Trospium Chloride

iStock, PCH-Vector Despite the recent emergence of a new drug class, schizophrenia remains one of the most challenging neuropsychiatric diseases to treat—and Cobenfy’s first steps into the market indicate there is still room to grow. When the FDA greenlit Bristol Myers Squibb’s Cobenfy in 2024 as the first novel drug for schizophrenia in 35 years, it was widely seen as a turning point in treating the intractable neuropsychiatric disease. But with the drug struggling out of the gate and a still imperfect side effect profile, there is plenty of room for improvement—and competitors. “The magnitude of our effect is deep,” Laura Gault, senior vice president and head of neuroscience development at BMS, told BioSpace in an interview . “Cobenfy is a novel [mechanism of action] with a very different side effect pro to what people have been using for the last 75 years.” Cobenfy—formerly KarXT—is a combination of xanomeline, a muscarinic agonist, and trospium chloride, also a muscarinic antagonist, that came to BMS in the $14 billion acquisition of Karuna Therapeutics in 2023. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); However, side effects are still a part of the Cobenfy story, particularly with regard to pro-cholinergic symptoms that impact the gastrointestinal system, according to Christopher Kroeger, CEO of MapLight Therapeutics, which is also developing a muscarinic receptor agonist and hopes to compete with BMS’s first-to-market entry. “The challenge with Cobenfy has been that it is not proven to be particularly tolerable,” Kroeger told BioSpace . Because the components of the drug “have to be in exquisite balance, you can have high interpatient variability.” Two years in, however, BMS has already heard a lot of success stories, Gault said, where even after a short time on treatment, patients are seeing “very meaningful changes in terms of a reduction in symptoms, but also their ability to engage in life in a way that they had been unable to do.” Sales numbers, however, reflect a smaller splash. Cobenfy brought in $155 million in sales for BMS in 2025, well below some analysts’ predictions during the drug’s late phase development at Karuna. Early sales forecasts for Cobenfy were more than double this number, Mizuho analyst Graig Suvannavejh told BioSpace . Still, Gault said BMS isn’t concerned with the slow start. Since re-entering the neuroscience space with its $74 billion mega-merger with Celgene in 2019, the company has built up its acumen in the arena, which has enjoyed something of a Big Pharma renaissance over the past few years. “Anytime you bring a new drug, especially a drug with a new [mechanism of action], into the field … [doctors] need to take some time to get to know it,” Gault said.“They need to see those first few experiences with their own eyes before they feel confident to prescribe it regularly.” Suvannavejh agreed that with schizophrenia in particular, requiring a “Goldilocks approach” to balance side effects and efficacy, Cobenfy has strong potential. “I do think Cobenfy can be a good drug,” he said. Schizophrenia FDA Approves First Novel Schizophrenia Drug in 35 Years BMS’ KarXT targets muscarinic receptors and “is at least 2-3 years ahead of the competition” including AbbVie and Neurocrine Biosciences, Truist Securities wrote in a note to investors. September 27, 2024 · 8 min read · Heather McKenzie Read more A balancing act In schizophrenia, decades of treatment have laid bare the challenges inherent in the disease—and the tightrope drug developers must walk between efficacy and tolerability. Older drugs that primarily affect the brain’s dopamine receptor leave patients with “very potent, very harsh side effects,” Suvannavejh said. From earlier medicines like Eli Lilly’s Zyprexa to Johnson & Johnson’s Risperdal to next generation antipsychotics such as BMS’ Abilify and more recently, AbbVie’s Vraylar and J&J’s Caplyta, the mechanism of action remained the same despite differences in potency. “These are just different mousetraps with the same biology, trying to optimize efficacy and safety tolerability,” Suvannavejh said. Enter muscarinics. Marked by sizable acquisitions, including BMS’s purchase of Karuna and AbbVie’s $8.7 billion pick-up of Cerevel Therapeutics in 2023 and emraclidine—which ultimately led to a high-pro failure in schizophrenia—muscarinic receptor inhibitors gained a good deal of attention for their potential to avoid some of the worst side effects of drugs targeting the dopamine receptors. In