The clinical and cost effectiveness of quetiapine for people with borderline personality disorder: A pragmatic, double-blind, placebo-controlled, randomised trial

Start Date09 Feb 2026

Sponsor / Collaborator

The University of Liverpool

CTIS2025-522967-13-00

/ Not yet recruitingPhase 4IIT

A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.

Start Date19 Jan 2026

Sponsor / Collaborator

Fundación para la Investigación Biomédica del Hospital

100 Clinical Results associated with Quetiapine Fumarate

100 Translational Medicine associated with Quetiapine Fumarate

100 Patents (Medical) associated with Quetiapine Fumarate

6,762

Literatures (Medical) associated with Quetiapine Fumarate

01 Dec 2026·Journal of Clinical Sleep Medicine

Mortality in US veterans with insomnia, sleep apnea, and comorbid insomnia and sleep apnea (COMISA); an exploratory, hypothesis-generating cohort study

Article

Author: Sharafkhaneh, Amir ; Soltani, Pegah ; Kokonda, Manasa ; Azarian, Mehrnaz ; Sweetman, Alexander ; Wallace, Douglas ; Crew, Earl ; Buenaver, Luis ; Razjouyan, Javad

PURPOSE:

This study examined the association of insomnia, sleep apnea, and comorbid insomnia and sleep apnea (COMISA) with all-cause mortality in a large Veteran sleep clinic cohort.

METHODS:

We retrospectively identified Veterans with insomnia and/or SA using ICD-9/10 codes, requiring two diagnoses within 13 months (≥ 30 days apart). Insomnia cases also required relevant prescriptions and/or cognitive behavioral therapy for insomnia (CBT-I); SA cases required positive airway pressure prescriptions within three years. Patients were classified as insomnia only (INS), SA only, or COMISA. Adjusted odds ratios (aOR) for mortality were estimated using SA as the reference. Model 1 adjusted for age, sex, race, ethnicity, and Charlson Comorbidity Index (CCI); Model 2 additionally adjusted for trazodone and quetiapine; Model 3 additionally adjusted for benzodiazepines and benzodiazepine receptor agonists. Model 4 included all Model 3 covariates plus CBT-I.

RESULTS:

Among the 1,720,090 patients, 47.6% had SA (mean age 56.3 ± 13.7; 93.3% male; 69% White; 26.2% with CCI > 2), 41.1% had INS (mean age 57.0 ± 16.8; 87.1% male; 70.3% White; 25.4% with CCI > 2), and 11.2% had COMISA (mean age 51.9 ± 13.2; 89.4% male; 66.7% White; 19.6% with CCI > 2). Compared with SA, unadjusted ORs for mortality were 1.75 (95% CI: 1.73-1.76) for INS and 0.68 (95% CI: 0.67-0.69) for COMISA. Fully adjusted aORs were 1.51 (95% CI: 1.49-1.52) for INS and 0.79 (95% CI: 0.78-0.80) for COMISA.

CONCLUSION:

Among the Veterans referred to sleep clinics, insomnia alone was associated with the highest mortality, followed by SA, and the lowest in COMISA. These findings contrast with published studies and need to be seen considering the limitations of our approach, including the possibility that lack of a pre-specified hypothesis increases the risk of spurious findings.

STUDY RATIONALE:

Insomnia and sleep apnea commonly coexist as comorbid insomnia and sleep apnea (COMISA), which has been linked to increased mortality in population-based studies. Evidence from clinical cohorts, particularly among Veterans, remains limited.

STUDY IMPACT:

In this exploratory, hypothesis-generating large cohort of Veterans referred to sleep clinics, insomnia alone was associated with the highest mortality, followed by sleep apnea, and the lowest in COMISA. These results contrast with prior population studies and should be interpreted cautiously given study limitations (including possible chance findings without a pre-specified hypothesis), warranting confirmation.

