Leuprolide Mesylate

TAIPEI, June 8, 2026 /PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO), ("Foresee") announced today that Foresee's oral ALDH2 activator, mirivadelgat, has been selected to enter clinical testing in Parkinson's disease in the SLEIPNIR Phase 2a platform trial, in collaboration with Haukeland University Hospital, Bergen, Norway. SLEIPNIR is a multi-arm Phase 2a clinical trial platform designed to evaluate investigational disease-modifying therapies in Parkinson's disease, with focus on brain penetration, biological target engagement, and mechanistic biomarker effects. The trial has been funded by Cure Parkinson's. Professor Charalampos Tzoulis, MD, Ph.D, Chief Investigator of the SLEIPNIR Platform and Director of the Neuro-SysMed Center of Excellence for Clinical Neurological Research and the Innovation Center for Neuroresilience (ICoN) at Haukeland University Hospital and the University of Bergen, said: "Foresee's oral ALDH2 activator, mirivadelgat, was selected through a highly competitive and scientifically rigorous process as one of several therapies to be included in SLEIPNIR. This platform is specifically designed to assess central nervous system penetration and biological target engagement in patients with Parkinson's disease. This information will be indispensable in allowing us to prioritize treatments for further development. We are very pleased to collaborate with Foresee and look forward to evaluating the therapeutic potential of ALDH2 activation in PD" Dr. Simon Kverneng, MD, PhD, a neurology resident and experienced clinical researcher in Prof. Tzoulis' group, is the Principal Investigator of SLEIPNIR. Dr. Ben Chien, Chief Executive Officer of Foresee, said: "This is a significant opportunity to provide further validation of mirivadelgat/ALDH2 activation as a potential treatment approach for Parkinson's, and potentially other CNS diseases. We are grateful to the SLEIPNIR team, potential participants in the study and Cure Parkinson's for their support". Dr. Wenjin Yang, CSO at Foresee stated: "The role of ALDH2 in the pathophysiology of PD and other neurological diseases is quite compelling when looking at the current body of data. We are confident the results from this study will provide a strong foundation for further development in PD and other CNS diseases as this study will provide data related to CNS penetration and target/biomarker engagement of mirivadelgat". About mirivadelgat Research suggests that toxic compounds called aldehydes can build up inside brain cells, playing a critical role in PD pathogenesis. Over time, aldehydes cause proteins to clump together and contribute to the loss of nerve cells. Mirivadelgat is designed to increase the activity of ALDH2, an enzyme that directly clears these harmful compounds from the brain. By supporting this natural defense system, mirivadelgat accelerates detoxification and could potentially slow the ongoing loss of nerve cells in neurodegenerative diseases, such as PD. About SLEIPNIR SLEIPNIR is a biomarker-driven Phase 2a multi-arm platform trial designed to assess whether candidate disease-modifying therapies for Parkinson's disease reach the brain and interact with their intended biological targets. By testing multiple investigational drugs in parallel against a shared placebo group, SLEIPNIR will efficiently determine which treatments should be prioritized to advance to larger efficacy trials SLEIPNIR is funded by Cure Parkinson's, a UK-based charity, whose mission is help develop a cure for Parkinson's disease. The project is also funded by the Research Council of Norway, Western Norway Regional Health Authority, Norwegian Parkinson's Research Fund and the Norwegian Parkinson's Association. Study Design The Phase 2a mirivadelgat study in Parkinson's disease is designed to assess whether mirivadelgat reaches the central nervous system, engages its intended biological target, and is safe and well tolerated in people with PD. The study will be conducted as part of SLEIPNIR, a biomarker-driven Phase 2a platform trial designed to accelerate the clinical evaluation of potential disease-modifying therapies for Parkinson's disease. Rather than testing each treatment in a separate stand-alone study, SLEIPNIR evaluates several investigational therapies in parallel using a shared platform design, enabling more efficient assessment of brain penetration, target engagement, and mechanistic biomarker effects. Within the mirivadelgat cohort, 40 eligible participants with Parkinson's disease will be randomized 3:1 to receive either mirivadelgat once daily or matching placebo, in addition to standard dopaminergic treatment. The placebo participants from the mirivadelgat cohort will contribute to a pooled placebo group shared across concurrent SLEIPNIR treatment arms, resulting in an effective comparison of 30 participants receiving mirivadelgat versus 30 participants receiving placebo across the platform. Participants will receive study treatment for 12 weeks, followed by a two-week post-treatment safety follow-up. The primary assessment will take place at the end of the 12-week