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TNX-1500

Phase 2

Kidney Transplant | Small molecule | Nephrology |Tonix Pharmaceuticals Holding Corp.|Last Updated: Feb 25, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07204080(TNX-1500) in Kidney Transplant RecipientsPHASE2 NOT YET_RECRUITING 5Jul 1, 2026Jun 30, 2029Feb 25, 20262 United States
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Study Endpoints
Primary Endpoints
Number of Adverse Events in each subject
12 Months

The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).

Number of Serious Adverse Events in each subject
12 Months

The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).

Secondary Endpoints
Incidence of Biopsy Proven Acute Rejection
12 months
Incidence of treatment for acute rejection
12 Months
Incidence of de novo DSA development
Months 1, 3, 6, 9, 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Kidney Transplant RecipientEXPERIMENTAL -
Interventions
NameTypeDescription
TNX-1500DRUGThis is an open-label, single-center, single-arm study to assess the safety and efficacy of TNX-1500, an Fc-modified anti-DF154 mAb in five adult kidney transplant recipients.
Kidney TransplantPROCEDUREKidney Transplant
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male or female subjects ≥18 to 75 years of age. 2. Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital. 3. Recipient of an ABO-compatible, non-human leu...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07204080studyFirstPostDate: changed