Icodec Insulin

Gan & Lee Pharmaceuticals (SSE: 603087) reported that its investigational once-weekly basal insulin analog, GZR4, met the primary endpoint of superior HbA1c reduction versus both insulin glargine U100 (Lantus) and insulin degludec (Tresiba) across two pivotal Phase III trials in adults with type 2 diabetes, positioning the molecule as a direct challenger to Novo Nordisk’s recently FDA-approved insulin icodec (Awiqli). The SUPER-1 and SUPER-2 trials are active-controlled, treat-to-target Phase III studies enrolling 588 insulin-naïve and 631 basal-insulin-experienced Chinese adults with type 2 diabetes, respectively, conducted across more than 80 medical centers in China. In SUPER-1, the estimated mean HbA1c change from baseline at 26 weeks was -1.45% with GZR4 versus -1.22% with glargine U100, a between-group difference of -0.23%. In SUPER-2, GZR4 produced a -1.00% reduction compared with -0.58% for degludec, a difference of -0.42%. Both trials also showed GZR4 achieved a higher rate of the composite endpoint of HbA1c below 7.0% or at or below 6.5% without clinically significant or severe hypoglycemia. No severe (Level 3) hypoglycemic events occurred in either treatment group across both trials. GZR4 is an ultra-long-acting basal insulin analog engineered to provide full-week basal insulin coverage from a single subcutaneous injection, without requiring a loading dose. The absence of a loading dose distinguishes it from Awiqli, which requires a double maintenance dose in the first week to reach steady-state rapidly. The SUPER program describes a greater than 85% reduction in annual injection frequency compared with once-daily regimens — from approximately 365 injections per year to 52. The competitive context is acute. Novo Nordisk’s Awiqli received FDA approval for adults with type 2 diabetes on March 26, 2026 — five days before Gan & Lee released the SUPER-1 and SUPER-2 top-line data. Awiqli, which uses albumin binding to extend its half-life to approximately 196 hours, is now the only approved once-weekly basal insulin in the US market. GZR4 enters that comparison as an investigational molecule with Phase III superiority data versus daily analogs, but without head-to-head data against icodec yet available. That comparison is the subject of SUPER-8, a 26-week trial enrolling 300 patients with type 2 diabetes previously treated with basal insulin, with results expected within the next 12 months. Cross-trial comparisons are limited by differences in patient populations, titration algorithms, and background therapies. The magnitude of HbA1c separation in SUPER-2 — 0.42 percentage points versus degludec — is notable within the context of basal insulin trials, where active comparators are themselves well-optimized agents. The SUPER-1 difference of 0.23 percentage points versus glargine U100 is more modest, though both results met pre-specified superiority thresholds. Full statistical outputs, including confidence intervals and p-values, have not yet been disclosed; detailed results are planned for presentation at a scientific conference and peer-reviewed publication. The trials enrolled exclusively Chinese adults, which will be relevant to any regulatory filing strategy outside China. The SUPER program is described as a global Phase III development program, though the four currently initiated trials are all China-based. Whether Gan & Lee pursues regulatory submissions in the US or EU, and whether additional international trials are planned, was not addressed in the top-line release. Gan & Lee also has two additional SUPER trials underway: SUPER-3, enrolling 580 patients on basal-bolus therapy, comparing GZR4 against glargine U100 in combination with insulin aspart; and SUPER-8, the icodec head-to-head. The full dataset from all four trials will determine the breadth of the clinical package available for any regulatory submission. Detailed results from SUPER-1 and SUPER-2 are planned for presentation at a scientific conference later in 2026, with peer-reviewed publication to follow. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

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