5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), 5-HT1B receptor agonists(Serotonin 1b (5-HT1b) receptor agonists), 5-HT1D receptor antagonists(Serotonin 1d (5-HT1d) receptor antagonists)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic DiseaseOther Diseases

Active Indication

Depressive DisorderDepressive Disorder, MajorFrontotemporal Dementia

Inactive Indication

Anxiety DisordersAttention Deficit Disorder With HyperactivityBinge-Eating Disorder+ [7]

Originator Organization

H. Lundbeck A/S

Active Organization

H. Lundbeck A/S

Lundbeck LLC

Sun Pharmaceutical Industries Ltd.

+ [4]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (30 Sep 2013),

Depressive Disorder, Major

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC18H23BrN2S

InChIKeyVNGRUFUIHGGOOM-UHFFFAOYSA-N

CAS Registry960203-27-4

194

Clinical Trials associated with Vortioxetine Hydrobromide

CTRI/2024/09/073258

/ Not yet recruitingNot Applicable

To assess the safety, effectiveness and utility of vortioxetine as initial line therapy in the Management of depression through an observational, multicenter Study - IMPRESS

Start Date02 Jul 2025

Sponsor / Collaborator

Torrent Pharmaceuticals Ltd.

NCT06604520

/ RecruitingPhase 2IIT

Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia

The goal of this clinical trial is to learn if vortioxetine improves mood symptoms and cognition in patients with early-stage behavioral variant Frontotemporal Dementia (bvFTD). The main questions this study aims to answer are:
1. Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD?
2. Do mood symptoms and cognition improve following treatment with vortioxetine?
Researchers will also determine whether there are changes in the brain associated with vortioxetine treatment.
Participants will:
* Undergo a screening visit that involves clinical assessments and laboratory tests
* Undergo an initial brain magnetic resonance imaging (MRI) and fluorodeoxyglucose (18F) Positron Emission Tomography (FDG PET) scan before starting treatment with vortioxetine
* Undergo memory and problem-solving tests before starting treatment with vortioxetine
* Undergo approximately 12 weeks of treatment with vortioxetine, during which time there will be regular contact and assessments with the study psychiatrist
* Undergo a repeat PET scan and repeat memory and problem-solving tests after 12 weeks of treatment with vortioxetine

Start Date20 Mar 2025

Sponsor / Collaborator

The Johns Hopkins University

[+2]

NCT06805266

/ Not yet recruitingPhase 4IIT

An Open Study to Evaluate the Efficacy of Vortioxetine on Freezing of Gait in Patients Affected by Parkinson Disease with Depressive Symptoms

The present study involves patients with Parkinson Disease (PD) suffering from freezing of gait (FOG) and depressive symptoms. The main aim of the study is evaluating the efficacy of vortioxetine in reducing moderate/severe FOG not responsive to dopaminergic treatment in patients with PD with depressive symptoms.

Start Date01 Feb 2025

Sponsor / Collaborator

University of Salerno

100 Clinical Results associated with Vortioxetine Hydrobromide

100 Translational Medicine associated with Vortioxetine Hydrobromide

100 Patents (Medical) associated with Vortioxetine Hydrobromide

1,068

Literatures (Medical) associated with Vortioxetine Hydrobromide

01 Jun 2025·NEUROPHARMACOLOGY

Vortioxetine attenuates rotenone-induced enteric neuroinflammation via modulation of the TLR2/S100B/RAGE signaling pathway in a rat model of Parkinson's disease

Article

Author: Özbey, Gül ; Yıldırım, Sendegül ; Maytalman, Erkan ; Samur, Dilara Nemutlu ; Tanrıöver, Gamze ; Kalay, Merzuka

