LY03014 / Luye Group - LARVOL DELTA

Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Luye Pharma Group Ltd.

New P2 trial • Surgery • Musculoskeletal Pain • Orthopedics • Pain

Pharmacokinetics, pharmacodynamics, and safety of LPM3480392 in two phase I clinical trials in healthy Chinese male subjects. (PubMed, Basic Clin Pharmacol Toxicol) - "Moreover, LPM3480392 at dose of 0.6 mg under 2 min infusion rate elicited effective analgesia as the peak effect within 10-30 min, which measured by cold pain test and pupillometry. These findings suggest that LPM3480392 could be a potential treatment for acute pain management."

Journal • P1 data • PK/PD data • Oncology • Pain

Subacute toxicity evaluations of LPM3480392 in rats, a full µ-opioid receptor biased agonist. (PubMed, Front Pharmacol) - "Oliceridine, a G protein-biased MOR agonist, only presents modest safety advantages as compared to other opiates in clinical trials, possibly due to its limited bias. In the toxicokinetics study, the dose-dependent elevation of drug exposure was observed, which partly explained the toxicity of high dose. In summary, LPM3480392 has exhibited good safety characteristics in this subacute toxicity study in rats."

Journal • Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Pain • Psychiatry • ARRB1

Reproductive and developmental toxicity assessments of LPM3480392, a novel mu opioid receptor biased agonist in rats. (PubMed, Reprod Toxicol) - "In addition, although minor effects were found on normal developmental milestones and behaviors in the pups, there was no evidence of malformed effect. In conclusion, these results suggest that LPM3480392 has a favorable safety profile with only minor effects on the reproductive and developmental outcomes in animals, which support the development of LPM3480392 as a novel analgesic."

Journal • Preclinical • Pain