1. Introduction: Has NABOTA Been Directly Compared With BOTOX?

NABOTA is a botulinum toxin type A (BoNT-A) product developed by Daewoong Pharmaceutical. Its associated clinical development program includes studies published under the names DWP450 and prabotulinumtoxinA.

BOTOX is a separate botulinum toxin type A product containing onabotulinumtoxinA.

Unlike comparisons that rely on results from unrelated studies, the DWP450/prabotulinumtoxinA development program includes randomized trials in which participants received the investigated product or onabotulinumtoxinA under the same clinical protocol. ［1,2］

Two published studies are particularly relevant:

• A 2015 randomized, double-blind study involving 268 participants, comparing DWP450 with onabotulinumtoxinA.

• A subsequent Phase III study involving 540 participants, comparing prabotulinumtoxinA with onabotulinumtoxinA and placebo.

Both studies evaluated treatment of glabellar lines, commonly known as frown lines between the eyebrows. Their prespecified analyses supported non-inferiority of the investigated preparation relative to onabotulinumtoxinA. ［1,2］

Understanding these findings requires examining the study populations, treatment protocols, responder definitions and clinical endpoints rather than relying on response percentages alone.

2. NABOTA, DWP450 and PrabotulinumtoxinA: Understanding the Names

Botulinum toxin products may be identified by different names in clinical publications and commercial markets.

NABOTA is a trade name associated with Daewoong Pharmaceutical's botulinum toxin type A product. DWP450 is a development designation, while prabotulinumtoxinA is the nonproprietary name used in the relevant clinical program.

BOTOX is a trade name for onabotulinumtoxinA.

Table 1. Product Terminology

Term

Meaning

NABOTA

Trade name associated with Daewoong Pharmaceutical's BoNT-A product

DWP450

Development designation used in clinical research

PrabotulinumtoxinA

Nonproprietary name used in the associated clinical program

BOTOX

Trade name for onabotulinumtoxinA

OnabotulinumtoxinA

Nonproprietary name of the BOTOX active ingredient

The exact relationship between the preparation investigated in a study and the marketed product should be verified against current product documentation.

Trade names, available presentations and approved indications may differ between jurisdictions.

3. The 2015 DWP450 vs BOTOX Clinical Trial

Won CH and colleagues published a multicenter, randomized, double-blind, active-controlled study comparing DWP450 with onabotulinumtoxinA for glabellar lines. ［1］

The study included 268 participants who were randomized in a 1:1 ratio.

Both treatment groups received a total dose of 20 units of their assigned product under the study protocol.

3.1 Study Design

Table 2. Overview of the 2015 Comparative Trial

Study Parameter

Description

Study design

Multicenter, randomized, double-blind, active-controlled

Total participants

268

Randomization

1:1

Investigational treatment

DWP450, 20 U

Active comparator

OnabotulinumtoxinA, 20 U

Treatment indication

Glabellar lines

Key assessment

Physician-rated response at Week 4

Comparative framework

Non-inferiority

This design allowed the investigators to compare the products within a common study population and assessment protocol.

3.2 What Were the Week-4 Results?

The study reported physician-rated responder rates of 93.89% for DWP450 and 88.64% for onabotulinumtoxinA at Week 4. ［1］

Table 3. Physician-Rated Response at Week 4

Treatment

Responder Rate

DWP450

93.89%

OnabotulinumtoxinA

88.64%

The study met its prespecified non-inferiority criterion.

The numerical difference between the responder rates should be interpreted within the statistical framework used by the investigators. The principal comparative conclusion was non-inferiority, not demonstrated superiority.

3.3 What Does Non-Inferiority Mean?

A non-inferiority trial is designed to evaluate whether a new treatment is not unacceptably less effective than an established comparator by more than a predefined margin.

The investigators establish that margin before analyzing the results.

A successful non-inferiority result therefore supports a conclusion about the specified treatment, endpoint, population and margin.

It does not establish that the two products are identical in formulation, biological potency, clinical duration or every safety outcome.

4. The 540-Participant Phase III Comparative Study

A subsequent Phase III study reported by Rzany BJ and colleagues evaluated prabotulinumtoxinA against onabotulinumtoxinA and placebo in participants with moderate-to-severe glabellar lines. ［2］

The study used a multicenter, randomized, double-blind design and included 540 participants.

