This section highlights FDA-related milestones and regulatory updates for drugs developed by Maze Therapeutics (MAZE).
Over the past two years, Maze Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MZE782 and MZE829. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
MZE782 FDA Regulatory Events
MZE782 is a drug developed by Maze Therapeutics for the following indication: first-in-class therapy for patients with CKD.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MZE782
- Announced Date:
- September 11, 2025
- Indication:
- first-in-class therapy for patients with CKD.
Announcement
Maze Therapeutics, Inc. announced positive clinical results from the Phase 1 healthy volunteer study of MZE782, an oral small molecule targeting the solute transporter, SLC6A19.
AI Summary
Maze Therapeutics announced positive results from its Phase 1 study of MZE782, an oral inhibitor of the SLC6A19 transporter. In a randomized, placebo-controlled trial with 112 healthy volunteers, single ascending doses (30 to 960 mg) and multiple ascending doses (120 to 720 mg daily) were tested to evaluate safety and pharmacodynamic effects.
MZE782 was well tolerated with no serious adverse events. It produced dose-dependent increases in 24-hour urinary phenylalanine excretion, a biomarker for PKU, reaching up to a 39-fold rise after 960 mg and a 42-fold increase on Day 7 at 240 mg twice daily. An initial dip in estimated glomerular filtration rate, similar to that seen with SGLT2 inhibitors, supports potential kidney protection in CKD.
Phase 2 trials in PKU and CKD are expected to start in 2026.
Read Announcement
MZE829 FDA Regulatory Events
MZE829 is a drug developed by Maze Therapeutics for the following indication: For APOL1 Kidney Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MZE829
- Announced Date:
- March 31, 2025
- Indication:
- For APOL1 Kidney Disease
Announcement
Maze Therapeutics, Inc highlighted recent progress and reiterated upcoming milestones.
AI Summary
Maze Therapeutics, Inc. is marking a pivotal phase in its journey to develop precision medicines for kidney and metabolic diseases. The company has emphasized recent progress following its successful IPO, which has strengthened its financial foundation and supported ongoing clinical programs.
Maze is advancing two key candidates. Its lead program, MZE829, is being tested in the Phase 2 HORIZON trial for patients with APOL1 Kidney Disease, with initial data expected in the first quarter of 2026. Meanwhile, MZE782 is under evaluation in healthy volunteers, with early Phase 1 data anticipated in the second half of 2025, setting the stage for Phase 2 trials in chronic kidney disease and phenylketonuria. These milestones highlight Maze's commitment to translating genetic insights into breakthrough therapies that could transform patient care.
Read Announcement- Drug:
- MZE829
- Announced Date:
- February 7, 2025
- Indication:
- For APOL1 Kidney Disease
Announcement
Maze Therapeutics, Inc announced the first patient has been dosed in the company's Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients with APOL1 kidney disease (AKD).
AI Summary
Maze Therapeutics, Inc. has started dosing the first patient in its Phase 2 clinical trial, called the HORIZON Study, for the investigational drug MZE829. This oral, small molecule is designed to treat APOL1 kidney disease (AKD), a condition that affects over one million Americans. The HORIZON Study uses an open-label basket design to include a wide range of AKD patients, from those with severe proteinuria to diabetic kidney disease patients. By studying MZE829 in a broad group of patients, Maze aims to prove the drug’s potential to reduce proteinuria—a key marker of kidney health—and to refine patient selection for future pivotal trials. The company is hopeful that MZE829 will become a disease-modifying therapy, offering a new treatment option and hope to patients suffering from this challenging kidney condition.
Read Announcement
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