01 Oct 2026·JOURNAL OF AFFECTIVE DISORDERS

Real-World treatment patterns in inpatients with newly diagnosed bipolar disorder in China: A descriptive longitudinal study

Article

Author: Xu, Ni ; Xie, Shuting ; Yang, Ruotong ; Yu, Huan ; Wang, Kun ; Li, Teng ; Zheng, Liuyan ; Hu, Yonghua ; Wu, Yiqun ; Yu, Xin ; Wu, Jingxian ; Chang, Zheng ; Wang, Huairong ; Chen, Yalin ; Lv, Xiaozhen

BACKGROUND:

Bipolar disorder imposes a substantial global health burden. While international clinical guidelines exist, real-world treatment patterns for bipolar disorder in China remains poorly characterized. This study aimed to characterize initial treatment selection, pharmacologic class distribution, and longitudinal prescription adjustments among inpatients with newly diagnosed bipolar disorder in Beijing, China, from 2010 to 2017.

METHODS:

A population-based longitudinal study was conducted utilizing data from the Beijing Medical Claim Data for Employees. We included 3034 inpatients newly diagnosed with bipolar disorder using ICD-10 code. We analyzed initial treatment patterns, annual prescription trends, and treatment modifications from the acute phase to maintenance phase.

RESULTS:

Over half (57.3%) of patients started on polypharmacy. Quetiapine was the most prescribed antipsychotic (43.8%), and lithium the most common mood stabilizer (37.7%). Alarmingly, the rate of treatment discontinuation reached 42.7% by the end of the first year after initiating treatment. Prescribing trends showed increasing use of aripiprazole and valproate over time. The high rate of antidepressant use (44.2% during follow-up) and significant treatment discontinuation highlight the complexity of real-world clinical management compared with international guideline recommendations.

CONCLUSIONS:

These findings highlight a gap between real-world practices and guideline recommendations, underscoring need for initiatives to promote evidence-based, continuous care for bipolar disorder management in China.

01 Sep 2026·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Shared and distinct effects of mood stabilizers on epigenetic machinery gene expression: an exploratory study in HeLa cells

Article

Author: Bellivier, Frank ; Marie-Claire, Cynthia ; Hennion, Vincent ; Rathes, Arthna ; Decleves, Xavier ; Puszkiel, Alicja ; Etain, Bruno ; Froelicher-Bournaud, Léo

Mood stabilizers (MS) are the cornerstone of maintenance treatment for bipolar disorder. However, their mechanisms of action remain only partially understood. Increasing evidence suggests that MS may exert part of their therapeutic effects through epigenetic modulations. In this exploratory study, we investigated the effects of therapeutic concentrations of six MS - valproic acid (VPA), lithium, lamotrigine, risperidone, aripiprazole, and quetiapine - on the expression of 82 genes involved in DNA methylations and histone modifications in HeLa cells. After seven days of exposure, VPA induced the most extensive transcriptional changes, with differential expression of 17 out of 82 genes, predominantly involved in histone modifications (acetylation, methylation, phosphorylation, ubiquitination). Notably, VPA upregulated HDAC1, HDAC2, HDAC9, HDAC11, KDM5B, and PAK1 mRNA levels with fold-changes >1.3. Corresponding increased protein levels were observed only for KDM5B and PAK1. VPA also induced direct inhibition of total HDAC activity, unlike lithium and quetiapine. Lithium and quetiapine upregulated HDAC2 and ESCO1 mRNA levels. Lithium and quetiapine did not modify HDAC2 protein levels. Other MS showed no significant transcriptional effects at day 7. Overall, MS-induced transcriptional changes were mainly restricted to genes involved in histone modifications, with minimal effects on DNA methylation-related genes. These findings suggest that MS, particularly VPA, modulate the transcription of epigenetic machinery genes in HeLa cells. HDAC2 upregulation may represent a shared transcriptional response across several MS, although the absence of consistent protein-level changes warrants caution. These results are exploratory and require replication in more physiologically relevant models to determine their biological and clinical significance.

