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Zydelig

Phase 2

Non Hodgkin Lymphoma | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Jun 27, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT031332211630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell TransplantationPHASE2 COMPLETED 17Oct 23, 2017Sep 29, 2024Jun 27, 20253 United States
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Study Endpoints
Primary Endpoints
Discontinuation Rate Due to Zydelig-related Adverse Events at 1 Year
1 year.

The proportion of patients who discontinued the study due to Zydelig-related adverse events.

Secondary Endpoints
Progression-free Survival at 1 and 2 Years After Autologous Stem Cell Transplantation.
1- and 2-year Progression-free survival
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Oral Zydelig 150 mg BIDEXPERIMENTALZydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.
Interventions
NameTypeDescription
ZydeligDRUGZydelig given at 150mg continuously in 28-day cycles
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Histologically documented (by HPI or pathology report) iNHL as defined by follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma/Waldenstrom disease (LPL/WM) and small lymphocytic lymphoma (SLL) or tiNHL as defined by large B cell transformation of...

Countries:United States
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