A Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 Over 52 Weeks in Participants with Early Alzheimer's Disease (Polaris-AD)

This AR1001-ADP3-US01 protocol is a double-blind, randomized, placebo-controlled, multi- center, parallel-group comparison pivotal Phase 3 study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early AD.

Start Date23 Dec 2022

Sponsor / Collaborator

ARIBIO Co., Ltd.

NCT03625622

/ CompletedPhase 2

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease

A double-blinded, randomized, placebo-controlled study will be performed to evaluate the efficacy and safety of treating AR1001 in patients with mild to moderate Alzheimer's disease for 26 weeks.

Start Date01 Apr 2019

Sponsor / Collaborator

ARIBIO Co., Ltd.

CTR20244348

/ Not yet recruitingPhase 3

一项评价AR1001治疗早期阿尔茨海默病受试者持续52周的有效性和安全性的III期、双盲、随机、安慰剂对照、多中心试验

[Translation] A Phase III, double-blind, randomized, placebo-controlled, multicenter trial evaluating the efficacy and safety of AR1001 in subjects with early Alzheimer's disease for 52 weeks

评价AR1001与安慰剂相比在早期阿尔茨海默病受试者中的有效性

[Translation]

To evaluate the efficacy of AR1001 compared with placebo in subjects with early Alzheimer's disease

Start Date-

Sponsor / Collaborator

Bonacia (Hefei) Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Mirodenafil dihydrochloride

100 Translational Medicine associated with Mirodenafil dihydrochloride

100 Patents (Medical) associated with Mirodenafil dihydrochloride

5,002

Literatures (Medical) associated with Mirodenafil dihydrochloride

01 Jun 2025·SEPARATION AND PURIFICATION TECHNOLOGY

Energy-efficient CO2 capture using novel low-viscosity water-lean aromatic amine solvent MBA/BDMA/EG/H2O: Performance, mechanism and thermodynamics

Author: Chi, Shudan ; Yang, Linjun ; Li, Wenrui ; Yu, Hang ; Hou, Dawei ; Wang, Xin ; Jin, Lijian ; Kong, Sining ; Hou, Xueyan ; Yang, Hangqi

To address the challenges of high regeneration energy and corrosion in traditional mixed amine absorbents, as well as the increased viscosity issues in water-lean absorbents post-saturation, this study introduces the co-solvent ethylene glycol (EG) to replace part of the water in the high stability N-methylbenzylamine (MBA) and N, N-dimethylbenzylamine (BDMA) systems, resulting in a novel water-lean aromatic amine solvent, MBA/BDMA/EG/H₂O, is proposed as an alternative solutionThe addition of the tertiary amine BDMA significantly enhanced the regeneration efficiency of the absorbent.When the mass ratio of MBA/BDMA/EG/H₂O is set at 1.5:1.5:3.5:3.5, the CO₂ loading reaches 0.36 mol/mol, while the viscosity is only 10.82 mPa·s at room temperatureThe CO₂ capture mechanism of this absorbent was elucidated using ¹³C NMR and quantum chem. calculationsInitially, CO₂ reacts with MBA to form MBACOO^-/MBAH⁺.Subsequently, MBA⁺COO^- undergoes deprotonation to produce MBAH⁺ and BDMAH⁺.As the concentration of free MBA decreases to a certain level, BDMA undergoes hydrolysis, resulting in the formation of HCO^-₃.In the later stages of absorption, some of the carbamate products convert to unstable alkyl carbonates by reaction with EG.Notably, the regeneration energy of MBEH is reduced by 21.1% (estimate), compared to 30% MEA aqueous solutionThe corrosion rate of 30% MEA (after absorption) on carbon steel is 3.6 times higher than that of MBEH (after absorption).Therefore, the proposed MBEH solution presents a promising absorbent with excellent desorption performance, low viscosity, reduced regeneration energy, and low corrosion rate.

