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ZL-3101

Phase 2

Eczema | Small molecule | Dermatology |Zai Lab Limited|Last Updated: Jan 24, 2019

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 Enrollment290
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03134352Study to Evaluate the Efficacy and Safety of ZL-3101 in Subjects With Subacute EczemaPHASE2 COMPLETED 290Apr 26, 2017Sep 10, 2018Jan 24, 20196 China
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Study Endpoints
Primary Endpoints
Eczema Area and Severity Index (EASI) score changes from baseline to day 21
21 days

To evaluate efficacy of Fugan ointment applied to involved skin of subjects with mild to moderate subacute eczema

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZL-3101(Fugan) bid groupEXPERIMENTALFugan AM + Fugan PM
ZL-3101(Fugan) qd groupEXPERIMENTALFugan AM + Placebo PM
placebo groupPLACEBO_COMPARATORPlacebo AM + Placebo PM
Interventions
NameTypeDescription
ZL-3101DRUGA brown ointment, 10g/tube, 0.4g herb/g ointment, Topical
PlaceboDRUGA brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Male or female subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent; from outpatient clinic; 2. Subjects with a diagnosis of subacute eczema (Zhao 2001). Subacute eczema is often developed from improperly treated acute eczema or a few...

Countries:China
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