Emerging evidence suggests that gastrointestinal dysfunction and enteric nervous system pathology play a critical role in the early stages of Parkinson's disease. Considering the bidirectional relationship between gastrointestinal symptoms and mood disorders, this study aimed to elucidate the effects and possible mechanisms of action of vortioxetine, a serotonergic antidepressant, on the pathophysiological changes induced by rotenone in the enteroglial cells. α-synuclein, phosphorylated α-synuclein, TLR2, S100B and RAGE expression were detected in duodenal tissues of rats administered rotenone (2 mg/kg/day, s.c.) and/or vortioxetine (10 mg/kg/day, s.c.) for 28 days. For the mechanism of action studies, rat-derived enteroglial cells were treated with rotenone (10 μM) and/or vortioxetine (5 μM or 1 μM) for 24 h. The effects of vortioxetine were evaluated in the presence of the TLR2 antagonist C29, RAGE antagonist FPS-ZM1 and the S100B inhibitor pentamidine. TLR2, S100B, RAGE, and NFκB mRNA levels and proinflammatory cytokines via RT-qPCR and ELISA. Our results demonstrate that rotenone treatment significantly increased α-synuclein, pS129-α-synuclein, TLR2, and S100B expression while reducing RAGE levels, indicating marked enteric pathology. Vortioxetine administration attenuated these effects, reducing α-synuclein accumulation and proinflammatory markers. In vitro, rotenone impaired glial responses, decreasing S100B, RAGE, and NFκB markers, while vortioxetine improved these responses, promoting resynthesis of inflammatory molecules. Notably, S100B, NFκB, and cytokine levels (TNF-α, IL-1β, IL-6) were affected by C29, FPS-ZM1, and pentamidine pretreatments. Thus, vortioxetine is thought to have beneficial effects on rotenone-induced pathological changes in EGCs, and some of these effects are thought to be mediated by the TLR2/S100B/RAGE pathway.

01 Jun 2025·Current Neuropharmacology

Vortioxetine versus SSRI/SNRI with Pregabalin Augmentation in Treatment-Resistant Burning Mouth Syndrome: A Prospective Clinical Trial

Article

Author: Albert, Umberto ; Ottaviani, Giulia ; Canfora, Federica ; Aria, Massimo ; Pellegrini, Luca ; Leuci, Stefania ; D’Aniello, Luca ; Adamo, Daniela ; Mignogna, Michele Davide ; Coppola, Noemi ; Rupel, Katia ; Pecoraro, Giuseppe ; Marenzi, Gaetano

Objectives::

The treatment of Burning Mouth Syndrome (BMS) represents a challenge in tailoring appropriate medication for individual patients. The augmentation of pregabalin to conventional treatment has shown promising outcomes in relieving pain and improving the quality of life in chronic pain conditions. This study aimed to compare the efficacy of vortioxetine with other antidepressants (SSRIs/SNRIs) in combination with pregabalin in a cohort of unresponsive BMS patients and to predict treatment response by using clinical data.

Methods::

A 52-week randomized, open-label, comparative clinical study was conducted, enrolling 203 BMS patients previously treated with one antidepressant for 12 weeks and non-responders to the treatment (clinical trial registration: NCT06025474). The study sample included two groups: Group A (136) received vortioxetine, while Group B (67) received SSRIs/SNRIs. Pregabalin (75 mg/day) was added to both groups, with a potential dosage increase to 150 mg/day for inadequate responders after 12 weeks. Treatment response was assessed with VAS and SF-MPQ, HAM-A, and HAM-D scores at 12, 24, 36, and 52 weeks. Stepwise logistic regression analysis was used to predict treatment response.

Results::

A total of 84 (61.8%) BMS patients in Group A and 39 (58.2%) in Group B showed treatment response. Group A reported a faster onset of action compared to Group B (44.8% versus 22.4% at time 1; p:0.002**) and lower adverse event rates (8.8% versus 20.8%; p:0.001).

Conclusion::

The addition of pregabalin to vortioxetine may be considered a potential treatment option for BMS. Further research is required to corroborate these findings and optimize personalized treatment approaches for BMS patients.

