 |
Diseases |  |
Trials |
|
Trials |  |
News |  |
- mirodenafil (AR1001) / ariBio, Samjin Pharma
Evaluation Of POLARIS AD-Aligned Enrollment Criteria And Longitudinal Outcomes In A Phase 2 AR1001 Study (In-Person; Exhibit Hall; Board No Monday-1168) - Jun 29, 2026 - Abstract #AAIC2026AAIC_6496;
- mirodenafil (AR1001) / ariBio, Samjin Pharma
Polaris-AD: AR1001 Additional Phase 2 Data And Phase 3 Trial Update With Topline Results Expected Later This Year (ICC Auditorium) - Jun 29, 2026 - Abstract #AAIC2026AAIC_5926;
- | mirodenafil (AR1001) / ariBio, Samjin Pharma
Journal: Protective effects of phosphodiesterase 5 inhibitor, mirodenafil, on traumatic brain injury-induced neuron death. (Pubmed Central) - Jan 7, 2026
These findings suggest that mirodenafil supports neuronal survival by preserving cGMP levels, enhancing NO function, and mitigating oxidative stress related to zinc dysregulation. This study highlights mirodenafil as a potential therapeutic option for limiting TBI-induced neuronal injury and preserving brain function.
- || mirodenafil (AR1001) / ariBio, Samjin Pharma
Clinical, P2 data, Journal: A phase 2 randomized, placebo-controlled study on the efficacy and safety of AR1001, a phosphodiesterase-5 inhibitor, in patients with mild-to-moderate Alzheimer's disease. (Pubmed Central) - Sep 26, 2025
P2
AR1001 was safe and well tolerated. Although primary efficacy endpoints were not met after 26 weeks of treatment, participants receiving 30 mg AR1001 showed favorable changes in AD-related plasma biomarkers compared to placebo.
- ||||| mirodenafil (AR1001) / ariBio, Samjin Pharma
Enrollment change: 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) (clinicaltrials.gov) - Jul 16, 2025
P3, N=1535, Active, not recruiting, Sponsor: AriBio Co., Ltd.
Although primary efficacy endpoints were not met after 26 weeks of treatment, participants receiving 30 mg AR1001 showed favorable changes in AD-related plasma biomarkers compared to placebo. N=1150 --> 1535
- | mirodenafil (AR1001) / ariBio, Samjin Pharma
Preclinical, Journal: Mirodenafil improves cognitive function by reducing microglial activation and blood-brain barrier permeability in ApoE4 KI mice. (Pubmed Central) - May 30, 2025
These findings suggest that mirodenafil enhances cerebrovascular function, preserves BBB integrity, and mitigates neuroinflammation in ApoE4 KI mice, leading to cognitive improvement. PDE5 inhibition may serve as a promising therapeutic approach for addressing ApoE4-associated cerebrovascular and cognitive dysfunction.
- ||||| mirodenafil (AR1001) / ariBio, Samjin Pharma
Enrollment closed: 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) (clinicaltrials.gov) - Apr 24, 2025
P3, N=1150, Active, not recruiting, Sponsor: AriBio Co., Ltd.
PDE5 inhibition may serve as a promising therapeutic approach for addressing ApoE4-associated cerebrovascular and cognitive dysfunction. Recruiting --> Active, not recruiting
- mirodenafil (AR1001) / ariBio, Samjin Pharma
DIVERSITY IN A PIVOTAL REGISTRATION TRIAL FOR AR1001 IN THE TREATMENT OF EARLY ALZHEIMER () - Mar 10, 2025 - Abstract #ADPD2025ADPD_2242;
This trial demonstrates that efforts to enroll a diverse population can be successful. AriBio continues to refine its recruitment strategy aimed at a trial population that more closely reflects the diversity of the AD patient community.
- | mirodenafil (AR1001) / ariBio, Samjin Pharma
Preclinical, Journal: Therapeutic effects of mirodenafil, a phosphodiesterase 5 inhibitor, on stroke models in rats. (Pubmed Central) - Feb 2, 2025
Using pMCAO and tMCAO rat models of stroke, we determined that mirodenafil improves the recovery of sensorimotor and cognitive functions after MCAO and protects cortical cells from apoptosis and degeneration. Greater benefit was observed with longer duration of treatment, and improvement was seen even when treatment was delayed.
- | mirodenafil (AR1001) / ariBio, Samjin Pharma
Journal: Developing Topics. (Pubmed Central) - Jan 12, 2025
P3
We demonstrate target engagement of AR1001, a PDE5 inhibitor, by showing an increase in cGMP and BNDF levels in the hippocampus following daily treatment. AR1001 had pronounced effects in recovery of cognitive functions in a transgenic mouse model of AD at a dose equivalent to that being tested in the Phase 3 trial in early AD patients.
