This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

Start Date21 Apr 2025

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT06701396

/ RecruitingPhase 3

A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.

Start Date08 Oct 2024

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT05922995

/ Not yet recruitingEarly Phase 1IIT

A Single Center, Open Label Prospective Observational Pilot Study to Evaluate the Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log.
To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validated questionnaires (Insomnia Severity Index [ISI], Pittsburgh Sleep Quality Inventory [PSQI], Epworth Sleepiness Scale [ESS], Clinical Global Impression of Change Scale (CGI-C), Patient Global Impression of Change Scale (PGI-C)) as well as rest/activity pattern from actigraphy.
To assess the effects of 20 mg tasimelteon on patients who have a reduced or aberrant melatonin secretion compared to normal secretion by measuring salivary DLMO at baseline and correlating with the degree of change in RBD symptoms by end of the study.
To assess for any role a patient's unique genome may play in their response to tasimelteon; obtained via whole genome sequencing.
To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.

Start Date30 Sep 2023

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

[+1]

100 Clinical Results associated with Tasimelteon

100 Translational Medicine associated with Tasimelteon

100 Patents (Medical) associated with Tasimelteon

166

Literatures (Medical) associated with Tasimelteon

01 Nov 2024·Science of The Total Environment

Effects of low-molecular-weight organic acids on the transport of polystyrene nanoplastics: An insight at the structure of organic acids

Article

Author: Wei, Xuan ; Chen, Feiyu ; Gong, Yi ; Lu, Taotao ; Chen, Dong

Plastic nanoparticles are extensively used in various products, leading to inevitable pollution in soil. Understanding their transport in soils where various organic substances exist is crucial. This study examined the impact of low-molecular-weight organic acids (LMWOAs) on the transport of polystyrene nanoplastics (PS-NPs) through saturated quartz sand. The experiments involved three dibasic acids-malonic acid (MA₁), malic acid (MA₂) and tartaric acid (TA) - and four monobasic acids- formic acid (FA), acetic acid (AA), propanoic acid (PA) and glycolic acid (GA) -under different pH levels (4.0, 5.5, 7.0) and in the presence of cations (Na⁺, Ca²⁺). The results demonstrated that in the presence of Na⁺, dibasic acids significantly enhanced PS-NPs transport, with TA being the most effective, followed by MA₂ and MA₁. This enhancement is attributed to the adsorption of LMWOAs onto the nanoparticles and sand, creating a more negative ζ-potential, which increases the electrostatic repulsion and decreases the PS-NPs deposition, thereby facilitating the transport. Applying the Derjaguin-Landau-Verwey-Overbeek theory, higher pH levels increased the energy barrier and secondary energy minimum, decreasing PS-NPs deposition. Moreover, dibasic acids significantly enhanced the hydrophilicity of PS-NPs. Conversely, monobasic acids, except for GA, slightly reduced the hydrophilicity of PS-NPs, as indicated by a small increase in the water contact angle, hereby minimally affecting PS-NPs transport. As for GA, although it is a monobasic acid, the additional -OH group in its molecular structure promoted PS-NPs transport, similar to dibasic acids. For example, GA also significantly enhanced the hydrophilicity of PS-NPs. In the presence of Ca²⁺, the enhancement of PS-NPs transport by LMWOAs was comparable to that with Na⁺, primarily due to the complex-forming and bridging effects of Ca²⁺ with the organic acids and PS-NPs. These findings provide important insights into predicting and analyzing the transport behaviors of PS-NPs.

01 Oct 2024·iScience

Few-shot meta-learning applied to whole brain activity maps improves systems neuropharmacology and drug discovery

Article

Author: Cheng, Shuk Han ; Zeng, Shangzhi ; Wang, Xin ; Zhang, Wenchong ; Zhang, Jin ; Liu, Zhen ; Luo, Xuan ; Haggarty, Stephen J ; Li, Honglin ; Haggarty, Stephen J. ; Shi, Peng ; Ding, Yanyun ; Cao, Yi

In this study, we present an approach to neuropharmacological research by integrating few-shot meta-learning algorithms with brain activity mapping (BAMing) to enhance the discovery of central nervous system (CNS) therapeutics. By utilizing patterns from previously validated CNS drugs, our approach facilitates the rapid identification and prediction of potential drug candidates from limited datasets, thereby accelerating the drug discovery process. The application of few-shot meta-learning algorithms allows us to adeptly navigate the challenges of limited sample sizes prevalent in neuropharmacology. The study reveals that our meta-learning-based convolutional neural network (Meta-CNN) models demonstrate enhanced stability and improved prediction accuracy over traditional machine-learning methods. Moreover, our BAM library proves instrumental in classifying CNS drugs and aiding in pharmaceutical repurposing and repositioning. Overall, this research not only demonstrates the effectiveness in overcoming data limitations but also highlights the significant potential of combining BAM with advanced meta-learning techniques in CNS drug discovery.

