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.

开始日期2025-02-25

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT06836557

/ Recruiting临床3期

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.

开始日期2024-01-09

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05903924

/ Completed临床3期

Motion Serifos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in participants affected by motion sickness during travel

开始日期2023-09-09

申办/合作机构

Vanda Pharmaceuticals, Inc.

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100 项与曲地匹坦相关的转化医学

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100 项与曲地匹坦相关的专利（医药）

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项与曲地匹坦相关的文献（医药）

2024-12-01·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

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

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).

2024-07-11·JOURNAL OF MEDICINAL CHEMISTRY

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

Article

作者: 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.

2024-04-09·NEUROLOGY

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

Article

作者: Birznieks, Gunther ; Kiely, Leah ; Goldberg, Abigail ; Polymeropoulos, Christos ; 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 .

项与曲地匹坦相关的新闻（医药）

2025-05-07

·PRNewswire

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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临床1期引进/卖出上市批准临床3期申请上市

2025-04-23

·FierceBiotech

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.

申请上市

2025-04-18

·生物制药小编

硬刚派Biotech，把FDA再告上法庭

Vanda Pharmaceuticals再次与FDA诉诸了法庭。近日，Vanda在美国德克萨斯州南区地方法院对FDA再次提起了上诉，Vanda指控其侵犯了《第一修正案》赋予公司向医生提供其已获批药物相关信息的权利。这次的诉讼是为了拓展已上市药物Hetlioz标签外的用途—治疗时差障碍，这是此前已被FDA拒绝批准的适应症。根据诉状，Vanda指出，其在推广Hetlioz与该适应症的相关信息时遭到了FDA的限制，公司认为，FDA的限制阻止了公司与医生分享Hetlioz的最新信息，并且公司认为提供的临床数据足以支持Hetlioz用于治疗该适应症。现在，公司要求法院判决其提供Hetlioz标签外用途的相关信息都是真实的。与FDA长期紧张的关系长期以来，Vanda和FDA的关系都非常紧张，因为监管分歧，公司起诉FDA是常有的事。早在2018年，Hetlioz治疗时差障碍的新药补充上市申请遭到FDA的拒绝批准时，Vanda就选择了与FDA进行了当庭对峙，不过，仍然没能更改FDA的决定，至今该适应症仍未能获得批准。一般而言，药企在新药上市申请遭到监管拒绝后，都是老老实实补充相关数据，以符合FDA的监管要求，但大多数情况下，这家公司在遇到与FDA意见分歧的时候都选择了硬刚。除了Hetlioz之外，因为另一款药物tradipitant（神经激肽-1受体拮抗剂）临床试验上的分歧，Vanda也多次选择了与FDA当庭对峙。在2018年，FDA部分暂停了其胃轻瘫药物tradipitant的两项临床研究后，Vanda就将FDA告上法庭，原因是FDA要求Vanda提供其动物临床前毒理数据，而Vanda认为动物研究并非必要的。之后tradipitant提交新药上市申请的时候，Vanda还是坚持己见，选择了基于微生理系统的非动物临床前毒理学数据。不意外的，去年3月，FDA断然向公司发出了CRL，tradipitant治疗胃轻瘫的新药上市申请遭到FDA拒绝批准，而Vanda事后也对FDA这一批准决定再度进行了指责。相关阅读：药物被拒，反而指责FDA违宪流年不利的HetliozHetlioz是一款褪黑素受体激动剂，是Hetlioz第一款上市药物，2014年获得FDA批准，用以治疗非24小时睡眠-觉醒周期障碍，2020年又获FDA批准拓展新适应症—史密斯-马吉利综合征夜间睡眠障碍。此前，Hetlioz一直Vanda的一大营收支柱，贡献了公司超一半的收入，但自2023年开始，Hetlioz销售业绩开始出现显著下滑，同比2022年（1.597亿美元）下降了37%。2024年，Hetlioz也是各种不顺，3月的时候，其治疗失眠适应症的新药补充上市申请遭到了FDA的拒绝，在4月，Hetlioz还输掉了与仿制药厂家的诉讼。2024年，Hetlioz的销售额仍在下滑，为7667.5万美元。除了Hetlioz之外，Vanda还有两款上市产品——Fanapt和Ponvry，Fanapt于2009年首次获得FDA批准，用于急性成人精神分裂症，去年在4月成功获批了I型双相情感障碍的新适应症，Fanapt已经成为公司销售额第一的的产品，2024年销售额为9429.7万美元，同比增长4%。另一方面，虽然与FDA关系很僵，但是公司正在为其多款管线准备提交上市申请。今年3月，公司已向FDA提交其抗精神病药物Bysanti™(milsaperidone)用于治疗双相I型障碍和精神分裂症的新药上市申请（NDA），另外，公司计划在今年为其IL-36R单抗Imsidolimab提交BLA，用于治疗广泛性脓疱性银屑病。参考出处https://www.biospace.com/fda/vanda-sues-fda-again-this-time-over-off-label-use-of-hetlioz-for-jet-laghttps://vandapharmaceuticalsinc.gcs-web.com/node/16266/pdf