News (Medical) associated with Quetiapine Fumarate

11 Jun 2026

·www.prnewswire.com

Agitation in Alzheimer's Disease Market to Register Immense Growth at a CAGR of 14.9% During the Forecast Period (2026-2036) | DelveInsight

The recent approval of Axsome Therapeutics' AUVELITY has transformed the agitation in Alzheimer's disease market. The emergence of investigational therapies, including IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), COBENFY (KarXT; xanomeline–trospium chloride) (Bristol Myers Squibb/Karuna Therapeutics), and others, is also transforming the agitation in Alzheimer's disease treatment landscape through novel and diverse mechanisms of action. These advancing therapies are anticipated to broaden available treatment choices and support the ongoing evolution of the market. LAS VEGAS, June 11, 2026 /PRNewswire/ -- Recently published Agitation in Alzheimer's Disease Market Insights report includes a comprehensive understanding of current treatment practices, agitation in Alzheimer's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Agitation in Alzheimer's Disease Market Summary The market size for agitation in Alzheimer's disease was found to be USD 600 million in the 7MM in 2025. The United States accounted for the largest agitation in Alzheimer's disease treatment market size, approximately 83% of the total market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The total number of diagnosed cases of agitation in alzheimer's in the 7MM is ~11 million in 2025. Leading agitation in Alzheimer's disease companies, such as IGC Pharma, Suven Life Sciences, Exciva GmbH, Bristol Myers Squibb, Karuna Therapeutics, and others, are developing new agitation in Alzheimer's disease treatment drugs that can be available in the agitation in Alzheimer's disease market in the coming years. The promising agitation in Alzheimer's disease therapies in clinical trials include IGC-AD1, Masupirdine (SUVN-502), EXV-801 ± Dextromethorphan, COBENFY (KarXT; xanomeline–trospium chloride), and others. Discover what is the future of the agitation in Alzheimer's disease treatment market @ Key Factors Driving the Growth of the Agitation in Alzheimer's Disease Market Rising Prevalence of Alzheimer's Disease: The increasing global burden of Alzheimer's disease is directly contributing to a larger patient pool experiencing agitation symptoms. In 2025, the total number of diagnosed cases of agitation in Alzheimer's disease in the 7MM was around 11 million. Among the 7MM countries, the US accounted for the highest number of diagnosed prevalent cases of Alzheimer's disease, contributing around 49%, while the UK reported the lowest number of cases in 2025. Increasing Awareness and Early Diagnosis: Growing awareness among caregivers, physicians, and healthcare organizations is improving recognition of neuropsychiatric symptoms in Alzheimer's disease. Entry of Axsome Therapeutics' AUVELITY: In April 2026, Axsome Therapeutics secured FDA approval for AUVELITY to treat agitation associated with Alzheimer's-related dementia, making it the first oral non-antipsychotic therapy approved for this indication. The approval was backed by the Phase 3 ADVANCE-1 and ACCORD-2 trials. Previously approved in 2022 for MDD, the label expansion significantly enhances AUVELITY's therapeutic and commercial potential. Emergence of Novel Therapies: The dynamics of the agitation in Alzheimer's disease market are expected to change in the coming years due to the launch of emerging therapies such as IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), COBENFY (KarXT; xanomeline–trospium chloride) (Bristol Myers Squibb/Karuna Therapeutics), and others. Ramandeep Singh, a neurology expert at DelveInsight, said that with increasing clinical and commercial momentum, the space is poised for substantial evolution, and by 2036, COBENFY is expected to emerge as the leading revenue-generating therapy across the 7MM for this indication. Agitation in Alzheimer's Disease Market Analysis Despite the immense burden of disease, the treatment landscape for agitation in Alzheimer's disease has long relied more on clinical improvisation than targeted therapeutic precision. Real-world