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

Angina, UnstableAttention Deficit Disorder With HyperactivityBinge-Eating Disorder+ [9]

Originator Organization

H. Lundbeck A/S

Active Organization

H. Lundbeck A/S

Xiamen Encheng Pharmaceutical Co., Ltd

Libbs Farmacêutica Ltda.

+ [8]

Inactive Organization-

License Organization

H. Lundbeck A/S

Takeda Pharmaceutical Co., Ltd.

Sun Pharmaceutical Industries Ltd.

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

189

Clinical Trials associated with Vortioxetine Hydrobromide

NCT07284628

/ RecruitingPhase 2IIT

A Phase II Drug Repurposing Trial of Vortioxetine for the Treatment of Patients With Newly Diagnosed Glioblastoma

There is a very urgent need to improve on the currently limited treatment options for patients with glioblastoma. Despite extensive knowledge on the molecular pathogenesis of glioblastoma obtained through genomic, transcriptional and proteomic profiling, targeted therapy efforts have not yielded major advances, likely because of interindividual and intraindividual tumor heterogeneity and redundant oncogenic pathway activation.
Accordingly, there is a strong rationale to approach the challenge of glioblastoma from a different angle, e.g., by ex vivo drug sensitivity profiling which is agnostic to the molecular profile of a tumor. This approach that we have termed "pharmacoscopy", has previously been explored in liquid cancers and probably led to improved patient outcomes. Using pharmacoscopy, the antidepressant drug, vortioxetine, has been identified as a lead candidate for further exploration in patients with glioblastoma. Vortioxetine also demonstrated synergistic anti-glioma activity in combination with temozolomide or lomustine.
The ReVoGlio trial aims at demonstrating that vortioxetine, a drug selected based on ex vivo drug profiling (pharmacoscopy), is of benefit for patients with newly diagnosed glioblastoma.

Start Date24 Jun 2026

Sponsor / Collaborator

University of Zurich

[+3]

CTR20261907

/ Active, not recruitingNot Applicable

氢溴酸伏硫西汀片生物等效性试验

[Translation] Bioequivalence study of vortioxetine hydrobromide tablets

主要研究目的评价中国健康成年试验参与者空腹条件下单次单剂量口服氢溴酸伏硫西汀片受试制剂[规格：10mg（以C18H22N2S计），申办者：苏州第三制药厂有限责任公司]和参比制剂[商品名：心达悦®（Brintellix®），规格：10mg（以C18H22N2S计），持证商：H.Lundbeck A/S]后的药代动力学特点和生物等效性。次要研究目的研究氢溴酸伏硫西汀片受试制剂[规格：10mg（以C18H22N2S计）]和参比制剂[商品名：心达悦®（Brintellix®），规格：10mg（以C18H22N2S计）]在中国健康成年试验参与者中的安全性。

[Translation]

Primary Objective: To evaluate the pharmacokinetic characteristics and bioequivalence of a single, fasting oral dose of vortioxetine hydrobromide tablets (test formulation: 10 mg (C18H22N2S), Sponsor: Suzhou Third Pharmaceutical Factory Co., Ltd.) and reference formulation (Brintellix®, 10 mg (C18H22N2S), Licensee: H. Lundbeck A/S) in healthy adult Chinese participants. Secondary Objective: To investigate the safety of vortioxetine hydrobromide tablets (test formulation: 10 mg (C18H22N2S)) and reference formulation (Brintellix®, 10 mg (C18H22N2S)) in healthy adult Chinese participants.

Start Date15 Jun 2026

Sponsor / Collaborator

Suzhou No.3 Pharmaceutical Factory Co., Ltd.

CTR20260729

/ Active, not recruitingNot Applicable

VHDT口崩片在健康人体空腹和餐后条件下的生物等效性试验

[Translation] Bioequivalence studies of VHDT orally disintegrating tablets in healthy subjects under fasting and postprandial conditions.