- Integrating a Speech-based Prescreening Tool in Central Recruitment Strategies for Alzheimer's Disease Clinical Trials: A Pilot Study () - Aug 31, 2024 - Abstract #CTAD2024CTAD_104;
- mirodenafil (AR1001) / ariBio, Samjin Pharma
Diversity in a Registrational Trial for AriBio's AR1001 for Treatment of Early Alzheimer's Disease () - Aug 31, 2024 - Abstract #CTAD2024CTAD_97;
- | mirodenafil (AR1001) / ariBio, Samjin Pharma
Journal: Developing Topics. (Pubmed Central) - Aug 9, 2024
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- mirodenafil (AR1001) / ariBio, Samjin Pharma
Target Engagement and Therapeutic Effects of AR1001, a Phosphodiesterase-5 Inhibitor, in Alzheimer (Exhibit (Pennsylvania Convention Center); In-Person) - Jun 19, 2024 - Abstract #AAIC2024AAIC_1414;
P3
Conclusion : We demonstrate target engagement of AR1001 , a P DE5 inhibitor, by showing a n increase in cGMP and BNDF levels in the hippocampus following daily treatment. AR1001 had pronounced effects in recovery of cognitive functions in a transgenic mouse model of AD at a dose equivalent to t hat being tested in the Phase 3 trial in early AD patients.
- ||||| mirodenafil (AR1001) / ariBio, Samjin Pharma
Enrollment change: 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) (clinicaltrials.gov) - Oct 23, 2023
P3, N=1150, Recruiting, Sponsor: AriBio Co., Ltd.
AR1001 had pronounced effects in recovery of cognitive functions in a transgenic mouse model of AD at a dose equivalent to t hat being tested in the Phase 3 trial in early AD patients. N=800 --> 1150
- AR1001 / ariBio
Protective Effects of AR1001 in Alzheimer (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_7042;
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- AR1001 / ariBio
Protective Effects of AR1001 in Alzheimer (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_4975;
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- AR1001 / ariBio
Protective Effects of AR1001 in Alzheimer (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_2730;
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- AR1001 / ariBio
Protective Effects of AR1001 in Alzheimer (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_511;
P2
Furthermore, AR1001 showed more pronounced activity in the modulation of GR and Wnt signaling among the various PDE-5 inhibitors. It is suggested that the multimodal activity of AR1001 contributes to the therapeutic effects of AR1001 observed in the phase 2 clinical trial in AD patients (NCT03625622).
- AR1001 / ariBio
PLASMA BIOMARKER ANALYSIS FROM A PHASE 2 TRIAL OF AR1001 IN MILD TO MODERATE ALZHEIMER'S DISEASE PATIENTS. (ONSITE - HALL C) - Dec 23, 2022 - Abstract #ADPD2023ADPD_289;
Furthermore, the dramatic reduction of pTau-181 is consistent with the expected mechanism of AR1001. A Phase 3 trial to further evaluate the therapeutic potential of AR1001 in early AD population will be conducted this year.
- |||||| mirodenafil (AR1001) / ariBio, Samjin Pharma
Enrollment open: 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) (clinicaltrials.gov) - Dec 21, 2022
P3, N=800, Recruiting, Sponsor: AriBio Co., Ltd.
A Phase 3 trial to further evaluate the therapeutic potential of AR1001 in early AD population will be conducted this year. Not yet recruiting --> Recruiting
- |||| mirodenafil (AR1001) / ariBio, Samjin Pharma
Trial completion date, Trial primary completion date: 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) (clinicaltrials.gov) - Oct 12, 2022
P3, N=800, Not yet recruiting, Sponsor: AriBio Co., Ltd.
Not yet recruiting --> Recruiting Trial completion date: Jun 2027 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2025
- |||||||||| mirodenafil (AR1001) / ariBio, Samjin Pharma
New P3 trial: 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) (clinicaltrials.gov) - Sep 8, 2022
P3, N=770, Not yet recruiting, Sponsor: AriBio Co., Ltd.
