Long COVID is a condition where debilitating symptoms can persist for months after a COVID-19 infection. This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or remembering things ("brain fog") and fatigue.
Researchers will compare NE3107 to a placebo (a look-alike substance that contains no drug) to see if NE3107 works to treat neurocognitive and fatigue symptoms of long COVID.
Participants will:
* Take NE3107 or a placebo twice daily for 84 days
* Visit the clinic 5 times for checkups and tests and have a follow up phone call

开始日期2025-04-29

申办/合作机构

BioVie, Inc.

NCT06757010

/ Recruiting临床2期

A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease

The goal of this clinical trial is to learn if bezisterim can treat movement symptoms of Parkinson's disease in patients that are 45 to 80 years old, in generally good physical and mental health, and are nearing the need for treatment to relieve their symptoms but have not yet been prescribed any form of levodopa or drug with similar activity. The main questions it aims to answer are:
* Will bezisterim decrease movement symptoms of Parkinson's disease?
* What medical problems do participants have when taking bezisterim?
Researchers will compare the effects of bezisterim treatment to placebo (a look-alike substance that contains no drug) to see if bezisterim works to treat movement symptoms of Parkinson's disease.
Participants will
* have a physical examination that includes an electrocardiogram
* take drug or placebo twice daily for four months
* visit a clinical site or receive an at home visit seven times over the course of five months

开始日期2025-03-26

申办/合作机构

BioVie, Inc.

NCT05970575

/ Terminated临床2期IIT

Open Label Phase IIa Study Evaluating the Safety and Efficacy of NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury

This study seeks to measure changes in cognition through verbal and visual test procedures and changes in biomarkers of Traumatic Brain Injury and inflammatory and metabolic parameters.

开始日期2023-12-21

申办/合作机构

BioVie, Inc.

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100 项与 Triolex 相关的专利（医药）

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项与 Triolex 相关的文献（医药）

2025-03-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Progress in the study of anti-Alzheimer's disease activity of pyrimidine-containing bioactive molecules

Review

作者: Zhang, Di ; Zhang, Qi ; Zhang, Lin-Lin ; Liu, Yu-Lin ; Chui, Rui-Hao ; Zhang, Qian ; Li, Bing-Qian ; Ma, Li-Ying

Pyrimidines are aromatic, heterocyclic organic compounds characterized by a six-membered ring that contains four carbon atoms and two nitrogen atoms. They have been reported to exhibit a variety of biological activities such as antifungal, antiviral, and anti-Parkinsonian effects. Recently, there has been an increased focus on their potential anti-Alzheimer's properties. Several pyrimidine-based drugs and their analogs are currently undergoing various phases of clinical trials, indicating pyrimidine as a promising chemical structure for drug development. Notably, modifications to the pyrimidine structure significantly influence their activity against Alzheimer's disease. For instance, the introduction of heteroatoms into the pyrimidine ring or alternations in the length of the linkage region have been shown to enhance therapeutic efficacy. This review provides a comprehensive overview of pyrimidine derivatives as potential therapeutics for Alzheimer's disease, with a focus on structure-activity relationship (SAR) studies, design strategies, and binding mechanisms. These insights could pave the way for the development of more effective anti-Alzheimer's medications.

2024-07-26·MEDICINE

A phase 2, open-label study of anti-inflammatory NE3107 in patients with dementias

Article

作者: Sheldon Jordan ; Christopher Reading ; Victoria Venkatraman ; Jean Rama Surya ; Kaya Jordan ; Clarence Ahlem ; Dayan Goodenowe ; Bijan Pourat ; Joseph Palumbo ; Taylor Kuhn ; Margaret Zielinski ; Sergio Becerra ; Kaitlyn Hofmeister ; Elisabeth Rindner ; Kennedy Mahdavi ; Jeffrey Zhang ; Jonathan Haroon

Background::

Alzheimer’s disease (AD) is a progressive, multifactorial, neurodegenerative disorder affecting >6 million Americans. Chronic, low-grade neuroinflammation, and insulin resistance may drive AD pathogenesis. We explored the neurophysiological and neuropsychological effects of NE3107, an oral, anti-inflammatory, insulin-sensitizing molecule, in AD.