4.1 Three Treatment Groups

Participants were randomized to one of three groups:

1. PrabotulinumtoxinA, 20 U.

2. OnabotulinumtoxinA, 20 U.

3. Placebo.

The inclusion of placebo allowed the study to assess treatment response against an inactive control, while the active-comparator group supported the prespecified non-inferiority analysis.

4.2 Day-30 Efficacy Results

The reported primary responder rates at Day 30 were 87.2% for prabotulinumtoxinA, 82.8% for onabotulinumtoxinA and 4.2% for placebo. ［2］

Table 4. Phase III Primary Responder Rates at Day 30

Treatment Group

Primary Responder Rate

PrabotulinumtoxinA, 20 U

87.2%

OnabotulinumtoxinA, 20 U

82.8%

Placebo

4.2%

The prespecified comparative analysis supported non-inferiority of prabotulinumtoxinA relative to onabotulinumtoxinA. ［2］

The placebo group also provides context for the observed treatment response under the study's endpoint definition.

4.3 Why the Placebo Group Matters

An active-controlled trial can evaluate a new treatment against an established product, but it does not necessarily include an untreated or inactive comparison.

The addition of placebo provides another reference point for interpreting the clinical response.

In this study, the Day-30 responder rates in both active-treatment groups were substantially higher than the reported placebo response. ［2］

However, placebo-controlled and active-comparator analyses answer different questions. Their findings should be reported separately.

5. Comparing the Two Head-to-Head Trials

Both studies investigated glabellar-line treatment using 20 U of the relevant DWP450/prabotulinumtoxinA preparation and 20 U of onabotulinumtoxinA.

Nevertheless, the studies differed in sample size, design and assessment timing.

Table 5. Comparison of the Published Trials

Parameter

Won et al., 2015

Rzany et al., 2020

Total participants

268

540

Investigated preparation

DWP450

PrabotulinumtoxinA

Active comparator

OnabotulinumtoxinA

OnabotulinumtoxinA

Investigational dose

20 U

20 U

Comparator dose

20 U

20 U

Placebo group

No

Yes

Reported response time point

Week 4

Day 30

Investigational-product responder rate

93.89%

87.2%

Active-comparator responder rate

88.64%

82.8%

Main comparative finding

Non-inferiority

Non-inferiority

Although Week 4 and Day 30 are close in time, the percentages should not be treated as interchangeable measurements.

Differences in eligibility criteria, endpoint definitions, assessment procedures and statistical populations can influence the reported results.

The appropriate interpretation is that each study supports its own prespecified conclusion.

6. Does a 20-U vs 20-U Study Establish Universal Dose Equivalence?

Both identified studies used 20 U of the investigated product and 20 U of onabotulinumtoxinA in their glabellar-line protocols.

This is a description of the tested doses, not a universal conversion rule.

Botulinum toxin potency units are product-specific and are defined through the relevant product's potency assay.

Consequently, a numerical dose used in one study cannot automatically be transferred to a different indication, injection pattern or preparation.

Table 6. Interpreting the 20-U Comparative Protocol

Study Finding

Interpretation

Both active groups received 20 U

The trial compared these numerical doses under its defined protocol

Non-inferiority criterion was met

The result supports the prespecified clinical comparison

The products belong to the BoNT-A class

Their potency units remain product-specific

The trial evaluated glabellar lines

Its dosing protocol should not be generalized to other indications

Current locally approved product information remains the reference for authorized dosing, administration and preparation.

7. What Do the Trials Report About Safety?

Both trials collected safety information alongside their efficacy assessments. ［1,2］

Safety evaluation in botulinum toxin studies may include adverse-event frequency, severity, treatment-relatedness and events associated with local administration.

The interpretation of these findings depends on the number of participants, duration of follow-up and definitions used in each study.

For a meaningful safety comparison, the full publications should be reviewed for the types of adverse events reported, their denominators and the statistical analyses performed.

The responder rates presented in this article are efficacy outcomes; they should not be used as numerical indicators of safety.

Likewise, the absence of a statistically significant difference in a particular safety endpoint would not independently establish identical safety profiles in all populations or clinical settings.

8. What Can These Studies Tell Us About Treatment Duration?

The two comparative trials provide efficacy findings at their specified assessment time points.

The Week-4 and Day-30 responder rates describe clinical response at those visits. They do not, by themselves, establish how long an individual patient's treatment effect will persist.