01 Aug 2024·Journal of Pineal Research

Relationship Between Melatonin Receptor Agonists and Parkinson's Disease

Article

Author: Noguchi, Yoshihiro ; Yoshimura, Tomoaki ; Aizawa, Haruka ; Masuda, Rikuto

AbstractParkinson's disease affects millions of people worldwide, and without significant progress in disease prevention and treatment, its incidence and prevalence could increase by more than 30% by 2030. Researchers have focused on targeting sleep and the circadian system as a novel treatment strategy for Parkinson's disease. This study investigated the association between melatonin receptor agonists and Parkinson's disease, using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS). The target drugs were melatonin receptor agonists including ramelteon, tasimelteon, and agomelatine. Parkinson's disease cases were defined according to the Medical Dictionary for Regulatory Activities (MedDRA) 25.0; Standardized MedDRA Query (SMQ) using both the “narrow” and “broad” preferred terms (PTs) associated with Parkinson's disease. The association between melatonin receptor agonists (ramelteon, tasimelteon, and agomelatine) and Parkinson's disease was evaluated by the reporting odds ratio. Upon analyzing the data from all patients registered in the FAERS, ramelteon (ROR: 0.66, 95% confidence interval [95% CI]: 0.51–0.84) and tasimelteon (ROR: 0.49, 95% CI: 0.38–0.62) showed negative correlations with Parkinson's disease. Conversely, only agomelatine was positively correlated with Parkinson's disease (ROR: 2.63, 95% CI: 2.04–3.40). These results suggest that among the melatonin receptor agonists, ramelteon and tasimelteon are negatively correlated with Parkinson's disease. In contrast, agomelatine was shown to be positively correlated with Parkinson's disease. These results should be used in research to develop drugs for the treatment of Parkinson's disease, fully considering the limitations of the spontaneous reporting system.

News (Medical) associated with Tasimelteon

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

11 Apr 2025

·www.fiercepharma.com

After Hetlioz's rejection in jet lag disorder, Vanda sues FDA for right to promote off-label use

