Status Change

HengRui's herombopag Phase 3 closes enrollment, pushes readout to Dec 2026

The China-only trial finished enrollment at 127 patients and moved its completion date a year later, entering a field where four thrombopoietin-receptor agonists are already approved for surgical thrombocytopenia in chronic liver disease.

Jiangsu HengRui Medicine's Phase 3 trial of herombopag in chronic liver disease patients with thrombocytopenia stopped recruiting, locked enrollment at 127 patients, and pushed its primary completion date to December 1, 2026, a year later than previously listed.
Trial NCT06507436

Executive Summary

  • Jiangsu HengRui Medicine's Phase 3 trial of herombopag in liver-disease patients with thrombocytopenia has finished enrolling and moved to Active, not recruiting, with its primary completion date now set roughly a year later than previously listed.
  • The trial measures whether herombopag can lift platelet counts high enough, and keep them there, for patients with chronic liver disease to undergo planned surgery without a platelet transfusion, the standard bar this drug class has already cleared in other approved agents.
  • Herombopag enters a class where lusutrombopag and avatrombopag already carry US approval for this exact surgical-thrombocytopenia use in chronic liver disease, making replication of that established effect, not novelty, the relevant test.
  • The completion-date shift and the enrollment increase reflect routine registrational trial mechanics in China rather than a sign of trial distress, and the study is tracking toward a readout window later this year.

The status change

NCT06507436 moved from Recruiting to Active, not recruiting, on July 17, 2026, the registry status that follows the close of enrollment. Enrollment landed at 127 patients, up from a prior anticipated count of 101, and is now recorded as actual rather than anticipated. The trial's primary completion date moved from December 1, 2025, to December 1, 2026, the second such shift since the trial's original target of August 30, 2025. NCT06507436The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive SurgeryNCT06507436

Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.

Endpoint Met82%
Completes95%
Clinical Significance25%
Regulatory63%

What the trial tests

The Phase III study enrolls adults with Child-Pugh Class A or B liver disease and platelet counts below 50x10^9/L who have elective surgery planned. Its central primary endpoint is the proportion of patients whose platelet count reaches at least 50x10^9/L within 24 hours of surgery, rising at least 20x10^9/L from baseline, without needing a platelet transfusion or other rescue treatment. That is a binary, transfusion-avoidance measure, the same kind of endpoint regulators have already used to approve competing agents in this setting. NCT06507436The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive SurgeryNCT06507436

The competitive bar

Four thrombopoietin receptor agonists, eltrombopag, lusutrombopag, romiplostim, and avatrombopag, carry FDA approval for thrombocytopenia, with lusutrombopag and avatrombopag specifically labeled for chronic liver disease patients scheduled for a procedure, the identical population herombopag is testing. Herombopag is not first to this target: five industry trials across five sponsors have already tested thrombopoietin receptor agonists in thrombocytopenia, with the drug class's maximum phase already at Phase 3. The relevant question is not whether the mechanism works, since it already carries regulatory precedent, but whether herombopag's platelet-response rate in this trial reproduces the response levels that got avatrombopag and lusutrombopag approved.

Operational context

The enrollment increase from 101 to 127 patients falls within the operational model's typical range and is not treated as a red flag. The trial has changed status twice and its completion date twice since 2024, a rate of roughly 4.5 registry changes per year, but none of these amendments touched the endpoints or the eligibility criteria. Herombopag also has three other active or recorded trials in immune thrombocytopenia and cancer-associated thrombocytopenia, none of which are terminated, indicating the sponsor is running a broader development program around this molecule rather than concentrating risk in a single study. NCT06507436The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive SurgeryNCT06507436

Sponsor track record

Jiangsu HengRui Medicine has completed 272 of 300 trials it has run, a completion rate of roughly 91%, giving it an established base of registrational trial experience across its broader pipeline. The company also runs a separate Phase 3 program for hetrombopag, a related thrombopoietin receptor agonist, in thrombocytopenia, indicating this molecule sits inside a wider internal franchise rather than a standalone bet. NCT06507436The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive SurgeryNCT06507436

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.