prescribing patterns show that atypical antipsychotics account for the majority of treatments (55.5% of prescriptions), followed by selective serotonin reuptake inhibitors (SSRIs) at 29.3% and benzodiazepines at 23.2%, all prescribed off-label for this indication. Agents such as risperidone, quetiapine, olanzapine, and haloperidol have traditionally formed the backbone of management strategies, despite lacking formal approval for agitation in AD. Their widespread use has been accompanied by significant safety concerns, including sedation, falls, metabolic complications, cardiovascular risks, and notably, increased mortality among elderly patients. A major breakthrough came in 2023, when REXULTI (brexpiprazole), jointly developed by Otsuka Pharmaceutical and Lundbeck, became the first FDA-approved therapy specifically indicated for agitation associated with Alzheimer's dementia. Momentum in the field accelerated further in late April 2026, when Axsome Therapeutics secured FDA approval for AUVELITY (dextromethorphan hydrobromide/bupropion hydrochloride) for agitation associated with dementia due to Alzheimer's disease. The approval marked a significant milestone, making AUVELITY the first oral non-antipsychotic therapy approved for this condition. The emergence of AUVELITY represents more than a single product approval; it signals an increasingly competitive and innovation-driven market. Several promising candidates are advancing through the pipeline, including IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), and COBENFY (KarXT; xanomeline–trospium chloride) from Bristol Myers Squibb/Karuna Therapeutics, among others. Agitation in Alzheimer's Disease Competitive Landscape Some of the agitation in Alzheimer's disease drugs under development include IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), COBENFY (KarXT; xanomeline–trospium chloride) (Bristol Myers Squibb/Karuna Therapeutics), and others. IGC Pharma's IGC-AD1 (melatonin/tetrahydrocannabinol) is an investigational combination therapy for agitation linked to Alzheimer's disease. By integrating THC with melatonin, the therapy is designed to influence neuroinflammatory pathways, neuronal communication, and circadian rhythm regulation, to alleviate agitation and improve behavioral outcomes in patients who currently have limited therapeutic options. Suven Life Sciences' Masupirdine, a selective 5-HT6 receptor antagonist, represents a non-dopaminergic strategy aimed at stabilizing symptoms through serotonin pathway modulation. Its global Phase III study had reached nearly 50% enrollment by November 2025, and topline findings are expected in Q1/Q2 2027. Meanwhile, Bristol Myers Squibb/Karuna Therapeutics' COBENFY, which has already generated significant interest in schizophrenia treatment, is being explored for agitation in Alzheimer's disease via muscarinic receptor modulation, offering a cholinergic mechanism that may also support cognitive function. Exciva GmbH's EXV-802, an advanced Phase II/III neuroactive therapy candidate under investigation both as a standalone treatment and in combination with EXV-801 to address multiple CNS signaling pathways associated with agitation. This reflects an industry-wide move toward multi-target and combination-based therapeutic strategies intended to enhance efficacy while maintaining functional tolerability in complex neurobehavioral conditions. In November 2024, EXV-802 also received Fast Track Designation from the US FDA for the treatment of agitation associated with Alzheimer's disease. The anticipated launch of these emerging therapies are poised to transform the agitation in Alzheimer's disease market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the agitation in Alzheimer's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about which pipeline drugs could transform agitation in Alzheimer's disease treatment @ Agitation in Alzheimer's Disease Drugs Recent Developments in the Agitation in Alzheimer's Disease Market In April 2026, Axsome Therapeutics, Inc. announced that the FDA had approved AUVELITY for managing agitation linked to dementia caused by Alzheimer's disease. AUVELITY becomes the first treatment of its