考察空腹及餐后条件下，健康研究参与者单次口服厦门恩成制药有限公司提供的受试制剂（VHDT口崩片，规格：10mg）和H.Lundbeck A/S持证的参比制剂（氢溴酸伏硫西汀片，商品名：心达悦®，规格：10mg）的药代动力学特征，评价两制剂间的生物等效性。

[Translation]

The pharmacokinetic characteristics of the test formulation (VHDT orally disintegrating tablets, strength: 10 mg) provided by Xiamen Encheng Pharmaceutical Co., Ltd. and the reference formulation (vortioxetine hydrobromide tablets, trade name: Xindayue®, strength: 10 mg) certified by H. Lundbeck A/S were examined under fasting and postprandial conditions to evaluate the bioequivalence between the two formulations.

Start Date10 Apr 2026

Sponsor / Collaborator

Fuzhou Changfuxing New Drug Development Co., Ltd.

[+1]

100 Clinical Results associated with Vortioxetine Hydrobromide

100 Translational Medicine associated with Vortioxetine Hydrobromide

100 Patents (Medical) associated with Vortioxetine Hydrobromide

966

Literatures (Medical) associated with Vortioxetine Hydrobromide

01 Oct 2026·PHYSIOLOGY & BEHAVIOR

Vortioxetine transiently alters basal locomotor activity but does not produce sedation in rats

Article

Author: Salazar-Juárez, Alberto ; Barbosa-Méndez, Susana

Sedation is a major side effect of many pharmacotherapies for depression, negatively affecting treatment compliance, particularly in long-term treatment. Vortioxetine, a recently approved antidepressant for major depressive disorder, has been reported in clinical studies to be safe and well-tolerated, without causing sedation. However, recent reports have indicated that vortioxetine may, in fact, cause daytime sedation. Therefore, this study aimed to explore the effects of acute and chronic administration of varying doses of vortioxetine on sedation in rats. Sedation was assessed behaviorally using the rota-rod, spontaneous locomotor activity, and fixed-bar tests. In addition to behavioral assessments, the sedation rating scale was used, and body weight was monitored to indicate metabolic effects of different vortioxetine doses (5, 10, and 20 mg/kg). Our results showed that, compared to trazodone, acute and chronic dosing of vortioxetine produced a transient reduction in spontaneous locomotor activity. Furthermore, the fixed-bar, rota-rod, and sedation ratings were not significantly altered by any dose of vortioxetine. These results suggest that vortioxetine, at the tested doses, is safe, well-tolerated, and does not produce significant sedative effects.

01 Aug 2026·ACTA PSYCHIATRICA SCANDINAVICA

Educational Differences in Treatment of Individuals Diagnosed With Major Depression: A Register‐Based Cohort Study

Article

Author: Jørgensen, Terese Sara Høj ; Jørgensen, Martin Balslev ; Gronemann, Frederikke Hørdam ; Osler, Merete ; Rosenqvist, Thomas Wolff ; Jørgensen, Anders

ABSTRACT:

Background:

In individuals with depression, lower socioeconomic position is associated with poorer prognostic outcomes, which may be attributed to inequitable care. We investigated educational differences in treatment of individuals diagnosed with depression at a psychiatric hospital.

Methods:

This nationwide register‐based cohort study included 156,922 Danish citizens with a first‐time psychiatric hospital diagnosis of depression (ICD‐10: F32–F33) between 2000 and 2022. Highest attained educational level was categorized as short, medium, or long. Treatment data included antidepressant prescriptions, electroconvulsive therapy (ECT), and contacts with private practicing psychiatrists or psychologists. Logistic regression and Cox proportional hazard regression models with adjustments for covariates were used to estimate associations between educational level and treatment before and after diagnosis.

Results:

Within 2 years before diagnosis, 72.0% of individuals had redeemed at least one antidepressant prescription, and 83.8% had initiated or continued pharmacological treatment within 2 years after diagnosis. Education was not associated with redeemed prescriptions of antidepressants regardless of type before diagnosis, whereas long education was associated with higher rates of treatment with any type of antidepressants after diagnosis. For specific antidepressants, individuals with long education were less likely to redeem prescriptions for noradrenergic and specific serotonergic antidepressants (NaSSAs) and more likely to redeem monoamine oxidase inhibitors (MAOIs) and newer antidepressants such as vortioxetine. Longer educated also more often consulted private practicing mental health specialists both before and after diagnosis, respectively. After diagnosis, individuals with long education were also more likely to receive ECT.

