Recent Updates
Recently added Catalysts

DA-007

Phase 3

Chemotherapy Induced Alopecia | Small molecule | Other |Applied Therapeutics, Inc.|Last Updated: May 23, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

DA-007 · 1 trial · 2 indications

Phase 3 1
NCT06762548Clinical Study of DA-007 for the Treatment of Chemotherapy Induced AlopeciaChemotherapy Induced Alopecia
NOT YET_RECRUITING140 Analytics
PHASE3NOT YET_RECRUITING
Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia
Chemotherapy Induced AlopeciaUnlock trial analytics

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]
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about DA-007

What is DA-007 used for?

DA-007 is an investigational small molecule being developed for the treatment of chemotherapy induced alopecia, a condition characterized by hair loss as a side effect of chemotherapy. It is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.

Who makes DA-007?

DA-007 is being developed by Applied Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol APLT. The company is conducting a Phase 3 clinical trial to evaluate the drug's efficacy and safety in patients with chemotherapy induced alopecia.

What phase is DA-007 in?

DA-007 is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 3 trial is designed to assess its effectiveness in treating chemotherapy induced alopecia.

What clinical trials is DA-007 in?

DA-007 is being evaluated in a Phase 3 clinical trial with the identifier NCT06762548. This randomized, double-blind, placebo-controlled study is planned to enroll 140 female participants aged 18 years and older in Italy. The trial is not yet recruiting and will assess the drug for chemotherapy induced alopecia.

Is DA-007 the same as any other drug?

DA-007 is the primary name used for this investigational drug in clinical development. No alternative names have been reported for this compound. It is being studied specifically for its potential to treat chemotherapy induced alopecia.