A Prospective, Open-label, Single-arm, Multicenter Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia

Schizophrenia is a long-lasting and serious mental health disorder that affects about 1% of people worldwide. It can cause symptoms such as hallucinations and delusions (called positive symptoms), confused or disorganized thinking, reduced motivation and emotional expression (negative symptoms), difficulties with memory and concentration (cognitive symptoms), and movement problems like restlessness or slowed activity. Current treatments, called antipsychotics, mainly work by blocking dopamine in the brain. These medicines are helpful for hallucinations and delusions, but they do little to improve negative or cognitive symptoms.
A new medicine, Xanomeline/Trospium (XT), works differently. It targets a brain system called the muscarinic acetylcholine receptors while limiting side effects elsewhere in the body. Clinical trials have shown that XT reduces psychotic symptoms effectively and is generally well tolerated. The FDA approved XT in 2024 for adults with schizophrenia. Importantly, early results also suggest that XT may help improve thinking and memory (cognition domains), though this has not yet been studied in depth.
Most schizophrenia drug studies pay little attention to long-term changes in cognition, often using only short screening tests. This study will be the first to take a deep look at cognitive function over a full year of XT treatment. It will also examine how changes in thinking skills connect with other aspects of life, such as symptom control, daily functioning, and quality of life. By making cognition a central outcome, the study responds to an urgent need in schizophrenia research: moving beyond just controlling hallucinations and delusions toward improving real-world recovery. The results could help shape future treatment strategies and support the idea that cognition should be a core treatment target in schizophrenia.

Start Date01 Jan 2027

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT07721272

/ Not yet recruitingEarly Phase 1IIT

Studying Human Cognition During Deep Brain Stimulation Surgery Using High-Density Neural Probes and Pharmacological Interventions

This is a research study to determine how COBENFY KarXT (FDA approved), a drug which has been approved for treatment of certain disorders, affects brain activity and cognitive tasks which may be regulated by the cholinergic system.
This study aims to answer: 1) how cholinergic circuitries act during task performance in humans, and 2) develop a better understanding of how cognitive control interacts with learning, memory and decision making in the setting of cholinergic manipulation.
Participants will complete a single treatment arm, regardless of which surgical procedure they are to receive. An anesthesiologist or other clinical staff will administer either the drug or the saline at a critical point which addresses the research questions, prior to patient surgery. This will be either with the drug, or the placebo pill. Half of the participants will be randomized to receive the drug, and the other half of these the placebo. Participants will be unaware whether the actual drug has been received.
Essential tremor patients who participate will complete a cognitive task during an awake surgery. Epilepsy patients who participate will have a resting state recording during the procedure from the deep cortical layers of the brain. A probe will be used during the surgery to measure the effects of this drug and other procedures of the study on the cholinergic system. This probe is the clinical probe known as the AlphaOmega, which is FDA approved for standard of care procedures.
Researchers will compare the brain activity between treatment arms to determine what brain activity changes based on the cholinergic manipulation.

Start Date01 Oct 2026

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

NCT07228338

/ Not yet recruitingEarly Phase 1IIT

Muscarinic Agonist Modulation of Memory Processing Oscillatory Activity

The goal of this study is to learn about the effects of Cobenfy KarXT (xanomeline and trospium chloride) on episodic memory processing, including specific effects on areas of the brain involved in memory and changes it may have on brain activity. The investigators will do this by testing epileptic patients who are already undergoing intracranial surgery for seizure monitoring, and measuring the activity from the brain areas being assessed.
The main questions it aims to answer are 1) whether Cobenfy KarXT changes memory activity based on its agonist effect on muscarinic receptors and acetylcholine, and 2) what the nature of these brain activity changes are. This work builds on previous experiments evaluating cholinergic antagonists.
Participants will complete two treatment arms. One of these will be with the drug, and the other will be with a placebo pill, so that the participants are unaware which session the actual drug has been received. Patients will complete a verbal serial recall and/or associative recognition task each of the two days. An anesthesiologist or patient nurse will administer either the drug or the placebo at a critical point which addresses both of the research questions.
Researchers will compare the brain activity between the two treatment arms to determine what brain activity changes, and whether there is an additional behavioral effect on memory.