Conclusion:

Educational differences in pharmacological treatment and private specialist visits among individuals with depression are present both before and after their first hospital contact. Individuals with long education seem more likely to receive specialized and high‐value care (ECT, MAOIs, newer antidepressants, and consultations with private psychiatrists and psychologists) compared to individuals with short or medium education.

01 Jul 2026·PSYCHIATRY RESEARCH-NEUROIMAGING

Changes in functional connectivity of the default mode network and thalamus may be a therapeutic mechanism for the treatment of major depressive disorder with vortioxetine

Article

Author: Liu, Jizhou ; Xu, Xiufeng ; Lian, Jigang ; Shen, Zonglin ; Yuan, Lijin ; Song, Zhengfen ; Zhu, Yun ; Jin, Mengyun ; Wang, Haijin

This study investigates the pathogenic mechanisms underlying major depressive disorder (MDD) and the therapeutic mechanisms of vortioxetine in treatment-naive, first-episode MDD patients. 22 treatment -naive, first-episode MDD patients and 22 healthy controls (HCs) matched for age, gender, and education were enrolled in the study. After undergoing a 12-week vortioxetine treatment, MDD patients were stratified into remission and non-remission groups using the 17-item Hamilton Depression Rating Scale (HAMD-17) cutoff score of ≤7 at the treatment endpoint. All participants underwent resting-state magnetic resonance imaging (rs-MRI) scans. Baseline analysis revealed a significant reduction in the fractional amplitude of low-frequency fluctuations (fALFF) in the bilateral posterior cingulate cortex (bPCC) of MDD patients compared to HCs. Following treatment, the remission group exhibited a significant reduction in resting-state functional connectivity (rsFC) between the bPCC and both the bilateral middle cingulate cortex (bMCC) and thalamus compared to pretreatment levels. Furthermore, the rsFC of the bPCC was significantly lower in the remission group than in the non-remission group following treatment. No significant correlations were observed between the functional metrics of these brain regions and clinical data (p > 0.05). Our results support the involvement of default mode network (DMN) dysfunction in MDD and propose that vortioxetine may alleviate depressive symptoms by modulating the DMN and thalamus.

News (Medical) associated with Vortioxetine Hydrobromide

22 May 2026

·www.biospace.com

Protagenic Therapeutics Engages Floyd Regulatory Strategic Consulting as Regulatory Affairs Advisor and Danforth Health as Strategic Operations Partner

