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DA-001

Phase 2

Telogen Effluvium | Small molecule | Rare Disease |Applied Therapeutics, Inc.|Last Updated: Apr 13, 2026

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 Enrollment1,120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06648850Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-GrowthPHASE2 NOT YET_RECRUITING 1,120May 1, 2026Apr 26, 2027Apr 13, 2026 -
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Study Endpoints
Primary Endpoints
Mean Change in Hair Shedding
Minutes [0,5]

Number of hairs shedding during brushing at target area

Secondary Endpoints
Mean Change in Hair Shedding
Week [0, 4, 12, 24]
Mean Change in Target Area Hair Count (TAHC)
Week [0, 4, 12, 24]
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DA-001 TopicalEXPERIMENTALPhenylephrine 2.5% Topical + TAAR agonist
PlaceboPLACEBO_COMPARATORPlacebo
Phenylephrine TopicalEXPERIMENTALPhenylephrine 2.5% Topical (per application volume - males 5mL and females 20mL)
DA-001 Topical + DA-005 Oral (HIF-1α supplement)EXPERIMENTALDA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement)
DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)EXPERIMENTALOral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)
Phenylephrine Topical 0.25% + Intact Pro TopicalEXPERIMENTALPhenylephrine Topical 0.25% + Intact Pro Topical
Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)EXPERIMENTALPhenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)
Interventions
NameTypeDescription
DA-001DRUGPhenylephrine 2.5% Topical + TAAR Agonist (GRAS) Topical Solution
PlaceboOTHERPlacebo Topical Solution
PhenylephrineDRUGPhenylephrine 2.5% Topical
DA-001 Topical + DA-005 Oral (HIF-1α supplement)OTHERDA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement)
DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)OTHEROral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)
Phenylephrine Topical 0.25% + Intact Pro TopicalDRUGPhenylephrine 0.25% + Intact Pro (50% stronger)
Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)OTHERPhenylephrine 0.25% + Intact Pro (50% stronger) + DA-005 Oral (HIF-1α supplement)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Age 18 or older * Diagnosed with telogen effluvium * Willing and able to apply the treatment as directed, comply with study * Otherwise healthy * Able to give informed consent Exclusion Criteria: * A medical history that may interfere with study objectives * Women who are pr...

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