What Is Nabota? Product Background and Published Clinical Evidence

Explore Nabota, a Daewoong botulinum toxin type A product, including its formulation, relationship to prabotulinum toxinA, randomized clinical trials, safety and evidence-based comparison with Neuronox.

9/23/20267 min read

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Answer-First Summary

Nabota is a botulinum toxin type A product developed and manufactured by Daewoong Pharmaceutical in the Republic of Korea. Its clinical development program includes randomized trials in moderate-to-severe glabellar lines. The related prabotulinumtoxinA product is marketed as JEUVEAU in the United States, although product names, regulatory labels, and approved indications must be checked for each market. [1–3]

Published studies have evaluated prabotulinum toxinA against placebo and onabotulinumtoxinA. These studies support efficacy for their specified glabellar-line protocols, but do not establish universal unit interchangeability or superiority over other botulinum toxin products. [2,3]

Neuronox is a separate Korean botulinum toxin type A product with its own direct comparative clinical evidence against onabotulinumtoxinA. Its evidence base includes randomized studies in glabellar lines and therapeutic indications; these results should be assessed independently rather than treated as a direct comparison with Nabota. [4,5]

Key Takeaways

  • Nabota is a Daewoong-manufactured botulinum toxin type A product. [1]

  • PrabotulinumtoxinA has been evaluated in randomized, controlled studies for glabellar lines. [2,3]

  • In a 540-participant Phase III study, prabotulinumtoxinA met the prespecified non-inferiority criterion against onabotulinumtoxinA. [3]

  • Botulinum toxin potency units are product-specific; a study-specific dose comparison does not create a universal conversion rule. [1]

  • Neuronox also has published direct comparative trials, including a randomized glabellar-line study that met its non-inferiority criterion against onabotulinumtoxinA. [4]

  • The Nabota and Neuronox evidence bases should not be used to imply a head-to-head result between the two products.

1. What Is Nabota?

Nabota is an injectable botulinum toxin type A preparation manufactured by Daewoong Pharmaceutical, Republic of Korea. It is supplied as a vacuum-dried product for reconstitution and intramuscular administration according to its locally approved product information. [1]

The Daewoong-developed prabotulinumtoxinA preparation is marketed in the United States as JEUVEAU (prabotulinumtoxinA-xvfs). [2,3] The relationship between product names is relevant when searching clinical literature, but a publication or label for one market should not automatically be presented as the approved prescribing information for Nabota in another.

For clinical and regulatory accuracy, distinguish:

  • Nabota: the product name used in specified markets.

  • PrabotulinumtoxinA: the nonproprietary name used in published clinical research.

  • JEUVEAU: the U.S. brand name for prabotulinumtoxinA-xvfs.

The exact registered product, formulation, presentation and indications must be verified locally.

2. How Does Nabota Work?

Like other botulinum toxin type A preparations, Nabota acts at peripheral cholinergic nerve terminals to inhibit acetylcholine release. The resulting temporary reduction in targeted muscle activity is the pharmacological basis for its use in relevant clinical indications. [1]

A shared mechanism of action does not mean that Nabota, Neuronox and onabotulinumtoxinA are identical pharmaceutical products. Their formulations, manufacturing processes, potency assays and clinical evidence must be considered separately.

3. What Is in the Nabota Formulation?

A published regulatory product-identification document for Nabota describes a 100-U vial containing botulinum toxin type A, human serum albumin 0.5 mg and sodium chloride 0.9 mg. [1]

The U.S. JEUVEAU label likewise identifies a vacuum-dried botulinum toxin type A preparation with human serum albumin and sodium chloride. [2]

These details establish product composition, not a clinical advantage over another formulation. Claims about comparative onset, duration, diffusion, immunogenicity or patient satisfaction require direct, appropriately designed evidence.

4. Why Are Nabota Potency Units Product-Specific?

The U.S. JEUVEAU label warns that dosing units of commercial botulinum toxin products are not interchangeable. [2]

Clinical trials may compare specific numerical doses—for example, 20 U of prabotulinumtoxinA against 20 U of onabotulinumtoxinA—but those doses belong to the studied indication and protocol. [3]

An equal-unit trial does not establish that the products have universally interchangeable units across facial regions, therapeutic indications or injection techniques.

