Latest Pharmacokinetics News

Neuren Pharmaceuticals has received detailed feedback from the US FDA on its clinical development plans for NNZ-2591 targeting hypoxic ischemic encephalopathy and Pitt Hopkins syndrome, paving a clearer path forward despite some delays.

Island Pharmaceuticals secures FDA confirmation on Galidesivir’s development under the Animal Rule, unlocking a streamlined two-stage approval process and significant commercial incentives.

InhaleRx Limited has progressed its clinical trials for three drug candidates targeting cancer pain, panic disorder, and treatment-resistant depression, while securing additional funding and preparing for a company rebrand.

Arovella Therapeutics has secured a crucial regulatory nod from the U.S. FDA, allowing its lead CAR-iNKT cell therapy, ALA-101, to enter first-in-human clinical trials targeting blood cancers.

LTR Pharma has marked a key milestone with over 1,000 SPONTAN prescriptions under Australia’s Special Access Scheme and is advancing clinical trials and US market preparations for its erectile dysfunction treatments.

LTR Pharma has initiated dosing in its Phase II clinical trial for SPONTAN, a rapid-acting intranasal spray targeting erectile dysfunction, marking a key step toward FDA approval and commercial expansion.

Arovella Therapeutics has taken a significant step forward by submitting an IND application to the U.S. FDA for its lead CAR-iNKT cell therapy, ALA-101, targeting blood cancers. This milestone paves the way for a first-in-human Phase 1 trial in both Australia and the U.S.

Racura Oncology has appointed Beyond Drug Development to oversee its HARNESS-1 Phase 1a/b trial combining RC220 with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward clinical advancement.

Immutep Limited reports encouraging Phase I results for IMP761, a novel LAG-3 agonist antibody targeting autoimmune diseases, demonstrating dose-dependent immunosuppression and a strong safety profile. Further trial updates are expected in early 2026.

LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration to commence its Phase II clinical trial of SPONTAN, focusing on men aged 65 and over. Patient recruitment is set to begin early next year, aiming to address a key gap in erectile dysfunction treatment.

InhaleRx has boosted its funding facility by $12.6 million to accelerate clinical trials of SRX-25, a novel oral treatment for Treatment-Resistant Depression. This brings total available capital to $52.3 million, positioning the company for pivotal Phase III studies.

LTR Pharma has secured ethics approval for its Phase II SPONTAN clinical trial, focusing on pharmacokinetics and dosing in men aged 65 and older. Recruitment begins early 2026 with initial results expected mid-year.