Galmed Pharmaceuticals Ltd. is a clinical-stage drug development biopharmaceutical company, which engages in the development of oral therapy for the treatment of non-alcoholic steato-hepatitis (NASH). Its product candidate, Aramchol, is a synthetic fatty acid-bile acid conjugate molecule for the oral treatment of NASH in patients who are overweight or obese and have prediabetes or type II diabetes mellitus. The company was founded by Allen Baharaff and Tuvia Gilat in 2000 and is headquartered in Tel Aviv, Israel.
相关临床试验
13
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2000
进行中（未招募）
4
30.8%
已完成
7
53.9%
招募中
1
7.7%
终止
1
7.7%
暂无批准数据
- Galmed Pharmaceuticals entered a definitive agreement to acquire Colospan Ltd., a commercial-stage medical device company focused on colorectal surgery complications. - Colospan's CG-100 intraluminal bypass device holds FDA Breakthrough Device Designation and CE mark, designed to reduce anastomotic leaks and eliminate the need for diverting stomas. - Galmed plans a $6 million investment to launch CG-100 commercially in Germany, Austria, and Switzerland during the second half of 2026. - The transaction, valued at $4.5 million in cash and shares, is expected to close in Q2 2026 pending customary conditions.
- Galmed announced an orally dispersible film (ODF) formulation of Aramchol meglumine demonstrating ~150% higher systemic bioavailability and ~300% increase in CNS exposure compared to conventional oral administration. - The ODF formulation addresses dysphagia, which affects up to 80% of Parkinson's patients during disease progression, by dissolving within seconds without water. - Aramchol targets SCD1, a central regulator implicated in α-synuclein aggregation and Lewy body formation, representing a disease-modifying approach distinct from dopaminergic symptomatic therapies. - Galmed positions the program as an out-licensing candidate targeting the $6+ billion global Parkinson's therapeutics market where disease-modifying options remain critically needed.
- Tissue Dynamics and Galmed Pharmaceuticals announced a collaboration to develop a human-centered chronic cardiac fibrosis model using vascularized cardiac organoids with embedded sensors to advance Aramchol-based therapeutics. - The platform will focus on chronic post-myocardial infarction remodeling and heart failure with preserved ejection fraction, targeting the SCD1 enzyme pathway that links lipid metabolism to cardiac fibrosis. - The DynamiX® platform can test over 20,000 human organoids in parallel with real-time monitoring, addressing the lack of effective models for chronic cardiac fibrosis research. - Cardiovascular disease remains the leading cause of death globally with 20.5 million deaths in 2025, yet no approved therapies directly reverse cardiac fibrosis.
- Galmed Pharmaceuticals and Barcode Nanotech have developed a breakthrough brain-penetrating formulation of Aramchol using lipid nanoparticles to cross the blood-brain barrier. - The new formulation targets stearoyl-CoA desaturase 1 (SCD1) and demonstrated dose-dependent reduction of α-synuclein aggregation in vitro studies without toxicity. - This represents the first potential disease-modifying therapy for Parkinson's disease and related synucleinopathies, with Phase 1b/2 studies planned for H2 2026. - The development addresses a critical unmet need, as 98% of drugs cannot reach the brain due to blood-brain barrier limitations.
- Galmed Pharmaceuticals announced acceptance of a late-breaking abstract at HEP-DART 2025 demonstrating that Aramchol enhances regorafenib activity in hepatocellular carcinoma models. - The research shows SCD1 inhibition by Aramchol augments regorafenib activity through ATM-AMPK-autophagy signaling pathways in gastrointestinal cancer models. - VCU Massey Comprehensive Cancer Center will initiate an investigator-initiated Phase 1/2 clinical trial of the Aramchol-regorafenib combination in advanced GI cancers starting in 2026. - The company plans to evaluate a three-drug combination including Metformin in a dose expansion cohort once the recommended Phase 2 dose is established.
- Galmed Pharmaceuticals has received a new use patent in South Korea for the combination of Aramchol and Madrigal's Rezdiffra (resmetirom) to treat metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis. - The patent extends Aramchol's global intellectual property protection until July 2042, building on previous patents granted in the United States, Europe, Canada, and other jurisdictions. - Aramchol is positioned as a first-in-class, Phase 3-ready drug candidate with demonstrated robust fibrosis improvement in advanced clinical studies and excellent safety profile. - The patent grant comes as the MASH treatment field shifts toward combination therapies due to limited efficacy of monotherapies in addressing this complex liver disease.
- Galmed Pharmaceuticals announced top-line results showing synergistic effects of Aramchol, Stivarga (regorafenib), and metformin in killing gastrointestinal tumor cells both in vivo and in vitro. - The three-drug combination demonstrates potential as a fixed-dose treatment that could enhance Bayer's top-selling cancer drug Stivarga, which generated €458 million in the first nine months of 2022. - Phase 1b clinical trials are planned to begin in early 2026 at VCU Massey Comprehensive Cancer Center for patients with metastatic colorectal cancer, hepatocellular carcinoma, and cholangiocarcinoma. - The combination could serve as a life-cycle intellectual property strategy for regorafenib as its main patents expire in August 2028 in Europe and July 2032 in the U.S.
• Galmed Pharmaceuticals has signed a binding term sheet with Entomus for a novel sublingual semaglutide formulation using Self-Emulsifying Drug Delivery System technology that bypasses first-pass metabolism. • The innovative delivery method offers a non-invasive alternative to injectable GLP-1 agonists like Ozempic and Wegovy, potentially improving patient compliance while enhancing bioavailability compared to oral Rybelsus. • With the global GLP-1 market projected to reach $120B+ by 2030, Galmed aims to target markets where semaglutide patents expire as early as 2026, including India, Brazil, and Gulf countries with high diabetes and obesity rates.
- Aramchol, Galmed Pharmaceuticals' SCD1 inhibitor, significantly enhanced the anti-tumor effects of Bayer's Regorafenib in liver and colorectal cancer models through increased autophagy and death receptor signaling. - The drug combination demonstrated significant reduction in hepatic tumor growth in mice models without normal tissue toxicities, potentially offering a cost-effective alternative to current treatments for GI cancers. - A Phase 1b clinical trial evaluating the Aramchol-Regorafenib combination in patients with advanced GI cancers is planned to begin at Virginia Commonwealth University's Massey Cancer Center in Q4 2025.
- Analysis of blood samples from Aramchol-treated patients in the Phase 3 ARMOR MASH study revealed a panel of 70 proteins that form a pharmacodynamic signature, indicating decreased markers of inflammation, oxidative stress, and atherosclerotic plaque formation. - The findings show Aramchol significantly reduces Atrial Natriuretic Peptide (ANP), a validated heart failure biomarker, while stimulating expression of KDM4C, a protein involved in repressing liver fibrosis, suggesting broader therapeutic applications. - Through collaboration with Proteas Health, Galmed aims to develop a cost-effective, high-throughput assay to measure Aramchol's unique pharmacodynamic signature, potentially transforming clinical development and enabling real-time evaluation of drug response.