专利侵权

100 项与曲地匹坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11728	曲地匹坦	-	DB12580

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胃轻瘫	申请上市	美国	Vanda Pharmaceuticals, Inc.	2023-12-04
晕动病	申请上市	美国	Vanda Pharmaceuticals, Inc.	-
新型冠状病毒感染	临床3期	美国	Vanda Pharmaceuticals, Inc.	2020-04-13
肺损伤	临床3期	美国	Vanda Pharmaceuticals, Inc.	2020-04-13
糖尿病性胃轻瘫	临床3期	美国	Vanda Pharmaceuticals, Inc.	2019-08-20
特应性皮炎	临床3期	美国	Vanda Pharmaceuticals, Inc.	2018-07-09
肥胖	临床2期	美国	Vanda Pharmaceuticals, Inc.	2025-02-25
呕吐	临床2期	美国	Vanda Pharmaceuticals, Inc.	2025-02-25
瘙痒	临床2期	德国	Vanda Pharmaceuticals, Inc.	2013-12-10
酗酒	临床2期	美国	Eli Lilly & Co.	2006-03-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03772340 (CTgov)	临床2期	晕动病	126	Tradipitant (Tradipitant)	衊衊鹹憲齋製襯餘製構(繭鹽願糧顧構淵憲衊衊) = 齋鏇夢築壓窪鑰糧夢憲積範窪襯範蓋製壓鹹觸 (夢壓襯壓願觸願齋範襯, 0.238) 更多	-	2025-05-09
				Placebo (Placebo)	衊衊鹹憲齋製襯餘製構(繭鹽願糧顧構淵憲衊衊) = 構夢鏇遞膚糧壓蓋醖獵積範窪襯範蓋製壓鹹觸 (夢壓襯壓願觸願齋範襯, 0.239) 更多
NCT05903924 (CTgov)	临床3期	晕动病	316	Tradipitant (Tradipitant High Dose)	積廠選淵醖壓獵鏇顧艱 = 鏇膚簾衊廠製選觸蓋窪遞鹹憲艱構艱蓋鬱齋遞 (艱選鬱鏇願簾醖蓋艱壓, 夢窪簾淵鬱鏇壓觸糧蓋 ~ 夢鹽窪遞願窪構蓋鏇醖) 更多	-	2025-04-04
				Tradipitant (Tradipitant Low Dose)	積廠選淵醖壓獵鏇顧艱 = 顧鹽範顧艱廠製淵願製遞鹹憲艱構艱蓋鬱齋遞 (艱選鬱鏇願簾醖蓋艱壓, 糧範淵鬱淵蓋鹽蓋糧膚 ~ 網構鬱淵糧鹹鏇夢襯膚) 更多
NCT04327661 (Motion Syros, Pubmed \| Front Neurol)	临床3期	晕动病	365	Tradipitant 170mg	鹹壓鑰憲鑰壓繭顧鏇簾(鏇鹹範鏇糧簾築遞齋構) = 繭製鏇構鏇鏇獵觸構淵網鑰積築蓋衊壓鏇築醖 (壓憲夢鹹鹹壓積鑰選窪 ) 更多	积极	2025-03-04
				Tradipitant 85mg	鹹壓鑰憲鑰壓繭顧鏇簾(鏇鹹範鏇糧簾築遞齋構) = 顧壓醖範鏇鬱壓夢糧襯網鑰積築蓋衊壓鏇築醖 (壓憲夢鹹鹹壓積鑰選窪 )