The April 9 complaint, filed in federal district court in Texas on behalf of Vanda, a doctor and a frequent flier, disputes the “chilling effect” of the FDA’s “restrictive regulatory regime.” After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda Pharmaceuticals is pursuing a new route to establish the drug in the space.Hetlioz was approved more than a decade ago for non-24-hour sleep-wake disorder, a circadian rhythm condition, and expanded its label in 2020 to target nighttime sleep disorders associated with the rare neurodevelopmental disorder Smith-Magenis syndrome.In 2019, the FDA issued a complete response letter regarding Vanda’s application to expand Hetlioz's label to include people experiencing sleep issues from jet lag.Following an unsuccessful attempt to dispute the snub, Vanda requested a hearing on the application in 2022; a few months later, when that process had failed to advance, the company sued the FDA over its alleged failure to abide by required timelines.The dispute came to a head in the spring of 2024 with the FDA’s official rejection of both the hearing request and the supplemental application for Hetlioz.An FDA rejection is typically the end of the road for most drugmakers, at least until they resubmit a filing, but Vanda is treating it as more of a speed bump. The pharma this week filed suit against the agency once again, this time protesting the rules around promoting drugs’ off-label uses.Though doctors are legally allowed to prescribe medications for uses other than those listed on their FDA-approved labels, companies are restricted in the information they can share with healthcare providers and patients about unapproved uses.The April 9 complaint, filed in federal district court in Texas on behalf of Vanda, a doctor and a frequent flier, disputes the “chilling effect” of the FDA’s “restrictive regulatory regime” that allegedly violates Vanda’s right under the First Amendment of the U.S. Constitution to communicate information about its product’s uses, approved or otherwise. Drugmakers are largely barred from promoting unapproved uses of their approved drugs, and, as Vanda noted in the filing, the FDA has frequently taken legal action against companies that engage in what it deems “misbranding.” There is, however, some leeway when it comes to sharing scientific information about off-label usage.A recently finalized guidance document (PDF) from the FDA offers recommendations for firms looking to share such information with healthcare providers. Among other stipulations, the information should be “truthful and non-misleading” as well as “scientifically sound,” according to the document. Further, the communications should be accompanied by information about the FDA-approved labeling and a statement “that the unapproved use(s) of the medical product has not been approved by FDA and that the safety and effectiveness of the medical product for the unapproved use(s) has not been established,” the guidance doc explains.Overall, per the FDA, scientific information that companies provide about off-label drug use can’t be seen in any way as encouraging or persuading doctors of the benefits of such usage; it should merely offer them objective information that they can then use to “make their own clinical decisions.”In its lawsuit, Vanda said it maintains a “credible fear” of being prosecuted for sharing clinical efficacy data about Hetlioz’s use in treating jet lag disorder—even if that information is accurate. The company also refuses to “contradict the extensive evidence confirming the safety and efficacy of Hetlioz” with the FDA's suggested disclaimer.“Because FDA’s regulations prevent pharmaceutical manufacturers from sharing their new discoveries with doctors and condition speech on an obligation to mislead doctors about the safety and efficacy of their products, patients ultimately suffer,” the plaintiffs wrote. Vanda said it contacted the FDA in 2022 detailing certain information it wished to share about off-label use of Hetlioz and received only a “vague response” stating that the proposal “raised some concerns” for the FDA, with no further follow-up. The company said this feedback confirmed its fear of prosecution if it were to share the materials.The 63-page complaint details the clinical data that Vanda would like to share, which it says demonstrates Hetlioz’s ability to improve sleep in people with jet lag disorder, plus mockups of various cover sheets for the data. The filing also veers at one point into a re-litigation of Vanda’s application for approval in the indication, calling the FDA’s reasons for rejection “mistaken in multiple ways” and proceeding to dispute several aspects of the decision.Vanda concludes by asking the court to confirm that the statements it wants to make about off-label use of Hetlioz are truthful and non-misleading, and to uphold the First Amendment rights of both the company and the public to make and receive such statements.In response to a request from Fierce Pharma Marketing, a spokesperson for the FDA’s parent agency said the Department of Health and Human Services “does not comment on ongoing litigation.”Editor's note: This story was updated with a response from the HHS.

Patent Infringement

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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug ApprovalNDAPhase 1Phase 3