01 Mar 2025·AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY

A Systematic Review of Antidepressants and Psychotherapy Commonly Used in the Treatment of Late Life Depression for Their Effects on Cognition

Review

Author: Gandelman, Jason A ; Gandelman, Jason A. ; Gandelman, Jason ; Nelson, J Craig ; Mackin, R Scott ; Nelson, J. Craig ; Mackin, R. Scott

Cognitive dysfunction is common in late life depression (LLD) and is a major risk factor for dementia. Recent studies show limited improvement in cognition with commonly employed treatments for LLD, contradicting the notion that cognition "returns to normal" with treatment. However, findings differ with the treatments used. The aim of this study is to perform a systematic review of studies of antidepressants and psychotherapies commonly employed in LLD to determine their effects on cognition, particularly processing speed, memory, and executive function. We searched for trials of acute phase treatment, in nondemented individuals 60 years and older with unipolar nonpsychotic Major Depressive Disorder, that assessed cognitive performance with neuropsychological tests before and after treatment. We compared the magnitude of change in cognition by examining within group effect sizes. Six antidepressant trials and two psychotherapy trials (both using Problem Solving Therapy)(PST) provided relatively comparable data that allowed for quantitative comparison. Nine other antidepressant trials provided descriptive findings. Sertraline and vortioxetine had significant positive effects on processing speed and memory. Duloxetine had significant effects on memory. The most selective SRIs-citalopram and escitalopram-had minimal effects on cognition and citalopram had adverse effects in depression nonresponders. PST had modest effects on processing speed and no effect on memory. Effects of practice and improvement in depression on cognition are examined. In all but one study, cognition was a secondary outcome and various quality indicators (e.g. blinding cognitive assessment to treatment) were often not reported. As a consequence, these findings must be considered preliminary.

News (Medical) associated with Vortioxetine Hydrobromide

24 Jan 2025

·www.globenewswire.com

Firefly Neuroscience Announces Publications Demonstrating the Utility of Advanced EEG Analytics in Drug Development and Neuropsychiatric Care

Growing body of clinical evidence supports use of Company’s FDA-Cleared BNA™ platform to provide objective measures of drug efficacy and cognitive change, driving innovation in brain health Company highlights its potentially transformative role in Neuropharmacology and Psychiatry with two groundbreaking publications KENMORE, N.Y., Jan. 24, 2025 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, is pleased to highlight two impactful studies that demonstrate the utility of advanced Resting Electroencephalograms (EEG) and Cognitive EEG (ERP) data analytics in drug development and neuropsychiatric care. As illustrated by the two studies, Firefly’s BNA™ system can uniquely provide objective measures of treatment efficacy and cognitive change: Study 1: Advancing Neuropharmacology with Novartis’ MIJ821 The first paper, entitled "MIJ821 (onfasprodil) in healthy volunteers: First-in-human, randomized, placebo-controlled study (single ascending dose and repeated intravenous dose)," conducted by Novartis, explores the safety, pharmacokinetics, and pharmacodynamics of MIJ821. EEG was essential in assessing the drug’s ketamine-like antidepressant effects on the brain. Key findings include: Dose-Dependent EEG Changes: Administration of MIJ821 showed clear trends linking post-dose resting EEG activity to dosage, supporting its role as a distal target engagement biomarker.Validation of EEG as a PK–PD Tool: EEG revealed changes consistent with ketamine’s known effects, including increased gamma power and decreased alpha power, potentially reflecting enhanced cognitive processing and sensory integration.Clinical Potential: These insights pave the way for EEG-driven biomarker development, improving drug dose selection and patient-specific treatment strategies. Study 2: Objective Cognitive Assessments in Major Depressive Disorder (MDD) Treatment The second paper, entitled "Evaluating an EEG-based tool for assessing acute clinical and cognitive changes in adult outpatients with MDD treated with open-label, flexible-dose vortioxetine: A pilot study," highlights the application of EEG in monitoring cognitive changes during treatment for MDD. Key findings include: BNA™ Metrics as Cognitive Biomarkers: Baseline brain activation latencies, as measured through Firefly’s BNA™ technology, were longer in MDD patients compared to controls, but normalized post-treatment, reflecting improved cognitive functioning independent of antidepressant effects.Personalized Psychiatry: Firefly’s BNA™ pipeline for automatic EEG analysis offers a scalable solution for evaluating treatment efficacy, addressing both cognitive and emotional health in MDD patients. “We are proud to be at the forefront of EEG innovation, and these studies exemplify how our proprietary technology can transform complex brain data into actionable insights for clinicians and researchers alike,” said Greg Lipschitz, Executive Chairman of Firefly. About FireflyFirefly (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use. Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly’s extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician’s ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient’s outcome. Please visit https://fireflyneuro.com/ for more information. Forward-Looking StatementsCertain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws concerning Firefly. These forward-looking statements include express or implied statements relating to Firefly’s management teams’ expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to development and commercialization of BNA™ technology; risks related to Firefly’s ability to recognize the anticipated benefits of the merger (the “Merger”) with WaveDancer, Inc. (“WaveDancer”); risks related to Firefly’s ability to correctly estimate its operating expenses and unanticipated spending and costs that could reduce Firefly’s cash resources; the ability of Firefly to protect its intellectual property rights; competitive responses to the Merger; unexpected costs, charges or expenses resulting from the Merger; potential adverse reactions or changes to business relationships resulting from the completion of the Merger; legislative, regulatory, political and economic developments; and those factors described under the heading “Risk Factors” in the registration statement on Form S-4 filed by WaveDancer with the Securities and Exchange Commission on January 22, 2024, as amended, and declared effective on February 6, 2024. Should one or more of these risks or uncertainties materialize, or should any of Firefly’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Investor & Media ContactStephen Kilmer(646) 274-3580stephen.kilmer@fireflyneuro.com

