Prasinezumab

No alpha-synuclein inhibitors are approved, underscoring a major need for therapies that slow or halt Parkinson's progression. Developing safe, brain-penetrant drugs that target toxic alpha-synuclein while preserving normal function is vital for early intervention and better outcomes. Late-stage candidates like Buntanetap (Annovis Biopharm), Prasinezumab (Roche/Prothena), and Amlenetug (Lundbeck) highlight growing innovation and competition in the alpha-synuclein inhibitors market. LAS VEGAS, July 28, 2025 /PRNewswire/ -- DelveInsight's Alpha-synuclein Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Parkinson's disease, Alzheimer's disease, Lewy body dementia, Multiple system atrophy, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging alpha-synuclein inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the Alpha-synuclein Inhibitors Market Report As per DelveInsight's analysis, the total market size of alpha-synuclein inhibitors in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Parkinson's disease, Alzheimer's disease, Lewy body dementia, Multiple system atrophy, and others. Leading alpha-synuclein inhibitors companies, such as Annovis Biopharm, Lundbeck, Roche, Prothena, and others, are developing novel alpha-synuclein inhibitors that can be available in the alpha-synuclein inhibitors market in the coming years. Some of the key alpha-synuclein inhibitors in the pipeline include Buntanetap, Amlenetug, Prasinezumab, and others. In March 2025, Annovis Bio participated in AD/PD 2025, scheduled from April 1–5 in Vienna. During the conference, the company Annovis gave two presentations, showcasing findings from its Phase III Parkinson's disease trial and data on buntanetap in ApoE4 carriers from its Phase II/III Alzheimer's disease study. In February 2025, the FDA granted Fast Track Designation (FTD) to amlenetug for the treatment of MSA. In January 2025, Annovis Bio secured a significant milestone with the issuance of a US patent protecting its novel methods for treating and preventing acute brain and nerve injuries through buntanetap. Discover which indication is expected to grab the major alpha-synuclein inhibitors market share @ Alpha-synuclein Inhibitors Market Report Alpha-synuclein Inhibitors Market Dynamics The alpha-synuclein inhibitors market is driven by the growing prevalence of neurodegenerative disorders such as Parkinson's disease, Lewy body dementia, and multiple system atrophy, where alpha-synuclein aggregation plays a critical pathogenic role. With the global burden of Parkinson's disease expected to double by 2040, there is a pressing demand for disease-modifying therapies that can go beyond symptomatic relief. Current treatment options, such as dopaminergic drugs, primarily address motor symptoms but fail to halt disease progression. This unmet medical need is pushing pharmaceutical and biotechnology companies to focus on alpha-synuclein inhibitors, which target the underlying pathology by preventing protein misfolding, aggregation, and the subsequent neurodegenerative cascade. Significant research and development investments are shaping the competitive landscape of the alpha-synuclein inhibitors market. Several leading pharmaceutical players are actively pursuing monoclonal antibodies and small molecule inhibitors targeting alpha-synuclein. Clinical trials have advanced the understanding of the therapeutic potential of targeting alpha-synuclein, though some setbacks have been observed due to limited clinical efficacy in late-stage trials. Nonetheless, advancements in biomarker discovery and imaging technologies for early diagnosis and monitoring disease progression are expected to enhance the success rate of ongoing and future clinical programs. Market dynamics are also influenced by regulatory and reimbursement factors. Given the high cost and complexity of neurodegenerative disease drug development, regulatory agencies like the FDA and EMA are encouraging accelerated pathways and breakthrough therapy designations for promising candidates. However, high development costs, combined with stringent clinical efficacy requirements, pose challenges for new entrants and smaller biotech firms. Moreover, reimbursement policies in major markets will play a critical role in determining the commercial success of these therapies once approved. Collaborations and strategic partnerships are increasingly shaping the alpha-synuclein inhibitors landscape. Big pharmaceutical companies are entering licensing agreements, mergers, or co-development partnerships with biotech firms to expand their neurodegenerative pipelines. For instance, Roche and Prothena's collaboration on prasinezumab reflects the industry trend of leveraging external innovation to accelerate drug development. Furthermore, increasing venture capital funding and public-private initiatives are supporting the growth of innovative startups working on novel alpha-synuclein-targeting approaches, such as antisense oligonucleotides and gene therapy-based strategies. Looking ahead, the alpha-synuclein inhibitors market is poised for steady growth. The next decade is expected to witness significant milestones in the approval and commercialization of disease-modifying therapies, which could revolutionize the treatment paradigm for