ultra-long-acting basal insulin (GZR33) / Gan & Lee Pharma - LARVOL DELTA

Pharmacodynamic properties of novel once-daily insulin GZR33 in people with type 1 diabetes (EASD 2026) - "In individuals with T1D, once-daily GZR33 showed a sustained glucose-lowering effect over the 24-hour dosing interval, with a more evenly distributed glucose-lowering effect than insulin degludec. These pharmacological characteristics support further clinical development of GZR33 as a once-daily basal insulin."

PK/PD data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Apr 2027 ➔ Apr 2026

Enrollment open • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=350 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

GZR33-T1D-US101: A Trial to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR33 Compared with Insulin Degludec at steady state in participants with Type 1 Diabetes (clinicaltrialsregister.eu) - P1 | N=14 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals USA Corp.

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

GZR33-T1D-US101: A Trial to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR33 Compared with Insulin Degludec at steady state in participants with Type 1 Diabetes (clinicaltrialsregister.eu) - P1 | N=14 | Completed | Sponsor: Gan & Lee Pharmaceuticals USA Corp. | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Gan and Lee Pharmaceuticals, USA

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

GZR101, a Novel Premixed Insulin for the Treatment of Diabetes Mellitus. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "This study evaluated insulin GZR33 (GZR33), an ultra-long basal insulin, and insulin GZR101 (GZR101), which is a premix of GZR33 and postprandial insulin aspart...Potency was tested in vivo in streptozotocin-induced T1DM rats and db/db T2DM mice, using insulin degludec (degludec, IDeg) and insulin degludec/insulin aspart (IDegAsp) as controls...Therefore, GZR101 provides a promising once-daily premixed insulin candidate with potential to enhance glycemic control and patient adherence. Clinical trial number: not applicable."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • IR