Latest Pharmacokinetics News

Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.

Nexalis Therapeutics has advanced its IRX-211 program by screening the first patient in a pivotal Phase 2 trial for Breakthrough Cancer Pain, aiming to address a significant unmet need in oncology supportive care.

Radiopharm Theranostics has reported encouraging initial results from the Phase 1 HEAT trial of its novel HER2-targeted radiopharmaceutical, 177Lu-RAD202, highlighting tumor uptake and a clean safety profile at the lowest dose with dose escalation approved.

Racura Oncology has enrolled the first patient in its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib to tackle resistance in EGFR-mutant non-small cell lung cancer. This milestone sets the stage for a multi-centre study aiming to improve treatment outcomes.

Nexalis Therapeutics has initiated dosing in its Phase 1 trial of IRX-616a, a novel cannabidiol inhalation treatment targeting panic disorder. The trial aims to evaluate safety and pharmacokinetics, with dose escalation decisions expected soon.

Immutep Limited has successfully completed the single ascending dose phase of its IMP761 trial, showing promising safety and immunosuppressive effects in healthy volunteers. The biotech’s novel LAG-3 agonist could reshape autoimmune disease treatment.

Racura Oncology has secured governance approval to launch its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib in EGFR-mutated non-small cell lung cancer patients. This milestone sets the stage for a potentially pivotal new approach to overcoming resistance in lung cancer treatment.

Telix Pharmaceuticals has announced that Part 1 of its ProstACT Phase 3 trial for TLX591-Tx met its primary safety and dosimetry objectives, with no new safety concerns. The study’s success supports ongoing global enrolment in Part 2 and regulatory engagement in the US.

LTR Pharma has finalised recruitment for its Phase II clinical trial of SPONTAN, a rapid-acting intranasal spray for erectile dysfunction, with initial results expected in the second quarter of 2026.

Nexalis Therapeutics has initiated its Phase 1 trial for IRX-616a, an inhaled cannabidiol treatment aimed at panic disorder, marking a significant step in developing rapid-onset anxiety therapies.

Bio-Gene Technology Limited reports strong progress in toxicology studies for Flavocide, targeting its first regulatory submission in Australia by March 2027. This milestone sets the stage for global registrations of the novel insecticide with a new mode of action.

Nyrada Inc. reported a $3.19 million loss for the half-year ending December 2025, while advancing its lead drug candidate Xolatryp® into Phase IIa clinical trials targeting heart attack treatment.