Parkinson's and related disorders. Alpha-synuclein Inhibitors Treatment Market Alpha-synuclein inhibitors are therapeutic agents developed to prevent the aggregation of alpha-synuclein, a protein closely linked to neurodegenerative disorders such as Parkinson's disease, Lewy body dementia, and multiple system atrophy. These inhibitors function by blocking protein misfolding, reducing toxic buildup, and promoting clearance pathways. By targeting alpha-synuclein pathology, they aim to slow the progression of these diseases, offering promising advancements in neuroprotection and symptom relief. Although no alpha-synuclein inhibitors have yet received regulatory approval, the FDA has issued a 'Letter of Support' encouraging the use of the synuclein-based biomarker, αSyn-SAA, in clinical trials for Parkinson's disease and related disorders. This recognition underscores the biomarker's potential to improve disease monitoring, streamline drug development, and refine treatment strategies. With no approved therapies in this category, several companies, including Annovis Bio, Roche/Prothena, and Lundbeck, are actively progressing their pipelines to develop innovative candidates. These initiatives aim to enhance therapeutic approaches, improve drug effectiveness, and address the significant unmet needs in neurodegenerative conditions such as Parkinson's, Lewy body dementia, and MSA. Learn more about the alpha-synuclein inhibitors @ Alpha-synuclein Inhibitors Analysis Key Emerging Alpha-synuclein Inhibitors and Companies Emerging alpha-synuclein inhibitors in the pipeline, including buntanetap (Annovis Biopharm), prasinezumab (Roche/Prothena), amlenetug (Lundbeck), and others, are showing promise for expanding treatment options. Buntanetap, formerly known as Posiphen or ANVS401, works against neurodegeneration by preventing the build-up of toxic proteins such as amyloid beta, tau, alpha-synuclein, and TDP43. This action helps boost synaptic function, improve axonal transport, and reduce neuroinflammation—key processes required to maintain healthy neurons. The accumulation of these proteins disrupts neural pathways, leading to neuronal damage and cell death, which underlie diseases like Alzheimer's and Parkinson's. By targeting these mechanisms, buntanetap aims to reverse neurodegeneration, restore brain function, and significantly enhance patients' quality of life. In March 2025, Annovis Bio participated in the AD/PD 2025 conference (April 1–5, Vienna), where it delivered two presentations highlighting data from its Phase III Parkinson's disease trial and findings on buntanetap in ApoE4 carriers from its Phase II/III Alzheimer's disease study. Earlier, in July 2024, Annovis announced results from its Phase III Parkinson's disease trial (NCT05357989). Among patients diagnosed with Parkinson's for over three years, buntanetap demonstrated significant improvements in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores, Parts II, III, II+III, and Total, compared with placebo and baseline. Prasinezumab, an experimental monoclonal antibody, is designed to selectively bind aggregated alpha-synuclein (α-syn) and reduce its neurotoxic effects. By targeting α-syn accumulation and its cell-to-cell spread, prasinezumab has the potential to slow disease progression. Targeting α-syn aggregates is supported by extensive research as a viable therapeutic strategy for Parkinson's disease. At the AD/PD 2025 conference, the company presented results from the Phase IIb PADOVA study. While the drug showed potential in slowing motor symptom progression, it did not achieve statistical significance in the primary analysis, and further evaluations are ongoing. Amlenetug, a human monoclonal antibody, is designed to bind all major extracellular forms of α-syn, preventing their uptake and halting aggregation seeding. Its active Fc region may promote immune-mediated clearance of α-syn/antibody complexes through microglial uptake, thereby reducing pathological deposits. Developed by Lundbeck in collaboration with Genmab A/S, amlenetug is part of ongoing efforts to develop disease-modifying therapies for neurodegenerative conditions. In February 2025, the FDA granted Fast Track Designation (FTD) for amlenetug in treating multiple system atrophy (MSA). It previously received Orphan Drug Designation (ODD) from the FDA in April 2024, SAKIGAKE designation from Japan's Ministry of Health, Labour and Welfare in March 2023, and ODD from the European Medicines Agency (EMA) in May 2021. The anticipated launch of these emerging therapies are poised to transform the alpha-synuclein inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the alpha-synuclein inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about alpha-synuclein inhibitors clinical trials, visit @ Alpha-synuclein Inhibitors Treatment Alpha-synuclein Inhibitors Overview Alpha-synuclein is a highly soluble and intrinsically disordered protein that accumulates in Lewy bodies and Lewy neurites, playing a key role in the development of Parkinson's disease and other synucleinopathies. While predominantly located in the brain, smaller amounts are also present in the heart, muscles, and various tissues. Within neurons, α-Syn is concentrated in presynaptic terminals, where it regulates synaptic vesicle