kind for Alzheimer's-related agitation, acting through modulation of the NMDA and sigma-1 receptors. In February 2026, IGC Pharma reported that approximately 70% of the planned enrollment in its ongoing randomized, double-blind, placebo-controlled Phase II CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer's disease had been completed. In November 2025, Suven Life Sciences reported that its global Phase III clinical trial of masupirdine (SUVN-502) achieved 50% patient enrollment for agitation in Alzheimer's disease, with the multicenter, randomized, double-blind, placebo-controlled study ongoing across North America and Europe. What is Agitation in Alzheimer's Disease? Agitation in Alzheimer's disease refers to a cluster of behavioral and emotional symptoms characterized by excessive restlessness, irritability, aggression, emotional distress, or inappropriate verbal and physical behaviors that occur in individuals with Alzheimer's-related dementia. It is one of the most common neuropsychiatric manifestations of the disease and can include pacing, shouting, resistance to care, wandering, verbal outbursts, or physical aggression. Agitation often arises from a combination of cognitive decline, impaired communication, environmental stressors, unmet physical or emotional needs, and underlying neurobiological changes associated with disease progression. These symptoms can significantly impair quality of life, increase caregiver burden, accelerate institutionalization, and complicate disease management, making agitation a major clinical challenge in Alzheimer's disease care. Agitation in Alzheimer's Disease Epidemiology Segmentation The agitation in Alzheimer's disease epidemiology section provides insights into the historical and current agitation in Alzheimer's disease patient pool and forecasted trends for the leading markets. According to DelveInsight's estimates, in the United States, diagnosed cases of agitation in Alzheimer's disease are predominantly made up of females, accounting for ~3 million cases in 2025. The agitation in Alzheimer's disease treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into: Total Diagnosed Prevalent Cases of Alzheimer's Disease. Total Diagnosed Prevalent Cases of Agitation in Alzheimer's disease. Gender-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's disease. Age-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's disease. Total Treated Cases of Agitation in Alzheimer's Disease Scope of the Agitation in Alzheimer's Disease Market Report Agitation in Alzheimer's Disease Patient Population Forecast Agitation in Alzheimer's Disease Therapeutics Market Size Agitation in Alzheimer's Disease Pipeline Analysis Agitation in Alzheimer's Disease Market Size and Trends Agitation in Alzheimer's Disease Market Opportunity Agitation in Alzheimer's Disease Market Unmet Needs KOL's Views on Agitation in Alzheimer's Disease Agitation in Alzheimer's Disease Market Access and Reimbursement Download the report to understand the top emerging therapies in agitation in Alzheimer's disease @ Agitation in Alzheimer's Disease Market Analysis Table of Contents Related Reports Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies, including Novo Nordisk, Eli Lilly, Suven Life Sciences, Bristol Myers Squibb, IGC Pharma, T3D Therapeutics, Lexeo Therapeutics, Axsome Therapeutics, Araclon Biotech S.L., Eisai, TauRx Therapeutics, GemVax & KAEL, AC Immune SA, Johnson & Johnson, Longeveron, Vaccinex, Sinaptica Therapeutics , and others. Alzheimer's Disease Clinical Trial Analysis Alzheimer's Disease Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Alzheimer's Disease companies, including Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., and others. Psychosis in Parkinson's and Alzheimer's Disease Market Psychosis in Parkinson's and Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psychosis in Parkinson's and Alzheimer's disease companies, including Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, Suven Life Sciences, Enterin, Intra-Cellular Therapies, Merck Sharp & Dohme, and others. Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, LLC, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