- AR1001 / ariBio
A Global Phase 3 Study of AR1001 in Early Alzheimer's Clinical Syndrome Patients. (Virtual Platform) - Aug 15, 2022 - Abstract #AAIC2022AAIC_4334;
- AR1001 / ariBio
A novel multimodal compound, AR1001 attenuates multimodal and cognitive dysfunction in a 3xTg mouse model of Alzheimer's disease (Virtual Only) - Dec 20, 2021 - Abstract #Neuroscience2021Neuroscience_2293;
Furthermore, AR1001 played a role in the down-regulation of caspase-3/9 proteins, MMP2/9 and reduced the early apoptosis and oAβ deposits that normally followed APP processing in 3xTg AD mice. The results of this study showed that the treatment of AR1001 had neuroprotective effects in oAβ-deposited 3x Tg AD mouse model.
- AR1001 / ariBio
Results of a Phase 2 Study of AR1001 in Mild to Moderate Alzheimer’s disease Patients () - Aug 7, 2021 - Abstract #CTAD2021CTAD_48;
- |||| mirodenafil (AR1001) / ariBio, Samjin Pharma
Trial completion, Trial completion date: Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Jul 21, 2021
P2, N=210, Completed, Sponsor: AriBio Co., Ltd.
The results of this study showed that the treatment of AR1001 had neuroprotective effects in oAβ-deposited 3x Tg AD mouse model. Active, not recruiting --> Completed | Trial completion date: Jan 2021 --> Jun 2021
- AR1001 / ariBio
[VIRTUAL] TOPLINE RESULTS OF PHASE 2 STUDY OF AR1001 IN MILD TO MODERATE ALZHEIMER'S DISEASE PATIENTS () - Dec 24, 2020 - Abstract #ADPD2021ADPD_1062;
The Phase 2 study will be completed by the end of 2020, and the topline results will be available by January or February of 2021. We will update the conclusion section as soon as the topline analysis is completed.
- AR1001 / ariBio
[VIRTUAL] AR1001 ameliorates Alzheimers disease pathology and symptoms by multi-mechanisms () - Aug 2, 2020 - Abstract #AAIC2020AAIC_520;
Our findings strongly support that AR1001 has benefits against the accumulation of Ab and cognitive deficits in AD mouse models. We have demonstrated that AR1001 serves as a polypharmacological agent to inhibit PDE5 activity, promoting cell survival, and downregulate GR activity, reducing APP/BACE1 expression.
- ||| AR1001 / ariBio
Preclinical: AR1001, a PDE5 inhibitor from ARIBIO, improves memory function in NSE/APP-C105 mice #AAIC20 (Twitter) - Jul 29, 2020
- ||| mirodenafil (AR1001) / ariBio, Samjin Pharma
Enrollment closed: Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Jul 7, 2020
P2, N=210, Active, not recruiting, Sponsor: AriBio Co., Ltd.
We have demonstrated that AR1001 serves as a polypharmacological agent to inhibit PDE5 activity, promoting cell survival, and downregulate GR activity, reducing APP/BACE1 expression. Recruiting --> Active, not recruiting
- || mirodenafil (AR1001) / ariBio, Samjin Pharma
Trial completion date, Trial primary completion date: Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Mar 6, 2020
P2, N=210, Recruiting, Sponsor: AriBio Co., Ltd.
Recruiting --> Active, not recruiting Trial completion date: Aug 2020 --> Nov 2020 | Trial primary completion date: Jun 2020 --> Nov 2020
- rasagiline / Generic mfg.
[VIRTUAL] ALZHEIMER’S DRUG DEVELOPMENT PIPELINE: NOVEL TARGETS AND INNOVATIVE APPROACHES (Hall E) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_54;
One novel combination approach consists of losartan, amlodipine, atorvastatin and exercise and rasagiline is an example of molecule with pleiotropic effects on dopamine and disease-biology pathways...Novel designs being integrated into AD drug development include basket trials, randomized withdrawal trials, serial parallel comparison designs, and platform trials. Conclusions Progress in development of agents with novel targets and novel approaches will accelerate drug development for AD, clarify the disease-biology, and contribute to the development of treatments and treatment combinations for different phases of AD.
- |||| mirodenafil (AR1001) / ariBio, Samjin Pharma
Enrollment open, Trial initiation date, Trial primary completion date: Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Jan 3, 2019
P2, N=210, Recruiting, Sponsor: AriBio Co., Ltd.
Conclusions Progress in development of agents with novel targets and novel approaches will accelerate drug development for AD, clarify the disease-biology, and contribute to the development of treatments and treatment combinations for different phases of AD. Not yet recruiting --> Recruiting | Initiation date: Sep 2018 --> Jan 2019 | Trial primary completion date: Mar 2020 --> Jun 2020
- | mirodenafil (AR1001) / ariBio, Samjin Pharma
New P2 trial: Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Aug 9, 2018
P2, N=210, Not yet recruiting, Sponsor: AriBio Co., Ltd.