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Thymoglobulin Injectable Product

Phase 2

Hematological Malignancy | Small molecule | Other |Sanofi|Last Updated: Feb 20, 2024

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06066255PROPHYLAXIS OF GVH IN ELDERLY PATIENTS RECEIVING HAPLOIDENTICAL ALLOGENIC HEMATOPOIETIC STEM CELL TRASNPLANTATION USE OF A LOW DOSE ANTI-LYMPHOCYTIC SERUMPHASE2 NOT YET_RECRUITING 27Mar 31, 2024Mar 31, 2026Feb 20, 2024 -
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Study Endpoints
Primary Endpoints
Rate of acute GVH
Day 100

To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.

Secondary Endpoints
Acute GVH
day(D) 30, D60, D90, D100, D120, D180, D270 and D365
chronic GVH
day(D)100, D120, D180, D270 and D365
Cumulative incidence of chronic GVH
1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
Thymoglobulin Injectable ProductDRUGsingle intravenous injection of thymoglobulin
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Eligibility Criteria
Age Range60 Years — 100 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Adults aged ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3), * Hematological malignancies except myeloproliferative syndrome and myelodysplastic syndrome, * Patient having received an allograft within ≤ 35 days, performed with the following modalities: * First...

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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06066255studyFirstPostDate: changed