01 Apr 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Effects of silica nanoparticle addition and PDMS coating on membrane performance and stability in the extraction of aromatic amines

Article

Author: Luis, Patricia ; Garcia-Chirino, Julieta ; Van Eygen, Gilles ; Gilles, Amaury ; Baylan, Nilay ; Buekenhoudt, Anita ; Van der Bruggen, Bart

This study investigates novel strategies to improve membrane performance and stability in the extraction of aromatic amines for chiral amine production. The effects of silica nanoparticle addition and polydimethylsiloxane (PDMS) coating were explored, with a focus on the selective extraction of α-methylbenzylamine (MBA) and 1-methyl-3-phenylpropylamine (MPPA) from isopropyl amine (IPA). This work introduces a comparative analysis between open and tight membrane extraction (ME) systems, with and without the ionic liquid (IL) [P_6,6,6,14][N(Tf)₂]. The results reveal that PDMS creates a uniform and dense coating, particularly on PTFE and PVDF supports, while silica nanoparticle coatings were less stable, retaining only 50 % of nanoparticles after ME testing. A PDMS-coated PTFE membrane achieved significantly higher solute fluxes of 1.12 ± 0.01, 1.66 ± 0.02, and 0.36 ± 0.08 g/(m²h) for MBA, MPPA, and IPA, respectively, compared to an IL-wetted PTFE membrane, which was found to have fluxes of 0.60 ± 0.06, 1.01 ± 0.04, and 0.33 ± 0.10 g/(m²h) for the same solutes. A reduction in the pore size of the PTFE support further increased the fluxes to 1.74 ± 0.28, 2.75 ± 0.25, and 0.45 ± 0.08 g/(m²h) for MBA, MPPA, and IPA, respectively, achieving selectivity values of 3.83 ± 0.65 for MBA/IPA and 6.24 ± 0.88 for MPPA/IPA. Although IL impregnation marginally improved selectivity, it caused a significant reduction in solute fluxes. The PDMS coating retained 92.1 % of its mass after 24 h, while the IL retained 87.2 % over the same period. Compared to the tested IL, which presents safety concerns due to its flammability and corrosiveness, PDMS coatings provide a safer and more environmentally friendly alternative, as PDMS is non-toxic and does not bioaccumulate. These findings underscore the superior performance and environmental benefits of novel PDMS-coated membranes in tight ME setups compared to IL-based open ME systems.

17 Mar 2025·ANGEWANDTE CHEMIE-INTERNATIONAL EDITION

Catalytic Reductive Amination and Tandem Amination–Alkylation of Esters Enabled by a Cationic Iridium Complex

Article

Author: Ruan, Zhong‐Lei ; Lu, Guang‐Sheng ; Ye, Jian‐Liang ; Lü, Jin‐Fang ; Wang, Yan ; Huang, Pei‐Qiang

Abstract:

Reported herein is a convenient and efficient method for one‐pot, catalytic reductive amination, as well as the first multi‐component tandem reductive amination—functionalization of bench‐stable and readily available common carboxylic esters. This method is based on the cationic [Ir(COD)2]BArF‐catalyzed chemoselective hydrosilylation of esters, followed by one‐pot acid‐mediated amination and nucleophilic addition. The reaction was conducted under mild conditions at a very low catalyst loading (0.1 mol % of Ir), which could be further reduced to 0.001 mol %, as demonstrated by a reaction at a 15 g scale. The method is highly versatile, allowing the use of esters with or without α‐protons for the N‐mono‐alkylation of primary and secondary amines to produce diverse secondary and tertiary amines, as well as α‐branched/functionalized amines. The method is highly chemoselective and tolerates a variety of functional groups such as bromo, trifluoromethyl, ester, and cyano groups. The value of the method was demonstrated by the one‐step catalytic synthesis of two bio‐relevant N‐mono‐methyl α‐amino esters and the antiparkinsonian agent piribedil, as well as by the use of two shorter chain triglycerides as alkylating feedstock.

News (Medical) associated with Mirodenafil dihydrochloride

15 Oct 2024

·www.prnewswire.com

Neurophet-AriBio to develop 'Next-Gen Platform for Alzheimer's diagnosis'

