Trial Registered

Shanghai Huilun opens second Phase 2/3 HL-1186 pain trial against oxycodone

The new abdominal-surgery trial pairs a prior orthopedic-surgery study testing the same oral analgesic against an active opioid comparator, in a postoperative-pain field with no approved oral small-molecule alternative to opioids.

By AppliedXLJuly 16, 2026Trial NCT07709598

Executive Summary

Shanghai Huilun Pharmaceutical has opened a Phase 2/3 trial of its oral analgesic HL-1186 for pain after abdominal surgery, run against both placebo and an active opioid combination rather than placebo alone.
This is the sponsor's second trial of the same drug on the same primary endpoint, run in a different surgical population, with both studies converging on completion within the same quarter.
The postoperative pain field has produced dozens of oral and injectable candidates but no oral small-molecule agent yet approved as a non-opioid alternative, leaving an active-comparator design as one of the more informative tests available in the category.
The molecular target behind HL-1186 is not established in available records, which limits any claim about how the drug's mechanism compares with the opioids and NSAIDs already used in this setting.

The registration

Shanghai Huilun Pharmaceutical Co., Ltd. registered a new trial, NCT07709598, to test HL-1186 tablets for postoperative analgesia in patients undergoing abdominal surgery. The study is designed as a multi-center, randomized, quadruple-masked comparison against both placebo and oxycodone-acetaminophen, an active opioid combination. It plans to enroll 330 patients across four arms, with a primary completion date of October 1, 2026, and full completion targeted for December 1, 2026. The primary endpoint is SPID48, the time-weighted sum of pain intensity difference measured on a 0-to-10 numeric rating scale over the first 48 hours after the first dose, with a secondary endpoint tracking treatment-related adverse events through day 9. NCT07709598+1

A second concurrent trial

HL-1186 has other active trials testing the same SPID48 endpoint in different surgical populations, part of a combined enrollment target near 700 patients across the drug's program, with none of its trials terminated. One of those trials, in patients undergoing orthopedic surgery, also carries an October 2026 primary completion date. Running similarly designed pivotal-track studies in different surgical populations lets the sponsor test whether an SPID48 result generalizes across surgery types rather than resting on a single population.

The competitive field

Postoperative pain is a heavily populated indication: dozens of small-molecule candidates are in active development, including opioids such as oxycodone and tramadol, NSAIDs such as ibuprofen and meloxicam, local anesthetics such as bupivacaine and ropivacaine, and newer entrants such as Vertex Pharmaceuticals Incorporated's suzetrigine, a Nav1.8-targeted non-opioid now in Phase 4 testing for this indication. None of these named comparators shares HL-1186's mechanism, since HL-1186's molecular target is not established in available records; the field is better read as mechanistically diverse than as convergent on any single approach. Only one drug in the approved-drug roster for postoperative pain, promethazine, carries an FDA-labeled indication that covers this setting, and it is used as an adjunct antiemetic and sedative rather than as a primary analgesic. Given that gap, an oral agent that separates from an active opioid comparator on SPID48, and does so consistently across the surgical populations HL-1186 is being tested in, would be the result that carries weight beyond either single trial. NCT07538570

Sponsor footprint

Shanghai Huilun Pharmaceutical Co., Ltd. runs a pipeline of 13 total trials, with seven currently recruiting and three not yet recruiting; one trial has completed and none have been terminated. The company has not previously reported a completed, terminated, or withdrawn Phase 2 trial of HL-1186 specifically in postoperative pain. The trial's protocol has shown no amendment activity since registration, and its enrollment target of 330 matches the number reported as analyzed, consistent with a study that is early in its recruiting period rather than showing signs of operational strain. NCT07709598

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.