Clinical Trial News

Siamak Daneshmand, MD, discusses TAR-200's safety, tolerability, and high complete response rates (85%) in NMIBC patients from the SunRISe-1 trial. He highlights the psychological benefits of a continuous drug release system and future potential for combination therapies.

Vivos Inc. initiates first human clinical trial for RadioGel® Precision Radionuclide Therapy™ in India, successfully treating five cancer patients. The trial aligns with the protocol designed for the Mayo Clinic, focusing on safety. Vivos continues discussions with the FDA to initiate trials in the U.S., aiming to expand to 30 patients and publish comprehensive data in 2025.

Gary Gibson hypothesizes that thiamine deficiency alters glucose metabolism in brain cells, leading to Alzheimer’s. His research culminated in the Benfoteam clinical trial evaluating benfotiamine, a thiamine precursor, for slowing Alzheimer’s progression. The trial aims to determine the highest safe dose and its efficacy in improving cognition and global function.

Humacyte's SYMVESS, a bioengineered vascular conduit, received FDA approval for treating extremity arterial injuries, offering an off-the-shelf alternative to autologous vein grafts, reducing surgical time and complications.

The US FDA gave Novo Nordisk an early Christmas present on Saturday.

XBiotech halts rheumatology clinical program due to irregularities in Phase II RA study with Natrunix, failing to meet primary endpoint. Additional studies on hold pending evaluation.

Nuvation Bio's NDA for taletrectinib, a next-gen ROS1 TKI for advanced ROS1+ NSCLC, has been accepted by the FDA with a PDUFA goal date of June 23, 2025. Taletrectinib, supported by Phase 2 TRUST studies, shows potential as a best-in-class treatment with durable responses and prolonged PFS.

The FDA added a boxed warning for rare but serious liver injury to fezolinetant (Veozah) labeling, emphasizing hepatotoxicity and increased LFT testing. A postmarketing report detailed a patient's severe hepatic injury, resolved after treatment cessation. Fezolinetant, approved in May 2023 as the first non-hormonal VMS treatment, restores neurokinin B balance disrupted by menopause. The updated prescribing info includes monthly LFT testing for 2 months post-initiation, then at 3, 6, and 9 months, with immediate discontinuation upon liver injury symptoms.

US FDA approved crinecerfont (Crenessity) for congenital adrenal hyperplasia (CAH) in adults and children aged 4+; first new therapy for CAH in 70 years. Indicated as adjunctive treatment to glucocorticoid replacement therapy, it reduces excess adrenal androgens. Based on phase 3 CAHtalyst trial data.

Sumitomo Pharma America announces FDA approval of GEMTESA® (vibegron), the first β3 agonist for men with OAB symptoms on pharmacological therapy for BPH, available for prescription in the U.S.