NEW YORK, NY / ACCESS Newswire / May 19, 2026 / Protagenic Therapeutics, Inc. (OTCQB:PTIX), a clinical-stage biopharmaceutical company developing novel peptide-based therapies for stress-related neuropsychiatric disorders, today announced two strategic engagements to support the advancement of its lead candidate, PT00114. The Company has engaged Floyd Regulatory Strategic Consulting, led by regulatory affairs veteran Dr. Eric Floyd, Ph.D., MBA, as Regulatory Affairs Advisor, and DanforthHealth, a premier life science operational consulting firm, to establish institutional-grade operational processes and infrastructure. Together, these engagements reflect Protagenic's deliberate, lean operating model concentrating resources and expertise on PT00114's Phase 2 advancement while positioning the Company for long-term value creation for patients and shareholders. Dr. Floyd brings more than 25 years of senior regulatory leadership experience in the pharmaceutical and biopharmaceutical industries. As U.S. Head of Regulatory Affairs at Lundbeck, he led strategic regulatory activities supporting the U.S. approvals of Abilify Maintena ® (aripiprazole extended-release injectable suspension), Trintellix ® (vortioxetine), and Rexulti ® (brexpiprazole) - three landmark CNS products spanning schizophrenia and major depressive disorder. Dr. Floyd has also held senior regulatory roles at Novartis, Cephalon, and Axovant Sciences, and most recently served as Global Head of Regulatory Affairs at Neurogene, Inc. He serves as adjunct faculty in Neuroscience at Harvard Medical School and Wake Forest University School of Medicine. As Regulatory Affairs Advisor, Dr. Floyd will lead Protagenic's regulatory strategy for PT00114, including IND maintenance, pre-Phase 2 FDA meeting preparation and Phase 2 submission planning. "Eric's regulatory track record in CNS and his leadership on three of the most important CNS approvals of the past decade is exceptional," said Bill Nichols Jr., President of Protagenic Therapeutics . "And his deep knowledge of FDA's expectations in neuropsychiatric drug development is precisely what PT00114 requires as we advance toward Phase 2." "PT00114's mechanism of action targeting the TCAP pathway, and the clean Phase 1 safety data the program has generated, create a strong foundation for a rigorous Phase 2 program," said Dr. Eric Floyd, Ph.D., MBA, Founder and Principal of Floyd Regulatory Strategic Consulting . "I have spent my career moving CNS therapies from concept to patients and I look forward to bringing that experience to bear for Protagenic at this pivotal moment." Protagenic has also engaged the finance & human resources consulting arm of Danforth Health to establish streamlined operational processes and infrastructure aligned with the Company's current stage and strategic priorities. Danforth has served more than 1,800 life science companies across business operations, development, and commercialization, and brings a flexible, scalable team of cross-functional biotech professionals. Danforth's extensive strategic relationships across the life science ecosystem - spanning investors, clinical service providers, and investment banks - provide Protagenic with access to a network very well uniquely suited to accelerate its development trajectory. "Danforth has built an unmatched capability serving exactly the kind of company Protagenic is today," said Mr. Nichols. "Their flexible, scalable model allows us to build institutional-grade operations - investor-ready financial processes, disciplined governance, and strategic access to the broader life science ecosystem - without the overhead of a large internal infrastructure. That is precisely the model Protagenic needs as we advance PT00114 toward Phase 2." These engagements build on recent operational and clinical milestones at Protagenic, including the completion of the Phytanix separation in March 2026, which strengthened the Company's balance sheet by removing more than $6.3 million in liabilities and more than $1 million in annualized costs. Coupled with its completed PT00114 Phase 1 multiple-dose safety and tolerability study, these milestones position Protagenic to advance PT00114 into Phase 2 enrollment in 2026 with a focused team, clean capital structure and experienced advisory partners. About PT00114 PT00114 is Protagenic's lead clinical asset - a first-in-class investigational neuropeptide targeting the TCAP pathway for the treatment of stress-related neuropsychiatric disorders, including anxiety, PTSD, and treatment-resistant depression. In December 2025, the program reported positive Phase 1 multiple-dose safety and tolerability data, with no serious adverse events observed across dose levels. Protagenic plans to advance PT00114 into Phase 2 clinical studies in 2026. About Protagenic Therapeutics, Inc. Protagenic Therapeutics, Inc. (OTCQB: PTIX) is a clinical-stage biopharmaceutical company dedicated to developing breakthrough peptide-based treatments for stress-related neuropsychiatric disorders. The Company is headquartered in New York, NY. About Floyd Regulatory Strategic Consulting Floyd Regulatory Strategic Consulting is a specialized regulatory affairs advisory firm founded and led by Dr. Eric Floyd, Ph.D., MBA. With more than 25 years of experience in pharmaceutical and biopharmaceutical regulatory affairs, Dr. Floyd provides strategic regulatory guidance to clinical-stage companies across CNS, oncology, and rare disease therapeutic areas. The firm's expertise spans IND strategy, FDA engagement and meeting management, clinical protocol regulatory review, NDA/BLA planning, and submission management. About Danforth Health Danforth Health is a unified platform purpose-built to empower life science innovation. By integrating the capabilities of best-in-class affiliates, Danforth Health provides tailored, cross-functional support across finance and human resources, investor and public relations, discovery and development, regulatory and clinical, commercial and marketing, market research and analytics, and market access and value. The model is built for flexibility, scalability, and impact - serving life science companies at any stage and helping them move faster, smarter, and more efficiently to achieve transformative outcomes for patients. Headquartered in Waltham, Massachusetts, Danforth Health has partnered with more than 1,800 life science companies around the world. Learn more at . Trademark Notice Abilify Maintena ® is a registered trademark of Otsuka Pharmaceutical Co., Ltd. Trintellix ® is a registered trademark of H. Lundbeck A/S. Rexulti ® is a registered trademark of Otsuka Pharmaceutical Co., Ltd. Danforth Advisors ™ is a trademark of Danforth Advisors, LLC. All other trademarks are the property of their respective owners. For more information, visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding the anticipated role and contribution of Dr. Floyd, the planned timing of Phase 2 enrollment for PT00114, and the therapeutic potential of PT00114. These statements are based on current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Protagenic Therapeutics undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Investor & Media Contact: Protagenic Therapeutics, Inc. | info@protagenic.com | SOURCE: Protagenic Therapeutics, Inc. View the original press release on ACCESS Newswire