5. What Does the Published Clinical Evidence Show?

5.1 Earlier Korean Active-Controlled Study

An earlier Korean randomized comparison evaluated a Daewoong botulinum toxin type A preparation against onabotulinumtoxinA in moderate-to-severe glabellar lines.

The Day-30 investigator-assessed responder rates reported in the subsequent Phase III publication were 93.89% for the Daewoong preparation and 88.64% for onabotulinumtoxinA. The study met its prespecified non-inferiority criterion. [3]

These figures describe a defined endpoint in one clinical trial. The numerical difference does not establish superiority, and the study's original formulation should be distinguished from later marketed presentations where relevant.

5.2 Multicenter Phase III Study: PrabotulinumtoxinA Versus OnabotulinumtoxinA and Placebo

A randomized, double-blind, placebo-controlled Phase III study enrolled 540 adults with moderate-to-severe glabellar lines. Participants were assigned to prabotulinumtoxinA 20 U, onabotulinumtoxinA 20 U or placebo. [3]

The primary efficacy endpoint was the proportion of participants with a glabellar-line score of 0 or 1 at maximum frown on Day 30, assessed by the investigator in the per-protocol population.

Day-30 responder rates:

Group

Responders

PrabotulinumtoxinA

87.2% (205/235)

OnabotulinumtoxinA

82.8% (202/244)

Placebo

4.2% (2/48)

The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA was 4.4 percentage points, with a 95% confidence interval of −1.9 to 10.8 percentage points. Because the lower confidence limit remained above the prespecified −10% non-inferiority margin, the study concluded that prabotulinumtoxinA was non-inferior for the primary endpoint. [3]

Both active groups also demonstrated efficacy against placebo. [3]

Clinical interpretation: Non-inferiority is a study-specific statistical conclusion. The trial did not establish superiority of prabotulinumtoxinA over onabotulinumtoxinA, nor did it compare Nabota directly with Neuronox.

5.3 Placebo-Controlled Evidence and the U.S. Clinical Program

The U.S. JEUVEAU prescribing information summarizes the clinical studies supporting its glabellar-line indication. [2]

These studies contribute evidence for the evaluated prabotulinumtoxinA product and its approved U.S. use. However, individual trial outcomes must be interpreted according to their responder definitions, assessment time points, populations and analysis sets.

For publication, the exact U.S. indication should be taken from the current U.S. label, while any Thailand-specific indication should be taken from the current Thai-approved product information.

6. What Does the Evidence Show About Safety?

The 540-participant Phase III trial collected adverse-event data alongside efficacy outcomes. Five participants experienced serious adverse events across the three groups; none was considered related to the study drug. [3]

This finding does not establish that botulinum toxin treatment is risk-free. Safety assessment must consider the product's current contraindications, warnings, adverse reactions and locally approved instructions. [1,2]

Comparisons of adverse-event rates across separate brands or studies require particular caution because the populations, treatment protocols, definitions and follow-up periods may differ.

7. What Are the Evidence-Based Strengths of Neuronox?

Neuronox has an independently published clinical evidence base that includes direct randomized comparisons with onabotulinumtoxinA. This is relevant when discussing the clinical development of Korean botulinum toxin products. [4,5]

In a Phase III randomized, double-blind glabellar-line study, 314 participants were randomized to receive the studied Neuronox preparation or onabotulinumtoxinA. At Week 4, investigator-assessed responder rates were 93.7% (133/142) and 94.5% (138/146), respectively. The study met its prespecified non-inferiority criterion. [4]

Neuronox has also been studied in a multicenter randomized trial involving 196 participants with post-stroke upper-limb spasticity. The primary endpoint was the change in wrist-flexor Modified Ashworth Scale score at Week 4. Mean changes were −1.39 ± 0.79 with Neuronox and −1.56 ± 0.81 with onabotulinumtoxinA; the study met its non-inferiority criterion. [5]

Why this matters: Neuronox's clinical evidence is not limited to an indirect comparison of published response percentages. It includes direct active-controlled research in both an aesthetic indication and a therapeutic indication. [4,5]

These are strengths of its evidence base, not proof that Neuronox is clinically superior to Nabota. The therapeutic findings must not be used as evidence for an unapproved aesthetic claim.

