Latest Pharmacokinetics News

LTR Pharma has initiated commercial distribution of its nasal spray SPONTAN through Australia's Symbion pharmacy network and is advancing ROXUS development for a US launch in early 2026, while expanding its pipeline with a new intranasal treatment for swallowing disorders.

Radiopharm Theranostics has received FDA clearance to begin a Phase I clinical trial for RV-01, a novel radiopharmaceutical targeting the 4Ig isoform of B7-H3 in solid tumors, marking a significant step forward in cancer treatment innovation.

Neurizon Therapeutics has formally responded to the FDA's clinical hold on its lead ALS drug NUZ-001, submitting new animal safety data. The company aims to join the HEALEY ALS Platform Trial by late 2025, pending regulatory approval.

Nyrada has successfully dosed and discharged the final participants in its Phase I trial of Xolatryp, reporting no adverse safety signals and setting the stage for Phase II development.

Syntara Limited has initiated dosing in its Phase 1c SATELLITE trial for a novel topical treatment targeting keloid scars, marking a significant step in addressing a $3.5 billion global market. The study, led by Professor Fiona Wood, will evaluate safety and early efficacy over three months.

Nyrada has initiated the last cohort of its Phase I trial for Xolatryp, following a clean safety review of the highest dose tested so far. This step sets the stage for critical data that could shape the drug’s next development phase.

Neurizon Therapeutics has received positive feedback from the FDA on its plan to resolve the clinical hold on its ALS drug candidate NUZ-001, with key preclinical studies completed ahead of schedule. The company aims to resume clinical trials in late 2025.

Race Oncology has secured key ethics approvals to launch its Phase 1 RC220 trial at two major Hong Kong hospitals, marking a strategic expansion beyond Australia to accelerate patient recruitment and explore cardioprotective benefits.

Amplia Therapeutics has secured US ethics approval to launch a Phase 2 trial combining its drug narmafotinib with FOLFIRINOX chemotherapy for advanced pancreatic cancer, marking a key step in its clinical development.

Optiscan Imaging Ltd has entered a five-year exclusive collaboration with Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein drug AK-FLOUR®, supporting US clinical trials and FDA regulatory submissions for Optiscan’s InVue® surgical device.

Race Oncology has successfully dosed the first patient with its RC220 and doxorubicin combination in a Phase 1 trial for advanced solid tumours, reporting no dose-limiting side effects. This milestone marks a key step in evaluating the safety and potential cardioprotective benefits of the novel therapy.

Nyrada’s Phase I clinical trial for its novel drug Xolatryp has cleared safety reviews through four cohorts and will now test higher doses and longer infusions in an expanded trial design.