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)

The Challenge of Chemotherapy-Induced Alopecia (CIA)

Chemotherapy-Induced Alopecia (CIA) is a frequently encountered and highly distressing adverse event associated with numerous oncological treatments.[5] While not life-threatening, the loss of hair can have a profound negative impact on a patient's psychological well-being, body image, self-esteem, and overall quality of life. This is particularly pronounced in female patients, for whom hair often holds significant personal and societal value. The psychological burden of CIA can be so substantial that it influences treatment decisions, with reports indicating that approximately 8% of patients may consider rejecting potentially life-saving chemotherapy regimens due to the fear of hair loss.[5] This statistic highlights that CIA is not merely a cosmetic issue but a significant factor that can affect adherence to essential cancer therapies, potentially impacting treatment outcomes.

Current management strategies for CIA are primarily prophylactic and include physical methods such as scalp cooling. Scalp cooling devices, some of which have received FDA approval, aim to reduce blood flow to the scalp, thereby decreasing the exposure of hair follicles to cytotoxic agents.[5] While effective to varying degrees, scalp cooling is associated with several limitations. These include the necessity for prolonged attendance time at chemotherapy units (often exceeding two hours per session), discomfort due to cold intolerance, and inconsistent efficacy across different chemotherapy regimens and patient populations.[5] These drawbacks underscore an unmet medical need for alternative or complementary approaches to CIA prevention that are more convenient, better tolerated, and consistently effective.

Overview of DA-007 as a Potential Preventative Agent

DA-007 is emerging as a novel pharmacological intervention specifically designed for the prevention of CIA.[3] It is a topically applied solution containing a combination of α1​ adrenergic receptor agonists, intended to be administered to the scalp.[3] The development of DA-007 reflects an evolving understanding of the localized pathophysiological mechanisms underlying CIA and represents an attempt to target these mechanisms more directly and potentially more conveniently than existing physical interventions. By inducing localized vasoconstriction, DA-007 aims to reduce scalp blood perfusion and consequently limit the delivery of systemically administered chemotherapeutic agents to the vulnerable hair follicle niche.[5] This approach positions DA-007 as a potential alternative or adjunct to current CIA management strategies, with the goal of improving patient experience and outcomes in supportive cancer care.

3. DA-007: Drug Profile

Nomenclature and Classification

The investigational drug is primarily identified as DA-007.[4] An alternative name, DA 007, is also used in some documentation.[6] DA-007 is classified as a small molecule drug.[4] Its pharmacological class is an Alpha 1 (α1​) adrenergic receptor agonist.[6]

Composition and Formulation

DA-007 is formulated as a novel topical solution intended for application to the scalp.[5] The active pharmaceutical ingredients consist of a combination of three α1​ adrenergic receptor agonists: Phenylephrine, Tyramine, and Synephrine.[3] The strategy of combining these three specific agents, rather than relying on a single compound, suggests a deliberate formulation design. Phenylephrine is a direct-acting α1​ agonist. Tyramine acts as an indirect sympathomimetic, promoting the release of norepinephrine, which subsequently activates α1​ receptors. Synephrine also possesses α1​ agonist properties. This multi-component approach may be intended to target a broader range of α1​ adrenergic receptor subtypes, achieve a more potent or sustained vasoconstrictive effect, or leverage potentially different pharmacokinetic profiles of the individual components upon topical administration to optimize local efficacy on the scalp.

Developer: Applied Biology Inc.

DA-007 is being developed by Applied Biology Inc..[5] Applied Biology Inc. was founded in 2002 and has been described as a biotechnology company headquartered in Irvine, California, with a research focus on alopecia and androgen-mediated diseases.[9] Professor Dr. Andy Goren, a recognized researcher in the field of alopecia, including CIA, is associated with the development efforts for such therapies.[11]

The corporate history of Applied Biology Inc. includes an acquisition by Daniel Alain in April 2020.[9] Daniel Alain is a company that has significantly invested in research and development for women's hair loss solutions and has a long-standing partnership with Applied Biology.[12] More recent information suggests a corporate office in Cheyenne, WY, and a potential subsequent acquisition of Applied Biology by Safety Shot in June 2022.[10] Such corporate changes are not uncommon in the biotechnology sector and can influence a drug's development trajectory, funding, and strategic priorities. The website www.appliedbiology.com has been associated with the Irvine-based entity focused on alopecia research [9], though direct access to this specific URL was not possible during the information gathering for this report.[14] The impact of these corporate developments on the current operational status and stewardship of the DA-007 program warrants ongoing attention.