8. Nabota and Neuronox: What Can Be Compared?

Evidence question

Nabota / prabotulinumtoxinA

Neuronox

Product origin

Daewoong, Republic of Korea [1]

Separate Korean botulinum toxin type A preparation [4,5]

Published glabellar-line RCT against onabotulinumtoxinA

Yes [3]

Yes [4]

Non-inferiority finding in the cited glabellar trial

Met [3]

Met [4]

Direct post-stroke upper-limb spasticity trial against onabotulinumtoxinA cited here

Not assessed in this article

Yes [5]

Direct Nabota-versus-Neuronox result

Not established by the cited studies

Not established by the cited studies

Important: The glabellar trials used different study designs and responder definitions. Their percentages cannot be compared as if the two products were randomized within the same trial.

A dedicated evidence-limitation analysis is provided in BW-28: Neuronox vs Nabota: What Can and Cannot Be Compared.

9. What Does the Evidence Not Establish?

The studies reviewed here do not establish that:

  • Nabota and Neuronox are interchangeable products.

  • A numerical dose ratio is universally applicable.

  • A higher response percentage in one separate trial demonstrates cross-brand superiority.

  • Non-inferiority against a shared comparator proves equivalence between two products that were not directly compared.

  • Results from a therapeutic indication establish efficacy for an aesthetic indication.

Frequently Asked Questions

Is Nabota the same as JEUVEAU?

They are product names associated with Daewoong's botulinum toxin type A development program. JEUVEAU is the U.S. brand for prabotulinumtoxinA-xvfs. Exact product identity, regulatory status and approved labeling should be verified for each market. [1,2]

Does Nabota have randomized clinical evidence?

Yes. Published randomized studies have evaluated Daewoong's botulinum toxin type A preparation and prabotulinumtoxinA in glabellar lines. [3]

Was prabotulinumtoxinA superior to onabotulinumtoxinA in the 540-participant trial?

The prespecified conclusion was non-inferiority for the primary endpoint. The numerical difference in response rates should not be described as demonstrated superiority. [3]

What clinical evidence supports Neuronox?

Neuronox has published direct randomized comparisons against onabotulinumtoxinA, including studies in glabellar lines and post-stroke upper-limb spasticity. [4,5]

Has Neuronox been shown to be better than Nabota?

The studies cited in this article do not provide a direct Neuronox-versus-Nabota comparison. Separate trials against a shared comparator do not establish a cross-brand result.

Can Nabota and Neuronox units be converted directly?

A universal conversion should not be assumed. Refer to the current locally approved product information and the exact protocols used in clinical research. [1,2]

References

[1] Daewoong Pharmaceutical Co., Ltd. NABOTA: Product Identification and Label Information. Saudi Food and Drug Authority; 2025. https://www.sfda.gov.sa/sites/default/files/2025-10/Nabota.pdf

[2] Evolus, Inc. JEUVEAU (prabotulinumtoxinA-xvfs) for Injection: U.S. Prescribing Information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=17a914c1-e54b-4b50-965d-b0fd9111bba4

[3] Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthetic Surgery Journal. 2020;40(4):413–429. https://academic.oup.com/asj/article/40/4/413/5428816

[4] Won CH, Lee HM, Lee WS, et al. Efficacy and safety of a novel botulinum toxin type A product for the treatment of moderate to severe glabellar lines: a randomized, double-blind, active-controlled multicenter study. Dermatol Surg. 2013;39(1 Pt 2):171–178. doi:10.1111/dsu.12072. https://pubmed.ncbi.nlm.nih.gov/23301821/

[5] Seo HG, Paik NJ, Lee SU, et al. Neuronox versus BOTOX in the treatment of post-stroke upper limb spasticity: a multicenter randomized controlled trial. PLoS One. 2015;10(6):e0128633. doi:10.1371/journal.pone.0128633. https://pubmed.ncbi.nlm.nih.gov/26030192/

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