naproxen-pregabalin conjugate (XG004-03) / Xgene Pharma - LARVOL DELTA

Drugs in Development to Manage Acute Pain. (PubMed, Drugs) - "These agents include VX-548 (Suzetrigine), Cebranopadol, AAT-076, Combogesic intravenous (IV), sublingual ketamine, XG004 (naproxen/pregabalin conjugate), and HTX-011 (Zynrelef). We analyze the pharmacodynamics, pharmacokinetics, development status, and clinical implications of these drugs, emphasizing the importance of finding an agent that provides both a strong safety profile and effective relief from acute pain. Our findings show promise but also highlight the need for further large-scale research to allow these drugs to be utilized in a clinical context for patients experiencing acute pain."

Journal • Review • Pain

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Ascending-Dose Study Evaluating the Safety, Tolerability and Pharmacokinetics of XG004 Applied Topically in Participants with Osteoarthritis of the Knee (ACR Convergence 2023) - P1b | "While pregabalin (an active metabolite) was only measurable in plasms of 10% TID dosing cohort, XG004 and another active metabolite naproxen were readily assessable in both plasma and SF. XG004 topical gel in knee OA patients showed good tolerability and safety. XG004 and its active metabolites were detectable in sparse plasma and/or SF samples. 5% or 10% BID or TID dosing showed substantial improvement in knee pain, stiffness, physical function, as well as sleep quality."

Clinical • P1 data • PK/PD data • Immunology • Musculoskeletal Pain • Neuralgia • Osteoarthritis • Pain • Rheumatology

A Study of Topical XG004 in Participants With Osteoarthritis of the Knee (clinicaltrials.gov) - P1b | N=32 | Completed | Sponsor: Xgene Pharmaceutical Pty Ltd | Recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

A Study of Topical XG004 in Participants With Osteoarthritis of the Knee (clinicaltrials.gov) - P1b | N=32 | Recruiting | Sponsor: Xgene Pharmaceutical Pty Ltd

New P1 trial • Immunology • Osteoarthritis • Pain • Rheumatology