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ADX-097

Phase 2

IgA Nephropathy | Small molecule | Nephrology |Q32 Bio Inc.|Trials Updated: Oct 1, 2026

ADX-097 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2024

ADX-097 target and mechanism

Molecular targetC3d
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

ADX-097 clinical trials

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 Sites4

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)

LOWOct 1, 2026NCT06419205lastUpdatePostDate: changed
LOWOct 1, 2026NCT06419205lastUpdatePostDate: changed
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?

ADX-097 is an investigational small molecule being developed for the treatment of IgA Nephropathy, a kidney disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does ADX-097 target?

ADX-097 targets C3d, a fragment of the complement protein C3. By targeting C3d, the drug aims to modulate the complement system, which is involved in the pathogenesis of IgA Nephropathy and other complement-mediated kidney diseases.

Who is developing ADX-097?

ADX-097 is being developed by Q32 Bio Inc., a biopharmaceutical company. Q32 Bio is publicly traded on the Nasdaq under the ticker symbol QTTB.

What phase is ADX-097 in?

ADX-097 is in Phase 2 clinical development. It is currently being evaluated in a Phase 2 study that is recruiting participants. The drug is investigational and has not been approved by the FDA or other regulatory agencies.

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 evaluating the safety, pharmacodynamics, pharmacokinetics, and clinical activity of ADX-097 in participants with IgA Nephropathy, Lupus Nephritis, or C3 Glomerulopathy. The study is recruiting up to 30 participants in the United States and Brazil.