Methods::

In this phase 2, open-label study, 23 patients with mild cognitive impairment or mild dementia received 20-mg oral NE3107 twice daily for 3 months. Primary endpoints assessed changes from baseline in neurophysiological health and oxidative stress (glutathione level) using advanced neuroimaging analyses. Secondary endpoints evaluated changes from baseline in neuropsychological health using cognitive assessments, including the 11-item Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment, Clinical Dementia Rating, Quick Dementia Rating Scale, Alzheimer’s Disease Composite Score, and Global Rating of Change (GRC). Exploratory endpoints assessed changes from baseline in neuroinflammation biomarkers (tumor necrosis factor alpha, TNF-α) and AD (amyloid beta and phosphorylated tau [P-tau]).

Results::

NE3107 was associated with clinician-rated improvements in cerebral blood flow and functional connectivity within the brain. In patients with MMSE ≥ 20 (mild cognitive impairment to mild AD; n = 17), NE3107 was associated with directional, but statistically nonsignificant, changes in brain glutathione levels, along with statistically significant improvements in ADAS-Cog11 (P = .017), Clinical Dementia Rating (P = .042), Quick Dementia Rating Scale (P = .002), Alzheimer’s Disease Composite Score (P = .0094), and clinician-rated GRC (P < .001), as well as in cerebrospinal fluid P-tau levels (P = .034) and P-tau:amyloid beta 42 ratio (P = .04). Biomarker analyses also demonstrated directional, but statistically non-significant, changes in plasma TNF-α, consistent with the expected mechanism of NE3107. Importantly, we observed a statistically significant correlation (r = 0.59) between improvements in TNF-α levels and ADAS-Cog11 scores (P = .026) in patients with baseline MMSE ≥ 20.

Conclusion::

Our results indicate that in this study NE3107 was associated with what appear to be positive neurophysiological and neuropsychological findings, as well as evidence of improvement in biomarkers associated with neuroinflammation and AD in patients diagnosed with dementia. Our findings are consistent with previous preclinical and clinical observations and highlight a central role of neuroinflammation in AD pathogenesis.

2024-02-01·Ageing research reviews

Navigating the dementia landscape: Biomarkers and emerging therapies

Review

作者: Akhtar, Juber ; Ansari, Vaseem Ahamad ; Verma, Amita ; Maheshwari, Shubhrat ; Mahmood, Tarique ; Singh, Aditya ; Wasim, Rufaida

The field of dementia research has witnessed significant developments in our understanding of neurodegenerative disorders, with a particular focus on Alzheimer's disease (AD) and Frontotemporal Dementia (FTD). Dementia, a collection of symptoms arising from the degeneration of brain cells, presents a significant healthcare challenge, especially as its prevalence escalates with age. This abstract delves into the complexities of these disorders, the role of biomarkers in their diagnosis and monitoring, as well as emerging neurophysiological insights. In the context of AD, anti-amyloid therapy has gained prominence, aiming to reduce the accumulation of amyloid-beta (Aβ) plaques in the brain, a hallmark of the disease. Notably, Leqembi recently received full FDA approval, marking a significant breakthrough in AD treatment. Additionally, ongoing phase 3 clinical trials are investigating novel therapies, including Masitinib and NE3107, focusing on cognitive and functional improvements in AD patients. In the realm of FTD, research has unveiled distinct neuropathological features, including the involvement of proteins like TDP-43 and progranulin, providing valuable insights into the diagnosis and management of this heterogeneous condition. Biomarkers, including neurofilaments and various tau fragments, have shown promise in enhancing diagnostic accuracy. Neurophysiological techniques, such as transcranial magnetic stimulation (TMS), have contributed to our understanding of AD and FTD. TMS has uncovered unique neurophysiological signatures, highlighting impaired plasticity, hyperexcitability, and altered connectivity in AD, while FTD displays differences in neurotransmitter systems, particularly GABAergic and glutamatergic circuits. Lastly, ongoing clinical trials in anti-amyloid therapy for AD, such as Simufilam, Solanezumab, Gantenerumab, and Remternetug, offer hope for individuals affected by this devastating disease, with the potential to alter the course of cognitive decline. These advancements collectively illuminate the evolving landscape of dementia research and the pursuit of effective treatments for these challenging conditions.

