With this, Phase II studies of both the 4 mg and 16 mg strengths of D23 are now advancing in parallel.
In September 2026, Triastek announced that its self-developed 16 mg D23 (budesonide delayed-release tablet) had completed first-patient dosing in August, following the launch of its Phase II trial in mid-July.
D23 is being developed for primary IgA nephropathy. Its completed Phase I trial preliminarily validated the precision of ileum-targeted delivery and the stability of drug release. The Phase II trial uses a multicenter, randomized, open-label, active-controlled, parallel-group design. Over a 36-week treatment period, it will compare the efficacy and safety of D23 against budesonide enteric-coated capsules, using proteinuria and renal function as core endpoints.
IgA nephropathy requires long-term treatment, making pill burden a key consideration. At the same daily dose of 16 mg, the 16 mg strength reduces the number of tablets a patient takes each day, improving convenience. This strength follows D23's existing technical approach, relying on the MED® 3D printing process, in which digital models drive tablet formation. This allows flexible adaptation to different dose strengths without sacrificing drug loading. D23 uses the 3D Microstructure for Intestine Targeting system (3DμS®-IT), composed of a drug-containing controlled-release core and a time-dependent delay layer. While maintaining ileum-targeted release, this design overcomes the low drug-loading problem of complex multi-layer coating processes, supporting the development of a single 16 mg tablet.
Dr. Deng Feihuang, Vice President of Technology at Triastek, said that increasing the drug load of a single tablet while maintaining targeted release places higher demands on formulation design and manufacturing, and demonstrates the advantages of MED® 3D printing in developing complex formulations. With the 16 mg strength entering Phase II, this dosage form and process innovation will undergo further clinical validation.
D23 uses programmed controlled release to deliver budesonide precisely to the terminal ileum, intervening at the source of pathogenic IgA1 production. The 4 mg strength has completed patient enrollment in Phase II, while the 16 mg strength has completed first-patient dosing. Both strengths are advancing rapidly.
Note: D23 is still in clinical research, and its safety and efficacy await further validation.
