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High Dose SAB-142

Phase 2

Type 1 Diabetes | Small molecule | Metabolic |SAB Biotherapeutics, Inc.|Last Updated: May 29, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment159
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07187531SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 DiabetesPHASE2 RECRUITING 159Nov 25, 2025Dec 1, 2028May 29, 202671 United States, Australia +13
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Study Endpoints
Primary Endpoints
Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
From dose administration through Week 4
Part B: Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT)
From dose administration up to Month 12

This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\] at 12 months)

Secondary Endpoints
Part B: Time in tight range (TITR)
At baseline, Months 3, 6, 9 and 12
Part B: Haemoglobin A1c (HbA1c) levels
At baseline, Months 3, 6, 9 and 12
Part B: Time in range (TIR)
At baseline, Months 3, 6, 9 and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
High Dose SAB-142EXPERIMENTALPart A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.
Low Dose SAB-142EXPERIMENTALPart A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.
PlaceboPLACEBO_COMPARATORPart B: This is a double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.
Interventions
NameTypeDescription
High Dose SAB-142DRUGHigh Dose SAB-142
Low Dose SAB-142DRUGLow Dose SAB-142
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range5 Years — 40 Years
SexALL
Healthy VolunteersNo
Study Sites71

Inclusion Criteria: 1. Participant and/or appropriate legal guardian must have given written informed consent and/or assent according to local, regional and/or country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of...

Countries:United StatesAustraliaAustriaBelgiumDenmarkFinlandFranceGermanyItalyLithuaniaNew ZealandPolandSloveniaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07187531lastUpdatePostDate: changed
LOWMay 29, 2026NCT07187531lastUpdatePostDate: changed
LOWMay 26, 2026NCT07187531primaryCompletionDate: changed
LOWMay 24, 2026NCT07187531studyFirstPostDate: changed