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SSS17

Phase 2

Anemia in Pre-Dialysis Patients | Small molecule | Hematology |Co-Diagnostics, Inc.|Last Updated: Jun 18, 2025

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment86
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07014631Phase II Dose-Finding of Oral SSS17 for Anemia in Non-Dialysis CKDPHASE2 COMPLETED 86Mar 1, 2023Apr 8, 2025Jun 18, 20251 China
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Study Endpoints
Primary Endpoints
Changes in hemoglobin from baseline
Week7~Week9
Secondary Endpoints
Weekly changes in hemoglobin from baseline
Week2~Week9
Proportion of subjects achieving hemoglobin response (≥10 g/dL)
Week7~Week9
Cumulative proportion of subjects achieving both Hb increase ≥10 g/L and Hb level ≥100 g/L
Week9
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SSS17EXPERIMENTALThe SSS17 treatment arm comprises three dose levels: the first two dose levels will have an 8-week treatment duration, while the third dose level will extend to 24 weeks. At each dose level, participants will be allocated in a 4:1 ratio (SSS17:placebo) for enrollment
placeboPLACEBO_COMPARATORplacebo
Interventions
NameTypeDescription
SSS17DRUGThe SSS17 treatment arm comprises three dose levels: the first two dose levels will have an 8-week treatment duration, while the third dose level will extend to 24 weeks. At each dose level, participants will be allocated in a 4:1 ratio (SSS17:placebo) for enrollment.
PlaceboDRUGAt each dose level, participants will be allocated in a 4:1 ratio (SSS17:placebo) for enrollment.Placebo recipients will undergo weekly dosing identical to the active treatment group within their assigned dose cohort.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Non-dialysis CKD patients aged 18-75 years. 2. Screening eGFR \<60 mL/min/1.73 m² . 3. Mean Hb ≥7.0 g/dL and \<10.0 g/dL . 4. Agreement to use medically acceptable contraception from ICF signing until 6 months post-trial. Exclusion Criteria: 1. Hypoxia-inducible factor prol...

Countries:China
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