127

项与 Triolex 相关的新闻（医药）

2026-02-12

·BioSpace

BioVie Announces Abstracts Accepted for Presentation at the 2026 American College of Psychiatrists Annual Meeting

CARSON CITY, Nev., Feb. 12, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced the acceptance of two abstracts from studies on its lead candidate bezisterim (NE3107), in the treatment of Alzheimer’s Disease and Long COVID at the 2026 American College of Psychiatrists (ACP) annual meeting, to be held February 18-22, in Bonita Springs, FL. The two abstracts have been accepted for presentation as posters during a session to be held on February 18, 2026. Details of the abstracts are as follows: Abstract Title: Bezisterim-Associated Anti-inflammatory Epigenetic Modulation of Age Acceleration and Cognition in Alzheimer’s Disease Authors: Joseph M. Palumbo 1 ; Christopher L. Reading 1 ; Jiayan Yan 1 , Clarence Ahlem 1 ; Penelope Markham 1 ; Stephen O’Quinn 1 ; Varun B. Dwaraka 2 Abstract Title : Baseline Characteristics of Currently Enrolled Participants in Phase 2 Study of Bezisterim (NE3107) in Long COVID (ADDRESS-LC) Authors: Joseph M. Palumbo1*; Penelope Markham 1 ; Michael Peluso 3 ; Igor J. Koralnik 4 ; Sherry Hsiang-Yi Chou 4 ; Lisa McCorkell 5 ; Chantal Petit 6 ; Stephen O’Quinn 7 ; Chris Reading 1 ; Clarence Ahlem 1 ; Jiayan Yan 1 Affilations: 1 BioVie Inc., 2 TruDiagnostic, Inc., 3 University of California, San Francisco; 4 Feinberg School of Medicine, Northwestern University; 5 Patient-Led Research Collaborative, Oakland, California; 6 Biotechnant Solutions LLC; 7 Perissos Inc. About Bezisterim Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNF-α), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease, Long COVID, and Alzheimer’s disease. In Parkinson’s disease, BioVie has already completed a Phase 2 study that showed patients with moderate- to severe Parkinson’s taking bezisterim with levodopa had better motor control and fewer morning symptoms compared to those taking levodopa alone. Few drug-related side effects were observed. The current SUNRISE-PD just completed enrolling 60 patients to evaluate whether bezisterim alone can help improve motor and non-motor symptoms for Parkinson’s patients who have not been treated with carbidopa/levodopa. Topline results are expected in mid‑2026. For Long COVID, the ADDRESS-LC trial is enrolling about 200 patient to evaluate if bezisterim can reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long Covid, which are believed to be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). Topline data is expected mid-2026. In Alzheimer’s disease, BioVie has conducted both Phase 2 and Phase 3 trials. Early results suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with Alzheimer’s. About BioVie Inc. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for long COVID, where persistent inflammation is thought to underlie symptoms such as brain fog and fatigue. In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit . For Investor Relations Inquiries: For Media Inquiries: Contact: Chuck Padala Managing Director, LifeSci Advisors, LLC chuck@lifesciadvisors.com Contact: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com

