1. Introduction

PrabotulinumtoxinA is a botulinum toxin type A preparation evaluated in a clinical development program associated with Daewoong Pharmaceutical. Published randomized trials have investigated the preparation in adults with moderate-to-severe glabellar lines, including studies against placebo and direct comparisons with onabotulinumtoxinA. ［1–3］

The terminology requires care. Clinical publications may refer to DWP450 or prabotulinumtoxinA, while marketed product names include NABOTA in certain markets and JEUVEAU (prabotulinumtoxinA-xvfs) in the United States. Product identity, approved indications, and labeling should be verified for the jurisdiction being discussed. ［4, 5］

This article reviews the published clinical program through three questions: What outcomes were studied? What did the randomized trials report? And what can reasonably be concluded when interpreting placebo-controlled and active-comparator evidence?

2. Understanding the Clinical Evidence

The principal aesthetic indication evaluated in the studies discussed here is the temporary improvement of moderate-to-severe glabellar lines—the vertical frown lines between the eyebrows.

Randomized trials can address different questions depending on their design. A placebo-controlled trial evaluates whether the studied treatment produces a response beyond that observed with placebo. An active-controlled trial evaluates its performance against another specified treatment. A non-inferiority trial, meanwhile, tests whether a difference in a predefined outcome remains within a prespecified margin. ［1–3］

These designs should not be treated as interchangeable. The endpoint, assessment time, study population, dose, and statistical framework determine what each result supports.

3. Early Direct Comparative Evidence: DWP450 vs OnabotulinumtoxinA

DWP450 is the development code used for Daewoong Pharmaceutical’s botulinum toxin type A preparation, subsequently described in clinical literature as prabotulinumtoxinA. The preparation has been evaluated in randomized clinical trials for moderate-to-severe glabellar lines, including direct comparisons with onabotulinumtoxinA. Marketed product names include NABOTA in certain jurisdictions and JEUVEAU (prabotulinumtoxinA-xvfs) in the United States. ［1, 3–5］

A multicenter, randomized, double-blind, active-controlled study published by Won and colleagues evaluated DWP450 against onabotulinumtoxinA in 268 participants with moderate-to-severe glabellar lines. The study compared 20 U DWP450 with 20 U onabotulinumtoxinA. ［1］

The primary assessment was conducted at Week 4. The study reported physician-rated responder rates of 93.89% for DWP450 and 88.64% for onabotulinumtoxinA, meeting its prespecified non-inferiority criterion. ［1］

Table 1. Early Direct Comparative Evidence

Study characteristic

Reported information

Study design

Multicenter, randomized, double-blind, active-controlled

Participants

268

Treatment area

Moderate-to-severe glabellar lines

Investigational treatment

DWP450, 20 U

Active comparator

OnabotulinumtoxinA, 20 U

Primary assessment

Week 4

Physician-rated response

93.89% vs 88.64%

Main interpretation

Prespecified non-inferiority criterion met

Clinical interpretation: This trial provides direct comparative evidence for the studied DWP450 glabellar-line protocol. The numerical difference between the response rates should not be presented as proof of superiority. Likewise, the use of 20 U in both treatment groups does not establish universal equivalence or interchangeability of potency units across products and indications. ［1］

4. Phase III Placebo-Controlled Evidence

A subsequent clinical program evaluated prabotulinumtoxinA in two identically designed Phase III studies involving adults with moderate-to-severe glabellar lines. The trials used a 150-day observation period and randomized participants to 20 U prabotulinumtoxinA or placebo. ［2］

The Day-30 primary endpoint used a composite responder definition requiring both investigator and subject assessments. This is important because a composite endpoint is not directly equivalent to an investigator-only response measure used in another study.

The placebo-controlled program adds evidence that the studied preparation has a treatment effect in the specified glabellar-line population. However, its response rates should not be compared directly with those of another product in a separate trial without accounting for differences in endpoint definitions, populations, and study procedures. ［2］

5. Large Phase III Active-Comparator Study

Rzany and colleagues published a multicenter, randomized, double-blind, placebo-controlled Phase III non-inferiority study involving 540 participants with moderate-to-severe glabellar lines. Participants were assigned to prabotulinumtoxinA, onabotulinumtoxinA, or placebo. ［3］

The study evaluated 20 U prabotulinumtoxinA against 20 U onabotulinumtoxinA, with placebo included as an additional control. The reported Day-30 primary responder rates were 87.2%, 82.8%, and 4.2%, respectively. The prespecified analysis supported non-inferiority of prabotulinumtoxinA to onabotulinumtoxinA for the studied endpoint. ［3］

|Table 2. Large Phase III Active-Comparator Study

Treatment group

Studied dose

Day-30 primary responder rate

PrabotulinumtoxinA

20 U

87.2%

OnabotulinumtoxinA

20 U

82.8%

Placebo

—

4.2%

These results should be interpreted within the trial’s specified endpoint and non-inferiority framework. A finding of non-inferiority does not, by itself, establish superiority, identical products, or universal unit interchangeability. ［3］

6. How the Three Clinical Programs Fit Together

The studies provide complementary forms of evidence rather than three interchangeable efficacy estimates.

