相关临床试验
101
52 进行中
药物批准
101
批准总数
监管机构
7
监管机构数
成立时间
N/A
进行中（未招募）
51
50.5%
已完成
38
37.6%
尚未招募
1
1.0%
招募中
4
4.0%
暂停
2
2.0%
终止
4
4.0%
撤回
1
1.0%
- The European Medicines Agency's CHMP adopted a positive opinion on December 11, 2025, recommending extension of Vueway (gadopiclenol) approval to pediatric patients below 2 years of age, including neonates. - Vueway is a macrocyclic gadolinium-based contrast agent with the highest longitudinal relaxivity among approved GBCAs, delivering comparable diagnostic efficacy at half the gadolinium dose of gadobutrol. - The recommendation addresses a critical need for reduced gadolinium exposure in vulnerable populations whose brains and body tissues are still maturing, with unknown long-term effects of retained gadolinium. - The positive opinion was based on results from study GDX-44-015, reinforcing Vueway's established safety and diagnostic performance profile in this special patient population.
- NUCLIDIUM's 61Cu-NODAGA-PSMA I&T radiotracer successfully imaged the first patient in a phase 1 trial, showing more osseous lesions than FDA-approved 18F-piflufolastat at 1 hour post-injection. - The copper-based diagnostic agent demonstrated improved detection capabilities over time, identifying more osseous lesions at 2 and 4 hours compared to 1 hour post-injection. - The 61Cu-based radiotracer offers potential manufacturing advantages with room temperature production and a 3.3-hour half-life compared to 1-2 hours for current imaging agents. - NUCLIDIUM plans to advance into phase 1/2 theranostic trials in 2025, combining the diagnostic agent with its therapeutic counterpart 67Cu-NODAGA-PSMA I&T.
