hearing includes more than 15,000 pages, some of which are new materials that weren’t included in the company’s new drug application (NDA). The timeline also considers the fact that the staffers in the Office of Immunology and Inflammation (OII) reviewing the submission are the same employees working on Vanda’s pending NDA for tradipitant in a new proposed indication of vomiting induced by motion sickness, which Vanda submitted at the end of 2024.The agency said OII workers are also providing insight related to multiple lawsuits recently filed by Vanda regarding tradipitant. These suits against the FDA include challenging timeframes by which the FDA must act; Vanda has also said that CDER tried to wait six months to respond to actions for the company’s insomnia program. Plus, Vanda is challenging a partial clinical hold related to certain tradipitant trials and contests the authority of FDA officials to review and hold a hearing on the application.Earlier this month, Vanda filed suit against the agency related to its drug Hetlioz, protesting the rules around promoting drugs’ off-label uses.In relation to Vanda, OII staff are also helping with technical review and assistance related to an ongoing tradipitant expanded access trial for gastroparesis, the letter continues.Unrelated to Vanda, the FDA\'s letter outlined CDER’s other tasks, like reviewing applications and work related to other public health issues.Finally, the health agency underscored the widespread layoffs that occurred on April 1, when President Donald Trump’s administration cut 3,500 FDA workers. This impacted CDER offices assigned to lead the review and draft the written response for this matter, according to the federal letter.“Additionally, the RIF impacted leadership of the CDER Office of New Drugs, as well as CDER (including OII) review divisions’ access to relevant subject matter experts, administrative support staff, library staff and academic journal subscriptions,” Warren wrote in the letter. “CDER is still evaluating the impact the RIF may have on CDER’s immediate operations, which may limit the speed at which the center can complete a thorough analysis of Vanda’s submission in the near term.” At the time, HHS said the FDA workforce reduction wouldn’t impact drug, medical device or food reviewers. Since then, hundreds of biotech leaders signed a letter decrying the FDA changes and detailing how it has already affected some companies.In the letter, CDER expressed concerns that an earlier deadline would “strain already limited” resources and “unreasonably constrain” the center’s ability to properly address Vanda’s submission requesting summary judgment or a hearing.“CDER is committed to working diligently to comply with our obligations in this matter, including meeting the deadline to be set forth by the commissioner,” Warren concluded. “However, competing agency priorities and judicial developments relating to various lawsuits Vanda has initiated may arise unexpectedly that are outside the control of either the center or the agency as a whole.”Both the FDA and the agency’s parent organization, the Department of Health and Human Services, did not respond to Fierce Biotech’s request for comment.

NDA

14 Apr 2025

·www.biospace.com

Vanda Sues FDA Again, This Time Over Off-Label Use of Hetlioz for Jet Lag

iStock, photoguns Vanda is criticizing the FDA’s restrictions on information companies can provide regarding off-label use of approved medicines. Despite suffering a series of rebuffs from the FDA, Vanda Pharmaceuticals is continuing to fight for sedative Hetlioz, suing the regulator last week to use the drug off-label for jet lag. In the complaint, filed April 9 with the U.S. District Court for the Southern District of Texas, Vanda slammed the regulator’s “restrictive regulatory regime,” and alleged a violation of the company’s First Amendment right to provide doctors with relevant information about its drugs, as per reporting from Fierce Pharma . Hetlioz is a sedative that was first approved in 2014 for non-24-hour sleep-wake disorder and was later granted a label expansion to cover sleep disorders for the rare disease Smith-Magenis syndrome. At issue is Vanda’s desire to promote Hetlioz in off-label uses. Doctors can legally prescribe approved drugs off label for uses that have yet to be cleared by the FDA, but the agency limits the information that companies can share about unapproved uses. As per a recent guidance document , drug sponsors “should provide and appropriately present all information necessary” to allow healthcare providers to better assess the benefits and risks of the unapproved uses. Companies should also be “truthful and non-misleading,” according to the FDA guidance. Their communications to doctors should emphasize that the product has not yet been approved by the FDA for the use and include details regarding known contraindications and safety risks. Vanda took issue with these restrictions, noting in its press release that they “prevent pharmaceutical manufacturers from sharing their new discoveries with doctors” for fear of being misleading, Fierce reported. The biotech added that while they have a “credible fear” of being sanctioned for sharing Hetlioz data to doctors, it’s the patients who “ultimately suffer” from the FDA’s limitations. Also in the court complaint, Vanda provided detailed clinical information about Hetlioz’s efficacy and safety in patients with jet lag, for which the drug is not approved. Vanda insists that the data support the drug’s use in this indication. The biotech is asking the court to declare its information about off-label Hetlioz use to be truthful. Vanda’s latest lawsuit puts even more pressure on an already-strained relationship with the FDA. In July 2019, the regulator rejected Vanda’s bid for approval of Hetlioz in jetlag, a decision which the biotech appealed. Vanda asked for a hearing on the verdict in July 2022, but after months of not hearing back, the biotech sued the regulator for not being able to stick to its mandated timeline. The FDA last year also rejected Vanda’s application for the NK-1R antagonist tradipitant for gastroparesis, a move that the biotech again contested. In September 2024, Vanda argued that the regulator’s verdict “generally disregarded the evidence provided.” The biotech again blasted the FDA’s timeline—the decision on tradipitant was delayed by more than 185 days, which violates the Federal Drug and Cosmetic Act’s 180-day deadline, Vanda argued. In January, the biotech escalated the matter to then-FDA Commissioner Robert Califf. In a letter, Vanda called attention to the “culture of obfuscation and closemindedness” at the agency, which it faults for the lack of transparency regarding tradipitant’s rejection. A few days after the letter, the FDA finally provided Vanda with a justification for the rejection and gave the company the chance to request a hearing.