addition to MapLight, AbbVie continues to progress emraclidine in Phase 2 , while smaller biotechs like Neurocrine BioSciences and Neumora Therapeutics are also hoping to challenge BMS in the muscarinic space. Because muscarinic receptors are not expressed in key brain regions, patients avoid many of the side effects associated with the classic dopamine-based drugs, Carlos Dortrait, senior vice president of neuroscience commercialization and global commercial strategy, told BioSpace prior to Cobenfy’s approval. But Cobenfy’s main muscarinic agonist xanomeline comes with other adverse effects, primarily gastrointestinal, which require an additional ingredient to balance them out and avoid conditions that can lead to poor patient compliance—already a challenge among those with schizophrenia or Alzheimer’s disease psychosis, Suvannavejh said. MapLight hopes to differentiate and challenge Cobenfy on a couple of fronts. MapLight posted mixed trial results from a Phase 2 trial of its candidate earlier this month, garnering significant scrutiny from analysts. The results for ML-007-MA “muted” the competitive threat to Cobenfy, BMO Capital Markets said in a note to investors on July 27. Neuroscience MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb’s Cobenfy is likely to hold its market share. July 27, 2026 · 2 min read · Michael Gibney Read more A twice-daily formulation of MapLight’s ML-007C-MA met the Phase 2 ZEPHYR trial’s primary endpoint, reducing symptoms of schizophrenia on the Positive and Negative Syndrome Scale (PANSS) at five weeks, with patients seeing a 4.5-point improvement. However, a once-a-day version of the pill that the company hoped would rival Cobenfy’s twice-daily regimen failed to meet the same expectation. Cobenfy demonstrated an 8-to-10-point reduction in a pair of Phase 3 trials dubbed EMERGENT, according to BMO. Still, Kroeger believes MapLight showed what it needed to earn a place next to Cobenfy on the market. He additionally argued that the results have been “misinterpreted” in the public sphere. The misinterpretation, he said, stems from trying to compare specific PANSS scores across trials and ignoring aspects that are important in the real world, such as cognition and a secondary endpoint measuring clinicians’ global impression of disease severity. MapLight’s drug also demonstrated important signals in cognition, according to Kroeger. While PANSS measures alleviation of so-called positive symptoms such as hallucination, delusion and disordered thinking and negative symptoms including apathy, withdrawal and lack of engagement with the world, 80% of patients with schizophrenia also suffer from cognitive challenges that have a meaningful impact on quality of life, the CEO noted. Unlike Cobenfy—whose cognitive signal data were drawn from post-hoc pooled analyses, according to a MapLight spokesperson—ML-007C-MA hit a prespecified secondary endpoint in the ZEPHYR trial, which looked at cognitive performance. Cobenfy’s market challenges are an opportunity for MapLight to showcase “significant differences in safety we’ve seen in the clinic [that are] going to be even larger when we get to real-world experience,” Kroeger said. “The whole idea was to develop a drug that can give you the same kind of efficacy that Cobenfy delivered in a way that patients can tolerate,” Kroeger said. “And that’s what we showed in the study.” Rates of discontinuation in MapLight’s program were lower than with Cobenfy, Kroeger said, attributing this result to fewer moderate and severe adverse events despite instances of mild side effects such as nausea and vomiting. BMO in its note conceded this point, writing that MapLight’s pill could be more impactful in older adults with schizophrenia alongside Alzheimer’s disease due to lower rates of symptoms such as dry mouth, blurry vision and constipation. MapLight saw a GI discontinuation rate of just 2% in ZEPHYR, the biotech reported. However, BMO said the effect will likely not be enough to derail Cobenfy’s leadership from a market share perspective. Comparing across clinical trials from different drugmakers is messy at best, Suvannavejh said. While acknowledging that MapLight’s “efficacy seemed to fall short of what was shown in the Karuna clinical trials,” the analyst said that given the high unmet need in schizophrenia, there’s room for more than just one or two of the same kind of drug. “Just because we have one muscarinic right now in Cobenfy doesn’t mean there can’t be another five more,” Suvannavejh said.