Phase 3Clinical ResultPhase 2Drug ApprovalFast Track

02 Jun 2026

·www.globenewswire.com

FundaMental Pharma appoints depression drug developer Dr. Hans Eriksson as Chief Medical Officer to advance its lead treatment-resistant depression candidate

Exceptional track record across multiple clinical development programs for depression, three of which have resulted in regulatory approvalsAppointment strengthens confidence in clinical readiness and execution as the Company progresses toward first-in-human development HEIDELBERG, Germany, June 02, 2026 (GLOBE NEWSWIRE) -- FundaMental Pharma GmbH (or “the Company”), a preclinical-stage biopharmaceutical company focused on developing innovative, dual-acting N-methyl-D-aspartate receptor (NMDAR) modulators aimed at delivering rapid and sustained relief for patients with treatment-resistant depression (TRD), today announces the appointment of Dr. Hans Eriksson as Chief Medical Officer. Dr. Eriksson brings more than 25 years of clinical development experience across pharma and biotech, including leading clinical development programs at AstraZeneca, Lundbeck, Compass Pathways and HMNC Brain Health. He has contributed to eight late-phase clinical development programs in depression, three of which resulted in regulatory approvals for Major Depressive Disorder (MDD). Most recently, Dr. Eriksson served as Chief Medical Officer at HMNC Brain Health, where he led the clinical development of Ketabon (KET01), an oral prolonged‑release formulation of ketamine for MDD and TRD. Before this, he was Chief Medical Officer at Compass Pathways, where he led the clinical development of psychedelic treatment, psilocybin (COMP360), for TRD. Dr. Eriksson has held senior clinical research and leadership roles at AstraZeneca, where he was the global medical lead for Seroquel, Seroquel XR and TC5214, and at Lundbeck, where he was the clinical lead for the co-development of brexpiprazole for depression. Dr. Eriksson holds an MD and PhD from Lund University in Sweden and an Executive MBA from the Stockholm School of Economics and has a clinical background as a consultant psychiatrist working with patients with depression and schizophrenia. Dr. Dirk Beher, Chief Executive Officer of FundaMental Pharma, said: “Hans brings an exceptional track record in depression drug development across both pharma and biotech, with direct experience advancing programs through late-stage development and ultimately to market. His depth of expertise will be critical to our mission as we work to overcome the challenges of treatment-resistant depression and progress into the clinic.” Dr. Hans Eriksson, newly appointed Chief Medical Officer of FundaMental Pharma, commented: “FundaMental Pharma’s approach has the potential to offer a truly differentiated therapy option for patients living with treatment-resistant depression. FMP374 addresses a significant unmet medical need and has demonstrated a compelling preclinical profile. I am excited to be working with the team to prepare this innovative therapy for clinical development.” As Chief Medical Officer, Dr. Eriksson will have overall responsibility for the Company’s clinical strategy for FMP374 aimed at rapid value generation, and supporting scientific and clinical engagement with investors and partners. Dr. Eriksson’s appointment comes as FundaMental Pharma accelerates preparations for IND‑enabling studies of FMP374, an orally bioavailable, dual‑acting NMDAR modulator that uniquely combines disruption of the NMDAR/TRPM4 complex with NMDAR antagonism. This differentiated mechanism is designed to enhance antidepressant efficacy while avoiding the exaggerated NMDAR pharmacology that limits the current standard of care. Members of the FundaMental Pharma leadership team will be attending BIO International Convention 2026, taking place 22–25 June in San Diego, US. To schedule a meeting, please contact info@fundamentalpharma.com. For more information, please contact: FundaMental PharmaCEO, Dr. Dirk Beherinfo@fundamentalpharma.com Optimum Strategic CommunicationsZoe Bolt, Elena Bates, Nellie Stephens+44 (0) 203 882 9621fundamentalpharma@optimumcomms.comAbout FundaMental Pharma FundaMental Pharma GmbH is a preclinical, biopharmaceutical company committed to advancing mental health by addressing treatment-resistant depression (TRD). FundaMental Pharma is headquartered in Heidelberg, Germany, and its research builds on the pioneering work of Professor Hilmar Bading and Dr. Jing Yan, published in Science (Yan et al., 2020), leading to the development of proprietary dual-acting N-methyl-D-aspartate receptor (NMDAR) modulators. These dual-acting molecules uniquely disrupt the complex formed between NMDAR and the transient receptor potential cation channel subfamily M member 4 (TRPM4), while simultaneously acting as potent NMDAR antagonists. FMP374 has shown robust antidepressant‑like efficacy at low nanomolar unbound drug concentrations, without evidence of dissociation‑associated behaviors, ataxia, or hyperactivity at efficacious doses in preclinical proof-of-concept studies, supporting its potential as an at‑home therapy. The molecule is orally bioavailable and ready for IND‑enabling studies. Through its innovative, neurobiology‑driven approach, FundaMental Pharma aims to redefine the treatment paradigm for TRD and meaningfully improve outcomes for patients with severe unmet medical needs. For further information, please visit https://fundamentalpharma.com/.

