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MZE782

Phase 2

Phenylketonuria (PKU) | Small molecule | Metabolic |Maze Therapeutics, Inc.|Last Updated: Aug 20, 2026

Target and mechanism

Molecular targetSLC6A19
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

MZE782 · 1 trial · 1 indication

Phase 2 1
NCT07694440A Study of MZE782 in Adults With PKUPhenylketonuria (PKU)
RECRUITING38 Analytics
PHASE2RECRUITING
A Study of MZE782 in Adults With PKU
Phenylketonuria (PKU)
NCT0769444038
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Study Endpoints

Primary Endpoints

Safety and tolerability based on incidence of adverse events (AEs)
Week 0 to Week 17
For Cohorts 1A and 1B: Absolute change in plasma Phe levels from Baseline to the mean of plasma Phe levels
Baseline and Weeks 2, 3, and 4

Secondary Endpoints

For Cohorts 1A and 1B, analyzed separately: Geometric mean plasma concentrations of MZE782
Weeks 1, 2, 3, 4, 8, and 13
For Cohorts 1A and 1B, analyzed separately: Absolute and Percent change in plasma Phe levels from Baseline to the mean of plasma Phe levels
Baseline up to Week 13
For Cohorts 1A and 1B, analyzed separately: Proportion of participants with mean plasma Phe levels ≤600 μMol/L, ≤360 μMol/L, and ≤120 μMol/L
Baseline and Weeks 2, 3, 4, 8, 10, and 13
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MZE782 Low Dose (Cohort 1A)EXPERIMENTAL -
Placebo (Cohort 1A)PLACEBO_COMPARATOR -
MZE782 High Dose (Cohort 1B)EXPERIMENTAL -
Placebo (Cohort 1B)PLACEBO_COMPARATOR -
MZE782 High Dose (Cohort 2)EXPERIMENTAL -
Placebo (Cohort 2)PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
MZE782DRUGTablet, Low Dose
PlaceboOTHERTablet
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria: * Males and females 18 to 75 years old * Clinical diagnosis of PKU * Willing and able to keep diet and protein intake consistent during the study * For some study groups, is willing and able to stop certain PKU medications before starting study treatment * For some study gro...

Countries:United States
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Competitive Landscape -Phenylketonuria 12 trials (matched to "Phenylketonuria (PKU)")

CompanyTickerTrialsLead PhaseDrugs
BioMarin Pharmaceutical Inc.BMRN5PHASE3Pegvaliase
PTC Therapeutics, Inc.PTCT2PHASE3PTC923
Sanofi SA Sponsored ADRSNY1PHASE1SAR444836
Agios Pharmaceuticals, Inc.AGIO1PHASE1AG-181
Illumina, Inc.ILMN1 - Undisclosed
Q32 Bio IncQTTB1 - HMI-102
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07694440lastUpdatePostDate: changed
LOWAug 20, 2026NCT07694440lastUpdatePostDate: changed
LOWJul 14, 2026NCT07694440lastUpdatePostDate: changed
LOWJul 14, 2026NCT07694440lastUpdatePostDate: changed
LOWJul 10, 2026NCT07694440NEW_TRIAL: changed
LOWJul 10, 2026NCT07694440NEW_TRIAL: changed

Frequently asked questions about MZE782

What is MZE782 used for?

MZE782 is an investigational small molecule being developed for the treatment of phenylketonuria (PKU), a metabolic disorder. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does MZE782 target?

MZE782 targets and inhibits SLC6A19, a transporter protein involved in amino acid reabsorption. By inhibiting SLC6A19, the drug aims to reduce phenylalanine levels in patients with phenylketonuria (PKU).

Who makes MZE782?

MZE782 is being developed by Maze Therapeutics, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol MAZE.

What phase is MZE782 in?

MZE782 is currently in Phase 2 clinical development for phenylketonuria (PKU). It is an investigational drug and has not yet received regulatory approval.

What clinical trials is MZE782 in?

MZE782 is being studied in a Phase 2 clinical trial with the identifier NCT07694440, titled 'A Study of MZE782 in Adults With PKU'. This randomized, double-blind, placebo-controlled trial is recruiting 38 participants in the United States.