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ASC40

Phase 2

Acne Vulgaris | Small molecule | Dermatology |Co-Diagnostics, Inc.|Last Updated: May 16, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05104125Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne VulgarisPHASE2 COMPLETED 180 — — Jan 12, 2022Apr 10, 2023May 16, 20251 China
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Study Endpoints
Primary Endpoints
Percentage change of total lesion count compared with baseline and week 12.
Baseline to week 12
Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
Baseline to week 12
Secondary Endpoints
The changes status and changes of average percentage of inflammatory skin lesions count, non-inflammatory skin lesions count and total skin lesions count compared with baseline.
Baseline to week 2, 4, 8 and 12
Ratio of subjects, whose GA grades was 1 or 0, or GA grades was decreased y ≥2 grades compared with baseline and Improvements in classification
Baseline to week 2, 4, 8 and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental group 1EXPERIMENTALASC40 25mg for 12 weeks
Experimental group 2EXPERIMENTALASC40 50mg for 12 weeks
Experimental group 3EXPERIMENTALASC40 75mg for 12 weeks
Placebo groupPLACEBO_COMPARATORPlacebo for 12 weeks
Interventions
NameTypeDescription
ASC40 25mgDRUG25mg of ASC40 orally once daily for 12 weeks.
ASC40 50mgDRUG50mg of ASC40 orally once daily for 12 weeks.
ASC40 75mgDRUG75mg of ASC40 orally once daily for 12 weeks.
PlaceboDRUGPlacebo orally once daily for 12 weeks.
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * 18-40 years old (including 18 and 40 years old); * Investigator's Global Assessment of subject at baseline period was at 3-4. * Facial skin lesions of subject need counting as follows: 30 \~ 75 inflammatory lesions (the total number of papules, pustules and nodules is 30 \...

Countries:China
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