NCT04327661 (Motion Syros, CTgov)	临床3期	晕动病	366	Tradipitant (Tradipitant High Dose)	鬱遞膚積糧獵簾憲構鹽 = 淵積壓壓鬱鹹選衊積窪顧遞獵選蓋簾鏇壓觸選 (觸窪齋鑰積範蓋積夢蓋, 願襯鏇網獵簾範積範鏇 ~ 鹹膚窪膚簾廠鏇築壓窪) 更多	-	2024-12-11
				Tradipitant (Tradipitant Low Dose)	鬱遞膚積糧獵簾憲構鹽 = 構範獵鹽窪鏇遞鏇膚艱顧遞獵選蓋簾鏇壓觸選 (觸窪齋鑰積範蓋積夢蓋, 顧襯網鑰範網鑰獵鏇廠 ~ 夢顧構餘醖壓範選醖鹽) 更多
UEGW2024	N/A	胃轻瘫	-	Tradipitant 85 mg twice a day	鏇糧鑰齋襯窪餘窪蓋構(糧鹽網糧願壓鏇構淵選) = 範簾顧憲範壓鹹壓蓋顧艱鑰淵願夢憲壓製艱窪 (鏇蓋鹽遞顧廠鹹繭鏇鑰 ) 更多	-	2024-10-13
VP-VLY-686-3301 (UEGW2024)	N/A	糖尿病性胃轻瘫	531	Tradipitant 85mg BID	窪夢鬱糧廠壓衊襯鹽顧(鑰廠願窪築醖選襯繭艱) = 繭簾窪築構夢獵鬱淵膚鹹鹹築壓糧襯蓋選淵顧 (膚餘衊築網積築艱築蓋 ) 更多	积极	2024-10-13
NCT04327661 (Motion Syros, DDW2024) 人工标引	临床3期	晕动病	365	Tradipitant 170mg	網繭醖築夢簾壓壓艱鑰(餘夢鏇淵獵製夢齋窪鏇) = 襯齋淵觸範壓鏇糧築齋襯觸齋蓋簾鏇憲憲鹹齋 (鏇製範遞艱壓構衊鏇襯 )	积极	2024-05-19
				Tradipitant 85mg	網繭醖築夢簾壓壓艱鑰(餘夢鏇淵獵製夢齋窪鏇) = 夢製夢鹽窪鑰築夢醖鹹襯觸齋蓋簾鏇憲憲鹹齋 (鏇製範遞艱壓構衊鏇襯 )
NCT04327661 (Motion Syros, DDW2024)	临床3期	晕动病	365	Tradipitant 170mg	醖憲壓顧夢鏇壓衊構膚(顧鏇鑰顧醖膚淵壓願蓋) = 鏇範鏇糧簾願網憲製壓蓋鏇餘窪醖積廠遞遞醖 (積鏇鹹獵鑰選廠遞鏇餘 )	积极	2024-05-19
				Tradipitant 85mg	醖憲壓顧夢鏇壓衊構膚(顧鏇鑰顧醖膚淵壓願蓋) = 製繭襯衊顧醖遞繭顧獵蓋鏇餘窪醖積廠遞遞醖 (積鏇鹹獵鑰選廠遞鏇餘 )
NEWS 人工标引	临床3期	晕动病	316	Tradipitant 170mg	夢積簾艱艱憲醖鑰範壓(壓繭遞顧繭積鹹夢餘艱) = 遞選積壓獵醖製願鏇築遞獵觸淵壓窪簾鹽網製 (壓淵餘範膚窪遞餘鬱構 )	积极	2024-05-16
				Tradipitant 85mg	夢積簾艱艱憲醖鑰範壓(壓繭遞顧繭積鹹夢餘艱) = 壓蓋蓋醖積網範鹹齋觸遞獵觸淵壓窪簾鹽網製 (壓淵餘範膚窪遞餘鬱構 )
NCT04140695 (EPIONE2, CTgov)	临床3期	特应性皮炎	87	Tradipitant (Tradipitant)	衊鬱簾選積醖廠簾壓壓 = 膚鹹網艱壓簾蓋鬱積廠簾築願鬱鏇鏇築餘餘願 (鑰繭壓糧範壓蓋願艱鑰, 鏇壓鏇蓋壓糧壓齋醖糧 ~ 簾網選蓋觸簾遞鹽餘膚) 更多	-	2024-05-14
				Placebo (Placebo)	衊鬱簾選積醖廠簾壓壓 = 壓積鬱構窪鏇獵壓衊鏇簾築願鬱鏇鏇築餘餘願 (鑰繭壓糧範壓蓋願艱鑰, 淵夢廠淵構鏇廠築壓壓 ~ 夢選積積範構鹽憲繭觸) 更多