GSK tests depemokimab alone, without steroids, for nasal polyps in Japan
A Phase 4 trial will ask whether depemokimab holds up as monotherapy without intranasal steroids, a stricter bar than the placebo-controlled wins that backed its approval.
Executive Summary
- GlaxoSmithKline is starting a small Japan-focused trial to see whether depemokimab works as a standalone treatment, without the intranasal steroids that many patients use alongside it.
- The drug's approval rested on placebo-controlled trials measuring polyp and obstruction improvements, so this trial raises the bar to real-world monotherapy use rather than novel mechanism risk.
- No other IL-5-targeted program is active in this indication, so the trial extends a mechanism that has already cleared its pivotal bar rather than testing new biology against rivals.
- The trial is not yet recruiting and carries a small target enrollment, positioning it as a label-supporting and use-pattern study rather than a registrational event.
The trial
The study, NCT07701967, will enroll an anticipated 28 patients and test depemokimab alone against the same disease it already treats: chronic rhinosinusitis with nasal polyps (CRSwNP). It is titled to test efficacy and safety of depemokimab monotherapy without concomitant use of intranasal corticosteroids (INCS) in Japanese participants. The trial has not yet begun recruiting, with a start date of July 20, 2026, and a primary completion date of July 1, 2027. NCT07701967Efficacy and Safety of Depemokimab Monotherapy Without Concomitant Use of Intranasal Corticosteroids (INCS) in Japanese Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)NCT07701967
The endpoint
The registered primary outcome measures the percentage of participants achieving a one-point or greater decrease from baseline in total endoscopic nasal polyp score at Week 52, without first undergoing nasal surgery or starting disease-modifying medication for CRSwNP. Secondary measures track nasal obstruction, loss of smell, and rhinorrhoea using patient-reported verbal response scales, alongside the SNOT-22 quality-of-life instrument and Lund-Mackay CT scoring, all assessed through Week 52. NCT07701967Efficacy and Safety of Depemokimab Monotherapy Without Concomitant Use of Intranasal Corticosteroids (INCS) in Japanese Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)NCT07701967
The precedent
Depemokimab already cleared this bar in its pivotal program: ANCHOR-1 and ANCHOR-2, two Phase 3 placebo-controlled trials enrolling 276 and 264 patients, both met their co-primary endpoints, showing statistically significant reductions in total endoscopic nasal polyp score and nasal obstruction score against placebo, with adverse event rates similar between arms. Depemokimab holds FDA approval under the brand name Exdensur, administered by subcutaneous injection. This new trial does not need to establish a new efficacy signal; it needs to show the effect replicates when patients are not also using intranasal steroids and in a Japanese population, a narrower reproducibility question than the one the pivotal trials answered.
The competitive field
Depemokimab is the only Phase 4 asset targeting IL-5 in chronic rhinosinusitis with nasal polyps, and no other IL-5-targeted trial is currently active in this indication. The closest disease-area competitors work through different targets, including dupilumab (IL-4Ralpha), itepekimab (IL-33), lebrikizumab (IL-13), and tezepelumab (TSLP), all in Phase 3 testing for the same indication. GlaxoSmithKline also runs depemokimab programs across asthma, COPD, and hypereosinophilic syndrome, extending the same IL-5-neutralizing mechanism into adjacent Type 2 inflammatory diseases.
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