Table 3. How the Three Clinical Programs Fit Together

Evidence program

Comparator

Principal contribution

Early DWP450 randomized study

OnabotulinumtoxinA

Direct comparative evidence at Week 4

Two Phase III studies

Placebo

Evidence of efficacy using a Day-30 composite endpoint

Large Phase III study

OnabotulinumtoxinA and placebo

Direct comparison within a prespecified non-inferiority design

Taken together, the studies support the efficacy of the evaluated prabotulinumtoxinA/DWP450 preparation in the studied glabellar-line protocols. They do not establish that every market-specific product label, indication, or dosing approach is identical. ［1–5］

7. What Does Non-Inferiority Actually Mean?

Non-inferiority is a statistical framework designed to assess whether an investigational treatment is not worse than an active comparator by more than a predefined, clinically justified margin.

Its interpretation depends on the selected endpoint, the non-inferiority margin, the analysis population, and the confidence interval for the treatment difference.

For prabotulinumtoxinA, the cited active-comparator studies reported that their prespecified non-inferiority criteria were met. That conclusion applies to the outcomes and treatment protocols evaluated in those studies. ［1, 3］

Non-inferiority should not be rewritten as a general claim that one brand is stronger, lasts longer, is safer, or can replace another brand at the same numerical dose in every clinical setting.

8. Safety: What Should Be Considered?

Safety assessment is an essential component of the randomized clinical program. However, comparative safety claims must remain tied to each study’s sample size, adverse-event definitions, treatment exposure, and follow-up period. ［1–3］

Botulinum toxin products also have product-specific prescribing information, including contraindications, warnings, preparation instructions, and approved indications. The current locally approved product information should be consulted before publishing clinical or patient-facing safety statements. ［4, 5］

A trial reporting non-inferior efficacy should not automatically be interpreted as establishing equivalent safety across all populations or indications.

9. Why Product Naming and Jurisdiction Matter

The relationship among DWP450, prabotulinumtoxinA, NABOTA, and JEUVEAU should be explained rather than assuming that all terms are interchangeable in every context.

Daewoong identifies NABOTA as its botulinum toxin type A product. In the United States, JEUVEAU is marketed under the nonproprietary name prabotulinumtoxinA-xvfs. Market-specific approval, product presentations, and prescribing information should be checked separately. ［4, 5］

For an evidence-based article, the most precise approach is to use the product name appearing in the original clinical publication when describing that trial, then explain its verified relationship to the marketed product.

10. Where Does Neuronox Fit in the Evidence Discussion?

Neuronox is another botulinum toxin type A product with published randomized active-comparator evidence, including a glabellar-line study against onabotulinumtoxinA. Its clinical evidence should be evaluated separately from the prabotulinumtoxinA program.

The studies discussed in this article do not constitute a direct Neuronox-versus-NABOTA comparison. Response percentages drawn from separate studies should therefore not be used to rank the two products.

A product-to-product comparison requires attention to the exact preparation, study design, indication, endpoint, dose, and follow-up.

11. Frequently Asked Questions

Has prabotulinumtoxinA been evaluated in randomized clinical trials?

Yes. Published randomized studies include placebo-controlled Phase III trials and active-comparator trials in adults with moderate-to-severe glabellar lines. ［1–3］

Has DWP450/prabotulinumtoxinA been compared directly with BOTOX?

Yes. Published studies have compared the evaluated preparation with onabotulinumtoxinA in defined glabellar-line protocols. ［1, 3］

Do the trials establish superiority over onabotulinumtoxinA?

The principal comparative conclusions reported in the studies reviewed here were based on prespecified non-inferiority analyses. They should not be represented as general superiority findings. ［1, 3］

Can equal numerical doses in a clinical trial be used as a universal conversion rule?

No. The doses belong to the studied protocol, while product-specific labeling and potency units remain important for clinical interpretation. ［4, 5］

Are NABOTA and JEUVEAU the same trade name worldwide?

No. Trade names and regulatory terminology differ by market. The exact product identity and locally approved label should be verified. ［4, 5］

12. Conclusion

Published randomized trials provide evidence for the efficacy of the evaluated DWP450/prabotulinumtoxinA preparation in moderate-to-severe glabellar lines. The clinical program includes placebo-controlled Phase III studies and direct active-comparator studies with onabotulinumtoxinA, including trials that met their prespecified non-inferiority criteria. ［1–3］

The appropriate interpretation remains product- and protocol-specific. Clinical response, safety, dose, and regulatory claims should be reported alongside the relevant study design, endpoint, follow-up, and jurisdiction.

References

［1］ Won CH, et al. Comparative trial of DWP450 versus onabotulinumtoxinA in glabellar lines: multicenter, randomized, double-blind, active-controlled study. International Journal of Dermatology. 2015;54:227–234. doi:10.1111/ijd.12627.

［2］ Efficacy and Safety of PrabotulinumtoxinA for the Treatment of Glabellar Lines in Adult Subjects: Results From 2 Identical Phase III Studies. Dermatologic Surgery. 2019. Editorial note: Complete author, volume, issue, page, and DOI details should be verified against the original publication before release.

［3］ Rzany BJ, et al. A multicenter, randomized, double-blind, placebo-controlled, single-dose, phase III, non-inferiority study comparing prabotulinumtoxinA and onabotulinumtoxinA for moderate-to-severe glabellar lines. Aesthetic Surgery Journal. 2020;40:413–429. doi:10.1093/asj/sjz110.

［4］ Daewoong Pharmaceutical. NABOTA product information. Manufacturer product information; market-specific presentations and indications. Accessed September 2026.

［5］ Evolus. JEUVEAU (prabotulinumtoxinA-xvfs): Official prescribing and safety information. Accessed September 2026.

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