Executive Change

26 May 2026

·allsci.com

Autobahn’s CNS thyroid hormone receptor agonist earns FDA Fast Track designation for bipolar depression

Autobahn Therapeutics, a San Diego-based biotechnology company, announced receipt of US FDA Fast Track Designation for elunetirom (ABX-002), an oral, once-daily, brain-penetrant CNS thyroid hormone receptor (CNS-TR) agonist, for the adjunctive treatment of depressive episodes associated with bipolar I or bipolar II disorder in adults. Elunetirom is the company’s lead asset and has no prior expedited designations on record. Fast Track Designation allows Autobahn more frequent interactions with the US FDA during development and makes elunetirom eligible for Rolling Review of a future marketing application, as well as potential Priority Review and Accelerated Approval if relevant criteria are met at submission. Elunetirom is a small molecule prodrug designed to selectively engage CNS-TRs while limiting peripheral thyroid hormone receptor activity — the principal liability associated with systemic synthetic thyroid hormone administration, such as triiodothyronine (T3). T3 has demonstrated efficacy across multiple placebo-controlled studies in major depressive disorder (MDD) and bipolar depression, providing a validated biological rationale for the CNS-TR target. Elunetirom’s CNS-selective design is intended to capture that activity while avoiding cardiac, bone, and metabolic effects linked to peripheral thyroid hormone exposure. The company’s Phase II AMPLIFY-BD trial (NCT06869187), evaluating elunetirom as an adjunctive bipolar depression treatment, is ongoing, with topline data expected in Q2 2026. A parallel Phase II AMPLIFY trial (NCT06633016) in adjunctive MDD is also active, with topline data expected in Q3 2026. The most recent public clinical data for elunetirom come from a first-in-human Phase I single- and multiple-ascending dose study in healthy volunteers, results from which were presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in May 2025. The Phase I data showed no serious adverse events across all dose cohorts, dose-proportional pharmacokinetics supporting once-daily dosing, and evidence of CNS-TR target engagement in brain regions associated with depression. Research context Bipolar depression affects approximately 7 million adults in the US. Approved adjunctive options include quetiapine, lurasidone, cariprazine, and the olanzapine-fluoxetine combination, each carrying liabilities that include weight gain, metabolic effects, movement disorders, and sexual dysfunction. More than half of patients do not achieve adequate relief on available therapies, and the standard of care has not materially changed in decades. Elunetirom’s CNS-TR agonist mechanism is without an approved comparator in psychiatry. Unlike atypical antipsychotics, which act primarily through dopamine and serotonin receptor modulation, elunetirom targets mitochondrial function, cellular energy production, and neuroplasticity through CNS-TR agonism — a distinct biological pathway. No other CNS-selective thyroid hormone receptor agonist is currently approved or, based on available public data, in late-stage development for bipolar depression. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

100 Deals associated with Quetiapine Fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
D00458	Quetiapine Fumarate	N05AH04	DB01224

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bipolar and Related Disorders	Japan	Kyowa Pharmaceutical Industry Co., Ltd.	03 Jul 2017
Depressive Disorder, Major	United States	CHEPLAPHARM Arzneimittel GmbH	02 Dec 2009
Bipolar Disorder	United States	CHEPLAPHARM Arzneimittel GmbH	26 Sep 1997
Schizophrenia	United States	CHEPLAPHARM Arzneimittel GmbH	26 Sep 1997