临床2期临床3期快速通道临床结果

2026-01-29

·阿尔茨海默病研究

2021-2026年全球AD药物研发管线分析

AD_Drug_Development_2021-2026.xlsx 关键词：阿尔茨海默病、药物、临床、研发、Phase 25年的AD药物统计还没看到，AI先做了一个汇总表阿尔茨海默病(AD)药物研发汇总报告 2021-2026年全球AD药物研发管线分析数据摘要已上市药物 3个 (Lecanemab, Donanemab, Aduhelm[退市]) Phase 3在研 18个 Phase 2/3在研 8个 Phase 2在研 22个 Phase 1在研 10个研发失败/终止 19个总计 80个药物说明本报告汇总了2021-2026年间全球阿尔茨海默病药物研发情况，包括已上市药物、在研药物（Phase 1-3）以及研发失败的药物。数据来源于ClinicalTrials.gov、PubMed、FDA等权威机构。涵盖Aβ靶向、tau靶向、神经炎症、老药新用等多种机制。 23/24年大佬整理的药物研发情况汇总：参考文献 ClinicalTrials.gov https://clinicaltrials.gov PubMed https://pubmed.ncbi.nlm.nih.gov FDA https://www.fda.gov Alzheimer's & Dementia (Journal) https://alz-journals.onlinelibrary.wiley.com Nature Reviews Drug Discovery https://www.nature.com/nrd New England Journal of Medicine https://www.nejm.org JAMA Neurology https://jamanetwork.com/journals/jamaneurology Lancet Neurology https://www.thelancet.com/neurology Cummings et al. 2025 Pipeline Report Alzheimer's Dement 2025;11:e70098 Alzforum https://www.alzforum.org Alzheimers Dement (N Y). 2023 May 25;9(2):e12385. Alzheimers Dement (N Y). 2024 Apr 24;10(2):e12465. 本文内容来自公开信息及研究文献，不代表临床建议。如需投稿、转载、商务合作后台留言，回复有一定延迟敬请谅解。辅助编辑：腾讯元宝or（GPT、Gemini、Claude等）扫码加入ima知识库，获取本公众号所有文献全文资料，AI问答了解更多信息，文献实时更新药品名称进展阶段临床试验编号所属公司/机构开发起始时间备注 GV-971 (Sodium Oligomannate) 中国已上市/全球Phase 3终止 NCT04520412 (Green Memory) Green Valley Pharma (China) 2019 中国2019年批准，国际III期2022年终止 Lecanemab (Leqembi) 已上市 (FDA 2023.1加速批准, 2023.7完全批准) NCT03887455 (Clarity AD) Eisai / Biogen / BioArctic 2020 抗Aβ原纤维抗体，减缓认知下降27% Donanemab (Kisunla) 已上市 (FDA 2024.7批准) NCT04437511 (TRAILBLAZER-ALZ 2) Eli Lilly 2020.6 抗Aβ抗体，低/中tau患者减缓下降60% Remternetug Phase 3 (进行中) NCT05463731 (TRAILRUNNER-ALZ1) Eli Lilly 2022.8 第三代抗Aβ抗体，皮下/静脉给药 ALZ-801 (Valiltramiprosate) Phase 3 (进行中) NCT04770220 (APOLLOE4) Alzheon 2021.5 口服Aβ寡聚体抑制剂，针对APOE4/4纯合子 Semaglutide Phase 3 (进行中) NCT04777396 / NCT04777409 (EVOKE/EVOKE+) Novo Nordisk 2021.5 GLP-1受体激动剂，老药新用 Nilotinib Phase 3 (进行中) NCT05143528 Novartis 2022.2 酪氨酸激酶抑制剂，老药新用 Masitinib Phase 3 (进行中) NCT05564169 AB Science 2022 酪氨酸激酶抑制剂，抗炎 KarXT (Xanomeline-Trospium) Phase 3 (进行中) NCT05511363 Karuna Therapeutics / Bristol-Myers Squibb 2022 毒蕈碱受体激动剂组合 Masupirdine (SUVN-502) Phase 3 (进行中) NCT05397639 Suven Pharmaceuticals 2022 5-HT6受体拮抗剂，用于激越症状 Nabilone Phase 3 (进行中) NCT04516057 University of Toronto 2020 大麻素受体激动剂，老药新用，用于激越 Dextromethorphan/Quinidine Phase 3 (进行中) NCT03389922 Otsuka / Avanir 2018 用于AD相关激越 NE3107 Phase 3 (进行中) NCT04669028 BioVie 2021 口服抗炎胰岛素增敏剂 AR1001 Phase 3 (进行中) NCT05531526 AriBio 2022 PDE5抑制剂，老药新用 ATH-1017 (Fosgonimeton) Phase 3 (进行中) NCT04488419 Athira Pharma 2020 肝细胞生长因子增强剂 AXS-05 (Dextromethorphan/Bupropion) Phase 3 (进行中) NCT05526968 Axsome Therapeutics 2022 