相关临床试验
35
34 进行中
药物批准
5
批准总数
监管机构
2
监管机构数
成立时间
N/A
进行中（未招募）
34
97.1%
招募中
1
2.9%
- Purdue Pharma and GCAR have initiated enrollment of tinostamustine in the GBM AGILE adaptive platform trial for newly diagnosed and recurrent glioblastoma patients. - Tinostamustine represents a first-in-class therapeutic combining DNA alkylating activity and HDAC inhibition to target both genomic instability and epigenetic dysregulation in aggressive brain cancers. - The GBM AGILE trial's innovative design enables multiple therapies to be evaluated simultaneously against a shared control arm, potentially supporting future FDA registration. - Since 2019, the international platform has screened over 2,600 patients across approximately 60 trial locations in six countries, addressing the urgent need for new glioblastoma treatments.
- A controlled clinical study published in the Journal of Clinical Pharmacology found that ZURNAI (nalmefene injection) auto-injector reversed fentanyl-induced respiratory depression faster and with longer duration than intranasal naloxone. - The study demonstrated ZURNAI's onset of action between 2.5-5 minutes with significantly greater breathing improvement at 5 minutes (4.59 L/min increase vs 1.99 L/min for naloxone). - ZURNAI showed extended pharmacokinetic properties with a 7.98-hour half-life compared to naloxone's 1.64-hour half-life, supporting its potential as an important opioid overdose reversal option. - Purdue Pharma plans to make ZURNAI available in late 2025 as a no-profit distribution to help combat the ongoing opioid crisis.
- The FDA has approved Zurnai (nalmefene hydrochloride) auto-injector for emergency treatment of known or suspected opioid overdose in adults and pediatric patients aged 12 years and older. - Zurnai delivers 1.5 mg of nalmefene hydrochloride per actuation and is intended for immediate administration in settings where opioids may be present, but it is not a substitute for emergency medical care. - Nalmefene is the longest-acting opioid antagonist approved for opioid overdose reversal, providing an additional option to address overdoses caused by both prescription and illicit synthetic opioids. - Purdue Pharma L.P., the manufacturer of Zurnai, is committed to providing the auto-injector at no profit to the company, aiming to help address the opioid overdose crisis.
