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Clinical Studies

Under the developmental name DWP-450, Nabota has undergone several clinical trials proving its safety and efficacy for various conditions, such as glabellar frown lines, post-stroke upper limb spasticity, square jaw and shoulder pain syndrome.

  • 2daysFrown lines significantly reduced after administration
  • 0Neutralizing antibodies in 1,646 subjects across five studies
  • 2Phase 3 studies, with 180 and 197 patients

Safety and efficacy of Nabota

Improvement of glabellar lines

One study showed promising results of Nabota in the improvement of glabellar lines: within 2 days following administration, frown lines are significantly reduced, peaking on the 6th day, with maximum effects lasting for about 3 to 6 months.

Furthermore, Nabota produces precise and accurate results without diffusing to other tissues, maintaining its effects only in the desired treatment area.

85.4% improved at day 2

Glabellar lines improvement rate at maximum frown after Nabota administration

Glabellar lines improvement rate at maximum frown, by days after Nabota administration
Days after administrationSubjects improvedRate of improvement
2 days35 of 4185.4%
3 days35 of 4185.4%
4 days37 of 4190.2%
5 days39 of 4195.1%
6 days40 of 4197.6%
Rate of improvement
Proportion of subjects with at least a 1-point improvement after injection, out of the total subjects
Evaluation method
The investigator assigned each subject a grade from 0 (no wrinkles), 1 (mild), 2 (moderate) to 3 (severe), by the severity of glabellar lines at maximum frown
Research objective
To evaluate the efficacy and safety of Nabota in glabellar lines improvement
Research subjects
42 subjects with glabellar lines above moderate (above 2 points)
Research methods
Single-arm, open-label, single-center, phase 4 clinical study. Intramuscular injection at 5 points in total, 0.1 mL (4U/0.1 mL) per point, 20U of Nabota in total. Efficacy and safety were assessed at 2, 3, 4, 5 and 14 days.

No neutralizing antibodies

Another study proves Nabota’s safety without causing immune responses or adverse reactions. It confirmed that there were no neutralizing antibodies during repeated treatment or when maximum doses are given.

These neutralizing antibodies affect the effectiveness of botulinum toxin and can induce resistance with repeated treatments.

0 neutralizing antibodies

Incidence of neutralizing antibodies in Nabota domestic and global clinical studies

Neutralizing antibodies formed in Nabota domestic and global clinical studies
Clinical studySubjectsFormed
Glabellar line phase 3 domestic studyTreatments and dose: 1, 20U1350
Glabellar line phase 3 global studyTreatments and dose: 1, 20U4920
Glabellar line phase 2 studies, repeat treatment*Treatments and dose: Max. 4, 20U9220
Post-stroke upper limb spasticity, phase 3 studyTreatments and dose: 1, max. 360U970
Total1,6460

Nabota neutralizing antibody incidence by treatment and dose

  1. Single treatment16 weeks or 150 days after administration
  2. Repeat treatmentMaximum 4 treatments in a year
  3. Max. dose treatment12 weeks after 360U administration

The incidence of neutralizing antibodies: 0

* Glabellar line phase 2 studies, repeat treatment (EV-004, EV-006): proven efficacy and safety of repeated administration (maximum 4 treatments for a year) of prabotulinumtoxinA in improving moderate or severe glabellar lines.

Clinical studies of Nabota

Clinical study on Nabota for treatment of benign masseteric hypertrophy

  • 180patients
  • 48weeks
Objective
Reporting the safety and efficacy of Nabota in masseter muscle hypertrophy over a period of 48 weeks.
Method
Double-blind, randomized, placebo-controlled, multicenter, phase 3 trial, and open-label extension study with 180 patients.
Results
PrabotulinumtoxinA could significantly improve masseter muscle hypertrophy without major complications.

ReferenceSeok J, Koh YG, Hong JK, Yun SH, Kim DH, Son HS, Choi SY, Yoo KH, Lee YW, Kim BJ. Efficacy and Safety of PrabotulinumtoxinA in Subjects With Benign Masseteric Hypertrophy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase 3 Trial and Open-Label Extension Study. Dermatol Surg. 2024 Jun 1;50(6):527-533.

Clinical study on the efficacy and safety of Nabota in post-stroke upper limb spasticity

  • 197patients
  • 12weeks
Objective
Reporting the safety and efficacy of Nabota in patients with post-stroke upper limb spasticity over a period of 4, 8 and 12 weeks.
Method
A phase 3 multicenter, double-blinded, randomized controlled clinical trial with a total of 197 patients.
Results
Nabota demonstrated satisfactory results in efficacy and safety and was proven comparable to onabotulinumtoxinA (Botox). It may serve as an alternative for treatment of post-stroke upper limb spasticity.

ReferenceHyung Seok Nam, Yoon Ghil Park, Nam-Jong Paik, Byung-Mo Oh, Min Ho Chun, Hea-Eun Yang, Dae Hyun Kim, Youbin Yi, Han Gil Seo, Kwang Dong Kim, Min Cheol Chang, Jae Hak Ryu, Shi-Uk Lee. Efficacy and safety of NABOTA in post-stroke upper limb spasticity: A phase 3 multicenter, double-blinded, randomized controlled trial. Journal of the Neurological Sciences. Volume 357, Issues 1–2, 2015, Pages 192-197.

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