用于AD相关激越 Trontinemab (RO7126209) Phase 3 (进行中) NCT06385072 Roche / Genentech 2024 Brainshuttle技术抗Aβ抗体，基于gantenerumab ALZ-801 (Long-term Extension) Phase 3扩展 (进行中) NCT06304883 Alzheon 2023 APOLLOE4试验长期扩展 Blarcamesine (ANAVEX 2-73) Phase 2/3 (完成) NCT03790709 Anavex Life Sciences 2019 Sigma-1受体激动剂，已提交欧洲上市申请 Piromelatine Phase 2/3 (进行中) NCT05267535 Neurim Pharmaceuticals 2022.5 褪黑素受体激动剂 Buntanetap Phase 2/3 (进行中) NCT05686044 Annovis Bio 2023 神经毒性聚集蛋白翻译抑制剂 Metformin Phase 2/3 (进行中) NCT04098666 University of Pennsylvania 2021.3 降糖药，老药新用 E2814 (Etalanetug) Phase 2/3 (进行中) NCT05269394 (DIAN-TU Tau NexGen) Eisai / UCL 2022.1 抗tau抗体，靶向MTBR，获FDA快速通道资格 Rotigotine + Rivastigmine Phase 2/3 (进行中) NCT04185099 University of California 2019 多巴胺激动剂+胆碱酯酶抑制剂 Lecanemab + E2814 Phase 2/3 (进行中) NCT05269394 (DIAN-TU-001) Eisai 2022 抗Aβ+抗tau组合疗法 ABBV-916 Phase 2 (进行中) NCT05291234 AbbVie 2022 抗Aβ抗体，靶向N3pG-Aβ CT1812 (Zervimesine) Phase 2 (进行中) NCT03507790 (SHINE) / NCT05531656 (START) Cognition Therapeutics 2018 Sigma-2受体调节剂 Bepranemab (UCB0107) Phase 2 (进行中) NCT04867616 Roche / UCB 2021 抗tau抗体，靶向tau中央区域 JNJ-63733657 Phase 2 (进行中) NCT04619420 (AUTONOMY) Janssen 2020 抗tau抗体，靶向p-tau217 LY3372689 Phase 2 (进行中) NCT05063539 Eli Lilly 2021.9 O-GlcNAcase抑制剂，小分子 BIIB080 (IONIS-MAPTRx) Phase 2 (进行中) NCT05399888 (CELIA) Biogen / Ionis 2022 Tau反义寡核苷酸 ACI-35 Phase 2 (进行中) NCT04445831 AC Immune / Janssen 2020 抗tau疫苗 Hydralazine Hydrochloride Phase 2 (进行中) NCT04842552 University of Colorado 2021 老药新用，激活Nrf2通路 Caffeine Phase 2 (进行中) NCT04570085 University of Miami 2020 腺苷受体拮抗剂，老药新用 Sildenafil Phase 2 (进行中) NCT05403764 Cleveland Clinic 2022 PDE5抑制剂，老药新用 Dasatinib + Quercetin Phase 2 (进行中) NCT04063124 Mayo Clinic 2019 衰老细胞清除剂，老药新用 Liraglutide Phase 2 (进行中) NCT05653675 Novo Nordisk 2023 GLP-1受体激动剂，老药新用 Foralumab Phase 2 (进行中) NCT06382623 Tiziana Life Sciences 2024 抗CD3单抗，鼻内给药，针对神经炎症 PRX005 Phase 2 (进行中) NCT06126686 Prothena 2023 抗tau抗体 Exenatide Phase 2 (进行中) NCT04269349 University of Oxford 2020 GLP-1受体激动剂，老药新用 Lixisenatide Phase 2 (进行中) NCT05837287 Sanofi 2023 GLP-1受体激动剂，老药新用，帕金森病 Tirzepatide Phase 2 (进行中) NCT06556289 Eli Lilly 2024 GLP-1/GIP双受体激动剂，老药新用 Dulaglutide Phase 2 (进行中) NCT05844971 Eli Lilly 2023 GLP-1受体激动剂，老药新用 Tadalafil Phase 2 (进行中) NCT05422885 University of California 2022 PDE5抑制剂，老药新用 Vardenafil Phase 2 (进行中) NCT05575076 University of Pennsylvania 2022 PDE5抑制剂，老药新用 Ibudilast Phase 2 (进行中) NCT05549530 MediciNova 2022 PDE4/PDE3抑制剂，抗炎 Saracatinib Phase 2 (进行中) NCT05256052 AstraZeneca 2022 Src/Fyn激酶抑制剂 AZD0530 Phase 2 (进行中) NCT05256052 AstraZeneca 2022 Src激酶抑制剂 Posdinemab (ACI-35-028) Phase 2 (进行中) NCT06126686 AC Immune / Janssen 2023 抗磷酸化tau抗体 AADvac1 Phase 2完成 (未达主要终点) NCT04170891 (ADAMANT) Axon Neuroscience 2020 抗tau疫苗，未达主要终点 ASN51 Phase 2终止 (2025) NCT05544431 Asceneuron 2022 tau靶向药物，战略调整终止 Lu AF87908 Phase 1 (完成) NCT04149860 Lundbeck 2019 抗磷酸化tau抗体 PNT001 Phase 1 (完成) NCT05059380 Pinteon Therapeutics 2021 抗cis-pT231 tau抗体 MK-2214 Phase 1 (进行中) NCT05544431 Merck 2022 抗tau抗体 APNmAb005 Phase 1 (进行中) NCT05575076 Applied NeuroSolutions 2022 抗tau寡聚体抗体 Denali TVD (Transferrin Receptor) Phase 1 (进行中) NCT05712223 Denali Therapeutics 2023 脑穿梭技术平台，抗体递送 DNL919 Phase 1 (进行中) NCT05544431 Denali Therapeutics 2022 TREM2激活剂，脑穿梭技术 AL101 (GSK4527226) Phase 1 (进行中) NCT05575076 Alector / GSK 2022 Progranulin增强单抗 NI006 Phase 1 (进行中) NCT05575076 University Hospital Zurich 2022 抗Aβ纳米抗体 ATN-101 Phase 1 (进行中) NCT05575076 Aton Pharma 2022 抗Aβ抗体 RG7345 Phase 1终止 (2015) NCT01952637 Roche / Genentech 2015 抗tau抗体 BIIB076 Phase 1终止 (2022) NCT03113815 Biogen / Neurimmune 2017 抗tau抗体 AL002 Phase 2 (失败) NCT04592874 (INVOKE-2) Alector 2020 TREM2激动剂抗体，INVOKE-2试验未达终点 Ponezumab Phase 2失败 NCT00960531 Pfizer 2012 抗Aβ抗体 Gosuranemab (BIIB092) Phase 2失败 (2021终止) NCT03352557 Biogen / Bristol-Myers Squibb 2018 抗tau抗体，未达主要终点 Tilavonemab (ABBV-8E12) Phase 2失败 (2021终止) NCT03413319 Bristol-Myers Squibb / AbbVie 2018 抗tau抗体，未达主要终点 Zagotenemab (LY3303560) Phase 2失败 (2021终止) NCT03518073 Eli Lilly 2018 抗tau抗体，未达主要终点 Varoglutamstat (PQ912) Phase 2失败 (2024终止) NCT03919162 (VIVA-MIND) / NCT04498650 (VIVIAD) Vivoryon Therapeutics 2019 QPCT抑制剂，VIVIAD试验失败，已转向糖尿病肾病 Semorinemab Phase 2失败 (TAURIEL/LAURIET) NCT03289143 (TAURIEL) / NCT03828747 (LAURIET) Genentech / Roche 2018 TAURIEL未达终点，LAURIET部分终点阳性但功能终点阴性 Idalopirdine Phase 3失败 NCT01955143 Lundbeck / Otsuka 2015 5-HT6受体拮抗剂 Intepirdine Phase 3失败 NCT02585934 Axovant 2017 5-HT6受体拮抗剂 Bapineuzumab Phase 3失败 NCT00575055 / NCT00574132 Pfizer / Janssen 2014 抗Aβ抗体，未达临床终点 Verubecestat (MK-8931) Phase 3失败 (2017终止) NCT01739348 Merck 2017 BACE1抑制剂，因无效提前终止 Lanabecestat (AZD3293) Phase 3失败 (2018终止) NCT02245737 AstraZeneca / Eli Lilly 2018 BACE1抑制剂 Atabecestat (JNJ-54861911) Phase 3失败 (2018终止) NCT02569398 Janssen 2018 BACE1抑制剂，肝毒性 Crenezumab Phase 3失败 (2019终止/2022发表) NCT02670083 (CREAD) / NCT03114657 (CREAD2) Roche / Genentech 2019 CREAD/CREAD2试验因无效提前终止 Gantenerumab Phase 3失败 (2022.11) NCT03444870 (GRADUATE I) / NCT03443973 (GRADUATE II) Roche / Genentech 2018 GRADUATE试验未达主要终点，未能减缓认知下降 Solanezumab Phase 3失败 (2023年A4研究失败) NCT02008357 (A4 Study) Eli Lilly 2014 EXPEDITION 1/2及A4研究均未达终点 Simufilam (PTI-125) Phase 3失败 (2024-2025) NCT04994483 (RETHINK-ALZ) / NCT05026177 (REFOCUS-ALZ) Cassava Sciences 2021.11 Filamin A抑制剂，两项Phase 3均未达终点，已停止开发 Aduhelm (Aducanumab) 已退市 (FDA 2021.6加速批准, 2024.1停产) NCT02484547 (EMERGE) Biogen / Neurimmune 2021.6 2024年1月Biogen宣布停产，非安全/疗效原因

