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DA-001

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment1,120

FDA Designations

No designations recorded

Clinical trial landscape

DA-001 · 1 trial · 6 indications

Phase 2 1
NCT06648850Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-GrowthTelogen Effluvium
NOT YET_RECRUITING1,120 Analytics
PHASE2NOT YET_RECRUITING
Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
Telogen EffluviumUnlock trial analytics

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 to 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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Frequently asked questions about DA-001

What is DA-001 used for?

DA-001 is an investigational small molecule being developed for the treatment of Telogen Effluvium, a form of temporary hair shedding. It is also being studied for related hair loss conditions including Female Pattern Hair Loss, Androgenic Alopecia, Male Pattern Baldness, and Androgenetic Alopecia (AGA).

Who makes DA-001?

DA-001 is being developed by Applied Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol APLT. The company is conducting clinical research to evaluate the safety and efficacy of DA-001 for hair loss conditions.

What phase is DA-001 in?

DA-001 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 2 clinical trial is planned to evaluate its effects on hair shedding reduction and hair regrowth.

What clinical trials is DA-001 in?

DA-001 is being studied in a Phase 2 clinical trial registered as NCT06648850, titled "Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth." The trial is not yet recruiting and aims to enroll approximately 1,120 participants.

Is DA-001 a randomized controlled trial?

Yes, the Phase 2 clinical trial of DA-001 is randomized, double-blind, and placebo-controlled. This design helps ensure that the results are reliable by comparing the effects of DA-001 against a placebo in a blinded manner.