retogatein

Retogatein (rhGAD65-alum, Diamyd) is an investigational antigen-specific immunotherapy developed by Diamyd Medical for the treatment and prevention of type 1 diabetes (T1DM) and latent autoimmune diabetes in adults (LADA). It consists of recombinant human glutamic acid decarboxylase 65 kDa (rhGAD65) formulated with an aluminum hydrogel (alum) adjuvant. Retogatein is designed to induce antigen-specific immune tolerance to GAD65, a key autoantigen in autoimmune diabetes, thereby modulating the autoimmune response responsible for pancreatic beta-cell destruction and preserving endogenous insulin production. In April 2026, Diamyd Medical announced the discontinuation of its pivotal Phase 3 DIAGNODE-3 trial in Stage 3 type 1 diabetes patients carrying the HLA DR3-DQ2 genotype due to futility, though development continues in other settings such as LADA and early-stage/pre-symptomatic type 1 diabetes.

Brand names

Diamyd

Other names

recombinant human glutamic acid decarboxylase 65 kDarecombinant human GAD65glutamate decarboxylase 2human glutamate decarboxylase 65 kDa isoform