Hengrui opens dosing in third Phase 1 trial of inhaled COPD drug HRS-9821
The China-based study moved to recruiting status, extending Hengrui's early-stage program for an inhaled small molecule as a Phase 2 efficacy trial of the same drug awaits its own start.
Executive Summary
- A Phase 1 trial testing an inhaled COPD drug moved into active patient recruitment, opening the next stage of a safety and pharmacokinetics program for the compound.
- The study measures adverse-event rates and drug levels in blood after single and multiple inhaled doses, the standard early-stage bar for whether a new inhaled therapy is safe enough to advance.
- The sponsor already has a second Phase 1 trial of the same drug recruiting and a Phase 2 efficacy trial queued to start, showing continued investment in the inhaled program ahead of any safety readout.
- The sponsor has completed every prior early-stage trial it has run in this disease family, a pattern that supports the operational credibility of its timeline but does not speak to whether this drug candidate works.
The status change
NCT07567872 shifted from Not Yet Recruiting to Recruiting on July 20, 2026, according to the trial's registry record. The trial started dosing on July 9, 2026, and its primary completion date is set for September 1, 2026. It targets 48 participants, split between healthy volunteers receiving a single dose and COPD patients receiving multiple doses of HRS-9821 delivered as an inhaled powder. NCT07567872A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPDNCT07567872
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial measures
The primary endpoint is the change from baseline in adverse-event rates, tracked through 26 days after dosing. A secondary endpoint measures plasma drug concentration over 21 days. This is a randomized, quadruple-masked, placebo-controlled design with two arms, standard for an early-phase inhaled-drug safety and pharmacokinetics study. The design can establish tolerability and drug exposure levels; it is not built to show whether HRS-9821 improves lung function or reduces exacerbations. NCT07567872A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPDNCT07567872
Program footprint
This is one of four HRS-9821 trials Guangdong Hengrui Pharmaceutical has run in COPD. A separate Phase 1 trial, NCT07116915, is also recruiting and compares the drug against moxifloxacin and placebo across 160 participants with a primary completion date of December 1, 2026. A Phase 2 efficacy trial, NCT07640451, is not yet recruiting and would test HRS-9821 against placebo in 90 patients with moderate-to-severe COPD. An earlier Phase 1 trial of the same inhaled suspension, NCT05622864, completed in May 2025 with 106 participants.
Sponsor track record
Guangdong Hengrui Pharmaceutical has completed 20 of 21 trials globally, with one termination, and has completed all three of its prior trials in obstructive airway disease. The company runs 53 trials across its broader pipeline, with 18 currently recruiting. That completion history supports the operational premise that this trial will reach its stated completion date, though it says nothing about whether HRS-9821 itself will show a workable safety and exposure profile.
The competitive field
Chronic obstructive pulmonary disease drug development is dominated by small molecules, with more than 850 trials using the modality in the indication. Most late-stage COPD activity centers on biologics targeting inflammatory pathways, including GlaxoSmithKline's depemokimab and Sanofi's lunsekimig, both in Phase 3 trials for exacerbation reduction, and Hoffmann-La Roche's astegolimab, also in Phase 3. None of these programs share HRS-9821's inhaled small-molecule delivery route or its mechanism, since HRS-9821's target has not been characterized in available competitive data. The nearest comparators by modality are inhaled small molecules approved for COPD maintenance, including tiotropium/olodaterol and fluticasone/salmeterol combinations, both approved for long-term maintenance treatment of the disease.
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.