相关临床试验
26
2 进行中
药物批准
1
批准总数
监管机构
1
监管机构数
成立时间
1947
进行中（未招募）
2
7.7%
已完成
21
80.8%
招募中
3
11.5%
- Seikagaku Corporation has initiated three Phase III clinical studies in Japan for Gel-One®, evaluating its efficacy in both knee and hip osteoarthritis patients. - The treatment utilizes a unique cross-linked hyaluronate hydrogel technology, designed to provide long-term pain relief through a single intra-articular injection. - Already available in the US, Taiwan, and Italy for knee osteoarthritis since 2012, the Japanese trials aim to expand treatment options to include hip osteoarthritis.
- FDA advisory panel voted 8-4 in favor of condoliase for radicular leg pain due to lumbar disc herniation, highlighting its potential for patients who have not responded to conservative treatments. - The panel emphasized the need for a narrow indication, focusing on patients with confirmed nerve root impingement and failure of at least 6 weeks of conservative therapy. - Concerns were raised regarding potential immune-related adverse events and long-term effects on spinal health, necessitating careful monitoring and further research. - Condoliase, currently available in Japan, works by reducing disc volume and relieving pressure on the nerve root, offering a non-opioid alternative to surgery for some patients.
- SI-6603, an investigational treatment, significantly improved leg pain compared to sham in U.S. and placebo in Japan at Week 13 in Phase 3 trials. - The studies involved intradiscal injections of SI-6603 and demonstrated statistically significant changes from baseline in worst leg pain. - Common adverse events included spinal MRI abnormalities and back pain, with no treatment-related serious adverse events reported in the U.S. study. - These findings support SI-6603's potential as a therapeutic option for radicular leg pain associated with lumbar disc herniation.