04 Sep 2024

·www.businesswire.com

Alto Neuroscience Announces Peer-Reviewed Publication in the Journal of Clinical Psychiatry Demonstrating Baseline Cognitive Performance is Not a Moderator of Response to Standard-of-Care Antidepressants

MOUNTAIN VIEW, Calif.--( BUSINESS WIRE )--Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced a peer-review publication demonstrating baseline cognitive performance is not a moderator of response to standard-of-care antidepressants in patients with major depressive disorder (MDD). The analysis, titled “Baseline Cognition Is Not Associated With Depression Outcomes in Vortioxetine for Major Depressive Disorder: Findings From Placebo-Controlled Trials,” was published online in The Journal of Clinical Psychiatry . Prior studies have shown that patients with depression, who are characterized by poor cognition, are generally more chronic, disabled, resistant to treatment and experience greater functional impairment. The current analysis suggests that, despite its reported benefits for aspects of cognition, the monoamine-based agent vortioxetine does not show greater benefit on depressive symptoms in MDD patients with cognitive impairment. “These findings highlight the lack of effective treatment options for patients with MDD who experience cognitive impairment, comprising up to 50% of the overall MDD population,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “As there remains a high unmet need to develop effective treatment options, we are encouraged by the therapeutic potential of our lead program, ALTO-100, a first-in-class, oral small molecule, currently in development for this subgroup of MDD patients. Designed to enhance neural plasticity, ALTO-100’s differentiated mechanism is supported by a growing body of literature that suggests inhibition of hippocampal neurogenesis and a deficit in neuroplasticity leads to both impaired cognition and negative emotional biases in MDD. We are looking forward to reporting topline data from our Phase 2b MDD study in October 2024. We believe ALTO-100 could offer this underserved patient population a differentiated treatment option.” In the publication, which was a reanalysis of individual-level data from 1,812 participants with MDD across four placebo-controlled trials, baseline cognition was measured by the Digit Symbol Substitution Test (DSST), the primary measure used to demonstrate vortioxetine’s procognitive effects in clinical studies. The DSST assesses processing speed and attention, as well as executive function, associative learning and working memory. Baseline DSST did not predict placebo-adjusted treatment effects of vortioxetine on depressive symptoms (pooled Cohen d = −0.02, 95% CI = −0.12 to 0.07). Analyses of additional cognitive measures similarly did not predict placebo-adjusted treatment effects on depression, including memory. Finally, analyses of trials with selective serotonin reuptake inhibitors (SSRIs)/serotonin and norepinephrine reuptake inhibitors (SNRIs) as active comparators also revealed no prediction of SSRI/SNRI adjusted treatment effects of vortioxetine on depression (i.e. a comparison between vortioxetine and other standard-of-care treatments). About ALTO-100 ALTO-100 is a novel oral small molecule that has shown evidence of a pro-neurogenesis/neuroplasticity mechanism of action and first-in-class therapeutic potential. ALTO-100 is being developed for major depressive disorder (MDD). In a Phase 2a clinical trial, ALTO-100 demonstrated favorable safety and tolerability, and significantly greater treatment response in patients with an objectively defined cognitive biomarker. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in depression, PTSD, schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X . Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “could,” “expects,” “look forward,” “plans,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations with regard to the potential benefits, activity, effectiveness and safety of its product candidates and its ability to bring its product candidates to patients, Alto’s expectations for the timing and results of Alto’s Phase 2b study of ALTO-100, and other statements that are not historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of Alto’s product candidates; availability and timing of results from clinical trials; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that clinical trials may have unsatisfactory outcomes; and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled “Risk Factors” in Alto’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto’s Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.