临床3期上市批准抗体药物偶联物加速审批申请上市

2026-01-08

·BioSpace

BioVie Completes Enrollment in Phase 2 SUNRISE-PD Trial in Early Parkinson’s Disease

- Patient-centric trial aiming to evaluate whether bezisterim can help delay disease progression reaches enrollment milestone - - Topline Results from the SUNRISE-PD Trial Expected in 1H 2026 - CARSON CITY, Nev., Jan. 08, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced that it has completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim (NE3107) on motor and non-motor symptoms in individuals with early-stage Parkinson’s disease (PD) who have not been treated with carbidopa/levodopa. SUNRISE-PD explores whether bezisterim can affect the progression of Parkinson’s symptoms in patients diagnosed with PD within the past four years who need treatment for their symptoms. The trial uses a hybrid, decentralized Phase 2 trial designed to reduce common barriers to participation in PD research, including delayed diagnosis, limited mobility, geographic constraints, and access to specialized care. The study’s flexible design allows participants to complete their study visits either at home or in a clinic, improving access and flexibility while maintaining rigorous data quality and centralized oversight. Completion of enrollment for SUNRISE-PD reflects strong engagement from the PD community and highlights the feasibility of patient-centric trial designs in PD research. “We are looking to see how bezisterim treatment may affect symptomatic progression for Parkinson’s disease patients needing treatment for the first time,” said Cuong Do, President and CEO of BioVie Inc. “Completing enrollment in SUNRISE-PD is an important milestone for BioVie and a testament to the need for more accessible and inclusive clinical trials for people with Parkinson’s disease This milestone benefited from the strong engagement of the Parkinson’s disease community, and we look forward to advancing SUNRISE-PD toward topline data and continuing our mission to develop a potentially disease-modifying treatment for people living with Parkinson’s disease.” Bezisterim is an anti-inflammatory and insulin-sensitizing agent being developed for PD and other neurodegenerative diseases including Alzheimer’s disease (AD) and Long COVID (LC), all conditions where inflammation contributes to neurological damage. In previous clinical trials of PD, bezisterim was administered in combination with levodopa/carbidopa and demonstrated improvements in both motor and non-motor symptoms with a favorable safety profile. It is designed to target key biological processes believed to contribute to the progression of PD, with the goal of modifying the course of the condition over time. SUNRISE-PD enrolled individuals ages 41 to 80 who were diagnosed with PD within the past four years and had not been treated with carbidopa/levodopa. BioVie supported enrollment through outreach and awareness efforts with the support of leading advocacy organizations in the PD field, including The Michael J. Fox Foundation , Davis Phinney Foundation , and the Parkinson’s Foundation . Now that participant enrollment is complete, the Company anticipates analyzing and reporting top-line results first half of 2026. About Bezisterim Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNF-α), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease, Long COVID, and Alzheimer’s disease. In Parkinson’s disease, BioVie has already completed a Phase 2 study that showed patients with moderate- to severe Parkinson’s taking bezisterim with levodopa had better motor control and fewer morning symptoms compared to those taking levodopa alone. Few drug-related side effects were observed. The current SUNRISE-PD just completed enrolling 60 patients to evaluate whether bezisterim alone can help improve motor and non-motor symptoms for Parkinson’s patients who have not been treated with carbidopa/levodopa. Topline results are expected in mid‑2026. For Long COVID, the ADDRESS-LC trial is enrolling about 200 patient to evaluate if bezisterim can reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long Covid, which are believed to be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). Topline data is expected mid-2026. In Alzheimer’s disease, BioVie has conducted both Phase 2 and Phase 3 trials. Early results suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with Alzheimer’s. About BioVie Inc. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for long COVID, where persistent inflammation is thought to underlie symptoms such as brain fog and fatigue. In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit . For Investor Relations Inquiries: For Media Inquiries: Contact: Chuck Padala Managing Director, LifeSci Advisors, LLC chuck@lifesciadvisors.com Contact: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com