100 Deals associated with Tasimelteon

External Link

KEGG	Wiki	ATC	Drug Bank
D09388	Tasimelteon	N05CH03	DB09071

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	United States	Vanda Pharmaceuticals, Inc.	01 Dec 2020
Sleep Wake Disorders	United States	Vanda Pharmaceuticals, Inc.	31 Jan 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Jet Lag Syndrome	NDA/BLA	United States	Vanda Pharmaceuticals, Inc.	-
Smith-Magenis Syndrome	NDA/BLA	European Union	Vanda Pharmaceuticals, Inc.	-
Autism Spectrum Disorder	Phase 3	United States	Vanda Pharmaceuticals, Inc.	28 Jul 2021
Sleep Disorders, Circadian Rhythm	Phase 3	Germany	Vanda Pharmaceuticals, Inc.	01 Aug 2010
Sleep Disorders, Circadian Rhythm	Phase 3	United States	Vanda Pharmaceuticals, Inc.	01 Aug 2010
Pervasive child development disorders	Discovery	United States	Vanda Pharmaceuticals, Inc.	16 Sep 2021
Sleep Deprivation	Discovery	United States	Vanda Pharmaceuticals, Inc.	01 Sep 2015
Kidney Failure, Chronic	Discovery	United States	Vanda Pharmaceuticals, Inc.	01 Feb 2012
Renal Insufficiency	Discovery	United States	Vanda Pharmaceuticals, Inc.	01 Feb 2012
Depressive Disorder, Major	Discovery	United States	Vanda Pharmaceuticals, Inc.	01 Sep 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03373201 (JET8 Study, CTgov)	Phase 3	Jet Lag Syndrome	320	Placebo (Placebo)	ltskxozfvi(etjjpulzkq) = mqljogbdld vsfqebaxtd (pbtlfsjbyr, cpadbccuxa - nbejosulmg) View more	-	15 Sep 2023
				Tasimelteon (Tasimelteon)	ltskxozfvi(etjjpulzkq) = wswlrxosjg vsfqebaxtd (pbtlfsjbyr, plikwzsuqf - ezeyqmahpk) View more
NCT03291041 (JET, Pubmed) Manual	Phase 2	Jet Lag Syndrome	25	tasimelteon	rlzykyessa(yjbeiilufz): difference = 131	Positive	15 Sep 2022
				Placebo
NCT03291041 (JET, CTgov)	Phase 2	Jet Lag Syndrome	25	Tasimelteon (Tasimelteon)	xmbojokrep(jeoehfzeub) = qmnfpsnyzd kdcotimeaw (jsdhhvpubz, wrefwhaoob - ahgeoipjpc) View more	-	03 Nov 2021
				Placebo (Placebo)	xmbojokrep(jeoehfzeub) = drlugxfkdt kdcotimeaw (jsdhhvpubz, zdrsdeoszn - xghvxbwpxd) View more
JET8 (WSC2019)	Not Applicable	-	318	Tasimelteon	dgpesphgtr(nztsxplsxz) = bjqpmvjmyz etuxumjvcq (avdklduuvq )	Positive	20 Sep 2019
Magellan study (tasimelteon in MDD study) (WSC2017)	Not Applicable	Depressive Disorder, Major	507	Tasimelteon 20 mg	(mcghtqdkrq) = dolqolyzeq qzvfsqxora (kaultzrrdm ) View more	Positive	07 Oct 2017
				Placebo	(mcghtqdkrq) = fpbeolbpmi qzvfsqxora (kaultzrrdm ) View more
NCT01163032 (SET, Pubmed \| Lancet) Manual	Phase 3	Sleep Disorders, Circadian Rhythm	84	tasimelteon	huterbedla(mezbsrhgty) = xqtctiyufp wsbgfrbqyn (dwhlyfuche ) View more	Positive	31 Oct 2015
				Placebo	huterbedla(mezbsrhgty) = vlmqnfkfjn wsbgfrbqyn (dwhlyfuche ) View more
NCT01428661 (MAGELLAN, CTgov)	Phase 2/3	Depressive Disorder, Major	507	tasimelteon (Tasimelteon)	xwztdachil(rnlhjuszpa) = pwikifwabu cfnclskylr (ogwdlrchdr, vufjdobmxb - fqspyvjpff) View more	-	19 Jun 2015
				placebo (Placebo)	xwztdachil(rnlhjuszpa) = mgmhfilose cfnclskylr (ogwdlrchdr, kpgvkudmgz - svlbrdeszv) View more
NCT01163032 (SET, CTgov)	Phase 3	Sleep Disorders, Circadian Rhythm	136	tasimelteon (Tasimelteon (Randomized))	oibesjwvgh(mlscvlzwdq) = vekkkcmojb gwphiqebea (fvpdtffwyd, uwytglyvtz - fttfvfkxtg) View more	-	16 Oct 2014
				Placebo (Placebo (Randomized))	oibesjwvgh(mlscvlzwdq) = qoisjuzpea gwphiqebea (fvpdtffwyd, zxlluwxzet - bdhaeaqmnj) View more
NCT00291187 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders	411	Placebo	fjcdtozbid(hephxbouxe) = isilohawzr ysfkzkdfxp (wfzpqgfwoy, dihfzyfmfk - qaqmyxglfd) View more	-	15 Oct 2014
NCT01430754 (RESET, CTgov)	Phase 3	Sleep Disorders, Circadian Rhythm	20	tasimelteon (Tasimelteon)	yzhxkriybj(nzdyewcutq) = tmprlzltdn swsuzlqhix (jvqfklzsig, zsypxonkuy - ezkafqxilk) View more	-	10 Oct 2014
				Placebo (Placebo)	yzhxkriybj(nzdyewcutq) = mjaonzsyha swsuzlqhix (jvqfklzsig, tuafddutvc - mzgpwqbayr) View more

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