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 Diseases

Active Indication

Depressive DisorderDepressive Disorder, Major

Inactive Indication

Anxiety DisordersAttention Deficit Disorder With HyperactivityBinge-Eating Disorder+ [8]

Originator Organization

H. Lundbeck A/S

Active Organization

H. Lundbeck A/S

Sun Pharmaceutical Industries Ltd.

Shenzhen Foncoo Pharmaceutical Co. Ltd.

+ [3]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (30 Sep 2013),

Depressive Disorder, Major

RegulationPriority Review (CN)

Structure

Molecular FormulaC18H23BrN2S

InChIKeyVNGRUFUIHGGOOM-UHFFFAOYSA-N

CAS Registry960203-27-4

188

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 / Not yet 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 Date01 Jan 2025

Sponsor / Collaborator

The Johns Hopkins University

[+1]

TCTR20240809003 / Not yet recruitingPhase 1

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Vortioxetine 20 mg Film-coated Tablets and Reference Product (Brintellix 20 mg film-coated tablets) in Healthy Thai Volunteers under Fasting Conditions

Start Date13 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Vortioxetine Hydrobromide

100 Translational Medicine associated with Vortioxetine Hydrobromide

100 Patents (Medical) associated with Vortioxetine Hydrobromide

765

Literatures (Medical) associated with Vortioxetine Hydrobromide

01 Feb 2025·Current Neuropharmacology

Time- and Region-specific Effect of Vortioxetine on Central LPS-induced Transcriptional Regulation of NLRP3 Inflammasome

Article

Author: Blom, Johanna M.C. ; Ciani, Miriam ; Benatti, Cristina ; Brunello, Nicoletta ; Alboni, Silvia ; Pani, Luca ; Tascedda, Fabio ; Rigillo, Giovanna

Background::

Inflammasome overactivation, multiprotein complexes that trigger inflammatory responses, plays a critical role in Major Depressive Disorder (MDD) pathogenesis and treatment responses. Indeed, different antidepressants alleviate depression-related behaviours by specifically counteracting the NLRP3 inflammasome signalling pathway. The immunomodulatory effects of vortioxetine (VTX), a multimodal antidepressant with cognitive benefits, were recently revealed to counter memory impairment induced by a peripheral lipopolysaccharide (LPS) injection 24 hours (h) postchallenge. The potential link between VTX and NLRP3, along with other inflammasomes, remains un-explored.

Methods::

The potential link between VTX and NLRP3, along with other inflammasomes, remains unexplored. Hence, adult C57BL/6J male mice (n = 73) were fed with a standard or VTX-enriched diet (600 mg/kg of food, 28 days), injected with LPS (830 μg/kg) or saline, and sacrificed 6/24 h post-LPS. At these time-points, transcriptional effects of LPS and VTX on NLRP3, NLRP1, NLRC4, AIM2 (inflammasomes), ASC and CASP1 (related subunits) and NEK7 mediator (NLRP3 regulator) were assessed in dorsal and ventral hippocampal subregions, frontal-prefrontal cortex and hypothalamus, brain regions serving behavioural-cognitive functions impaired in MDD.

Results::

Varied expression patterns of inflammasomes were revealed, with long-term NLRP3 and ASC transcriptional changes observed in response to LPS. It was demonstrated that VTX counteracted the LPS-mediated NLRP3 and ASC upregulation in memory-related brain areas like the dorsal hippocampus at 24 h time-point, potentially via regulating NEK7 expression. No VTX-mediated transcriptional effects were observed on other inflammasomes, reinforcing a potentially specific modulation on the NLRP3 inflammasome signalling pathway.

Conclusion::

Thus, a novel VTX molecular mechanism in modulating the NLRP3 inflammasome in a time- and area-specific manner in the brain was highlighted, with significant clinical implications in treating depression and cognitive impairments.

