相关临床试验
17
5 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
N/A
进行中（未招募）
5
29.4%
已完成
7
41.2%
招募中
1
5.9%
终止
2
11.8%
撤回
2
11.8%
暂无批准数据
- Galectin Therapeutics' belapectin demonstrated a statistically significant reduction in new esophageal varices development in MASH cirrhosis patients in the per-protocol population of the NAVIGATE Phase 2b trial. - The galectin-3 inhibitor showed favorable effects on fibrosis markers and liver stiffness measures, with fewer patients experiencing clinically meaningful worsening compared to placebo. - Results published in Hepatology and presented at EASL 2026 support belapectin's potential as a disease-modifying therapy for portal hypertension in an area with significant unmet medical need.
- Galectin Therapeutics received FDA written response showing alignment on patient population for belapectin registration trial in MASH cirrhosis and portal hypertension. - The company will pursue a follow-up Type C meeting to finalize remaining clinical trial design components and present new biomarker data from the AASLD meeting. - Chairman Richard E. Uihlein provided an additional $10 million convertible line of credit, extending all debt maturity dates to June 2027. - The financing ensures sufficient cash resources to fund expected expenditures through at least March 2027 as the company advances toward a pivotal Phase 3 trial.
- DelveInsight's 2025 analysis reveals over 30 companies are actively developing more than 30 therapeutic candidates for liver cirrhosis, driven by rising global prevalence of liver diseases, particularly NAFLD associated with obesity and metabolic syndrome. - Sagimet Biosciences received FDA Breakthrough Therapy and Fast Track designations for denifanstat in February 2025, while Madrigal Pharmaceuticals plans to launch REZDIFFRA in Europe starting with Germany in the second half of 2025. - Multiple Phase III trials are progressing, including Akero Therapeutics' completed enrollment in the SYNCHRONY Real-World study with results expected in the first half of 2026, and ongoing ENLIGHTEN trials for MASH cirrhosis. - Key investigational therapies advancing through clinical development include Volixibat, TVB-2640, belapectin, RTX001, and LPCN 1148, representing diverse mechanisms of action from sodium-bile acid cotransporter inhibition to macrophage cell therapy.
- Belapectin 2 mg/kg demonstrated consistent antifibrotic effects in the Phase 2b NAVIGATE trial, reducing new variceal development by nearly half in high-risk MASH cirrhosis patients compared to placebo. - Multiple biomarker analyses including Pro-C3, YKL-40, and PRO-C4 supported belapectin's disease-modifying potential, with over 50% greater reduction in Pro-C3 levels versus placebo at 18 months. - The therapeutic benefits were sustained through 36 months of treatment, with belapectin maintaining reduced cumulative incidence of new varices in patients with compensated MASH cirrhosis and portal hypertension. - The galectin-3 inhibitor showed a favorable safety profile comparable to placebo, with no drug-related serious adverse events reported in the 355-patient randomized controlled trial.
- Galectin Therapeutics' belapectin demonstrated a 49.3% reduction in new varices development at the 2 mg/kg dose in its NAVIGATE Phase 2/3 trial for MASH cirrhosis. - The company reported improved Q2 2025 financials with a reduced net loss of $7.6 million and secured $13.8 million in cash plus a $10 million credit line extending operations through mid-2026. - GALT stock reached a 52-week high of $5.10, gaining over 119% since December 2024, driven by promising clinical data and strong financial positioning. - Additional biomarker analysis results are expected later in 2025, with belapectin maintaining Fast Track Designation and patent protection through 2032.
- Galectin Therapeutics announced a new $10 million unsecured credit line from Chairman Richard E. Uihlein to fund operations through June 2026. - The financing supports continued development of belapectin, a galectin-3 inhibitor with FDA Fast Track designation for MASH cirrhosis treatment. - The company plans to present NAVIGATE trial data to the FDA in fall 2025 while actively seeking partnerships for commercialization. - Maturity dates for existing $81 million in borrowings have been extended to September 2026, providing additional financial flexibility.
- DelveInsight's 2025 pipeline analysis reveals over 30 companies developing 30+ liver cirrhosis therapies, with promising candidates like Rezdiffra, efruxifermin, and belapectin showing significant clinical progress. - Madrigal Pharmaceuticals' Rezdiffra demonstrated reduced liver scarring in compensated cirrhosis patients in Phase 3 MAESTRO-NAFLD-1 trial data, while Akero Therapeutics reported preliminary results from its Phase IIb SYMMETRY study of efruxifermin. - The liver cirrhosis treatment market is experiencing robust growth driven by rising global prevalence of liver diseases, particularly NAFLD, fueled by lifestyle factors including obesity and metabolic syndrome. - Key pipeline therapies span diverse mechanisms including sodium-bile acid cotransporter inhibitors, regulatory T-lymphocyte stimulants, and Wnt signaling pathway inhibitors across oral, intravenous, and subcutaneous administration routes.
• The FDA updated safety information for obeticholic acid (Ocaliva) regarding liver injury risk in primary biliary cholangitis (PBC) patients without cirrhosis. • Breakthrough Therapy designation was granted to tobevibart and elebsiran by the FDA and EMA for chronic hepatitis delta (CHD) treatment, based on Phase 2 SOLSTICE trial data. • Atea Pharmaceuticals reported positive Phase 2 results for bemnifosbuvir and ruzasvir in hepatitis C virus (HCV) treatment, achieving a 98% SVR12 rate. • Belapectin, from Galectin Therapeutics, in MASH cirrhosis and portal hypertension, did not meet its primary endpoint in the Phase 2b/3 NAVIGATE trial.
- Belapectin demonstrates a statistically significant 68.1% reduction in the incidence of new varices compared to placebo in U.S. patients with MASH cirrhosis and portal hypertension. - The analysis comes from the NAVIGATE trial, focusing on per-protocol patients (completers) enrolled in the U.S., highlighting the drug's potential in this subgroup. - An estimated 3 million adults in the U.S. suffer from MASH cirrhosis with clinically significant portal hypertension, an area with no FDA-approved therapies. - Further analysis of the NAVIGATE trial, including data from patients completing 36 months of treatment, is expected by the end of Q1 2025.
- Galectin Therapeutics' NAVIGATE trial of belapectin in MASH cirrhosis patients with portal hypertension did not meet its primary endpoint of preventing varices. - While belapectin reduced varices incidence in the intent-to-treat population, the difference was not statistically significant compared to placebo. - In a per-protocol analysis, belapectin showed a 48.9% reduction in varices, but this fell short of the targeted 52.5%. - The safety profile of belapectin remains encouraging, with adverse events comparable to placebo; further analysis and 36-month outcomes are pending.