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Marijuana Abuse	Phase 3	Germany	AstraZeneca PLC	01 Sep 2009
Endogenous depression	Phase 3	Spain	AstraZeneca PLC	01 May 2009
Depressive Disorder, Treatment-Resistant	Phase 3	Australia	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	Austria	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	Belgium	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	Bulgaria	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	Denmark	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	Germany	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	Hungary	AstraZeneca PLC	01 Nov 2008
Depressive Disorder, Treatment-Resistant	Phase 3	Italy	AstraZeneca PLC	01 Nov 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01858948 (CTgov)	Phase 3	Bipolar Disorder \| Metabolic Syndrome	19	Placebo+Quetiapine fumarate	lgkztgljzp(veetuihnbe) = qksfdcaoka wcvqmaoycc (ykefdhjtvx, 7.4) View more	-	25 Nov 2022
NCT02845453 (CTgov)	Phase 4	Bipolar Disorder \| Substance Abuse	24	Quetiapine (Quetiapine)	uazaelvtkd(mogmywhzne) = qzerofliba ubopoyyebg (pgrgxddstx, 6.9) View more	-	18 Apr 2022
				Placebo (Placebo)	uazaelvtkd(mogmywhzne) = fjpfdilngg ubopoyyebg (pgrgxddstx, 6) View more
NCT00688818 (Pubmed \| J Clin Psychiatry)	Not Applicable	Depressive Disorder \| Anxiety Disorders Add-on	76	Quetiapine XR	phvkodkbwm(kocnmephtd) = slwkgwirep tdljplpdos (juugeqebuv, -7.41 to -0.64) View more	Positive	21 Mar 2022
NCT03568500 (CTgov)	Phase 4	Schizoaffective disorder \| Schizophrenia	44	Digital Medicine System+Aripiprazole (Aripiprazole)	zovzlnqwfr(nxmzxtdmye) = tzqhuxcqqa zlkocgawfo (wuwawbgnru, nzkgmslnkm - ysswdtugdx) View more	-	16 Jul 2020
				Digital Medicine System+Olanzapine (Olanzapine)	zovzlnqwfr(nxmzxtdmye) = ejxoaifszz zlkocgawfo (wuwawbgnru, mdmcvdztuf - myameudpyf) View more
NCT00579280 (CTgov)	Phase 4	Bipolar Disorder \| Panic \| Panic Disorder ... View more	224	quetiapine SR (Quetiapine SR)	lmbqgdtpvo(enhhxgiofh) = jooplumkjl onfbidrnvj (ddwsjxjjwv, 0.62) View more	-	11 Jun 2020
				divalproex sodium ER (Divalproex Sodium ER)	lmbqgdtpvo(enhhxgiofh) = lwerhsnsik onfbidrnvj (ddwsjxjjwv, 0.63) View more
NCT01725308 (Pubmed \| Clin Ther)	Phase 2/3	Bipolar Disorder	322	Quetiapine XR 150 mg	niwwxzqzxv(oikmmjvndc) = qpncuolqia ardlrqyzdj (ptgoebcfqe )	-	06 Jun 2020
				Quetiapine XR 300 mg	niwwxzqzxv(oikmmjvndc) = hqpehcxfcd ardlrqyzdj (ptgoebcfqe )
NCT01119014 (TEA, Pubmed \| J Am Acad Child Adolesc Psychiatry)	Phase 4	Psychotic Disorders	113	Quetiapine-Extended Release	gfovhqjgrv(nxoeiwgoav) = psnhlkkkfs meoagulert (xgcjujhyqe, 3.92 - 5.83)	Negative	01 Nov 2019
				Aripiprazole	gfovhqjgrv(nxoeiwgoav) = xddmiymswf meoagulert (xgcjujhyqe, 0.97 - 2.97)
NCT00515723 (Glulipid, CTgov)	Not Applicable	Diabetes Mellitus, Type 2 \| Schizoaffective disorder \| Schizophrenia ... View more	96	Olanzapine (Olanzapine)	lmnfztkgfs(ttjaaelmoz) = vxrcswytay cvkggokiod (fkdonkgyki, 2.48) View more	-	02 Oct 2019
				risperidone (Risperidone)	lmnfztkgfs(ttjaaelmoz) = xvlglkjypo cvkggokiod (fkdonkgyki, 2.64) View more
NCT00518973 (CTgov)	Not Applicable	Anorexia Nervosa	21	Placebo (Placebo)	lqdojadjvc(czjhsylqgo) = mfoebiwwfm irkmmpyprf (jsdruqlcrm, NA) View more	-	17 Jul 2019
				Quetiapine (Quetiapine)	lqdojadjvc(czjhsylqgo) = uxyrjroitr irkmmpyprf (jsdruqlcrm, NA) View more
NCT00457366 (CTgov)	Phase 4	Agitation	72	Quetiapine	ipaykxueqy(vtaimehzqd) = lxttouhzeu ogzimdrfpd (myhtcntzka, 0.69) View more	-	05 Jul 2019

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