The Alzheimer's disease market dynamics are anticipated to change due to the expected launch of emerging therapies, such as Masupirdinea (Suven Life Sciences), Trontinemabb (Roche), Buntanetap (Annovis bio), Masitinib (AB Science), Remternetug (Eli Lilly), AUVELITY (AXS-05) (Axsome Therapeutics), Bezisterim (NE3107) (Biovie), Valiltramiprosate (ALZ-801) (ALZHEON), Hydromethylthionine mesylate (HMTM) (TRx0237) (TauRx Therapeutics), COBENFY (KarxXT) (Bristol Myers Squibb), AR1001d (AriBio), Remlifanserin (ACP ‑ 204) (Acadia Pharmaceuticals), Tricaprilin (Cerecin), and others, and others. LAS VEGAS, Aug. 6, 2026 /PRNewswire/ -- The Alzheimer's disease treatment landscape is experiencing a major transformation with the introduction of disease-modifying therapies that target fundamental disease mechanisms, particularly amyloid-β pathology. Among these, LEQEMBI (lecanemab) has become a leading biologic for patients with early-stage Alzheimer's disease, demonstrating its ability to slow cognitive and functional deterioration in biomarker-confirmed individuals. Regulatory approvals across key global markets have strengthened the shift toward earlier diagnosis, timely intervention, and biologically targeted treatment approaches. Furthermore, the approval of LEQEMBI IQLIK, a subcutaneous maintenance formulation, is anticipated to enhance patient convenience by allowing at-home or simplified administration, reducing reliance on infusion-based therapy. Likewise, KISUNLA (donanemab) has emerged as another important anti-amyloid monoclonal antibody, offering clinically meaningful reductions in disease progression while distinguishing itself through the potential to discontinue treatment after achieving amyloid plaque clearance. Discover more about the Alzheimer's disease therapeutics market @ While disease-modifying biologics are reshaping therapeutic strategies, symptomatic treatments remain integral to the clinical management of Alzheimer's disease. ZUNVEYL (benzgalantamine), a next-generation oral acetylcholinesterase inhibitor (AChEI), has been developed to improve gastrointestinal tolerability and long-term treatment adherence. Similarly, ALLYDONE transdermal donepezil patches provide an alternative drug delivery option designed to improve compliance, particularly among elderly patients. In addition, REXULTI (brexpiprazole) has broadened the treatment landscape by addressing agitation associated with Alzheimer's disease dementia, reflecting the growing emphasis on managing both cognitive impairment and neuropsychiatric symptoms. Collectively, the combination of disease-modifying monoclonal antibodies with enhanced symptomatic and behavioral therapies is expected to redefine Alzheimer's disease management by promoting earlier intervention, personalized care, and a more comprehensive treatment approach. Sadaf Javed, Functional Head of Forecasting & Analytics at DelveInsight, said there is an opportunity for companies to conduct trials evaluating safer therapies with convenient patient doses at low cost that can enhance treatment compliance and adherence. Beyond currently available therapies, the late-stage Alzheimer's disease pipeline continues to diversify, with multiple investigational candidates employing mechanisms that extend beyond conventional amyloid-focused strategies, highlighting the field's evolving emphasis on targeting complementary pathological pathways. Key candidates include Masupirdinea (Suven Life Sciences), Trontinemabb (Roche), Buntanetap (Annovis bio), Masitinib (AB Science), Remternetug (Eli Lilly), AUVELITY (AXS-05) (Axsome Therapeutics), Bezisterim (NE3107) (Biovie), Valiltramiprosate (ALZ-801) (ALZHEON), Hydromethylthionine mesylate (HMTM) (TRx0237) (TauRx Therapeutics), COBENFY (KarxXT) (Bristol Myers Squibb), AR1001d (AriBio), Remlifanserin (ACP ‑ 204) (Acadia Pharmaceuticals), Tricaprilin (Cerecin), and others. Reflecting sustained innovation and expanding commercial opportunities, DelveInsight estimates that the Alzheimer's disease market across the seven major markets, comprising the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 4 billion in 2025. The market is projected to expand at a CAGR of 22.7% during the forecast period through 2036, driven by increasing disease prevalence, broader adoption of disease-modifying therapies, advancements in biomarker-based diagnosis, and a robust late-stage pipeline focused on improving clinical outcomes. Below, we highlight 6 emerging late-stage therapies poised to enter the Alzheimer's disease therapeutics market. Suven Life Sciences' Masupirdine 5-HT6 antagonist Masupirdine (SUVN-502) is an investigational small-molecule candidate from Suven Life Sciences that is being developed to treat cognitive impairment and neuropsychiatric manifestations, particularly agitation, in patients with Alzheimer's disease. As a highly selective serotonin 5-HT6 receptor antagonist, Masupirdine is designed to enhance the release of neurotransmitters involved in cognition and behavioral regulation, to improve cognitive performance as well as neuropsychiatric symptoms. In contrast to conventional treatment approaches that may be associated with sedation, Masupirdine is intended to offer a non-sedating therapeutic option by selectively modulating central serotonergic pathways. The