- Neurophet's brain MRI analysis technology incorporates fluid biomarker data from AriBio's global Phase 3 clinical trial for Alzheimer's disease - Collaborates leveraging Neurophet's medical image analysis technology and AriBio's clinical trial data analysis expertise SEOUL, South Korea, Oct. 15, 2024 /PRNewswire/ -- Neurophet, an artificial intelligence (AI) solution company for brain disease, announced its collaboration with AriBio, a biopharmaceutical company developing therapies for neurodegenerative diseases, to develop next-generation platform for Alzheimer's diagnosis. Continue Reading Neurophet-AriBio to develop ‘Next-Gen Platform for Alzheimer's diagnosis’ The collaboration aims to develop a new Alzheimer's diagnostic platform by integrating Neurophet's brain image analysis technology using MRI (magnetic resonance imaging) with fluid biomarker data from AriBio's global Phase 3 clinical trial for early Alzheimer's disease. AriBio's platform team with clinical trial data analytics capabilities will collaborate with Neurophet's AI team on developing this advanced diagnostic platform. The conventional method to diagnosing Alzheimer's disease typically involves amyloid-PET (positron emission tomography) scan or CSF (cerebrospinal fluid) test to detect cortical amyloid beta deposition and confirm the presence of Alzheimer's. However, amyloid-PET scans are relatively expensive, and the CSF test involves a lumbar puncture, where a long needle is inserted between the vertebrae to drain fluid, which causes pain and requires time for recovery. These limitations result in lower medical accessibility for patients. To address these challenges, Neurophet and AriBio are developing a new diagnostic platform. The plan is to create a platform that can predict the risk of amyloid beta protein positivity early by conducting MRI analysis and blood-based biomarker tests before amyloid-PET scans. This approach aims to reduce unnecessary amyloid-PET scans and actively utilize a more accessible Alzheimer's disease testing method. "By participating in AriBio's global Phase 3 clinical trial of AR1001, a broad range of medical data will be obtained to achieve meaningful research outcomes in various fields." said Jake Junkil Been, CEO of Neurophet. "If this platform is successfully developed, it could significantly reduce medical costs associated with dementia diagnosis and treatment, while also improving patient convenience." Jai Jun Choung, CEO of AriBio stated, "AriBio is working on a safe and easy-to-take oral tablet to ensure accessibility and convenience for Alzheimer's disease patients and their families, and we hope to further enhance diagnostic accessibility through our collaboration with Neurophet." Neurophet has entered into an agreement with AriBio to participate in the global phase 3 clinical trial of AR1001, an oral treatment for Alzheimer's disease. Neurophet plays a key role in identifying eligible patients for the trial and assessing the treatment effect of AR1001 using its brain imaging analysis technology. In addition, the two companies are conducting joint research and business development by utilizing the medical image, blood, and CSF data obtained from the large-scale, multinational AR1001 clinical trials. About Neurophet Neurophet has specialized in developing solutions for diagnosis support, treatment guides, and treatment devices targeting brain diseases based on cutting-edge artificial intelligence (AI) technology. The company was founded in 2016 by Jake Junkil Been, CEO, and Donghyeon Kim, CTO, who developed the next-generation neuro-navigation system. Major products include brain MRI analysis software "Neurophet AQUA", brain PET image analysis (PET tracer deposition) software "Neurophet SCALE PET", brain imaging treatment planning software for electric and magnetic brain stimulation "Neurophet tES/TMS LAB". Neurophet has set its top priority to helping patients suffering from brain diseases. Based on expertise in neuroscience, Neurophet will continue to challenge and grow to explore the human brain's health and pioneer solutions for brain diseases with AI technology. SOURCE Neurophet WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

04 Oct 2024

·www.mobihealthnews.com

Indian mental health app Lissun takes on AI with $3M and more briefs

Mental health app Lissun bags $3M for AI integration Mental health platform Lissun in India has scored $2.5 million in a pre-Series A funding round led by RPSG Capital Ventures. With its fresh funds, the startup plans to integrate AI into its suite of digital mental health solutions which target corporates, schools, and families of children with neurodevelopmental conditions. The new funds will also go to expanding their services and growing their team. Proceeds from this new investing round bring its total investment to $5 million. Lissun last raised over $1 million in seed funding in September of the previous year. Asan Medical Center first to prescribe locally-approved vision loss DTx Asan Medical Center (AMC), one of South Korea's biggest hospitals, has started prescribing a Korean-made digital therapeutic for visual impairment due to stroke. The mobile-based application Vivid Brain provides training through virtual reality to enhance a user's response to visual stimuli. AMC officially prescribed the solution in September, five months after it was cleared by the Korean government – the third for a local DTx. AMC professor Kang Dong-hwa, who developed Vivid Brain with Nunaps (a local company he founded), now plans to expand their DTx to hospitals locally and abroad. Neurophet's latest collab to predict Alzheimer's risk Korean medical imaging AI company Neurophet has announced a new partnership that will develop a new Alzheimer's disease diagnosis platform. In a statement, the company said it will collaborate with local biotechnology firm Aribio, which develops treatment for neurodegenerative diseases. They intend to integrate Neurophet's MRI-based image analysis software with Aribio's blood-based Alzheimer's diagnostic test to detect early people with Alzheimer's-positive amyloid beta protein deposits in their brains. Their solution, according to a press release, seeks to make Alzheimer's testing more accessible, reducing repeat testing with the costly amyloid-PET imaging. Neurophet and Aribio's collaboration builds on their existing work in the global clinical trial of Aribio's oral Alzheimer's treatment AR1001, phase 3. In July, Neurophet unveiled the Neurophet AQUA AD, its latest Alzheimer's treatment prescription and monitoring software.