A duration claim requires a clearly defined durability endpoint and appropriate follow-up data.

When discussing treatment duration, it is important to distinguish between the time of peak or early response assessment and the period over which a prespecified clinical improvement is maintained.

The published trial findings should therefore be reported using their actual assessment schedules rather than converted into a universal duration claim.

9. Where Does Neuronox Fit Into This Evidence?

Neuronox is a separate botulinum toxin type A product manufactured by Medytox Inc.

It has its own randomized clinical evidence, including a Phase III study comparing the investigated Neuronox preparation with onabotulinumtoxinA in 314 participants with glabellar lines.

That study reported Week-4 responder rates of 93.7% for Neuronox and 94.5% for onabotulinumtoxinA and met its prespecified non-inferiority criterion. ［3］

Table 7. Distinguishing the Three Clinical Programs

Product or Program

Relevant Direct Comparator

Reported Glabellar-Line Evidence

Neuronox

OnabotulinumtoxinA

Phase III randomized study

DWP450

OnabotulinumtoxinA

Randomized active-controlled study

PrabotulinumtoxinA

OnabotulinumtoxinA and placebo

Phase III randomized study

The Neuronox study and the DWP450/prabotulinumtoxinA studies were conducted separately.

Their results should remain linked to the product, population, endpoint and protocol evaluated in each publication.

10. Frequently Asked Questions

Has NABOTA been compared directly with BOTOX?

Yes. Published randomized studies associated with the DWP450/prabotulinumtoxinA development program compared the investigated preparation with onabotulinumtoxinA in glabellar-line treatment. ［1,2］

How many participants were included in the studies?

The 2015 DWP450 study included 268 participants. The subsequent Phase III prabotulinumtoxinA study included 540 participants. ［1,2］

What did the 2015 study report?

At Week 4, physician-rated responder rates were 93.89% for DWP450 and 88.64% for onabotulinumtoxinA. The prespecified non-inferiority criterion was met. ［1］

What were the Day-30 results in the Phase III study?

The reported primary responder rates were 87.2% for prabotulinumtoxinA, 82.8% for onabotulinumtoxinA and 4.2% for placebo. The active-comparator analysis supported non-inferiority. ［2］

Did the studies establish superiority over BOTOX?

Their principal comparative findings were non-inferiority under the specified study protocols.

Why did the studies use 20 U in both active-treatment groups?

The investigators selected those doses for the glabellar-line protocols. Equal numerical doses in these studies do not establish a universal conversion ratio between products.

Can these findings be applied to every aesthetic or therapeutic indication?

The findings are specific to the investigated glabellar-line populations, treatment protocols and endpoints. Other indications require their own supporting evidence.

11. Conclusion

The DWP450/prabotulinumtoxinA clinical development program includes randomized head-to-head studies against onabotulinumtoxinA in glabellar-line treatment.

The 2015 study of 268 participants reported Week-4 responder rates of 93.89% for DWP450 and 88.64% for onabotulinumtoxinA. A subsequent Phase III study involving 540 participants reported Day-30 primary responder rates of 87.2% for prabotulinumtoxinA, 82.8% for onabotulinumtoxinA and 4.2% for placebo. Both studies supported their prespecified non-inferiority conclusions. ［1,2］

These results provide product-specific comparative evidence under defined clinical protocols.

Neuronox, manufactured by Medytox Inc., has a separate clinical evidence program, including randomized comparative research in glabellar lines and selected therapeutic indications. Its clinical findings should be evaluated within the respective study designs and populations. ［3］

A complete assessment of botulinum toxin products should consider the exact preparation, clinical evidence, approved product information and the intended treatment indication.

References

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

［2］ 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. Aesthet Surg J. 2020;40:413–429. doi:10.1093/asj/sjz110.

［3］ Lee WS, et al. Efficacy and safety of a new botulinum toxin type A for glabellar lines: randomized, double-blind, active-controlled, multicenter phase III study. Dermatol Surg. 2013;39:171–178. doi:10.1111/dsu.12072.

［4］ Daewoong Pharmaceutical. NABOTA product information. Product presentations and approved indications by market. Accessed September 2026.

［5］ BOTOX Cosmetic (onabotulinumtoxinA). Official prescribing information. AbbVie/Allergan. Current locally applicable version to be verified before publication.

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