Table 1: DA-007 Drug Profile Summary

Feature	Details	References
Drug Name	DA-007	4
Alternative Name	DA 007	6
Drug Type	Small molecule drug	4
Pharmacological Class	Alpha 1 (α1​) adrenergic receptor agonist	6
Active Ingredients	Phenylephrine, Tyramine, Synephrine	3
Formulation	Topical solution	5
Developer	Applied Biology Inc.	5
Key Corporate Affiliations	Acquired by Daniel Alain (2020); Potentially by Safety Shot (2022)	9

4. Pharmacology and Mechanism of Action

Target: Alpha 1 Adrenergic Receptors

The pharmacological activity of DA-007 is mediated through its interaction with Alpha 1 (α1​) adrenergic receptors.[6] These receptors are part of the sympathetic nervous system and are found on the smooth muscle cells of blood vessels. The rationale for targeting these receptors is supported by previous research, cited in the clinical trial information for DA-007, which demonstrated that topically applied α1​ agonists, such as phenylephrine hydrochloride, can effectively penetrate the scalp and bind to these local α1​ receptors.[5] DA-007, as a novel formulation containing a combination of α1​ agonists (Phenylephrine, Tyramine, and Synephrine), is similarly designed for scalp penetration and targeted engagement with these receptors.[3]

Pharmacological Effect: Scalp Vasoconstriction

Upon binding to α1​ adrenergic receptors in the scalp vasculature, DA-007 is intended to induce localized vasoconstriction.[5] Activation of these G protein-coupled receptors leads to a cascade of intracellular events, ultimately resulting in the contraction of vascular smooth muscle and a reduction in the diameter of the blood vessels.

Rationale for CIA Prevention: Reduced Chemotherapeutic Delivery to Hair Follicles

The primary therapeutic goal of inducing scalp vasoconstriction with DA-007 is to reduce local blood perfusion in the scalp tissue.[5] Hair follicles are highly vascularized structures, and their cells, particularly those in the matrix responsible for hair growth, are characterized by rapid proliferation. This high rate of cell division makes them particularly susceptible to the cytotoxic effects of systemically administered chemotherapy agents. By constricting the blood vessels supplying the hair follicles, DA-007 aims to decrease the local blood flow and, consequently, reduce the amount of circulating chemotherapeutic drugs that reach the hair follicle niche.[5] This mechanism effectively creates a temporary, localized "pharmacological barrier," minimizing the exposure of the vulnerable hair follicle cells to the damaging effects of chemotherapy. This strategy is a targeted supportive care measure designed to selectively protect the hair follicles without interfering with the systemic efficacy of the chemotherapy against cancer cells elsewhere in the body.

Contextual Need: Addressing limitations of current CIA management strategies

The development of DA-007 also addresses the limitations associated with current CIA prevention methods, such as scalp cooling. While scalp cooling also operates on the principle of reducing scalp blood perfusion, it is often associated with practical challenges, including the need for extended time in the chemotherapy unit (reported as >2 hours) and adverse events such as intolerance to the cold.[5] A topically applied pharmacological agent like DA-007 could offer a more convenient and potentially better-tolerated alternative for patients.

The success of DA-007 is contingent upon achieving a sufficient degree and duration of vasoconstriction at the level of the hair follicles to confer protection, while simultaneously minimizing systemic absorption of the active ingredients to avoid undesirable systemic cardiovascular effects. The balance between local efficacy and systemic safety is a critical consideration for any topically applied vasoconstrictor, and this is reflected in the exclusion criteria for the clinical trial, which include conditions related to blood pressure and cardiovascular health.[3]

5. Therapeutic Indication and Target Population

Primary Indication

The primary therapeutic indication for DA-007 is the prevention of Chemotherapy-Induced Alopecia (CIA).[4] This is explicitly stated as the primary purpose of its ongoing Phase 3 clinical trial, NCT06762548.[5]

Specific Patient Cohort for NCT06762548

The clinical development of DA-007, particularly the pivotal Phase 3 trial NCT06762548, targets a highly specific patient population [3]:

• Gender: Female patients.
• Age: Adults between 18 and 65 years old.
• Cancer Type: Patients diagnosed with stage I or stage II breast cancer.
• Chemotherapy Regimen: Patients who are scheduled to receive, but have not yet initiated, at least 4 cycles of taxane and/or anthracycline-based chemotherapy.