Drug ApprovalPatent Infringement

100 Deals associated with Tradipitant

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R&D Status

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
Motion Sickness	NDA/BLA	United States	Vanda Pharmaceuticals, Inc.	-
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
Obesity	Phase 2	United States	Vanda Pharmaceuticals, Inc.	25 Feb 2025
Vomiting	Phase 2	United States	Vanda Pharmaceuticals, Inc.	25 Feb 2025
Pruritus	Phase 2	Germany	Vanda Pharmaceuticals, Inc.	10 Dec 2013
Alcoholism	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


NCT03772340 (CTgov)	Phase 2	Motion Sickness	126	Tradipitant (Tradipitant)	nmxvvepoak(hsjlecwguj) = jlqflwxzhp bwlqbdptjv (ovrzfdgain, 0.238) View more	-	09 May 2025
				Placebo (Placebo)	nmxvvepoak(hsjlecwguj) = mlumsnlcxe bwlqbdptjv (ovrzfdgain, 0.239) View more
NCT05903924 (CTgov)	Phase 3	Motion Sickness	316	Tradipitant (Tradipitant High Dose)	myujfadoex = whhaeqewzq ejokilxbmb (perixwuahk, sotcjbuoyf - fjazirfzvb) View more	-	04 Apr 2025
				Tradipitant (Tradipitant Low Dose)	myujfadoex = egjjxybvuo ejokilxbmb (perixwuahk, rwschtnwvy - aallyoziav) View more
NCT04327661 (Motion Syros, CTgov)	Phase 3	Motion Sickness	366	Tradipitant (Tradipitant High Dose)	fodgjpqovt = fwwvnpilja dviwwewlkw (qubhsoyjpz, vsifprqzcy - utsarbzkuc) View more	-	11 Dec 2024
				Tradipitant (Tradipitant Low Dose)	fodgjpqovt = nguhdjlrxg dviwwewlkw (qubhsoyjpz, fhdywlugye - zjbpwdzair) View more
NCT04327661 (Motion Syros, DDW2024) Manual	Phase 3	Motion Sickness	365	Tradipitant 170mg	veylitsgms(xgasuuxsox) = olioaijtkk whhsbjidrm (tjxxzqqwph )	Positive	19 May 2024
				Tradipitant 85mg	veylitsgms(xgasuuxsox) = bkndzqptfz whhsbjidrm (tjxxzqqwph )
NCT04327661 (Motion Syros, DDW2024)	Phase 3	Motion Sickness	365	Tradipitant 170mg	ugqqvocuyu(syfmpcxwrn) = wsfikurbje gsyesnaswx (qmqtjnsdps )	Positive	19 May 2024
				Tradipitant 85mg	ugqqvocuyu(syfmpcxwrn) = luqiiswbhq gsyesnaswx (qmqtjnsdps )
NEWS Manual	Phase 3	Motion Sickness	316	Tradipitant 170mg	rmxixuzwio(smlfmufekg) = glxbmcayba xqulmuzmec (jarckorsay )	Positive	16 May 2024
				Tradipitant 85mg	rmxixuzwio(smlfmufekg) = wqrecivrci xqulmuzmec (jarckorsay )
NCT04140695 (EPIONE2, CTgov)	Phase 3	Dermatitis, Atopic	87	Tradipitant (Tradipitant)	xctainoqiu = gwhjjpirba yvyvijciif (kthyfeuggw, sizexfqcaq - umwghefaxt) View more	-	14 May 2024
				Placebo (Placebo)	xctainoqiu = vxmtdsoemu yvyvijciif (kthyfeuggw, fbsryvodba - zhkzrdzqso) View more
NCT03568331 (EPIONE, CTgov)	Phase 3	Dermatitis, Atopic	375	Tradipitant (Tradipitant)	vphpbrkuqx(vsanjfsmxq) = jcrrkaujbf ypvxoxrbrk (oyzegzjkqz, 2.8) View more	-	13 May 2024
				Placebo (Placebo)	vphpbrkuqx(vsanjfsmxq) = stnhpleksw ypvxoxrbrk (oyzegzjkqz, 2.75) View more
NCT04849559 (VP-VLY-686-1301, CTgov)	Phase 1/2	-	27	Tradipitant (Tradipitant)	dwpjbngxph(kmxzqhskgj) = evzmtkvtdh fcysbpqvgg (rotebqokmi, vtyksgqndl - dlmkqyhwwr) View more	-	16 Apr 2024
				Placebo (Placebo)	dwpjbngxph(kmxzqhskgj) = kvaihakvje fcysbpqvgg (rotebqokmi, kdqmjqdqzf - xecxrwhcmc) View more
VP-VLY-686-3301 (UEGW 12023 \| UEGW 22023)	Phase 3	delayed gastric emptying \| moderate to severe nausea \| vomiting episode	201	Tradipitant 85 mg twice a day	hadcpflkaj(nwtttogjwf) = nxluibbrym kpswnjmokp (opgrkcodmr ) View more	Positive	15 Oct 2023
				Placebo	hadcpflkaj(nwtttogjwf) = ajtttkmzfo kpswnjmokp (opgrkcodmr ) View more

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