An Overview of DA-007: An Investigational Agent for Chemotherapy-Induced Alopecia

1. Executive Summary

DA-007 is an investigational small molecule drug, formulated as a topical solution, currently under development by Applied Biology Inc. It is a combination of three alpha 1 (α1​) adrenergic receptor agonists: Phenylephrine, Tyramine, and Synephrine.[3] The primary therapeutic goal of DA-007 is the prevention of Chemotherapy-Induced Alopecia (CIA), a common and distressing side effect of many cancer treatments, particularly in female breast cancer patients undergoing taxane and/or anthracycline-based chemotherapy regimens.[3]

The mechanism of action of DA-007 is based on inducing localized vasoconstriction in the scalp. By activating α1​ adrenergic receptors on the scalp vasculature, DA-007 aims to reduce local blood perfusion, thereby limiting the delivery of cytotoxic chemotherapeutic agents to the rapidly dividing cells of the hair follicles.[5] This targeted pharmacological approach offers a potential alternative to physical methods like scalp cooling, potentially providing improved convenience and tolerability for patients. The selection of a multi-component formulation suggests a strategy to achieve a more robust or sustained vasoconstrictive effect.

DA-007 is classified as a New Molecular Entity (NME) and is currently advancing through late-stage clinical development.[6] A pivotal Phase 3 clinical trial, NCT06762548, is designed to evaluate its efficacy and safety in the target patient population.[5] The outcomes of this trial will be critical in determining the future of DA-007 as a supportive care agent in oncology. If successful, DA-007 could significantly improve the quality of life for cancer patients by mitigating one of the most visible and psychologically burdensome side effects of chemotherapy.

2. Introduction to DA-007 and Chemotherapy-Induced Alopecia (CIA)