Phase 2Clinical Result

02 Aug 2024

·www.fiercepharma.com

Fierce Pharma Asia—Merck's surprise hiccup in China; Leqembi's slow ramp; Lawmakers' new biosecurity target

Merck's surprise Gardasil decline in China, Leqembi's regulatory setback in Europe, and several U.S. lawmakers' plan to target certain Chinese clinical trial sites made our news this week. Merck is trying to determine the reasons behind the surprise decline of Gardasil in China. Eisai and Biogen's Leqembi was rejected by European authorities amid a continued slow sales ramp. Lawmakers behind the BIOSECURE Act are trying to block drugmakers from working with certain Chinese clinical trial sites. And more.1. Merck mystified by sudden 'step down' in Gardasil sales in ChinaMerck’s Gardasil suddenly slowed down in China. The HPV vaccine franchise has been a big growth driver for Merck’s overall business, having recently helped the company surpass AstraZeneca to become the biggest global pharma in China by sales. And the company’s 9% stock price declined after the news spoke to the vaccine’s importance. Merck is working with its local partner Zhifei Biological Products to understand the situation, and it already has a few theories.2. Eisai, Biogen's Alzheimer's med Leqembi turned down in Europe—but analyst says it's merely a 'delay'Biogen retains biosimilars as Eisai-partnered Leqembi plows ahead amid business pivotEisai, Biogen show Leqembi provides added benefits over time as Alzheimer's showdown with Lilly heats upEisai and Biogen’s Leqembi continued its slow ramp, with second-quarter sales reaching $40 million, including $30 million from the U.S. The drug’s expansion efforts hit a snag as regulators at the European Medicines Agency declined to recommend the anti-amyloid drug, citing a “small” benefit and ARIA as a safety concern. Meanwhile, an extended study showed Leqembi’s benefit in cutting average cognitive declines appeared to widen to 31% over three years, compared with 27% in the original 18-month study.3. Congress targeting trials at Chinese military hospitals and in Xinjiang Uyghur Autonomous Region (Biocentury)The House Select Committee on the Chinese Communist Party, the driving force behind the draft BIOSECURE Act, has set its eyes on the next target in its crackdown against China. Lawmakers are looking for ways to block drugs seeking U.S. approvals from being tested at facilities associated with the Chinese army, including those that serve civilian patients, Biocentury reports, citing people familiar with the matter.4. With BIOSECURE Act looming, WuXi AppTec shows declining revenueAs the draft BIOSECURE Act threatens to push WuXi AppTec out of the U.S. market, the CRO giant’s business has so far remained relatively stable. The company’s U.S. sales, which accounted for 62% of the firm’s total, only fell by 1% in the first half of 2024. As the bill moves forward, WuXi spent $360,000 on lobbying efforts in the second quarter, more than tripling the $100,000 it spent in the fourth quarter of 2023.5. Takeda's Entyvio holds onto IBD market share despite threat from AbbVie's SkyriziTakeda takes $140M charge on failed epilepsy drug, while touting continued FDA potentialLundbeck leaves Trintellix to partner Takeda in the US, opting for royalties as it focuses efforts on RexultiDespite the entry of newer inflammatory bowel disease therapies such as AbbVie’s Skyrizi, Takeda’s Entyvio still grew sales by 7.6% during the three months ended in June, reaching $1.5 billion. The company took an impairment charge of about $143 million tied to the Ovid Therapeutics-partnered epilepsy med soticlestat’s recent phase 3 flop. Meanwhile, the Japanese pharma will take full U.S. control of depression drug Trintellix as its long-time partner Lundbeck wants to reallocate resources. The drug will lose U.S. patent protection at the end of 2026.6. Otsuka pays $800M for Jnana Therapeutics and its clinical-stage PKU drugThe dealmaking streak among Japanese pharmas continues. Otsuka is acquiring Jnana Therapeutics for $800 million, plus up to $325 million in milestones, to obtain a clinical-stage oral phenylketonuria (PKU) drug coded JNT-517, an allosteric small-molecule inhibitor of SLC6A19. A registrational study for the med is planned for next year.7. Kyowa Kirin looks to cut small molecule research and manufacturing jobs, slims down in AsiaKyowa Kirin is making some major adjustments to its business. The Japanese pharma is planning “a significant reduction” in small molecule research activities as it focuses on biologics. It’s also looking to trim some manufacturing jobs. In two separate deals, Kyowa will divest its Chinese operations to WinHealth Pharma and transfer rights to seven established brands in certain Asian markets to DKSH Holding.8. Instil refills pipeline in $2B biobucks deal with China's ImmuneOnco for 2 cancer assetsAfter Akeso and Summit Therapeutics’ positive readout for their PD-1xVEGF bispecific ivonescimab against Merck’s Keytruda in a Chinese phase 3 trial, Instil Bio has agreed to pay Shanghai biotech ImmuneOnco Biopharmaceuticals $50 million in upfront and near-term payments, plus up to $2 billion in potential milestones, for two assets, including a PD-L1xVEGF bispecific.Other News of Note:9. After tense standoff, AstraZeneca and Daiichi's Enhertu turned away by NICE on pricing grounds10. Chasing Pfizer and Lilly, Sun Pharma wins FDA nod for alopecia areata med Leqselvi11. South Korea regulator hits GSK for problems with asthma, acne drugs: report12. Ideaya, eyeing drug combos, bags option on Biocytogen bispecific ADC in $400M deal13. In Eisai, Medidata finds its first big buyer for new clinical trial management platform