therapy is being investigated to address significant unmet needs in Alzheimer's disease, especially for agitation and aggression, where effective and well-tolerated treatment options remain limited. Masupirdine is currently being assessed in a global Phase III clinical trial evaluating its efficacy in treating agitation associated with Alzheimer's disease dementia. The study is expected to conclude by the end of 2026, with topline results anticipated during the first half of 2027. In June 2026, Suven Life Sciences announced encouraging results from a pre-specified interim analysis and an independent review by the Data and Safety Monitoring Board (DSMB), supporting the continuation of the Phase III development program. According to Javed, Masupirdine has demonstrated a favorable safety and tolerability profile, reinforcing its potential as a therapeutic candidate. However, its ultimate success will depend on optimized clinical trial execution and appropriate patient selection. While the therapy holds considerable promise, additional clinical validation will be essential to confirm its efficacy and support future regulatory approval. Roche's Trontinemab Aβ-protein Inhibitors Trontinemab (RG6102) is an investigational bispecific monoclonal antibody engineered with Brainshuttle technology to enhance the delivery of anti-amyloid therapies across the blood–brain barrier for the treatment of Alzheimer's disease. It selectively binds aggregated amyloid-beta (Aβ) and is designed to promote rapid and robust clearance of amyloid plaques from the brain. The therapy integrates an anti-Aβ antibody with Roche's proprietary Transferrin Receptor 1 (TfR1)-mediated Brainshuttle platform, which improves transport into the central nervous system. By increasing brain exposure at lower doses than conventional anti-amyloid antibodies, trontinemab has the potential to accelerate and enhance amyloid plaque removal. This improved brain penetration may amplify the disease-modifying effects of amyloid-targeting therapies and help slow the progression of Alzheimer's disease. According to Roche, regulatory filings for trontinemab are currently expected after 2028. Explore more about recent advancements in Alzheimer's disease-modifying treatments @ Timeline of Alzheimer's Disease Treatment Axsome Therapeutics' AXS-05 NMDA receptor Antagonist AXS-05 is an investigational oral therapy engineered with a multimodal mechanism of action to address disorders of the central nervous system (CNS). It combines dextromethorphan and bupropion in a proprietary formulation that is designed to optimize the pharmacological activity of dextromethorphan. As part of its mechanism, dextromethorphan acts as both an N-methyl-D-aspartate (NMDA) receptor antagonist and a sigma-1 receptor agonist, helping regulate glutamatergic signaling and neuronal communication implicated in CNS disorders. The NMDA receptor is essential for synaptic function, learning, memory, and neuronal plasticity, and abnormalities in this pathway have been linked to a range of neurodegenerative and neuropsychiatric conditions. By modulating these signaling pathways, AXS-05 represents a promising therapeutic approach for disorders associated with cognitive dysfunction and behavioral disturbances. The therapy is currently under clinical investigation for several indications, including agitation related to Alzheimer's disease and smoking cessation. While these uses have not yet been approved by the U.S. FDA, AXS-05 has received Breakthrough Therapy Designation for the treatment of agitation associated with Alzheimer's disease. This designation highlights its potential to address a substantial unmet medical need by improving the management of neuropsychiatric symptoms in individuals living with Alzheimer's disease. Bristol Myers Squibb's COBENFY Muscarinic M1/M4 receptor agonist COBENFY (KarXT; xanomeline–trospium chloride) is a novel muscarinic receptor-targeting therapy under investigation for the treatment of Alzheimer's disease psychosis (ADP). In contrast to traditional antipsychotics, which primarily exert their effects through dopamine receptor antagonism, COBENFY selectively stimulates M1 and M4 muscarinic acetylcholine receptors within the central nervous system. This differentiated mechanism aims to alleviate both psychotic and cognitive symptoms associated with Alzheimer's disease while potentially reducing the risk of adverse effects commonly linked to dopamine-blocking therapies. Administered orally, COBENFY represents an innovative therapeutic strategy within the evolving Alzheimer's disease treatment landscape. COBENFY is currently advancing through Phase III clinical development for Alzheimer's disease psychosis, with topline results anticipated in 2026. Beyond psychosis, the therapy is also being evaluated for additional Alzheimer's disease-related conditions, including agitation and cognitive impairment, highlighting its potential as a broad-spectrum neuropsychiatric treatment. The ongoing ADEPT-1, ADEPT-2, and ADEPT-4 Phase III studies are expected to deliver topline results for Alzheimer's disease psychosis in 2026. If these studies are successful and regulatory approvals are secured, COBENFY could reach the market as early as 2027. In Alzheimer's disease agitation, the Phase III ADAGIO-2 trial is