01 Jan 2025·JOURNAL OF AFFECTIVE DISORDERS

Electroencephalography (EEG) spectral signatures of selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs) and vortioxetine in major depressive disorder: A systematic review

Review

Author: Rhee, Taeho Greg ; Meshkat, Shakila ; Teopiz, Kayla M. ; Zheng, Yang Jing ; Mansur, Rodrigo B ; Mansur, Rodrigo B. ; Gill, Hartej ; Rosenblat, Joshua D. ; Ho, Roger ; McIntyre, Roger S. ; Rosenblat, Joshua D ; Teopiz, Kayla M ; Vasudeva, Shreya ; Kwan, Angela T.H. ; Kwan, Angela T H ; Badulescu, Sebastian ; Portelles, Daylen Rodriguez ; Le, Gia Han ; Lu, Andy ; McIntyre, Roger S ; Wong, Sabrina

BACKGROUND:

Converging evidence suggests electroencephalography (EEG) methods may elucidate alterations in global structural and functional connectivity that underlie the pathophysiology of depressive disorders. Extant literature suggests SSRIs and SNRIs may broadly induce alterations to EEG-measured neural activity. Herein, this systematic review comprehensively evaluates changes to EEG spectral signatures associated with vortioxetine and each FDA-approved agent within the SSRI and SNRI class.

METHODS:

We conducted a systematic review of studies investigating changes to EEG spectral signatures associated with SSRI, SNRI, and/or vortioxetine treatment in persons with MDD. Database search occurred from database inception to May 3, 2024.

RESULTS:

Our search yielded 15 studies investigating overall spectral signature changes associated with SSRI- and/or SNRI-treatment. The existing literature presents with mixed findings. Notwithstanding, we did observe a pattern in which the SSRI and SNRI agents reproducibly affect EEG spectral signatures. We observed overlapping yet distinct spectral patterns for each agent within- and between-drug classes of SSRIs and SNRIs. Changes in resting/wake EEG were also observed.

LIMITATIONS:

The findings from our systematic review are mixed. Heterogeneity exists with sample size, composition, dosing of antidepressants, duration of antidepressant exposure, as well as the type of EEG devices used.

DISCUSSIONS:

Our findings provide support to the notion that although SSRIs, SNRIs and vortioxetine block reuptake of the serotonin transporter; they are different in their profile of pharmacology as evidenced by differential EEG signatures. EEG changes associated with SSRIs, SNRIs and vortioxetine are also highly replicated findings across mixed studies and populations.

01 Jan 2025·BRAIN BEHAVIOR AND IMMUNITY

Exploring the use of immunomethylomics in the characterization of depressed patients: A proof-of-concept study

Article

Author: Minelli, Alessandra ; Pisanu, Claudia ; Hohoff, Christa ; Fabbri, Chiara ; Su Atil, Ecem ; Serretti, Alessandro ; Van Assche, Evelien ; Baune, Bernhard T ; Squassina, Alessio ; Wissing, Sophia M. ; Wissing, Sophia M

Alterations in DNA methylation and inflammation could represent valid biomarkers for the stratification of patients with major depressive disorder (MDD). This study explored the use of DNA-methylation based immunological cell-type profiles in the context of MDD and symptom severity over time. In 119 individuals with MDD, DNA-methylation was assessed on whole blood using the Illumina Infinium MethylationEPIC 850 k BeadChip. Quality control and data processing, as well as cell type estimation was conducted using the RnBeads package. The cell type composition was estimated using epigenome-wide DNA methylation signatures, applying the Houseman method, considering six cell types (neutrophils, natural killer cells (NK), B cells, CD4+ T cells, CD8+ T cells and monocytes). Two cytokines (IL-6 and IL-1β) and hsCRP were quantified in serum. We performed a hierarchical cluster analysis on the six estimated cell-types and tested the differences between these clusters in relation to the two cytokines and hsCRP, depression severity at baseline, and after 6 weeks of treatment (celecoxib/placebo + vortioxetine). We performed a second cluster analysis with cell-types and cytokines combined. ANCOVA was used to test for differences across clusters. We applied the Bonferroni correction. After quality control, we included 113 participants. Two clusters were identified, cluster 1 was high in CD4+ cells and NK, cluster 2 was high in CD8+ T-cells and B-cells, with similar fractions of neutrophils and monocytes. The clusters were not associated with either of the two cytokines and hsCRP, or depression severity at baseline, but cluster 1 showed higher depression severity after 6 weeks, corrected for baseline (p = 0.0060). The second cluster analysis found similar results: cluster 1 was low in CD8+ T-cells, B-cells, and IL-1β. Cluster 2 was low in CD4+ cells and natural killer cells. Neutrophils, monocytes, IL-6 and hsCRP were not different between the clusters. Participants in cluster 1 showed higher depression severity at baseline than cluster 2 (p = 0.034), but no difference in depression severity after 6 weeks. DNA-methylation based cell-type profiles may be valuable in the immunological characterization and stratification of patients with MDD. Future models should consider the inclusion of more cell-types and cytokines for better a prediction of treatment outcomes.

