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DA-007

Phase 3

Chemotherapy Induced Alopecia | Small molecule | Other |Applied Therapeutics, Inc.|Last Updated: May 23, 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_CONTROLLEDDMC
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06762548Clinical Study of DA-007 for the Treatment of Chemotherapy Induced AlopeciaPHASE3 NOT YET_RECRUITING 140Oct 10, 2025Nov 6, 2026May 23, 20251 Italy
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Study Endpoints
Primary Endpoints
Prevention of Hair Loss (Common Terminology Criteria for Adverse Events V5.0)
Week [0,12]

Amount of hair loss during chemotherapy treatment measured by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0. The Common Terminology Criteria for Adverse Events is a common terminology developed by the National Cancer Institute to describe and grade adverse events related to cancer therapy.

Secondary Endpoints
Hair Re-Growth Post Treatment (Common Terminology Criteria for Adverse Events V5.0)
Week [12, 24]
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
DA-007ACTIVE_COMPARATORTopical DA-007 Solution
PlaceboPLACEBO_COMPARATORTopical Placebo Solution
Interventions
NameTypeDescription
DA-007DRUGTopical α1 agonist combination of Phenylephrine + Tyramine + Synephrine
PlaceboDRUGTopical placebo solution
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed with stage I or stage II breast cancer * Scheduled but not begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy. * Ages 18-65 * Able to give informed consent Exclusion Criteria: * Resting blood pressure outside the range of 105-140/ 55-99 * Un...

Countries:Italy
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