ACT Brief: AI, Caplyta Approval, and FDA Priority Vouchers

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert perspectives, and keep you current on what’s moving the industry.

• We begin with Part 3 of a recent video interview on how AI and tokenized data can improve patient-protocol matching. Matt Holms, vice president of sales at Citeline, explained that delays in clinical trials often stem from site variability, investigator shortages, and complex protocols. By combining proprietary and real-world datasets with tokenization and AI, sponsors can streamline feasibility, match patients to trials more accurately, and maintain privacy compliance—helping create a more efficient and equitable recruitment ecosystem.
• Next, the FDA approved Caplyta as an adjunctive therapy for adults with major depressive disorder. The decision is based on two Phase III trials showing significant improvements in MADRS scores compared with placebo, along with a favorable safety profile. Long-term data from an open-label extension showed that 80% of patients responded to treatment, and 65% achieved remission at six months. This marks Caplyta’s fourth FDA-approved indication, broadening its use in neuropsychiatric care.
• Finally, the FDA added six new therapies to its Commissioner’s National Priority Voucher program, bringing the total to 15. The program targets high-impact public health needs, including obesity, cancer, sickle cell disease, and drug-resistant tuberculosis. It accelerates review timelines from 10-12 months to as little as one to two months using a multidisciplinary “tumor board-style” review model. Recent additions include orforglipron and Wegovy for obesity, highlighting the FDA’s commitment to bringing transformative therapies to patients faster.

That’s all for today’s ACT Brief. Join us tomorrow for more insights shaping the future of clinical operations and drug development. Thanks for listening.