Start Date01 Oct 2026

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

100 Clinical Results associated with Xanomeline Tartrate/Trospium Chloride

100 Translational Medicine associated with Xanomeline Tartrate/Trospium Chloride

100 Patents (Medical) associated with Xanomeline Tartrate/Trospium Chloride

Literatures (Medical) associated with Xanomeline Tartrate/Trospium Chloride

01 Jul 2026·PSYCHIATRY RESEARCH

A real-world pharmacovigilance study of Xanomeline-Trospium events in the FDA adverse event reporting system (FAERS)

Article

Author: Lin, Haiyan ; Qian, Hong ; Feng, Tianpu ; Ji, Jing ; Song, Xiaoxue

BACKGROUND:

Xanomeline-Trospium (Cobenfy®) improves cognitive function in schizophrenia, yet its post-marketing reporting patterns remain incompletely characterized. This hypothesis-generating pharmacovigilance study explores adverse event associations during its first year on market.

OBJECTIVE:

To characterize disproportionate reporting patterns and generate hypotheses for clinical monitoring strategies, acknowledging the inherent limitations of spontaneous reporting data.

METHODS:

Adverse event reports from Q4 2024-Q3 2025 were analyzed using disproportionality methods (ROR, PRR, BCPNN) and temporal distribution analysis. A dual-track approach incorporated both statistical signal detection (n ≥ 3) and descriptive surveillance of rare serious events (n < 3).

RESULTS:

Of 1142 reports, urinary and neurological events exhibited the strongest statistical disproportionality: urinary retention (ROR=45.63, 95% CI: 35.97-57.87) and hypersalivation (ROR=64.39, 95% CI: 43.25-95.85). Psychiatric events were frequently reported but showed weaker specificity, likely reflecting disease confounding rather than drug-induced effects. Treatment non-adherence showed elevated reporting (ROR=7.58), potentially associated with psychiatric symptomatology. Time-to-onset analysis suggested acute-phase reporting concentration (median 2 days; 45.4% of non-day-0 events occurring within days 1-7).

CONCLUSION:

These findings suggest disproportionate reporting patterns for urinary, neurological, and psychiatric events associated with Xanomeline-Trospium. While these signals warrant further validation through prospective cohort studies, they offer complementary real-world context for clinical decision-making. Active monitoring during initial treatment weeks may be prudent, particularly among patients with renal impairment or concomitant anticholinergic use.

02 Jun 2026·INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY

Efficacy and safety of the muscarinic receptor agonist KarXT (Xanomeline-Trospium) in schizophrenia: a systematic review, meta-analysis and Bayesian sensitivity analysis

Review

Author: Kaur, Mandeep ; R, Roopashree ; Bushi, Ganesh ; Prasad, Garbham Venkata Siva ; Kumar, Amit ; Satapathy, Prakasini ; Sharma, Nikhil ; Mehta, Rachana ; Barwal, Amit ; Mittal, Vinamra ; Srivastava, Manish ; Sah, Sanjit ; Rajput, Pranchal ; Shabil, Muhammed ; Khatib, Mahalaqua N

Abstract:

Background:

Schizophrenia significantly impacts global health, with existing treatments primarily focusing on positive symptoms and often causing considerable side effects. KarXT (Xanomeline-Trospium), a novel treatment combining xanomeline, a muscarinic M1/M4 receptor agonist, and trospium, targets a broader range of symptoms including negative and cognitive deficits, potentially with fewer side effects. This systematic review and meta-analysis evaluates the efficacy and safety of KarXT in treating schizophrenia, assessing symptom reduction and safety profiles compared to placebo.

Methods:

We searched PubMed, Embase, and Web of Science up to November 10, 2024, for randomized controlled trials (RCTs) assessing the efficacy and safety of KarXT in schizophrenia. Data were pooled using a random-effects model, assessing outcomes like Positive and Negative Syndrome Scale (PANSS) scores and incidence of treatment-emergent adverse events (TEAEs). R software (Version 4.4.) was used for meta-analysis.