Phase 1Phase 2Executive ChangeClinical Result

01 Apr 2026

·www.fiercebiotech.com

‘There isn\'t as much meat left to cut’: Biopharma layoffs maintain slowdown in Q1

We have to go back to the 30 layoff rounds reported in the first quarter of 2022 to find a similarly low level during the first three months of the year.\n Have we passed the peak of biotech layoffs? It’s too early to say for certain—but an intriguing story is playing out in the figures.According to an analysis of Fierce Biotech’s layoff data, a total of 33 biopharma companies were reported to be either laying off employees or shutting down in the first three months of this year. While still high, this number is indicative of a gradual trend of slowing job cuts that Fierce first identified back in September. That downward trajectory resulted in a similar 33 layoff rounds in the final quarter of 2025, barely half of the 64 and 62 layoff announcements seen in the second and third quarters of last year, respectively.Last year was certainly tough, as demonstrated by a separate Fierce Pharma analysis that showed that the 17 pharma companies with at least $20 billion in annual revenue collectively reduced their workforces by more than 22,000 employees over the course of 2025.But to really put the latest layoff figures in context, we should compare them to previous first quarters. The 33 announcements in the first three months of 2026 are barely half of the 63 reports we saw in the same quarter of 2025, and significantly below the 57 and 58 rounds we listed in the first quarters of 2023 and 2024, respectively.In fact, we have to go back to the 30 layoff rounds reported in the first quarter of 2022 to find a similar level.The relative drop-off in layoff rounds that began in the final months of last year reflects the fact that many biopharmas have now conducted an overdue appraisal of their strategies, suggested Max Baumann, co-founder and Head of Execution at Treehill Partners, a healthcare-focused advisory firm.“During 2025, biotech and pharma started realizing things that they should have realized two or three years ago, which is: we need a course-correct,” Baumann told Fierce in an interview.“In early 2025, we saw panic, tariff fear, some clinical failures triggering individual layoffs at biotechs,” he added. “But within the larger pharma industry, we basically had a larger degree of uncertainty.” While some of this uncertainty may linger, there “just isn\'t as much meat left to cut” at larger companies, suggested Baumann, who pointed to Novo Nordisk’s decision in September to lay off 9,000 employees as well as Bayer’s long-running restructuring under CEO Bill Anderson.That’s not to paint too rosy a picture of the current state of the industry. In the final days of the first quarter, Takeda unveiled plans to cut 634 jobs in the U.S. as part of a massive restructuring designed to save the company more than 200 billion Japanese yen ($1.26 billion) annually. It followed the Japanese pharma’s announcement in January that it would remove 243 field-based commercial employees to prepare for the loss of exclusivity on its depression drug Trintellix.Other significant redundancy rounds included Germany’s Evotec—which will lay off 800 employees and shutter four sites over the next two years—and Viatris, which is shaving off around 10% of its 32,000-strong global workforce as part of plans to save up to $700 million annually. Among biotechs, some of the most severe layoffs were at Theravance Biopharma, which halved its headcount and abandoned its R&D ambitions in early March in the wake of a phase 3 fail for its blood pressure med.March also saw Gossamer Bio shrink its workforce by 48% after the company’s phase 3 study of seralutinib in patients with pulmonary arterial hypertension missed its primary endpoint. Meanwhile, Tessera Therapeutics unveiled plans at the start of the year to lay off 90 employees across a number of U.S. states despite the Flagship-founded company insisting it was “on the cusp of a critical inflection point” as it prepared its Regeneron-partnered in-vivo genome-editing product for the clinic.The quarter continued to see companies shutter, including IO Biotech, which followed its latest round of layoffs in January by filing for bankruptcy in March after its attempts to secure approval for its cancer vaccine ran out of road. Molecular glue company f5 Therapeutics also shut down in March, with the company’s CEO citing how “brutal” the past few years have been for early-stage biotechs. Another notable closure was Nido Biosciences, which decided to wind down after its small-molecule for a rare neurological disease disappointed in a phase 2 trial.While biopharma layoffs will remain a part of the life cycle of the industry, can we expect the relatively lower number of announcements to continue through the year?“I don\'t expect the same intensity to re-occur in 2026 from a general operations perspective,” Treehill Partners\' Baumann told Fierce.But there are the “wild cards” of the impact of AI and tariffs that could have unexpected impacts on the industry, he suggested.“Will that result in layoffs? I\'m not sure.”