News (Medical) associated with Vortioxetine Hydrobromide

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

09 May 2024

·www.biospace.com

Alto Neuroscience Announces Data Presentations Highlighting Late-Stage Clinical Pipeline and Robust Platform at Upcoming Scientific Conferences

– Breadth of Alto’s pipeline and Precision Psychiatry Platform™ will be highlighted across twelve posters and presentations at the Society of Biological Psychiatry and American Society of Clinical Psychopharmacology Annual Meetings – – Presented comprehensive identification and prospective replication of neurobiological markers linked to cognitive impairment associated with schizophrenia; Results inform design of planned ALTO-101 proof-of-concept study in CIAS – – Importance of developing ALTO-100 in depression characterized by poor cognition highlighted through new analyses demonstrating baseline cognition does not moderate response for vortioxetine and poor cognition in turn drives functional impairment in depression – LOS ALTOS, Calif.--(BUSINESS WIRE)-- Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced upcoming data presentations that highlight the company’s precision psychiatry pipeline and biomarker-based analyses at the Society of Biological Psychiatry (SOBP) and American Society of Clinical Psychopharmacology (ASCP) Annual Meetings, to take place May 9-11 in Austin, TX, and May 28-31 in Miami Beach, FL, respectively. “The vast amount of clinical and biomarker data we’ve generated to date enables our team to make important contributions to the scientific community and develop novel compounds for patients in need, in both depression and schizophrenia,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “Alto’s precision psychiatry platform continues to get stronger with each new dataset we analyze. Importantly, we have systematically identified and prospectively replicated neurobiological markers linked to cognitive impairment associated with schizophrenia in a comprehensive analysis inclusive of all major candidate biomarkers. Our rigorous data science approach derives its impact from prospectively validating important discoveries. In this case, doing so enables us to identify the most pertinent and consistent signals to use as primary outcome measures for proof-of-concept studies – with theta response as a notable example of this in the planned ALTO-101 study.” Summary of Data Presentations Across Clinical Programs ALTO-100: Data from the completed Phase 2a study highlight the identification, and prospective replication, of a memory-based cognitive marker predicting greater antidepressant response to ALTO-100. New analysis of vortioxetine Phase 3 data demonstrates that baseline cognitive performance is not a moderator of response to vortioxetine. Vortioxetine does not show greater benefit in patients with poor baseline cognitive performance despite its reported benefits for aspects of cognition. New analysis of a large depression trial demonstrates that poor memory predicts worse functional outcomes in depression – further highlighting the need for better treatment options for this underserved population. ALTO-101: Data from a completed randomized, double-blind, placebo-controlled Phase 1 study in healthy adult volunteers demonstrate significant effects of ALTO-101 on electrophysiological measures relevant to cognitive processing, including theta response, as well as information processing speed, an important area of cognitive impairment