FDA Events for Maze Therapeutics (MAZE)
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
MZE829. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MZE829 - FDA Regulatory Timeline and 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
Maze Therapeutics FDA Events - Frequently Asked Questions
As of now, Maze Therapeutics (MAZE) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Maze Therapeutics (MAZE) has reported FDA regulatory activity for MZE829.
The most recent FDA-related event for Maze Therapeutics occurred on March 31, 2025, involving MZE829. The update was categorized as "Provided Update," with the company reporting: "Maze Therapeutics, Inc highlighted recent progress and reiterated upcoming milestones."
Currently, Maze Therapeutics has one therapy (MZE829) targeting the following condition: For APOL1 Kidney Disease.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:MAZE) was last updated on 7/13/2025 by MarketBeat.com Staff
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