Results:

Three RCTs involving 674 participants were included. KarXT significantly reduced total PANSS scores of mean difference (MD) –9.707 (95% CI: –12.329 to –7.085), with notable improvements in both negative (MD = –1.623; 95% CI: –2.461 to –0.785) and positive symptom subscales (MD = –3.213; 95% CI: –4.033 to –2.393). The treatment was associated with a higher incidence of TEAEs, predominantly constipation [risk ratio (RR): 2.77; 95% CI: 1.72–4.45] and nausea (RR: 4.87; 95% CI: 2.73–8.68) compared to placebo. Bayesian meta-analysis confirmed the results.

Conclusion:

KarXT offers significant improvements in both negative and positive symptoms of schizophrenia with a manageable safety profile. Its potential as a transformative treatment for schizophrenia highlights the need for further research to confirm these findings and to fully understand its long-term efficacy and safety.

01 Jun 2026·SCHIZOPHRENIA RESEARCH

Low incidence of extrapyramidal symptoms following treatment with a muscarinic agonist medication for schizophrenia

Review

Author: Marcus, Ronald ; Lin, Wei-Chih ; Watson, Carolyn ; Targum, Steven D ; Novak, Keisha D ; Kaul, Inder ; Claxton, Amy ; Nicolas, Pierre ; Marder, Stephen R ; Brannan, Stephen K ; Horan, William P

BACKGROUND:

Extrapyramidal symptoms (EPS) have long been associated with the use of antipsychotic medications. The etiology of EPS has often been attributed to dopamine D₂ receptor antagonism. Most currently available antipsychotics bind to the D₂ receptor, albeit with different affinities, and consequently yield different EPS risk. Some novel medications for schizophrenia do not directly affect dopaminergic systems at all. For instance, xanomeline, a preferential M₁ and M₄ muscarinic receptor agonist combined with trospium chloride (KarXT) is approved for the treatment of schizophrenia and has shown a lower EPS liability.

METHODS:

We conducted a comprehensive review of the cumulative data regarding the occurrence of EPS in several studies of KarXT in schizophrenia that included 3 double-blind, placebo-controlled hospital-based studies and 2 open-label outpatient studies. We also tracked the progression of EPS in a small subgroup of study participants who presented with EPS prior to randomization.

RESULTS:

A small proportion of individuals receiving KarXT reported EPS-related treatment-emergent adverse events (3.8% in the 3 combined double-blind studies and 2.6% in 2 open-label studies), and most instances were not considered study drug-related. Akathisia occurred in 2.4% of participants receiving KarXT in the double-blind studies, but only 0.6% of cases were attributed to KarXT, and most resolved within 1 day without concomitant medication. Further, preexisting EPS identified by EPS scales before initiating KarXT treatment, particularly akathisia, attenuated during the studies.

CONCLUSIONS:

Non-dopamine-focused medications like KarXT offer an effective, alternative treatment for schizophrenia with minimal EPS liability that may benefit individuals who require these medications.

354

News (Medical) associated with Xanomeline Tartrate/Trospium Chloride

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

28 May 2026

·www.biospace.com

Alto Neuroscience Appoints Karuna Therapeutics Founder Andrew Miller, Ph.D. to Board of Directors