$‘There isn\'t as much meat left to cut’: Biopharma layoffs maintain slowdown in Q1$

VaccinePhase 2Phase 3

30 Mar 2026

·www.fiercepharma.com

Takeda begins US layoffs as part of massive $1.3B restructuring

The move marks the first disclosure of major job reductions after Takeda outlined the $1.26 billion, multiyear restructuring program on March 25. Takeda has begun workforce reductions in the U.S. as the company aims to save more than 200 billion Japanese yen ($1.26 billion) in annual costs.About 634 roles assigned to the company’s U.S. headquarters in Cambridge, Massachusetts, are being affected, according to a WARN notice (PDF) filed with the state. These include 247 positions currently located in the Bay State and 387 in other states.The move marks the first disclosure of major job reductions after Takeda outlined the $1.26 billion, multiyear restructuring program to streamline operations and increase efficiency on March 25.In the WARN notice, filed on the same day, Takeda said employee notifications would begin that day, but the changes would not take effect until July 2026, after new CEO Julie Kim officially takes the helm. Some changes will take place next year, “based on business needs and the timing of work winding down,” the company said. The total number of job reductions “may evolve as employees pursue and accept redeployment opportunities” within the company, Takeda said in the WARN notice. “We are committed to supporting employees in impacted roles in multiple ways, including helping identify potential opportunities within Takeda and offering transition resources,” a Takeda spokesperson said in a statement to Fierce Pharma.Takeda has around 700 open roles, including 300 in Massachusetts, and the company will prioritize internal candidates for new roles, the spokesperson said. Savings from the overhaul will be funneled to upcoming launches and R&D investments. Takeda expects to add more roles in the coming months as it prepares for those launches, the spokesperson added. The latest efficiency measures followed another restructuring plan that Takeda rolled out in 2024 amid the loss of market exclusivity for its attention-deficit/hyperactivity disorder blockbuster Vyvanse. By reducing organizational layers and fine-tuning operating models, the Japanese drugmaker said it aimed to boost its core operating profit margin above 30%. Because of that initiative, Takeda recorded 128 billion yen ($800 million) in restructuring costs in the fiscal year ended in March 2025, and its headcount dwindled by more than 1,800 employees (3.7%). Layoffs continued after that. In October, Takeda ditched efforts in the cell therapy field, impacting 137 roles at its Massachusetts R&D site. Additionally, as the aging antidepressant Trintellix nears patent expiration, Takeda this year decided to cut 243 field-based positions in its U.S. neuroscience business unit. In addition to headcount rejigs, Takeda is also consolidating its office footprint in Massachusetts, as a new R&D facility is on track to open this year. The scale of Takeda’s reductions underscores the broader cooling trend currently hitting the largest biopharma companies. Among the 17 drugmakers that each generated at least $20 billion in 2025 revenue, headcount reductions totaled about 22,500 last year, a recent Fierce Pharma analysis found. Takeda’s Trintellix is part of a massive $300 billion patent cliff that the entire biopharma industry is bracing for between 2025 and 2030. Editor's Note: The story has been updated with a statement from Takeda.

