409: Efficacy and Safety of Tetrapeptide Analgesic (Taphalgin) in Early Postoperative Pain: Phase III CT

Topic: Clinical Science
Subtopic: Pain category (ICD-11), Acute postsurgical pain, Drug development

Background and Aims: Effective management of early postoperative pain is critical to optimize recovery and reduce postoperative morbidity. Opioid analgesics remain widely used in this setting but are often limited by adverse effects and variability in clinical response. Taphalgin is a tetrapeptide administered by subcutaneous injection with preferential μ1-opioid receptor activity and modulation of calcium-dependent nociceptive signaling.
This Phase III, single-blind, randomized, multicenter, parallel-group study enrolled adults aged 18–65 years undergoing elective surgery associated with moderate surgical trauma (upper or lower abdomen or lesser pelvis).

Methods: Patients received general or regional anesthesia without postoperative regional analgesia. Following surgery, eligible patients were randomized to subcutaneous Taphalgin (4 mg three times daily), placebo followed by dexketoprofen, or subcutaneous promedol for two days. The primary endpoint was total pain relief over 0–6 hours (TOTPAR [0–6]). Secondary endpoints included NRS pain scores at rest and during movement, pain relief PAR scores, time to first rescue analgesic, proportion requiring rescue medication, and investigator-rated efficacy. Safety assessments included AEs, SAEs, laboratory parameters, and vital signs. All randomized patients were included in efficacy and safety analyses.

Results: A total of 250 patients were randomized. Baseline characteristics were comparable across groups. Taphalgin showed significant superiority over placebo for the primary endpoint (p<0.0001) and non-inferiority to promedol, with comparable TOTPAR [0–6] values. Taphalgin produced significantly lower NRS pain scores versus placebo at multiple early time points, with analgesia onset at 0.5 hours. Significant differences versus promedol were also observed at early time points. Fewer Taphalgin patients required rescue analgesia compared with placebo/dexketoprofen. AE incidence was low across all groups; all events were mild. No SAEs or clinically significant laboratory or vital sign abnormalities occurred.

Conclusions: In this Phase III randomized study, Taphalgin provided effective analgesia in early postoperative pain, demonstrating superiority to placebo and non-inferiority to an opioid comparator. Treatment was well tolerated, with a low incidence of mild adverse events. These findings support further evaluation of μ1-selective tetrapeptide analgesics as potential options for postoperative pain management.

References: 1. Karelov A.E., Kosorukov V.S., Kraevskaya Yu.N., Buyanova S.N., Petrakova S.A., Klimashevich A.V., Filimonov V.B., Gorelov V.P., Syrovatsky A.A., Belyaeva N.A., Aleksandrov M.I., Rodoman G.V. Efficacy of the new peptide analgesic Taphalgin in the treatment of postoperative pain. Anesthesiology and resuscitation. 2023; 6:75–83. https://doi.org/10.17116/anaesthesiology202306175

Presenting Author: Joseph Stauffer
Submitting Author: Viacheslav Kosorukov

Senior Author: Viacheslav Kosorukov

IASP 2026 Global Year theme of Neuropathic Pain: Yes

• Joseph Stauffer: Dr. - PVP laboratories
• Aleksey Evgenievich Karelov: Dr. - North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg
• Aleksey Andreevich Syrovatsky: Dr. - L.G. Sokolov North-Western District Scientific and Clinical Center FMB Agency
• Maksim Igorevich Aleksandrov: Dr. - City Clinical Hospital No. 24 of the Department of Health of Moscow
• Aleksandr Vladimirovich Klimashevich: Dr. - Moscow S.P. Botkin Multiprofile Research and Clinical Center
• Viktor Borisovich Filimonov: Dr. - Ryazan State Medical University named after academician I.P. Pavlov