associated with schizophrenia. A new analysis of the Bipolar and Schizophrenia Network for Intermediate Phenotypes (BSNIP) studies identified, and prospectively replicated, theta response as the EEG marker best linked to schizophrenia diagnosis and cognitive impairment in patients. A notable relationship between theta response and processing speed, which is thought to underpin cognitive impairment in schizophrenia, was observed. ALTO-300: Data from the completed Phase 2a study highlight the identification, and prospective replication, of an EEG-based cognitive marker predicting greater response to ALTO-300. The details of each presentation follow: Society of Biological Psychiatry Annual Meeting Thursday, May 9, 2024 Poster Session I: 5:30-7:30 p.m. CT, Griffin Hall Presentation Title: Identification and Prospective Replication of a Cognitive Biomarker for Predicting the Antidepressant Effect of ALTO-100, a Novel Pro-plasticity Drug Candidate, in Patients with Major Depression: Results from a Large Phase 2a Study Poster Authors: Joshua T. Jordan, Ph.D., Nicholas J. Cooper, Ph.D., Faizan Badami, M.S., Jessica Powell, Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Presentation Title: Identification and Prospective Replication of Electrophysiological Markers Linked to Cognitive Impairment in Schizophrenia Poster Authors: Chao Wang, Ph.D., Sam Goncalves, M.S., Joshua T. Jordan, Ph.D., Maimon Rose, Ph.D., Akshay Sujatha Ravindran, Ph.D., Mike Avissar, M.D., Ph.D., Greg Hajcak, Ph.D., Faizan Badami, M.S., Yueqi Guo, Ph.D., Wei Wu, Ph.D., Jessica Powell, Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Presentation Title: Verbal Memory and Inhibitory Control Predict Functional Capacity in Major Depressive Disorder: A Secondary Analysis of the ReMIND SWITCH Trial Poster Authors: Joshua T. Jordan, Ph.D, Li Shen, Ph.D, Wei Wu, Ph.D., Adam J. Savitz, M.D., Ph.D., Amit Etkin, M.D., Ph.D. Friday, May 10, 2024 Concurrent Symposia: 4:00-6:00 p.m. CT, JW Grand Ballroom 2 Session Title: Bringing Precision Psychiatry out of the Lab and Into the Clinic: Developing Biomarkers for Diagnosis, Drug Development, Treatment Selection and Tracking Clinical Status Speakers: Amit Etkin, M.D., Ph.D., founder and CEO of Alto will serve as Chair, and Adam Savitz, M.D., Ph.D., CMO of Alto, will serve as Co-chair of the session. Additional presenters include Daniel Mathalon, M.D., Ph.D., University of California, San Francisco; Magali Haas, M.D., Ph.D., Cohen Veterans Bioscience; Katharine Dunlop, Ph.D., University of Toronto Dr. Etkin will present from 5:25-5:50 p.m. CT: Development and Prospective Replication of Biomarkers for Predicting Treatment Outcome With ALTO-100 and ALTO-300 in Major Depression: Data from Multiple Phase 2 Programs. Dr. Savitz will serve as a discussant for the panel. Poster Session II: 6:00-8:00 p.m. CT, Griffin Hall Presentation Title: Identification and Prospective Replication of an EEG Biomarker for Predicting the Antidepressant Effect of ALTO-300 in Patients with Major Depression: Results from a Large Phase 2a Study Poster Authors: Maimon Rose, Ph.D., Joshua T. Jordan, Ph.D., Chao Wang, Ph.D., Faizan Badami, M.S., Jessica Powell, Fadi Abdel, M.D., Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Presentation Title: Baseline Cognition is Not Associated with Depression Outcomes with Vortioxetine for Major Depressive Disorder: Findings from Placebo-Controlled Trials Poster Authors: Joshua T. Jordan, Ph.D., Li Shen, Ph.D., Nicholas