Phase 3AcquisitionVaccine

100 Deals associated with Vortioxetine Hydrobromide

External Link

KEGG	Wiki	ATC	Drug Bank
D10185	Vortioxetine Hydrobromide	N06AX26	DB09068

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Depressive Disorder	China	H. Lundbeck A/S	21 Nov 2017
Depressive Disorder, Major	United States	Takeda Pharmaceuticals U.S.A., Inc.	30 Sep 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Brain Injuries, Traumatic	Phase 3	-	Takeda Pharmaceutical Co., Ltd.	01 Oct 2016
Cognitive Dysfunction	Phase 3	-	H. Lundbeck A/S	01 Dec 2011
Major depressive disorder, moderate (MDD)	Phase 3	-	H. Lundbeck A/S	01 Dec 2011
Sexual Dysfunction	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Jun 2011
Sexual Dysfunction	Phase 3	Canada	Takeda Pharmaceutical Co., Ltd.	01 Jun 2011
Generalized anxiety disorder	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Jun 2008
Generalized anxiety disorder	Phase 3	United States	H. Lundbeck A/S	01 Jun 2008
Frontotemporal Dementia	Phase 2	United States	Lundbeck LLC	20 Mar 2025
Bipolar Disorder	Phase 2	South Korea	H. Lundbeck A/S	08 Aug 2018
Binge-Eating Disorder	Phase 2	United States	Takeda Pharmaceutical Co., Ltd.	01 Jun 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05047952 (CTgov)	Phase 2	Cognitive Dysfunction \| Post Acute COVID 19 Syndrome	149	Vortioxetine (Vortioxetine)	xtcakbdllb(vmjfntgfcw) = ixflbbzuup jjzbtvyqpv (pjhkywrrtb, 0.0752) View more	-	16 Jan 2025
NCT05047952 (CTgov)	Phase 2	Cognitive Dysfunction \| Post Acute COVID 19 Syndrome	149	Placebo (Placebo)	xtcakbdllb(vmjfntgfcw) = xkmwydvtym jjzbtvyqpv (pjhkywrrtb, 0.0934) View more	-	16 Jan 2025
NCT04288895 (Pubmed \| Curr Med Res Opin)	Phase 4	Depressive Disorder, Major	395	Vortioxetine 5-20 mg/day	cizihmxukn(fuboccigcu) = 35.4% (n = 140) of patients experienced treatment-emergent AEs (mostly mild-moderate); nausea and pruritus were the most frequent (6.6%, n = 26 each) udnumdenpz (nxobejjzsc )	Positive	07 Aug 2024
NCT04448431 (Pubmed \| J Clin Psychiatry)	Phase 4	Depressive Disorder, Major	605	Vortioxetine	gvhysvbrrs(eywvikeful) = TEAEs were reported in 46.1% and 39.6% of patients in the vortioxetine and desvenlafaxine groups, respectively; these were mostly mild or moderate in intensity (> 98% of all TEAEs in each group) wvdgejrcrt (tznkbxamvp )	-	22 May 2023