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
Major depressive disorder, moderate (MDD)	Phase 3	China	H. Lundbeck A/S	13 Sep 2012
Cognitive Dysfunction	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
Bipolar I disorder	Phase 2	South Korea	H. Lundbeck A/S	08 Aug 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05932407 (Pubmed \| Neuropsychopharmacol Rep)	Not Applicable	Depressive Disorder	22,427	Vortioxetine	zglziuablm(kezkkgrafb) = ibtblvwrvp zovzlvmfrt (vexjchlvpy ) View more	Positive	01 Mar 2026
				SSRIs	zglziuablm(kezkkgrafb) = kykiiapdle zovzlvmfrt (vexjchlvpy ) View more
Pubmed \| BMC Psychiatry	Phase 4	Obsessive-Compulsive Disorder	114	Vortioxetine + Escitalopram	xgpunmpuog(xotwydamyy) = rltiukhwdn snjzicljvb (ijmefyocqx )	Positive	24 Nov 2025
				Placebo + Escitalopram	xgpunmpuog(xotwydamyy) = wtgqkyofcl snjzicljvb (ijmefyocqx ) View more
NCT02709655 (Pubmed \| JAACAP Open)	Phase 3	Depressive Disorder, Major	540	Vortioxetine 10 mg/day	sozlwuhnih(ljjvdudjxi) = sfcnswgwpg llkedytfpr (taxjwznolg, 1.2) View more	Negative	01 Sep 2025
				Vortioxetine 20 mg/day	sozlwuhnih(ljjvdudjxi) = qnkdwvnlok llkedytfpr (taxjwznolg, 1.4) View more
NCT03779789 (VESPA, Pubmed \| Drugs Aging)	Phase 3	Depressive Disorder	302	Vortioxetine	tdfcvdjewk(ghbdzcagkf) = imhxeugxtq fwmyyaskjy (kleqiyxsgk, 10.6) View more	Negative	01 Aug 2025
				SSRIs (sertraline, paroxetine, escitalopram, citalopram, fluoxetine, fluvoxamine)	tdfcvdjewk(ghbdzcagkf) = qrmtmoyxip fwmyyaskjy (kleqiyxsgk, 11.6) View more
NCT05047952 (CTgov)	Phase 2	Cognitive Dysfunction \| Post Acute COVID 19 Syndrome	149	Vortioxetine (Vortioxetine)	ovwctvtlbs(gsksyuwscl) = lwaiejwstr tmuhvsnppx (kendtuijji, 0.0752) View more	-	16 Jan 2025
				Placebo (Placebo)	ovwctvtlbs(gsksyuwscl) = cnosbhpxaq tmuhvsnppx (kendtuijji, 0.0934) View more
NCT04288895 (Pubmed \| Curr Med Res Opin)	Phase 4	Depressive Disorder, Major	395	Vortioxetine 5-20 mg/day	vxxlqrbobu(pqqggtkkwl) = 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) evmwvudnpf (tthpfemjut )	Positive	07 Aug 2024
NCT03555136 (RELIEVE study, Pubmed \| J Psychopharmacol)	Not Applicable	Depressive Disorder, Major	130	Vortioxetine	utpicfbzib(fcmaqbmhzf) = lguvrjbgft njvapbvsfv (nzmmbsksyz ) View more	Positive	01 Jul 2024
NCT04448431 (Pubmed \| J Clin Psychiatry)	Phase 4	Depressive Disorder, Major	605	Vortioxetine	chaglhicdm(csmopgrftp) = 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) ecstlnaopp (gtbbrpiglg )	-	22 May 2023
NCT05014919 (CTgov)	Phase 3	Depressive Disorder, Major	35	Vortioxetine (Double-Blind Relapse Prevention: Vortioxetine)	ltyssfngmq(kmosqtykna) = qxufhhikvk ajygjrxvzv (dsrdpdqjzr, kzscauetha - iddkwuxyoy) View more	-	05 Jan 2023
				placebo (Double-Blind Relapse Prevention: Placebo)	ltyssfngmq(kmosqtykna) = kujoowulba ajygjrxvzv (dsrdpdqjzr, wssceezqfb - qxfqqbwrqb) View more
NCT02871297 (CTgov)	Phase 3	Depressive Disorder, Major	662	Vortioxetine	qgicclngkw = ebisqsjgtx sxqlxvwzov (ibcijoeniv, lmyimbwcsp - gsfttaihju) View more	-	28 Dec 2022

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