J. Cooper, Ph.D., Samantha V. Goncalves, M.S., Madhukar H. Trivedi, M.D., Alan F. Schatzberg, M.D., Wei Wu, Ph.D., Adam J. Savitz, M.D., Ph.D., & Amit Etkin, M.D., Ph.D. Saturday, May 11, 2024 Poster Session III: 5:00-7:00 p.m. CT, Griffin Hall Presentation Title: Identification of Brain/Behavior-based Pro-cognitive Pharmacodynamic Effects for ALTO-101 in Healthy Volunteers: Results from a Randomized, Double-blind Phase 1 Study Poster Authors: Akshay Ravindran, Ph.D., Guhan Sundar, Samantha Goncalves, M.S., Chao Wang, Ph.D., Li Shen, Maimon Rose, Ph.D., Joshua T. Jordan, Ph.D., Nicholas J. Cooper, Ph.D., Sebastian Marquez, Ph.D., Faizan Badami, M.S., Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. American Society of Clinical Psychopharmacology Annual Meeting Tuesday, May 28, 2024 Pharmaceutical Pipeline Session: 2:00-4:00 p.m. ET, Salon 3 Presentation Title: Pro-cognitive Pharmacodynamic Effects of ALTO-101: Results from Brain and Behavioral Outcomes in a Randomized, Double-blind Phase 1 Study Poster Authors: Akshay Ravindran, Ph.D., Guhan Sundar, Samantha Goncalves, M.S., Chao Wang, Ph.D., Li Shen, Ph.D., Maimon Rose, Ph.D., Joshua T. Jordan, Ph.D., Nicholas J. Cooper, Ph.D., Sebastian Marquez, Ph.D., Tabitha Carreira, MPH, Jessica Powell, Faizan Badami, M.S., Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Workshop: 4:15-6:15 p.m. ET, Poinciana 3-4 Presentation Title: Good News/Bad News: Precision Neuroscience and the Clinical Trials Ecosystem Speakers: Mark Opler, Ph.D., M.P.H. (Chair); Adam Savitz, M.D., Ph.D., Alto Neuroscience; Seth C. Hopkins, Ph.D., Sumitomo Pharma America; John Carlos Diaz, GeoSera; John Sonnenberg, Ph.D., Uptown Research Institute; Barbara Echevarria, Ph.D., WCG; George Garibaldi, M.D., Garibaldi Consulting GMBH Wednesday, May 29, 2024 Individual Research Reports: 3:00-4:30 p.m. ET, Salon 2 Presentation Title: Baseline Cognition is not Associated with Depression Outcomes with Vortioxetine for Major Depressive Disorder: Findings from Placebo-controlled Trials Poster Authors: Joshua T. Jordan, Ph.D., Li Shen, Ph.D., Nicholas J. Cooper, Ph.D., Samantha V. Goncalves, M.S., Madhukar H. Trivedi, M.D., Alan F. Schatzberg, M.D., Wei Wu, Ph.D., Adam J. Savitz, M.D., Ph.D., & Amit Etkin, M.D., Ph.D. Thursday, May 30, 2024 Poster Session II: 12:30-2:15 p.m. ET, Salon 4 Presentation Title: A Biomarker-Based Enrichment Strategy for Neuropsychiatric Drug Development: Examples from Two Ongoing Phase 2b Studies Poster Authors: Michael Avissar, M.D., Ph.D., Joshua T. Jordan, Ph.D., Nicholas Cooper, Ph.D., Maimon Rose, Ph.D., Chao Wang, Ph.D., Faizan Badami, M.S., Peter Emmel, Kaitlly Zhu, Jessica Powell, Fadi Abdel, M.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Presentation Title: Prevalence and Correlates of Cognitive Impairment in Depression: Findings from the Texas Resilience Against Depression Study Poster Authors: Joshua T. Jordan, Ph.D., Li Shen, Ph.D., Cherise Chin-Fatt, Ph.D., Adam J. Savitz, M.D., Ph.D., Amit Etkin, M.D., Ph.D., & Madhukar H. Trivedi, M.D. 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 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 “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “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 for the timing, progress, and results of its studies. 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 Alto’s studies 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023 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.