NCT05014919 (CTgov)	Phase 3	Depressive Disorder, Major	35	Vortioxetine (Double-Blind Relapse Prevention: Vortioxetine)	xienhndrqn(fjfdrvlzcs) = gsjlbfhjrg ngloxobtas (pjxappjvvu, soayypajxg - uujgsffkub) View more	-	05 Jan 2023
NCT05014919 (CTgov)	Phase 3	Depressive Disorder, Major	35	placebo (Double-Blind Relapse Prevention: Placebo)	xienhndrqn(fjfdrvlzcs) = kgttfxijph ngloxobtas (pjxappjvvu, wledxcekjn - rqufuqmgpx) View more	-	05 Jan 2023
NCT02871297 (CTgov)	Phase 3	Depressive Disorder, Major	662	Vortioxetine	obnpamzxsq = sptxseygnk mjkpceugoo (boseojjiks, ysksycyexs - zfqayktsft) View more	-	28 Dec 2022
NCT03555136 (RELIEVE, Pubmed \| J Psychopharmacol)	Not Applicable	Depressive Disorder, Major \| Generalized anxiety disorder	180	Vortioxetine	rmgvpazcid(aduekuuzac) = zvlcznwlji fxoegnpwzc (vypbpfjdsi ) View more	Positive	15 Nov 2022
NCT02709655 (CTgov)	Phase 3	Depressive Disorder, Major	683	placebo (Double-Blind: Placebo)	ixrhnmdkzn(zmuzxnheiy) = eshyvyjrga wdbtsptczf (qagwkfraei, 1.35) View more	-	22 Sep 2022
NCT02709655 (CTgov)	Phase 3	Depressive Disorder, Major	683	Vortioxetine (Double-Blind: Vortioxetine 10 mg)	ixrhnmdkzn(zmuzxnheiy) = aprsfaapdg wdbtsptczf (qagwkfraei, 1.37) View more	-	22 Sep 2022
NCT03555136 (RELIEVE, Pubmed) Manual	Not Applicable	Depressive Disorder, Major	184	Vortioxetine Hydrobromide	ieucozqjch(nbaorkwemc) = lgfiyuqwaa phpzequnnw (jgkymcogmg ) View more	Positive	31 Aug 2022
NCT03555136 (RELIEVE, Pubmed) Manual	Not Applicable	Depressive Disorder, Major	231	Vortioxetine Hydrobromide	gwggsyovji(bztmerdsbw) = wjrexkudnb orgbzkhueq (wdlacffanm ) View more	Positive	09 Aug 2022
NCT02371980 (RESET, Pubmed \| J Affect Disord)	Phase 4	Depressive Disorder, Major Maintenance	1,106	Vortioxetine 5 mg	sglswgfkto(iftmkjiowi) = sqiwoiabva ypcxsdznxy (daysbfyfhu )	Positive	04 Feb 2022
NCT02371980 (RESET, Pubmed \| J Affect Disord)	Phase 4	Depressive Disorder, Major Maintenance	1,106	Vortioxetine 10 mg	sglswgfkto(iftmkjiowi) = tfkrituruy ypcxsdznxy (daysbfyfhu )	Positive	04 Feb 2022

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