projected to report results in 2028, which could support a commercial launch beginning in 2029. Additionally, the MINDSET-1 and MINDSET-2 trials are assessing the therapy's impact on cognitive impairment associated with Alzheimer's disease. These studies are also expected to report findings in 2028, with commercialization potentially commencing in 2029, subject to favorable clinical outcomes and regulatory clearance. According to Aparna Thakur, Project Manager of Forecasting & Analytics at DelveInsight, COBENFY (KarXT) introduces a differentiated, non-dopaminergic approach to managing neuropsychiatric manifestations of Alzheimer's disease by selectively targeting central M1 and M4 muscarinic receptors. This mechanism may overcome some of the safety challenges associated with conventional antipsychotic therapies. Its comprehensive Phase III clinical program spanning psychosis, agitation, and cognitive impairment underscores the company's strategy to establish COBENFY as a versatile, multi-indication treatment for neuropsychiatric complications in Alzheimer's disease. To know more about Alzheimer's disease drug development, visit @ Alzheimer's Disease Treatment Pipeline Eli Lilly's Remternetug Aβ-protein Inhibitors Remternetug (LY3372993) is an investigational monoclonal antibody being developed for the treatment of early-stage Alzheimer's disease. It is formulated for both intravenous (IV) and subcutaneous (SC) administration and selectively targets N3pG amyloid-beta (Aβ), a modified amyloid species implicated in the disease's pathology. By binding to toxic amyloid plaques in the brain, the therapy promotes their clearance through immune-mediated mechanisms to slow disease progression. Remternetug has completed Phase I clinical studies and is currently undergoing Phase III clinical evaluation in patients with early Alzheimer's disease. Thakur noted that remternetug underscores Eli Lilly's focus on advancing next-generation amyloid-targeting antibodies designed to improve patient convenience, particularly by enabling potential subcutaneous delivery and faster amyloid plaque clearance. Annovis Bio's Buntanetap Translational Inhibitor of Neurotoxic Aggregating Proteins (TINAPs) Buntanetap (previously known as ANVS401 or Posiphen) is an orally available small-molecule therapy developed using a proprietary synthetic biochemical process. It represents a first-in-class group of therapeutics called Translational Inhibitors of Neurotoxic Aggregating Proteins (TINAPs), which are designed to suppress the production of multiple neurotoxic proteins involved in the progression of neurodegenerative diseases. By targeting several pathogenic proteins simultaneously, Buntanetap offers a differentiated mechanism of action with the potential to address the underlying pathology of these disorders. The therapy is being evaluated across a range of neurodegenerative indications, including Alzheimer's disease, Parkinson's disease, and Alzheimer's disease associated with Down syndrome. Buntanetap has completed a Phase II/III clinical trial in patients with mild-to-moderate Alzheimer's disease and is currently being assessed in a Phase III trial for individuals with early Alzheimer's disease, highlighting its potential to deliver therapeutic benefits across different stages of disease progression. Download the report to understand the top emerging therapies in Alzheimer's Disease @ Alzheimer's Disease Drug Development Pipeline Source: Alzheimer's Disease Market Report 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 ARS Pharmaceuticals, Alfresa Pharma, Roche, Stallergenes Greer, DBV Technologies, Aquestive Therapeutics, Aravax, Siolta Therapeutics, GSK, Cue Biopharma, N-Fold, InnoUp Farma, Allergy Therapeutics, UKKO, Bryn Pharma, Poplar Therapeutics, Inimmune, Novartis (Excellergy), Intrommune Therapeutics, Regeneron Pharmaceuticals, Sanofi, Moonlight Therapeutics, Mabylon AG, Insignis Therapeutics, ALK-Abello, Cambridge Allergy, Prota Therapeutics, and others. Related Reports 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 Anavex Life Sciences Corp., TauRx Therapeutics Ltd, BioVie Inc., AriBio Co., Ltd., Novo Nordisk A/S, AgeneBio, Neurim Pharmaceuticals, Eisai Inc., T3D Therapeutics, Merck Sharp & Dohme, Shanghai Hengrui Pharmaceutical, NeuroSense Therapeutics, Pharmazz, Johnson & Johnson Innovative Medicine, NKGen Biotech, LEXEO Therapeutics, Inventage Lab, Neumora Therapeutics, Takeda, Perha Pharmaceuticals, Luye Pharma Group Ltd., Eli Lilly and Company, Prothena, Therabest Korea, Neurotez, TRIMTECH Therapeutics, Lexeo Therapeutics, and others. Agitation in Alzheimer's Disease Market Agitation in 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 agitation in Alzheimer's disease companies, including IGC Pharma, Suven Life Sciences, Exciva GmbH, Bristol Myers Squibb, Karuna Therapeutics, Otsuka Pharmaceutical, Lundbeck, Axsome Therapeutics, and others. Dementia-related Psychosis Market Dementia-related Psychosis 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 dementia-related psychosis companies, including Acadia Pharmaceuticals, Bristol Myers Squibb, Cognition Therapeutics, Maplight Therapeutics, Johnson & Johnson, AgeneBio, 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. 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