临床2期快速通道临床3期孤儿药

100 项与 Triolex 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	临床3期	美国	BioVie, Inc.	2021-08-05
新冠肺炎后遗症	临床2期	美国	BioVie, Inc.	2025-04-29
帕金森病	临床2期	美国	BioVie, Inc.	2025-03-26
创伤性脑损伤	临床2期	美国	BioVie, Inc.	2023-12-21
疲劳	临床2期	美国	BioVie, Inc.	2023-12-21
睡眠	临床2期	美国	BioVie, Inc.	2023-12-21
多发性骨髓瘤	临床2期	美国	NeurMedix, Inc.	2022-08-10
前列腺癌	临床2期	美国	NeurMedix, Inc.	2022-08-10
认知功能障碍	临床2期	美国	BioVie, Inc.	2022-01-19
类风湿关节炎	临床2期	美国	Harbor Therapeutics, Inc.	2008-07-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04669028 (NM101, GlobeNewswire) 人工标引	临床3期	阿尔茨海默症	33	bezisterim	範蓋鑰淵鬱構積淵鏇獵(鹹糧蓋齋醖淵鹹鬱顧蓋): Difference = −3.16, P-Value = 0.036 更多	积极	2025-07-09
				placebo
NCT05227820 (CTgov)	临床2期	阿尔茨海默症 \| 认知功能障碍	23	NE3107	鑰鑰艱鹽網鑰選製衊夢 = 積淵構憲衊顧獵糧醖夢製膚簾選觸選餘鬱憲窪 (築膚鹽蓋積繭鑰齋窪壓, 憲獵範鹽範淵獵範構衊 ~ 範遞鏇齋鬱衊獵簾網觸) 更多	-	2024-07-09
NCT04669028 (GlobeNewswire) 人工标引	临床3期	阿尔茨海默症	-	Bezisterim	艱窪範衊築蓋鑰繭醖選(夢廠夢簾選廠壓襯壓淵) = 醖範範構選簾築選顧簾蓋醖襯醖顧積鹽憲蓋簾 (遞鑰構鬱憲製襯製構願 ) 更多	积极	2024-04-25
NCT04669028 (GlobeNewswire) 人工标引	临床3期	阿尔茨海默症	57	placebo	遞襯築糧鑰壓鑰齋鏇衊(鬱願範鑰憲糧鏇築壓衊) = 構顧壓衊膚夢餘鏇鬱製觸顧觸繭遞鏇膚遞夢醖 (範鏇夢憲膚廠範鑰鏇製 ) 更多	积极	2023-11-29
				NE3107	遞襯築糧鑰壓鑰齋鏇衊(鬱願範鑰憲糧鏇築壓衊) = 構觸構範鑰網積艱窪糧觸顧觸繭遞鏇膚遞夢醖 (範鏇夢憲膚廠範鑰鏇製 ) 更多
NCT04669028 (NM101, Biospace) 人工标引	临床3期	阿尔茨海默症 Amyloid β 42 \| Amyloid β 40	322	NE3107 20 mg	窪窪製醖製範壓鬱構醖(觸夢衊夢壓齋願夢顧築) = Statistically significant population changes from baseline were observed for all primary and secondary cognitive and functional assessments measured: ADAS-Cog12, ADCS-CGIC, MMSE, CDR, CDR-SB, ADCOMS, and ADL. 鹹夢獵窪範獵鑰夢淵願 (選鏇鏇鹽壓糧蓋窪餘獵 ) 更多	积极	2023-10-25
NCT04669028 (NM101, CTAD2023)	临床3期	阿尔茨海默症	439	NE3107 20-mg BID	醖鹹淵餘襯簾構襯製膚(餘衊觸築憲築餘壓廠夢) = 廠鹹窪窪顧鏇淵壓醖艱糧遞獵憲鏇餘範鹽膚遞 (淵憲衊襯網構壓簾鏇獵 ) 更多	积极	2023-10-24
				Placebo	膚鬱繭選壓築鹽齋鹹醖(淵窪夢築夢鹹網鑰鑰鑰) = 窪襯鏇憲窪鑰獵選積觸繭築顧壓廠簾鏇襯範簾 (窪憲鹹醖膚鬱構構糧積 )
MDS 12023 \| MDS 22023 人工标引	临床2期	帕金森病	39	NE3107+carbidopa/levodopa	選窪衊願醖壓鏇憲襯鬱(網醖淵鏇餘壓顧廠簾構) = All patients tolerated NE3107 well, and no drug-related adverse events were reported. 夢齋選選衊鹽壓淵繭膚 (積觸夢廠糧願築醖構簾 ) 更多	积极	2023-08-30
				placebo+carbidopa/levodopa
NCT05083260 (NM201, NEWS) 人工标引	临床2期	阿尔茨海默症 \| 帕金森病	45	Carbidopa+Levodopa hydrate+HE 3286	製簾鑰顧醖餘膚壓廠糧(獵襯鏇壓憲網鏇鬱憲顧) = 蓋網繭鬱衊壓獵繭網遞觸齋淵遞簾醖積獵鑰繭 (觸獵構蓋餘鹽糧壓選構 ) 更多	积极	2022-12-05
				Carbidopa+Levodopa hydrate+Placebo	願獵窪糧夢壓膚窪顧鑰(廠獵醖鹹蓋鹹網鑰艱廠) = 獵網範積繭窪襯齋齋顧艱蓋夢遞淵製獵鏇顧製 (淵衊廠鏇窪選製鹽壓觸 )