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JADE101

Phase 2

IgA Nephropathy | Small molecule | Nephrology |Jade Biosciences, Inc.|Last Updated: Aug 20, 2026

Target and mechanism

Molecular targetAPRIL
Target classCytokine
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

JADE101 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT07541287A Study of JADE101 in Participants With Immunoglobulin A NephropathyIgA Nephropathy
RECRUITING30 Analytics
PHASE2RECRUITING
A Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA NephropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (safety and tolerability)
Day 1 through 100 weeks

The proportion of participants who experience one or more adverse events that begin or worsen after the first dose of study drug

Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants
Day 1 through 48 weeks

Incidence of treatment-emergent adverse events

Cmax
Day 1 through 48 weeks

Maximum observed serum concentration

Tmax
Day 1 through 48 weeks

Time to reach Cmax

AUClast
Day 1 through 48 weeks

The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration

T1/2
Day 1 through 48 weeks

Apparent first-order terminal elimination half-life

Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants
Day 1 through 48 weeks

Incidence of treatment-emergent adverse events

Secondary Endpoints

Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy
Day 1 through 100 weeks
Immunogenicity of JADE101 in healthy Japanese and Chinese participants
Day 1 through 48 weeks
Cmax
Day 1 through 48 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JADE101EXPERIMENTALSubcutaneous (SC) injection of JADE101
JADE101 Groups 1 and 2EXPERIMENTALSubcutaneous (SC) injection of JADE101
JADE101 Groups 3 and 4EXPERIMENTALSubcutaneous (SC) injection of JADE101
PlaceboPLACEBO_COMPARATORSubcutaneous (SC) injection of placebo

Interventions

NameTypeDescription
JADE101DRUGJADE101 is supplied as sterile solution to be administered by SC injection
PlaceboDRUGPlacebo solution to be administered at a matching volume by SC injection.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Male or female participants 18-60 years of age, inclusive, and of local legal consenting age at the time of signing the informed consent 2. eGFR ≥ 30 mL/min/1.73 m2 3. Biopsy-confirmed primary IgAN 4. Receiving stable and maximally tolerated doses of either ACEi or ARB as per...

Countries:United StatesAustraliaNew ZealandSouth KoreaTaiwan
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07541287lastUpdatePostDate: changed
LOWAug 20, 2026NCT07541287lastUpdatePostDate: changed
LOWJul 7, 2026NCT07541287lastUpdatePostDate: changed
LOWJul 7, 2026NCT07541287lastUpdatePostDate: changed

Frequently asked questions about JADE101

What is JADE101 used for?

JADE101 is an investigational small molecule being developed for IgA nephropathy, a kidney disease. It is currently being studied in healthy volunteers to assess safety and tolerability, and in patients with IgA nephropathy to evaluate its potential therapeutic effect. The drug is in Phase 1 and Phase 2 clinical trials.

What does JADE101 target?

JADE101 targets APRIL, a cytokine involved in the immune system. By targeting APRIL, JADE101 may modulate the immune response that contributes to IgA nephropathy. This mechanism is being investigated in clinical trials for the treatment of IgA nephropathy.

Who is developing JADE101?

JADE101 is being developed by Jade Biosciences, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of JADE101 in healthy volunteers and in patients with IgA nephropathy.

What phase is JADE101 in?

JADE101 is in Phase 1 clinical trials for healthy volunteers and Phase 2 clinical trials for IgA nephropathy. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical development to assess its safety and effectiveness.

What clinical trials is JADE101 in?

JADE101 is being studied in three clinical trials. NCT07059312 is a Phase 1 study in healthy participants in New Zealand. NCT07525947 is a Phase 1 single-dose study in healthy Japanese and Chinese participants in the United States. NCT07541287 is a Phase 2 study in participants with IgA nephropathy across multiple countries.

Is JADE101 the same as APRIL?

No, JADE101 is not the same as APRIL. APRIL is a cytokine that JADE101 targets. JADE101 is a small molecule drug designed to interact with APRIL to potentially treat IgA nephropathy. The drug itself is distinct from its molecular target.