Phase 2Phase 1ASCOClinical Result

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.

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

Developing

10 top R&D records.

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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	US	Takeda Pharmaceutical Co., Ltd.	01 Jun 2011
Sexual Dysfunction	Phase 3	CA	Takeda Pharmaceutical Co., Ltd.	01 Jun 2011
Generalized anxiety disorder	Phase 3	US	Takeda Pharmaceutical Co., Ltd.	01 Jun 2008
Generalized anxiety disorder	Phase 3	US	H. Lundbeck A/S	01 Jun 2008
Bipolar Disorder	Phase 2	KR	H. Lundbeck A/S	08 Aug 2018
Binge-Eating Disorder	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	01 Jun 2016
Attention Deficit Disorder With Hyperactivity	Phase 2	US	H. Lundbeck A/S	01 Dec 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04288895 (Pubmed \| Curr Med Res Opin)	Phase 4	Depressive Disorder, Major	395	Vortioxetine 5-20 mg/day	egjylqxusb(dtrftjzbmu) = 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) vbbunsjier (vdouqdwwwc )	Positive	07 Aug 2024
NCT04448431 (Pubmed \| J Clin Psychiatry)	Phase 4	Depressive Disorder, Major	605	Vortioxetine	rxbfnpkxge(gymrhkbetl) = 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) lhadqdwdxg (fghxefbexz )	-	22 May 2023
NCT05014919 (CTgov)	Phase 3	Depressive Disorder, Major	35	Vortioxetine (Double-Blind Relapse Prevention: Vortioxetine)	gsxppbjtze(nxomffrwif) = coeyjpioun szlvthlosj (fvvazrhoqr, ejfymxmkcd - qdbftromjg) View more	-	05 Jan 2023
NCT05014919 (CTgov)	Phase 3	Depressive Disorder, Major	35	placebo (Double-Blind Relapse Prevention: Placebo)	gsxppbjtze(nxomffrwif) = aqyowlpmyv szlvthlosj (fvvazrhoqr, clmpjjqjzr - xbcgyzyeit) View more	-	05 Jan 2023
NCT02871297 (CTgov)	Phase 3	Depressive Disorder, Major	662	Vortioxetine	thqpdotncl(pkqeynzolt) = jpnghigdiv vujspbycwd (tqgaukzimn, ibghrfklsh - ibwiwysgue) View more	-	28 Dec 2022
NCT02709655 (CTgov)	Phase 3	Depressive Disorder, Major	683	placebo (Double-Blind: Placebo)	iydvexxcim(uypozgkjqi) = wrfxkcpysm jjvhisizvs (gnucixlctx, lbyhqccxny - ptylqnfnod) View more	-	22 Sep 2022
NCT02709655 (CTgov)	Phase 3	Depressive Disorder, Major	683	Vortioxetine (Double-Blind: Vortioxetine 10 mg)	iydvexxcim(uypozgkjqi) = zqfzxnvvin jjvhisizvs (gnucixlctx, qeogzlxrsp - atmvzhojbx) View more	-	22 Sep 2022
NCT03555136 (RELIEVE, Pubmed) Manual	Not Applicable	Depressive Disorder, Major	184	Vortioxetine Hydrobromide	hxxrvlbqre(plheoyloem) = uorltaccrd yspgiqexxw (pfdrdrcsko ) View more	Positive	31 Aug 2022
NCT03555136 (RELIEVE, Pubmed) Manual	Not Applicable	Depressive Disorder, Major	231	Vortioxetine Hydrobromide	qneeddbnot(hollioheul) = gdejehhvmi mvwozyhrwo (ugqirhfvgy ) View more	Positive	09 Aug 2022
NCT02972632 (Pubmed \| BMC Psychiatry) Manual	Phase 4	Depressive Disorder, Major	122	vortioxetine	ihxjfnqefu(flcmmxngde) = pitmxtilae vmqbezydqj (edwvaromno ) View more	Positive	11 Dec 2021
NCT02749721 (CTgov)	Phase 4	Depressive Disorder, Major	31	Vortioxetine	wcfnmrdapg(impphlwbfs) = rtkilieryr fhzacsbkbj (endbyndvyf, xormrsmkgj - zwwgpnhyum) View more	-	04 Oct 2021
EPO112 (EAN)	Not Applicable	Post-stroke Fatigue	176	Vortioxetine 5mg	aoacridtws(vcmcshcbvh) = No adverse events and side effects were recorded cvqqynddcs (drdchalcoz )	Positive	18 Jun 2021
EPO112 (EAN)	Not Applicable	Post-stroke Fatigue	176	Vortioxetine 10mg		Positive	18 Jun 2021

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