This focused approach to defining the target population is common in clinical drug development. It likely reflects the higher incidence and significant psychological impact of CIA within this demographic when treated with these particular chemotherapy agents. Taxanes (e.g., paclitaxel, docetaxel) and anthracyclines (e.g., doxorubicin, epirubicin) are well-recognized for their high rates of inducing severe alopecia. Furthermore, patients with early-stage breast cancer are often undergoing adjuvant chemotherapy with curative intent, making quality of life considerations and the mitigation of distressing side effects, such as hair loss, particularly salient. Studying a homogenous patient group under specific treatment conditions increases the likelihood of detecting a true drug effect if one exists, by minimizing variability.

Should DA-007 demonstrate significant efficacy and an acceptable safety profile in this initial, well-defined population, there could be a strong rationale for exploring its use in broader patient populations. This could include male patients, individuals with other types of cancer (both solid tumors and hematological malignancies), and those receiving different chemotherapy regimens known to cause CIA. The underlying mechanism of action—reducing blood flow to limit drug exposure to hair follicles—is not inherently restricted to breast cancer or specific chemotherapeutic agents, although the degree of efficacy might vary. Successful outcomes in the current trial would pave the way for such label expansion studies.

6. Clinical Development Program for DA-007

Overview of Development Phases

DA-007 is currently in Phase 3 of clinical development.[5] While some sources noted preclinical trials in alopecia in the USA with the trial identifier NCT06762548 as of January 2025 [6], the predominant and more detailed clinical trial registry information clearly designates NCT06762548 as a Phase 3 study.[5] This report will prioritize the Phase 3 designation based on these direct trial sources.

Detailed Analysis of Phase 3 Trial: NCT06762548

The pivotal study for DA-007 is the Phase 3 trial identified as NCT06762548.

• Trial Identifier and Official Title: The trial is registered under the identifier NCT06762548 and officially titled "Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia".[3] It is also referred to by the study ID DA-007-CIA.[5]
• Sponsor: The sponsor of the trial is Applied Biology [5] (also listed as Applied Biology, Inc. [3]).
• Study Phase and Current Status: This is a Phase 3 clinical trial.[5] As of March 2025 (based on posting dates in some sources), the status was listed as "Not yet enrolling".[3]
• Study Objectives and Endpoints:
• The primary aim of the study is to test the hypothesis that DA-007 can reduce scalp blood perfusion and consequently reduce hair loss due to chemotherapy.[5]
• The Primary Outcome Measure is the "Prevention of Hair Loss," which will be assessed by quantifying the amount of hair loss during the chemotherapy treatment period using the Common Terminology Criteria for Adverse Events (CTCAE) V5.0. The timeframe for this assessment is from Week 0 to Week 12.[3]
• The Secondary Outcome Measure is "Hair Re-Growth Post Treatment." This will evaluate the amount of hair re-growth after the completion of chemotherapy treatment, also using the CTCAE V5.0. The timeframe for this assessment is from Week 12 to Week 24.[3] This two-stage outcome assessment (prevention during chemotherapy and re-growth after) allows for a comprehensive evaluation of DA-007's potential benefits, addressing both acute hair follicle protection and subsequent recovery.
• Study Design: The trial employs a randomized, placebo-controlled design.[3] Participants will be allocated to one of two patient groups: one receiving DA-007 and the other receiving a placebo.[5]
• Patient Population: The study aims to enroll an estimated 140 participants.[5] Eligible participants are female, aged between 18 and 65 years.[3]
• Intervention Details: The intervention arms consist of Topical DA-007 Solution (Drug: DA-007) versus a Topical Placebo Solution (Drug: Placebo).[5] DA-007 is identified as a topical α1​ agonist combination of Phenylephrine, Tyramine, and Synephrine.[3]
• Key Inclusion Criteria:
• Diagnosed with stage I or stage II breast cancer.[3]
• Scheduled for, but not yet begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy.[3]
• Ages 18-65.[3]
• Able to provide informed consent.[3]
• Key Exclusion Criteria:
• Resting blood pressure outside the range of 105-140 mmHg (systolic) / 55-99 mmHg (diastolic).[3]
• Uncontrolled or severe hypertension.[3]
• Pre-existing female pattern hair loss or other hair loss disorders.[3]
• Active scalp conditions such as folliculitis, scalp psoriasis, seborrheic dermatitis, or inflammatory scalp conditions (e.g., lichen planopilaris).[3] The exclusion of these pre-existing conditions is vital to ensure that any observed hair changes can be more confidently attributed to the effects of chemotherapy and the intervention (DA-007 or placebo), rather than being confounded by underlying dermatological issues.
• Subjects wearing wigs prior to the initiation of chemotherapy.[3]
• Concomitant use of Monoamine Oxidase Inhibitors (MAOIs).[3] This is a critical pharmacological exclusion. Tyramine, one of the active components of DA-007 [3], is an indirect sympathomimetic agent. If systemically absorbed in a patient taking MAOIs (which inhibit the breakdown of monoamines like tyramine and norepinephrine), tyramine can precipitate a hypertensive crisis. This exclusion criterion is a crucial safety measure to prevent potentially severe adverse drug interactions.
• Inability to provide consent or adhere to the schedule of clinical visits.[3]
• Study Locations: The trial is planned to be conducted in the USA.[6] Additionally, Applied Biology has indicated plans to conduct this Phase 3 trial in Italy, with an anticipated start in January 2025.[6] The international scope of the trial suggests an ambition for broader market access and regulatory approvals.