dynamics. Studies indicate that it may restrict vesicle mobility, thereby influencing synaptic recycling and neurotransmitter release. Another view suggests that α-Syn interacts with VAMP2 (synaptobrevin) to stabilize SNARE complexes, with recent research linking these interactions to synaptic function. Moreover, α-Syn may modulate dopamine release, affecting both voluntary and involuntary motor control. Synucleinopathies are marked by the accumulation of α-Syn amyloid deposits in the brain, driving neurodegeneration. Preventing α-Syn aggregation remains challenging due to its inherently disordered structure and the complex, unpredictable nature of fibrillogenesis. Nevertheless, targeting α-Syn is considered a promising therapeutic strategy, offering potential avenues for the treatment of Parkinson's disease and related conditions. Alpha-synuclein Inhibitors Epidemiology Segmentation The alpha-synuclein inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for Alpha-synuclein Inhibitors Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors Scope of the Alpha-synuclein Inhibitors Market Report Alpha-synuclein Inhibitors Therapeutic Assessment: Alpha-synuclein Inhibitors current marketed and emerging therapies Alpha-synuclein Inhibitors Market Dynamics: Conjoint Analysis of Emerging Alpha-synuclein Inhibitors Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Alpha-synuclein Inhibitors Market Access and Reimbursement Discover more about alpha-synuclein inhibitors in development @ Alpha-synuclein Inhibitors Clinical Trials Table of Contents Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 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, among others. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver 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 AB Science, Alzheon Inc., AriBio Co., Ltd., AgeneBio, Inc., Anavex Life Sciences Corp., Annovis Bio, Inc., Cerecin, BioVie, Cassava Sciences, Novo Nordisk, Eli Lilly, Neurim Pharmaceuticals, Suven Life Sciences, Bristol-Myers Squibb, Karuna Therapeutics, T3D Therapeutics, Inc., Lexeo Therapeutics, Axsome Therapeutics, Inc., Araclon Biotech S.L., Eisai Co., Ltd., TauRx Therapeutics, TrueBinding, Inc., AC Immune SA, Johnson & Johnson, Longeveron Inc., Vaccinex Inc., IGC Pharma LLC, among others. Multiple System Atrophy Market Multiple System Atrophy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key MSA companies including H Lundbeck A/S, Brain Neurotherapy Bio, Inc., Asklepios BioPharmaceutical, Inc., Theravance Biopharma, Ono Pharmaceutical Co. Ltd, Ionis Pharmaceuticals, Inc., Biogen, Alterity Therapeutics, Teva Pharmaceutical, MODAG GmbH, among others. Lewy Body Dementia Market Lewy Body Dementia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Lewy body dementia companies including EIP Pharma Inc., Cognition Therapeutics, Eisai Inc., Sun Pharma Advanced Research Company Limited, Georgetown University, Eli Lilly and Company, CuraSen Therapeutics, Inc., Athira Pharma, Aptinyx Inc., among 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 . 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Roche Pharma CEO Teresa Graham spoke to Fierce Biotech on the sidelines of the company\'s first-half earnings event.\n The uncertainty around the future of Elevidys hasn’t destroyed Roche’s belief in the potential of gene therapies, the Swiss company’s head of pharma has told Fierce Biotech, as the pharma continues to expand its research reach outside of its traditional oncology focus.Roche and its partner Sarepta Therapeutics both paused trials of Elevidys back in April following the death of a 16-year-old patient in the U.S. Since then, Roche—which markets the drug outside of the U.S.—has stopped all ex-U.S. distribution of the drug in the commercial setting for non-ambulatory patients, while the FDA requested that Sarepta halt Elevidys shipments in the U.S. Earlier this week, Roche paused shipments in all patients in countries where Elevidys’ approvals referenced the FDA.But Roche Pharma CEO Teresa Graham denied Fierce’s suggestion that the issues around Elevidys have altered how the company views gene therapy as a modality.“It doesn’t, actually,” Graham told Fierce in an interview at Roche’s headquarters in Basel, Switzerland on Thursday.“The reality is that gene therapy will be an important modality in the treatment of human health,” Graham continued. “There is a lot of promise in gene therapy. I think what the entire industry is learning is that, scientifically, it\'s just a little harder than we might have thought.” Even before the latest difficulties with Elevidys, Roche had announced a “fundamental reorganization” of Spark Therapeutics, the gene therapy unit the Swiss pharma bought for $4.3 billion in 2019. That overhaul closely followed Roche’s decision to end work on a hemophilia A gene therapy candidate, which was a focus of the Spark acquisition.Roche’s move came against a backdrop of wider industry retreat from gene therapy, with Pfizer pulling its FDA-approved hemophilia B treatment Beqvez. Bluebird bio, a gene therapy pioneer once valued at $10 billion at its peak, was sold for just $49 million upfront to private equity firms.But Roche still sees potential in the modality, according to Graham.