P3, N=157, Suspended, Galmed Research and Development, Ltd. | N=2000 --> 157

P=N/A, N=150, Enrolling by invitation, Wake Forest University Health Sciences | Not yet recruiting --> Enrolling by invitation

P=N/A, N=4016, Recruiting, Seoul National University Hospital

P=N/A, N=150, Not yet recruiting, Wake Forest University Health Sciences

P2, N=24, Suspended, Galmed Pharmaceuticals Ltd | Trial completion date: Dec 2026 --> Dec 2027 | Not yet recruiting --> Suspended | Trial primary completion date: Sep 2025 --> Sep 2026

P=N/A, N=200, Not yet recruiting, Xuanwu Hospital, Beijing

P=N/A, N=500, Recruiting, Cairo University | Trial completion date: Apr 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025

Correlations were significantly negative between BDNF and MDA, NO, TNF-α, COX 2, and caspase-3 immunoreaction and significantly positive with CAT, HO-1, and PCNA immunoreaction. EZE can safeguard inner ear tissues from GM via antioxidant, anti-inflammatory, and antiapoptotic mechanisms, as well as upregulation of BDNF mechanisms.

P1, N=57, Completed, Galmed Research and Development, Ltd. | Enrolling by invitation --> Completed

P1, N=60, Not yet recruiting, Hanmi Pharmaceutical Company Limited

P1, N=16, Not yet recruiting, Galmed Pharmaceuticals Ltd

P2, N=24, Not yet recruiting, Galmed Research and Development, Ltd. | Initiation date: Jun 2024 --> Jun 2025

P=N/A, N=18000, Active, not recruiting, Daewoong Pharmaceutical Co. LTD. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Dec 2023

P4, N=16, Completed, Esperion Therapeutics, Inc. | Recruiting --> Completed

P4, N=130, Not yet recruiting, University of Salerno

P=N/A, N=8606, Recruiting, Boryung Pharmaceutical Co., Ltd | Not yet recruiting --> Recruiting

P4, N=280, Active, not recruiting, Samsung Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Jan 2027 | Trial primary completion date: Dec 2023 --> Jan 2027

P=N/A, N=20, Completed, University at Buffalo | Unknown status --> Completed | Phase classification: P3 --> PN/A

P=N/A, N=39, Completed, The Hospital for Sick Children | Recruiting --> Completed | N=304 --> 39

Overexpression of TGFβ2 reversed the inhibitory effect of ezetimibe on the migration and invasion of breast cancer cells. Taken together, our results suggest that ezetimibe might be a potential candidate for the treatment of breast cancer metastasis.

P1, N=63, Completed, Chong Kun Dang Pharmaceutical | Not yet recruiting --> Completed

P4, N=200, Recruiting, University of Louisville | Not yet recruiting --> Recruiting

P=N/A, N=8606, Not yet recruiting, Boryung Pharmaceutical Co., Ltd

P=N/A, N=4310, Recruiting, Yonsei University | Not yet recruiting --> Recruiting

P=N/A, N=400, Active, not recruiting, Brigham and Women's Hospital | Trial completion date: Dec 2023 --> Sep 2024

P4, N=200, Not yet recruiting, University of Louisville

Ezetimibe reduced plasma and intrahepatic ox-LDL levels in the cirrhotic rats. Furthermore, it ameliorated intrahepatic fat accumulation and oxidative stress. However, ezetimibe did not alleviate hepatic fibrosis or inflammation in the biliary cirrhotic rats.

P1, N=70, Completed, Chong Kun Dang Pharmaceutical | Not yet recruiting --> Completed

P1, N=62, Completed, Chong Kun Dang Pharmaceutical | Recruiting --> Completed

P1, N=65, Completed, Chong Kun Dang Pharmaceutical | Not yet recruiting --> Completed | N=30 --> 65

P=N/A, N=200, Recruiting, Samara Regional Cardiology Dispensary

Cisplatin (Cis) is among the most powerful antineoplastic medications, nevertheless, its serious side effects; particularly nephrotoxicity designates a major concern. Collectively, Eze exerts significant renal protection against Cis-induced nephrotoxicity via antioxidant, anti-inflammatory and anti-apoptotic pathways that are probably mediated, at least partly, via activating AMPK/Nrf2/HO-1 pathway and conquering both TXNIP/NLRP3 inflammasome and TXNIP/ASK1 signaling pathways. To confirm the protective effect of Eze via AMPK-activation, an AMPK-inhibitor, dorsomorphin (Dors), when co-administered with Eze abolished its protective effect.

Cell cycle analysis revealed that both ezetimibe and F5-treated T47D cells exhibited an increase in the subG1 phase, indicating reduced DNA content and cell death. These findings suggest that F5 could serve as a proficient drug delivery system in augmenting the cytotoxic activity of ezetimibe against breast cancer.

Furthermore, the AKT inhibitor MK2206 enhanced the inhibitory effect of Ezetimibe on the cell cycle and proliferation ability of TNBC cells overexpressing PDGFRβ. In xenograft tumor models, we also found that Ezetimibe inhibited TNBC growth, an effect that can be blocked by overexpression of PDGFR or activation of AKT. In summary, we have demonstrated that EZ inhibits the PDGFR/AKT pathway, thereby halting TNBC cycle progression and tumor growth.

P4, N=280, Recruiting, Samsung Medical Center | Trial primary completion date: Dec 2022 --> Dec 2023

P1, N=60, Not yet recruiting, Chong Kun Dang Pharmaceutical

P2, N=24, Not yet recruiting, Galmed Research and Development, Ltd.

The combination of SCD1 inhibitor aramchol and deuterated sorafenib derivative donafenib displays promising anti-tumor effects in p53-wild type HCC patient-derived organoids and xenografted tumors. This combination therapy has potential clinical benefits for the patients with advanced HCC who have wild-type p53 and high levels of URI/SCD1.

The designed nanocarriers could serve as an ideal candidate for combination therapy of cancer. The results corroborated each other and presented successful EZ and DOX formulations containing PCEC NPs and their efficiency in treating prostate cancer.

In this study, the expressional and metabolic patterns of circRNAs in CLL was illustrated for the 1st time. Our findings revealed that circRIC8B regulates the lipid metabolism abnormalities in and development of CLL through the miR-199b-5p/LPL axis. CircRIC8B may serve as a promising prognostic marker and therapeutic target, which enhances the sensitivity to ezetimibe in CLL.

Early termination due to adverse events (AEs) was <5%, and Aramchol 600 and 400 mg were safe, well tolerated and without imbalance in serious or severe AEs between arms. Although the primary end point of a reduction in liver fat did not meet the prespecified significance level with Aramchol 600 mg, the observed safety and changes in liver histology and enzymes provide a rationale for SCD1 modulation as a promising therapy for NASH and fibrosis and are being evaluated in an ongoing phase 3 program.