Trial Registered

Fujian Shengdi advances HRS5580 to second Phase 2 PONV trial with Palonosetron

The Chinese sponsor moves its antiemetic candidate into a 260-patient combination study, layering it onto palonosetron after a first Phase 2 trial already completed.

Fujian Shengdi Pharmaceutical registered a second Phase 2 trial testing HRS5580 for injection combined with palonosetron hydrochloride to prevent postoperative nausea and vomiting, targeting 260 patients in China with a primary completion date of December 1, 2026.

By AppliedXLJuly 17, 2026Trial NCT07709897

Executive Summary

Fujian Shengdi Pharmaceutical has registered a Phase 2 trial pairing its antiemetic candidate with palonosetron, a combination step that follows directly from a completed single-agent study in the same postoperative nausea and vomiting population.
The registered design measures complete response, meaning no vomiting and no rescue therapy, in the days after surgery, and will determine whether adding a second antiemetic mechanism improves on the sponsor's earlier single-agent result.
The trial sits in a modality-crowded field where small-molecule antiemetics dominate prior Phase 2 and Phase 3 programs, and none of the closest precedents share the same undisclosed target, leaving differentiation to rest on the combination approach itself.
Fujian Shengdi has completed all 25 of its prior trials with no terminations, giving this program an operational track record that supports the credibility of a December 2026 completion date.

The registration

Fujian Shengdi Pharmaceutical Co., Ltd. has registered NCT07709897, a Phase 2 trial testing HRS5580 for injection combined with palonosetron hydrochloride for the prevention of postoperative nausea and vomiting. The trial is not yet recruiting, plans to start July 1, 2026, and targets 260 patients across sites in China, with a primary completion date of December 1, 2026. It uses a quadruple-masked, randomized design with four arms. NCT07709897

What the endpoint measures

The primary outcome is complete response rate within 72 hours after extubation, defined as the proportion of patients with no vomiting and no use of rescue antiemetic therapy. Secondary measures track nausea severity, vomiting-free rate, and time to first rescue therapy across intervals extending to 120 hours post-extubation. Eligible patients face at least three risk factors for postoperative nausea and vomiting, including female sex, prior history of the condition or motion sickness, non-smoking status, and expected postoperative opioid use, criteria consistent with a study population selected for higher baseline risk. NCT07709897

Building on a completed trial

This is not HRS5580's first test in this population. Fujian Shengdi's earlier Phase 2 trial of the same drug, compared against ondansetron and a blank preparation, enrolled 235 patients and completed with a primary completion date of October 29, 2024. The new trial adds palonosetron to the regimen rather than testing HRS5580 alone against an active comparator, a design shift that suggests the sponsor is testing whether combining mechanisms extends the response window further than monotherapy did. NCT07709897

The competitive field

Postoperative nausea and vomiting has drawn small-molecule antiemetic programs from Merck, GlaxoSmithKline, Helsinn Healthcare, and Acacia Pharma, spanning 5-HT3 and NK-1 receptor antagonists such as palonosetron, casopitant, rolapitant, and amisulpride, each tested in Phase 2 or Phase 3 trials in the same indication. HRS5580's own molecular target is not established in available records, so this trial cannot be placed on that axis; what is established is that 27 prior trials have used small-molecule interventions in this indication, making modality a crowded rather than a novel dimension here. Palonosetron itself already carries FDA approval for postoperative nausea and vomiting for up to 24 hours following surgery, a bar this combination trial's secondary endpoints, which extend measurement out to 120 hours, appear designed to test beyond.

Sponsor track record

Fujian Shengdi has completed all 25 of its prior trials with no terminations on record, and its broader pipeline spans 61 trials, including 26 completed and 13 currently recruiting. That completion history supports confidence that the December 2026 primary completion date is operationally realistic, though it says nothing about whether the combination will beat the single-agent result the sponsor already has in hand.

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.