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EQ101

Phase 2

Alopecia Areata | Small molecule | Immunology |Equillium, Inc.|Last Updated: Apr 10, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05589610Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia AreataPHASE2 COMPLETED 36Dec 19, 2022Apr 30, 2024Apr 10, 20255 Australia, New Zealand
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Study Endpoints
Primary Endpoints
Number of Treatment Emergent Adverse Events
Week 28

Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)

Secondary Endpoints
The Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia
Week 24
To Characterize the Pharmacokinetics (PK) of EQ101
Week 24
To Characterize the Pharmacodynamics (PD) of EQ101
Week 24
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EQ101EXPERIMENTALEQ101 weekly
Interventions
NameTypeDescription
EQ101DRUGEQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: 1.Subjects have AA, meeting all of the following criteria: 1. Clinical diagnosis of AA with no other aetiology of hair loss ; 2. At least 35% scalp hair loss, as defined by a SALT score ≥ 35, at Screening and Baseline. Approximately 25% of subjects with 35% to \<50% scalp h...

Countries:AustraliaNew Zealand
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