Miller brings deep neuropsychiatry drug development and value creation experience, having led R&D at Karuna Therapeutics through its $14 billion acquisition by Bristol Myers Squibb MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- $anro #cns --Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced the appointment of Andrew Miller, Ph.D. to its Board of Directors, effective May 27, 2026. “We are thrilled to welcome Andrew to Alto’s Board at a transformative time for the Company,” said Amit Etkin, M.D., Ph.D., Founder and Chief Executive Officer of Alto Neuroscience. “Few leaders in our industry have done more to advance the science and commercial reality of new medicines for serious mental illness. Andrew’s firsthand experience translating novel neuropsychiatric mechanisms into approved therapies — and building a category-defining company around them — will be invaluable as we execute on our potentially pivotal Phase 2b trial of ALTO-207 in treatment-resistant depression and advance multiple additional readouts across our precision psychiatry pipeline.” “Psychiatry remains one of the largest areas of unmet medical need in all of healthcare. Far too many patients with depression, schizophrenia, and other serious mental illnesses are left without treatments that truly work for them,” said Dr. Miller. “Alto’s pipeline reflects a clear-eyed focus on changing that — advancing novel mechanisms with the potential to deliver substantially better outcomes. I’m honored to join the Board and look forward to helping the team realize that vision for patients.” Dr. Miller is a highly accomplished biopharmaceutical executive with expertise in neuropsychiatric drug development, corporate strategy, and value creation. Most recently, he was the Founder and President of R&D at Karuna Therapeutics, where he was the lead inventor of KarXT — now marketed by Bristol Myers Squibb as COBENFY® for the treatment of schizophrenia, the first novel mechanism approved in the indication in decades. He previously served as Karuna’s Chief Operating Officer, Chief Executive Officer, and as a member of its Board of Directors, guiding the company through its $14 billion acquisition by Bristol Myers Squibb in 2024. Dr. Miller was named to Time magazine’s 100 Next Generation Leaders and 100 Most Influential People in Healthcare for 2025. Dr. Miller currently serves as Chairman of the Board of Progentos Therapeutics and a member of the Board of Montara Therapeutics and as an advisor to GV (Google Ventures), General Atlantic, Vida Ventures, Longwood Fund, and the One Mind Foundation. He holds a Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology and a B.S. in Chemical Engineering from the University of Illinois at Urbana-Champaign. About Alto Neuroscience Alto Neuroscience, Inc. (NYSE: ANRO) 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’s product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in treatment-resistant depression, major depressive disorder, bipolar depression, 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 “expects,” “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 about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform (“Platform”); and Alto’s expectations with regard to the design, timing, and results of its clinical trials. 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 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, 2025 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. Contacts Investor & Media Contact Nick Smith Investors@altoneuroscience.com

22 May 2026

·www.biospace.com

Zai Lab Announces Changes to Senior Leadership Team - May 21, 2026

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced changes to its senior leadership team aimed at strengthening operational performance and efficiency. As part of these changes, the Board has made the decision that Josh Smiley, President and COO, will no longer be with the Company, effective Friday, May 22. "I want to thank Josh for his contributions to Zai Lab over the past three and a half years and wish him well in his future endeavors," said Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. Zai Lab anticipates multiple clinical data readouts in 2026 for its lead global investigational therapies, including zoci in first-line ES-SCLC and extrapulmonary NECs, and ZL-1503 (IL-13/IL-31Rα), with a first-in-human data readout from the global Phase 1/1b study. The company is also preparing for the launch of COBENFY™ in China and for multiple anticipated regional regulatory approvals and expected data readouts. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit or follow us at . Zai Lab Forward-Looking Statements This press release contains certain forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “poised,” “positioned,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and on the SEC’s website at . Contacts For more information, please contact: Investor Relations: Christine Chiou / Cyan Liu +1 (917) 886-6929 / +86 195 3130 8895 christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Executive Change

