Huilun starts Phase 2/3 trial of oral HL-1186 for post-surgical pain in China
The 330-patient trial will test whether HL-1186 beats placebo on a 48-hour pain-relief score, entering a postoperative-pain field still built on opioids and older local anesthetics.
Executive Summary
- A newly registered Chinese trial will test an oral tablet against placebo and an opioid combination for pain after orthopedic surgery, using a design scaled for a regulatory case rather than early exploration.
- The result that matters is whether the drug separates from placebo on a time-weighted measure of pain relief over the first two days after surgery, the standard bar this drug class is judged against.
- Postoperative pain remains a modality-diverse but mechanism-crowded field, worked by opioids, NSAIDs, local anesthetics, and several China-based rivals running trials of similar scale and timing.
- A second, smaller trial of the same drug in abdominal surgery is running in parallel, so this trial's result will shape whether the sponsor's broader postoperative-pain program advances.
The trial
The trial, registered as NCT07699601, is evaluating HL-1186 tablets for postoperative analgesia in patients undergoing orthopedic surgery under general anesthesia. It combines Phase 2 and Phase 3 in a single protocol, targets 330 patients across sites in China, and started enrolling on May 9, 2026. The trial is not marked registrational on the registry despite its scale. Patients must have moderate-to-severe expected pain and a resting pain score of at least 4 on a 0-to-10 scale after surgery to qualify, and the design excludes patients with prior surgery at the same site or conditions that could confound pain assessment. NCT07699601Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Orthopedic SurgeryNCT07699601
The endpoint bar
The registered primary endpoint is SPID48, the time-weighted sum of pain-intensity difference measured on a 0-to-10 numeric rating scale over the 48 hours after the first dose, scored from -480 (worst) to 480 (best). A key secondary endpoint tracks treatment-related adverse events over nine days. The comparator arms include placebo and an oxycodone-acetaminophen combination, meaning the trial is designed to show separation from both an inert control and an active opioid standard. Primary completion is expected October 1, 2026, with full trial completion set for December 1, 2026. NCT07699601Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Orthopedic SurgeryNCT07699601
The competitive field
Postoperative pain is worked by a wide range of mechanisms without a single dominant one: opioids like oxycodone and tramadol, NSAIDs like ibuprofen and meloxicam, local anesthetics like bupivacaine and ropivacaine, and newer entrants like Vertex's Nav1.8-targeted suzetrigine, all run as modality precedents rather than direct mechanistic comparators to HL-1186, whose target is not established in available data. Within China specifically, Haisco Pharmaceutical's HSK21542 and HSK55718 programs and Jiangsu HengRui's SHR8554 and HRS4800 compounds are running comparable Phase 2 and Phase 3 postoperative-pain trials on a similar SPID-based endpoint, with Haisco's HSK21542 trial nearing completion in March 2026, months ahead of HL-1186's October readout. No competitor in this set shares HL-1186's target, so the differentiation case rests on the drug's clinical result rather than a distinct mechanism claim.
Sponsor context
Huilun is running a second HL-1186 trial in parallel, a 40-patient Phase 2 study of the same drug for pain after abdominal surgery, also placebo-controlled and expected to complete in February 2026. Across its broader pipeline, Huilun has six trials recruiting, three not yet recruiting, one completed, and one in unknown status, giving it a modest but active clinical-stage footprine. The company has no prior terminations on record in this indication. The trial has logged no protocol amendments since its registration this month, a pattern consistent with a trial just entering its recruitment phase.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.