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CG2001

Phase 1

Male Pattern of Hair Loss, Androgenic Alopecia | Small molecule | Rare Disease |Co-Diagnostics, Inc.|Last Updated: Jun 26, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07038941Phase I Clinical Trial of CG2001 in Chinese Adult Male Participants With Androgenetic AlopeciaPHASE1 COMPLETED 44Mar 19, 2024Jun 2, 2024Jun 26, 20251 China
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Study Endpoints
Primary Endpoints
Safety and tolerability
From baseline to 4 days post last administration

Incidence and severity of adverse events, vital signs, physical examination, laboratory tests, electrocardiogram, etc.

Secondary Endpoints
Single dose: Area under the plasma concentration versus time curve
Within 1 hour before and 24 hours after intervention administration
Single dose: Peak Plasma Concentration
Within 1 hour before and 24 hours after intervention administration
Single dose: Time to first peak drug concentration
Within 1 hour before and 24 hours after intervention administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL5% minoxidil and 0.025% finasteride, 1 gram Only once on Day 1
Arm 2EXPERIMENTAL5% minoxidil and 0.05% finasteride, 1 gram Once a day from Day 1 to Day 7
Arm 3EXPERIMENTAL5% minoxidil and 0.075% finasteride, 1 gram Once a day from Day 1 to Day 7
Arm 4EXPERIMENTAL5% minoxidil and 0.1% finasteride, 1 gram Once a day from Day 1 to Day 7
Arm 5EXPERIMENTAL5% minoxidil and 0.1% finasteride, 1 gram Once a day on Day 1, twice daily on Day 2 to Day 6, once a day on Day 7
Arm 6PLACEBO_COMPARATORPlacebo foam, 1 gram Once a day from Day 1 to Day 7
Arm 7PLACEBO_COMPARATORPlacebo foam, 1 gram Once a day on Day 1, twice daily on Day 2 to Day 6, once a day on Day 7
Interventions
NameTypeDescription
CG2001DRUGcombination of minoxidil and finasteride
Placebo foamDRUGPlacebo foam
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Participants must meet all of the following criteria to be included: 1. Voluntarily sign the informed consent form approved by the ethics committee before any research procedures begin; 2. Be able to understand and comply with the requirements of the protocol, and agree to coop...

Countries:China
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