100 Deals associated with Xanomeline Tartrate/Trospium Chloride

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Schizophrenia	United States	Bristol Myers Squibb Co.	26 Sep 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autistic Disorder	Phase 3	United States	Bristol Myers Squibb Co.	11 Sep 2026
Autistic Disorder	Phase 3	Argentina	Bristol Myers Squibb Co.	11 Sep 2026
Autistic Disorder	Phase 3	Australia	Bristol Myers Squibb Co.	11 Sep 2026
Autistic Disorder	Phase 3	Canada	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	United States	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	Japan	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	Argentina	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	Australia	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	Canada	Bristol Myers Squibb Co.	11 Sep 2026
Irritable Mood	Phase 3	France	Bristol Myers Squibb Co.	11 Sep 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06572449 (CTgov)	Phase 3	Schizophrenia	173	KarXTdose+KarXT (Cohort 1)	nprxqdihsj = wwunytmqdp vtlsjzpeut (amocdpjzkh, tiwtmbfkkw - qizjbwimuq) View more	-	22 Jun 2026
				KarXT (Cohort 2)	nprxqdihsj = suodjnhqeh vtlsjzpeut (amocdpjzkh, wxwznxgzhd - exkfsfwrlr) View more
NCT05145413 (ARISE \| KAR-012, CTgov)	Phase 3	Schizophrenia	396	Placebo	ixqbojcpgc(kpwnpfouet) = pwngdeeohn xblwenktwu (gdysnuavto, 0.98) View more	-	05 May 2026
NCT05919823 (UNITE-001 \| ZL-2701-001, CTgov)	Phase 3	Schizophrenia	202	trospium+KarXT+xanomeline (Double-Blind Part: KarXT)	wcvvjghngy(sbuwgidnab) = nbuldtgven ssykreaasq (xccjqoxynt, 2.122) View more	-	21 Nov 2025
				placebo+KarXT (Double-Blind Part: Placebo)	wcvvjghngy(sbuwgidnab) = ixozwekcko ssykreaasq (xccjqoxynt, 2.074) View more
NCT03697252 (EMERGENT-4, Pubmed \| Ann Pharmacother)	Phase 3	Schizophrenia	-	Xanomeline-Trospium	hqgysvmerr(exjbkkiiuz) = dakvlmgnmi wttwwrvvlv (bqtilufoll )	Positive	01 Oct 2025
NCT04820309 (EMERGENT-5, CTgov)	Phase 3	Schizophrenia	566	Xanomeline and Trospium Chloride Capsules	hswnrhytwt = rtbwibcygv sagdajdrlx (kvdboxrpcc, bvlwbjnryp - whfpqcmdiu) View more	-	17 Sep 2025
NCT05145413 (ARISE \| KAR-012, Company_Website) Manual	Phase 3	Schizophrenia	-	Cobenfy + APD (mITT)	gkkdlxkiwt(rqclagnblv) = zjebidjhme xwalhekenv (syzlevzeao, 1.01) Not Met View more	Negative	22 Apr 2025
				Placebo + APD (mITT)	gkkdlxkiwt(rqclagnblv) = xpbfdmnbdz xwalhekenv (syzlevzeao, 0.98) Not Met View more
NCT04738123 \| NCT04659161 \| NCT03697252 (EMERGENT-2, Pubmed \| J Clin Psychiatry)	Not Applicable	Schizophrenia	683	Xanomeline/Trospium	dwkzrmeokd(xngrucsbmh) = xqsbvkomae keovsfsoun (zoqdiclxbm ) View more	Positive	26 Feb 2025
				Placebo	dwkzrmeokd(xngrucsbmh) = bducnmwmyk keovsfsoun (zoqdiclxbm ) View more
NCT04738123 (EMERGENT-3 \| EMERGENT-1, EMERGENT-2, EMERGENT-3, CTgov)	Phase 3	Schizophrenia	256	Xanomeline and Trospium Chloride Capsules (KarXT)	lxyozylris(evpktnufez) = ltbidmnlad ogmeiurcyh (ushunsxxrk, 1.584) View more	-	09 Dec 2024
				Placebo (Placebo)	lxyozylris(evpktnufez) = scocvcsnhi ogmeiurcyh (ushunsxxrk, 1.552) View more
NCT04820309 (EMERGENT-5, Company_Website) Manual	Phase 3	Schizophrenia	566	COBENFY	woymggrsbw(ksgtvpscdl) = aavzfkmbst dkashyqlbo (tizhumvxfb ) View more	Positive	31 Oct 2024
NCT04659174 (EMERGENT-4, Company_Website) Manual	Phase 3	Schizophrenia	156	COBENFY	myphvcquah(zavafhvedp) = gmsbalhavc nelenzcbea (ylogrxnvij )	Positive	31 Oct 2024
				Placebo	-

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