Drug Approval

30 Sep 2024

·www.globenewswire.com

Adaptive Research Announces it has Begun Enrolling Patients in AriBio’s Phase 3 POLARIS-AD Clinical Trial

SAN FRANCISCO, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Adaptive Research, a clinical trial site organization whose mission is to democratize clinical trials by providing full-service support to trial investigators in community settings, announced two community practices that are part of the Adaptive Research network have begun patient enrollment and randomization in AriBio’s Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (POLARIS-AD). Noor Sachdev, MD and Perminder Bhatia, MD will serve as investigators with regulatory, finance, and clinical support for all study-related activities provided by Adaptive Research. “Studies such as this—which require participants to have signs and symptoms associated with the early stage of Alzheimer’s, such as some memory, planning, and organizational issues, and have a care partner who can accompany them to study visits—demonstrate the value of including community sites,” said Deepak Behera, MD, President and Chief Executive Officer of Adaptive Research. “Travel time to academic settings can contribute to inequalities in Alzheimer's disease clinical trial enrollment due to age, geography, and ethnicity. To recruit study populations that reflect the treatment population and make it easier for them to stay in the study, Sponsors need sites closer to patients that can produce quality data. In fact, community sites tend to know the patient population better resulting in a lower screen fail rate and better patient retainment compared to other settings.” “As we engage with interested investigators and sites across the world who are committed to making a difference in the treatment of patients with Alzheimer’s disease, we are pleased to have access to these community physicians who are on the front lines of patient care and often the first to see patients with early AD. These sites are paramount to running successful trials and providing access to diverse populations,” said James Rock, Chief Clinical Officer for AriBio. AriBio previously completed a Phase 2 study (NCT03625622) with AR1001 in a mild to moderate AD population in the US. AriBio is expected to enroll 1150 participants in this global Phase 3 clinical trial to evaluate the therapeutic potential of AR1001 in the treatment of early Alzheimer’s disease. About AR1001 About AR1001-ADP3-US01 AR1001-ADP3-US01 (NCT05531526) is Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 over 52 Weeks in Participants with Early Alzheimer’s Disease. The study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer's disease through various cognitive and functional assessments. The details of the clinical trial are available at ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT05531526). About Adaptive Research Founded in 2020, Adaptive Research Inc. is revolutionizing the landscape of clinical trials. By offering full-service support to trial investigators, Adaptive Research connects Sponsors of potential life-saving investigational agents and medical devices with community physicians and their patients nationwide. Adaptive Research’s expert team functions as a virtual clinical trials office, managing administrative and regulatory responsibilities, and enabling physicians to focus on their paramount task: providing exceptional clinical judgement and care. For additional information, visit https://adaptiveresearch.com. About AriBio AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in the United States. The company focuses on the development of novel therapies for neurodegenerative diseases including Alzheimer’s disease. Contacts:Inquiriesyour.partner@adaptiveresearch.com

Phase 2Phase 3

100 Deals associated with Mirodenafil dihydrochloride

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	United States	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	China	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	Czechia	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	Denmark	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	France	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	Germany	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	Italy	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	Netherlands	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	Poland	ARIBIO Co., Ltd.	23 Dec 2022
Alzheimer Disease	Phase 3	Spain	ARIBIO Co., Ltd.	23 Dec 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03625622 (BusinessWire) Manual	Phase 2	Alzheimer Disease	210	AR1001 10 mg	ehihqxdoal(qyutedixcw) = ovrmmgvjhg cefstidgyf (uffpdschfu )	Positive	04 Nov 2021
				AR1001 30 mg	aiinbplecs(gzjatalgrc) = islakefgyg ozpuivznvm (bdlvmmucdy ) View more

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