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ADX-097

Phase 2

IgA Nephropathy | Small molecule | Nephrology |Q32 Bio Inc.|Last Updated: Aug 4, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

ADX-097 · 1 trial · 3 indications

Phase 2 1
NCT06419205A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3GIgA Nephropathy
RECRUITING30 Analytics
PHASE2RECRUITING
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
IgA NephropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants reporting treatment emergent adverse events (TEAEs)
Up to 30 weeks

Secondary Endpoints

Change from baseline in urine protein-to-creatinine ratio (uPCR)
Baseline and up to 26 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
Baseline and up to 26 weeks
Trough plasma Concentration of ADX-097
At Days 1, 8, 22, 50, 78, 106, 134 and 176
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open Label: ADX-097OTHERParticipants will be administered ADX-097 weekly once

Interventions

NameTypeDescription
ADX-097DRUGSubcutaneous Infusions
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: All participants 1. Male or female participants aged ≥16 years. 2. uPCR ≥0.5 g/g (from the average of 3 first morning voids \[FMVs\]). 3. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR). ...

Countries:United StatesBrazil
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Recent Changes (Last 90 Days)

LOWAug 4, 2026NCT06419205Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 4, 2026NCT06419205Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about ADX-097

What is ADX-097 used for in IgA Nephropathy?

ADX-097 is an investigational small molecule being developed for IgA Nephropathy, a kidney disease. It is also being studied for Lupus Nephritis and C3 Glomerulopathy. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes ADX-097?

ADX-097 is being developed by Q32 Bio Inc., a biopharmaceutical company. The company's stock is traded under the ticker QTTB. Q32 Bio is conducting clinical trials to evaluate the safety and activity of ADX-097 in patients with kidney diseases.

What phase is ADX-097 in?

ADX-097 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The drug is currently being studied in a Phase 2 trial to evaluate its safety, pharmacokinetics, pharmacodynamics, and clinical activity in patients.

What clinical trials is ADX-097 in?

ADX-097 is being studied in a Phase 2 clinical trial with the identifier NCT06419205. This trial is recruiting participants with IgA Nephropathy, Lupus Nephritis, or C3 Glomerulopathy. The study is being conducted in the United States and Brazil and aims to enroll 30 participants.

Is ADX-097 the same as any other drug?

ADX-097 is the primary name for this investigational drug. No alternative names have been reported. It is a small molecule being developed by Q32 Bio Inc. for the treatment of kidney diseases, including IgA Nephropathy.