Table 2: Key Details of Clinical Trial NCT06762548

Feature	Details	References
Trial ID	NCT06762548 (DA-007-CIA)	3
Official Title	Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia	3
Sponsor	Applied Biology (Applied Biology, Inc.)	3
Phase	Phase 3	5
Status	Not yet enrolling (as of early 2025)	3
Primary Objective	To test if DA-007 reduces scalp blood perfusion and thus reduces chemotherapy-induced hair loss	5
Primary Outcome	Prevention of Hair Loss (CTCAE V5.0); Amount of hair loss during chemotherapy. Timeframe: Week	3
Secondary Outcome	Hair Re-Growth Post Treatment (CTCAE V5.0); Amount of hair re-growth post-chemotherapy. Timeframe: Week 1	3
Study Design	Randomized, Placebo-Controlled	3
Number of Participants	Estimated 140	5
Intervention Arms	Topical DA-007 Solution (Phenylephrine + Tyramine + Synephrine) vs. Topical Placebo Solution	3
Core Inclusion Criteria (Summary)	Female, 18-65 yrs, Stage I/II breast cancer, scheduled for ≥4 cycles taxane/anthracycline chemo, informed consent	3
Core Exclusion Criteria (Summary)	Abnormal BP, uncontrolled hypertension, pre-existing hair loss/scalp conditions, wig use pre-chemo, MAOI use, inability to consent/attend	3
Known Locations	USA, Italy (planned)	6

7. Regulatory Status

Designations

DA-007 is classified as a New Molecular Entity (NME).[6] This designation is significant even though its active components (Phenylephrine, Tyramine, Synephrine) are individually known substances. The NME status in this context likely arises from their novel combination, specific dosage within the formulation, the topical route of administration for this particular indication (CIA prevention), or the overall novelty of the final drug product. As an NME, DA-007 will be subject to comprehensive regulatory review for safety and efficacy by health authorities.

Orphan Drug Status

DA-007 has not been granted Orphan Drug status.[6] This is an expected regulatory status. Orphan Drug designation is typically reserved for therapies intended to treat rare diseases or conditions, which are defined by specific prevalence thresholds in major regulatory jurisdictions (e.g., affecting fewer than 200,000 people in the United States, or not more than 5 in 10,000 in the European Union). Chemotherapy-Induced Alopecia, while a serious concern for patients, is a common side effect experienced by a large number of cancer patients undergoing various chemotherapy regimens. Its prevalence far exceeds the criteria for an orphan condition. Consequently, if approved, DA-007 would enter a potentially larger market without the specific development and marketing incentives associated with orphan drug designation.