treatment period, with the week-14 visit used to evaluate safety after treatment discontinuation. The Parkinson's Disease (PD) Opportunity The PD treatment market will expand over the upcoming years, with overall sales in the US, Japan, and five major European markets growing from $2.2bn in 2023 to $3.6bn in 2032 at a compound annual growth rate (CAGR) of 5.47%. Revenues in the US and European markets are set to increase the most. The market is mainly comprised of levodopa-based therapies, COMT inhibitors, MAO-B inhibitors, and dopamine agonists, many of which are approved for patients with "off" episodes (resulting from long-term use of levodopa), which are more common in late-stage PD patients. Late-stage patients often require more complex and specialized therapies and as a result, developers tend to focus more on this group. Yet, people in the early stages of PD (Stages 1–3) make up about 60% of those receiving treatment, contributing significant revenue to the market. In view of the limited new approved therapies with novel mechanisms, the PD drug market is highly genericized in the US and Europe. While it is expected that several new therapies will enter the market, most focus on improved delivery and reformulation of existing mechanistic classes. Apart from a few new targeted therapies such as alpha-synuclein antibodies currently in development, there remains a high unmet need for first-in-class oral therapies with disease-modifying potential. New treatments with a differentiated clinical profile – including efficacy, safety and convenience - will have an opportunity to unlock a substantial market opportunity. About Cure Parkinson's Cure Parkinson's is working with urgency to find new treatments to slow, stop, or reverse Parkinson's. Their funding and innovation have redefined the field of Parkinson's research, enabling the world's leading researchers to prioritise the next generation of drugs for clinical trials. Together we will conquer Parkinson's. Further information at cureparkinsons.org.uk Cure Parkinson's is the operating name of The Cure Parkinson's Trust. The Cure Parkinson's Trust is a registered charity in England and Wales (1111816) and Scotland (SCO44368) and is a company limited by guarantee – company number 05539974 (England and Wales). About the Research Environment DECODE-PD is an interdisciplinary translational research group led by Prof. Charalampos Tzoulis in Bergen, Norway, focused on developing and testing potential disease-modifying therapies for Parkinson's disease and related neurodegenerative disorders. The group conducts a broad portfolio of biomarker, mechanistic and clinical research programs, including national and international investigator-driven multicenter trials in Parkinson's disease and other parkinsonian disorders. DECODE-PD is hosted by the University of Bergen and Haukeland University Hospital and operates as part of a larger Norwegian ecosystem for clinical neuroscience innovation, including the Neuro-SysMed Center of Excellence for Clinical Neurological Research, the K.G. Jebsen Center for Parkinson's Disease, the Mohn Center for Neuroprotection, and the Innovation Center for Neuroresilience (ICoN). SLEIPNIR is embedded within this translational trial infrastructure and is being developed under ICoN as a platform for accelerating biomarker-driven early-phase testing of candidate disease-modifying therapies for Parkinson's disease. Under Prof. Tzoulis' leadership, these initiatives aim to translate advances in neurobiology, biomarkers and clinical trial methodology into new treatments for neurodegenerative disease. Innovation Center for Neuroresilience (ICoN) | UiB About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, CAMCEVI ETM was approved by the U.S. FDA on August 25, 2025. Foresee was notified by its licensing partners in April and May 2026 regarding the successful drug approvals in Canada and the granting of EMA marketing authorization in the EU. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical trial successfully reached its primary endpoint in December 2025 (p-value = 0.0005), with an NDA submission to the U.S. FDA planned in the second half of 2026. Concurrently, CAMCEVI 6-month LAI formulation has completed its Phase 3 clinical trial for another indication in premenopausal breast cancer in China, and the supplemental New Drug Application (sNDA) for leuprolide injectable emulsion in premenopausal breast cancer has been accepted by China NMPA. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, successfully completed a Phase 2 proof-of-concept study in allergic asthmatic patients. Future development of aderamastat will be in rare immune-fibrotic diseases, including cardiac sarcoidosis. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted in severe asthma and COPD. In January 2026, the global rights for the MMP-12 Inhibitor series were exclusively licensed to Primevera Therapeutics LLC for all subsequent R&D. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients was initiated in the second quarter of 2025. SOURCE Foresee Pharmaceuticals 21% more press release views with Request a Demo