“I am firmly convicted that over time we will crack gene therapy and we will be able to deliver really meaningful treatments to patients,” she said.Graham spoke to Fierce on the sidelines of the company’s first-half earnings event, where Roche CEO Thomas Schinecker reminded journalists that 760 boys have successfully received Elevidys in the ambulatory setting.“I\'m really hopeful that we can find a path forward for this medicine,” Graham said in the interview on Thursday. “We clearly need to talk to regulators; we clearly need to have some good conversations about the safety—but we do firmly believe in the risk-benefit of this product.”Not all regulators sound ready to be convinced, with the European Medicines Agency (EMA) announcing Friday morning that it won\'t recommend Elevidys for approval in the ambulatory setting. Roche said in a statement that it “plans to continue to work with the EMA to explore a potential path forward.” Mixed results from emerging pipeline Another drug that Roche is keeping faith in is the Parkinson’s disease prospect prasinezumab. The future of the Prothena Biosciences–partnered asset looked in doubt after the anti-alpha-synuclein antibody failed a phase 2 study in December 2024.But Roche is giving prasinezumab a second chance, with plans to launch a phase 3 trial by the end of the year off the back of an analysis of data from the failed study. Specifically, the pharma pointed to longer-term follow-up data from an open-label portion of the study suggesting a clinical benefit on top of symptomatic treatment in early-stage Parkinson’s.“Given the dramatic unmet need in Parkinson\'s, it does feel like it would be a miss not to explore this,” Graham explained.“There\'s only really been minor improvements in treatments for these patients over the last 50 years, and, in every conversation I\'ve had with [key opinion leaders], they have really encouraged us to take this forward,” she said.“There\'s a little bit of a finger feel that there\'s something there, and we\'re only really ever going to be able to pull the signal out in a phase 3,” Graham added. Roche had less faith in CT-173, an early-stage obesity drug picked up as part of its $2.7 billion acquisition of Carmot Therapeutics in 2023. The Swiss pharma had previously touted the long-acting PYY analog’s potential to drive weight loss past the GLP-1 plateau, but Graham announced at the earnings event that Roche would no longer take CT-173 into human trials after assessing its “developability and competitiveness.”Despite this early-stage setback, Graham still feels that combinations offer Roche a path to carving out its own corner of the increasingly crowded obesity space.“Obesity is inherent in something like 200 other diseases,” she said. “So the ability to actually look at where we believe our portfolio in combination with other drugs can really help address some of these comorbidities is one of the more exciting pieces.”“This is an incredibly big market,” Graham added. “It is very diverse. There are a lot of scientific pathways to explore here.”One of those pathways is amylin, a hormone involved in the regulation of food intake. In March, Roche paid Zealand Pharma $1.6 billion for the long-acting amylin analog petrelintide. Graham sees the drug’s potential growing as the obesity market segments among patients “looking for maybe different depths of weight loss or different tolerability profiles.”Meanwhile, Roche has yet to make a final call on whether to take the GLP-1/GIP receptor agonist CT-388—another Carmot asset—into a phase 3 obesity trial, but Graham said the company is “right on the cusp” of taking that program forward.“We plan to make those decisions later this year, and, once we get rolling here, I think you\'re really going to see us flesh out our [obesity] strategy,” she said. When it comes to bringing new drugs into Roche’s pipeline, Graham was tight-lipped on which of the company’s five core focus areas—neurology, oncology/hematology, immunology, ophthalmology and CVRM (cardiovascular renal metabolic)—the company is prioritizing for M&A.“Clearly, within our five therapeutic areas, there are definitely places where we would like to bring in additional assets,” she told Fierce. “As Thomas [Schinecker] said, we look at an unbelievably large number of deals every year, and are constantly on the hunt, not only for things that will fit that strategy but things that are truly transformational.”With such a multifaceted pipeline, what are the readouts Graham is most excited about?“It\'s like trying to choose your favorite child,” she said, before name-checking the recent “super exciting” phase 2 results for the BTK inhibitor fenebrutinib in relapsing multiple sclerosis (MS). “It could be a really huge step forward for MS patients,” she explained.There’s also the “high-risk, high-reward bet” on the Parkinson’s drug prasinezumab, said Graham, who ended by referencing the IgG1 monoclonal antibody afimkibart.Along with CT-388 and the Alzheimer’s disease prospect trontinemab, afimkibart was one of the assets Roche fast-tracked as part of its reallocation of R&D resources.“I\'m an immunology girl at heart—it’s where I started my career,” Graham explained. “There\'s so much opportunity in the immunological space and so many diseases that we could potentially tackle with afimki.”