8. Discussion and Future Outlook

DA-007 represents an innovative pharmacological strategy to address the significant unmet need of Chemotherapy-Induced Alopecia. Its development as a topical, multi-agent α1​ adrenergic receptor agonist combination (Phenylephrine, Tyramine, and Synephrine) aims to provide a more convenient and potentially better-tolerated option for CIA prevention compared to existing physical methods like scalp cooling.[3] The shift from a physical intervention to a targeted topical drug could improve patient acceptance and adherence, which is particularly crucial given that the fear of hair loss can lead some patients to refuse essential chemotherapy.[5]

The outcomes of the ongoing Phase 3 clinical trial, NCT06762548, are paramount and will be the primary determinant of DA-007's future.[3] Successful achievement of the primary endpoint—demonstrating a statistically significant and clinically meaningful reduction in hair loss during chemotherapy—would be a major step towards regulatory submission. Positive results on the secondary endpoint, concerning hair re-growth post-treatment, would further enhance its clinical value proposition by showing benefits beyond the acute treatment phase.[3]

If DA-007 proves effective and safe, it could substantially alter the management paradigm for CIA. Beyond the direct benefit of hair preservation, this could lead to considerable improvements in patients' psychological well-being, body image, and overall quality of life during and after cancer treatment. The development of such an agent underscores an increasing focus within oncology on patient-reported outcomes and mitigating the burdensome side effects of therapy, moving beyond solely survival-centric endpoints.

Several considerations for future research and development emerge. Should the initial Phase 3 results be positive in the specific population of female breast cancer patients, investigations into other patient groups (e.g., male patients, individuals with different cancer types, or those undergoing other alopecic chemotherapy regimens) would be a logical next step. Long-term safety and efficacy data will also be essential for establishing its place in routine clinical practice. Further research could also delve into the specific contributions of each of the three α1​ agonists in the formulation to better understand their individual roles and potential synergies, possibly leading to further optimization.

The corporate evolution of Applied Biology Inc., including its associations with Daniel Alain and potentially Safety Shot, may also influence the continued development, strategic direction, and commercialization pathway for DA-007.[9] Access to resources, specialized expertise in dermatology or oncology, and market access capabilities can all be affected by such corporate changes.

The success of DA-007 could also stimulate further innovation in pharmacological interventions for supportive cancer care, particularly for managing other dermatological or quality-of-life-impacting side effects of treatment. However, if DA-007 reaches the market, careful patient selection will be necessary, particularly adhering to the cardiovascular and drug interaction-related exclusion criteria (e.g., uncontrolled hypertension, MAOI use) identified in the clinical trial protocol.[3] This highlights the ongoing need to balance therapeutic benefits with potential risks in a patient population that is often medically complex. The planned international scope of the Phase 3 trial, encompassing sites in the USA and Italy, suggests an ambition for broad regulatory approval and market access, potentially making DA-007 available to a global patient population if its development is successful.[6]

9. Conclusion

DA-007 is an investigational New Molecular Entity, formulated as a topical combination of three α1​ adrenergic agonists (Phenylephrine, Tyramine, and Synephrine), currently in late-stage Phase 3 clinical development for the prevention of Chemotherapy-Induced Alopecia.[3] Its novel mechanism of action, aimed at inducing localized scalp vasoconstriction to reduce the delivery of cytotoxic chemotherapy agents to hair follicles, offers a promising pharmacological alternative to existing CIA prevention methods.[5] The drug is being specifically evaluated in adult female patients with early-stage breast cancer undergoing taxane and/or anthracycline-based chemotherapy regimens.[3]

The ongoing Phase 3 trial, NCT06762548, is critical, and its results will determine the efficacy and safety profile of DA-007, ultimately guiding its path towards potential regulatory approval and clinical use.[5] The development of DA-007 reflects a targeted strategy to address a common and psychologically impactful side effect of cancer treatment, underscoring the growing importance of patient quality of life in comprehensive oncological care. Should DA-007 demonstrate a favorable benefit-risk profile, it has the potential to become a valuable addition to the supportive care armamentarium for cancer patients, significantly improving their treatment experience.

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