Drugs / PrabotulinumtoxinA
PrabotulinumtoxinA
also known as
DWP450 · ABP-450 · prabotulinumtoxinA-xvfs · Botulinum toxin type A · Nabota · PBoNT/A
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | Nuceiva | — | 2022-02-08 | “acceptance of its submission to the Australian Therapeutics Good Administration (TGA) for regulatory approval of Nuceiva ®” evolus.com ↗ |
| Approved | US (FDA) | JEUVEAU | — | 2019-02-01 | fda.gov ↗ |
| Filed | US (FDA) | Nabota | — | 2018-08-02 | “announced that today it is resubmitting its Biologics License Application (“BLA”) for its lead product candidate, DWP-450 (prabotulinumtoxinA), to the U. S Food and Drug...” evolus.com ↗ “On Aug. 30, Daewoong Pharrmaceutical (CEO Sengho Jeon) announced that it received an acceptance letter for resubmission of Biologic License Application for Nabota.” daewoong.co.kr ↗ “Daewoong Pharmaceutical submitted Biologics License Application to US FDA and Marketing Authorization Application to EU EMA for Nabota last year.” daewoong.co.kr ↗ “Biologics License Application has been submitted to US FDA and Marketing Authorization Application to EU for Nabota(DWP-450).” daewoong.co.kr ↗ |
| Filed | Other | — | glabellar lines | 2017-10-26 | “the New Drug Submission (NDS) for prabotulinumtoxinA, a 900 kilodalton (kDa) Botulinum toxin Type A, for the treatment of adult patients with glabellar lines, also known as...” evolus.com ↗ |
| Rejected (CRL) | US (FDA) | Nabota | — | — | “US FDA completed review on Nabota BLA and sent Complete Response Letter to Evolus, US partner to Daewoong.” daewoong.co.kr ↗ |
| Filed | EU (EMA) | Nabota | — | — | “Daewoong Pharmaceutical submitted Marketing Authorization Application for Nabota to EMA through its centralized procedure, last June, which was accepted in July.” daewoong.co.kr ↗ “Daewoong Pharmaceutical submitted Biologics License Application to US FDA and Marketing Authorization Application to EU EMA for Nabota last year.” daewoong.co.kr ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05807412 | May 2023 → Feb 2024 | — | Lupo Center for Aesthetic and General Dermatology | Completed | No outcome recorded |
| Phase 0 | NCT04715048 | Jan 2021 → May 2025 | — | University of Southern California | Unknown | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05016661 | Oct 2021 → Jul 2024 | migraine disorder | AEON Biopharma, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04871451 | Jul 2021 → Jul 2023 | cervical dystonia | AEON Biopharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04849988 | Mar 2021 → Jul 2022 | cervical dystonia | AEON Biopharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04845178 | Mar 2021 → Jun 2024 | migraine disorder | AEON Biopharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02428608 | May 2015 → Oct 2016 | — | Evolus, Inc. | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT06354127 | Aug → Nov 2020 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT04294251 | Mar 2020 → Jan 2021 | masticatory muscles, hypertrophy of | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT01629875 | Mar → Aug 2012 | — | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06903975 | May 2025 → Mar 2027 expected | — | Boston Medical Center | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07452510 | Jan → Apr 2026 | bruxism, masticatory muscles, hypertrophy of, parasomnia, sleep bruxism type, temporomandibular joint disorder | Recep Tayyip Erdogan University | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 0 | NCT05129319 Comparator | Dec 2021 → Jun 2023 | — | Clinical Testing of Beverly Hills | Completed | No outcome recorded |
| Phase 1 | NCT06604832 Comparator | Sep 2024 → Aug 2025 | — | Kalpna Kay Durairaj, MD, FACS | Completed | No outcome recorded |
| Phase 2 | NCT05320393 Comparator | Mar 2022 → May 2023 | — | Evolus, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT06448676 Comparator | Feb 2026 → Jan 2027 expected | — | Academic Medical Center - University of Amsterdam | Recruiting | No outcome recorded |
| Phase 4 | NCT07072806 Comparator | Jun → Aug 2022 | — | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT05840445 Comparator | Jun 2020 → Jan 2021 | — | Instituto de Oftalmología Fundación Conde de Valenciana | Completed | No outcome recorded |
| — | NCT05167864 Comparator | Mar 2022 → Jun 2023 | — | University of Pennsylvania | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 62
| Date | Issuer | Release |
|---|---|---|
| 2026-09-09 | AEON Biopharma, Inc. | Results AEON Announces Positive Pilot Forced Degradation Results Supporting Analytical Comparability of ABP-450 to BOTOX® aeonbiopharma.com ↗
Under thermal stress, both ABP-450 and BOTOX ® lost potency at comparable rates. |
| 2026-08-19 | AEON Biopharma, Inc. | Results AEON Reports Expanded Structural Data Supporting Molecular Similarity of ABP-450 to BOTOX® aeonbiopharma.com ↗
The expanded primary structure analysis achieved 98% sequence coverage of the active botulinum neurotoxin and demonstrated 100% amino acid identity across every region analyzed. |
| 2026-06-04 | AEON Biopharma, Inc. | Results AEON Biopharma to Present Data Demonstrating Structural and Functional Comparability of ABP-450 to BOTOX® at the 68th Annual Scientific Meeting of the American Headache Society aeonbiopharma.com ↗
The data being presented today builds on previously reported primary structure findings by adding functional evidence demonstrating highly similar biological activity between ABP-450 and BOTOX® across multiple orthogonal analytical approaches: genomic sequence alignment, LC-MS peptide mapping, and the LD 50 potency assay. |
| 2025-11-13 | AEON Biopharma, Inc. | Results AEON Biopharma Reports Positive and Robust Biosimilarity Results: Identical Amino Acid Sequence and Highly Similar Functional Analysis Data aeonbiopharma.com ↗
100% amino acid sequence identity confirmed between ABP-450 and BOTOX®, based on sequence coverage of 93% - 99% for the five proteins that comprise the 900kD botulinum toxin type A complex. |
| 2025-07-31 | Evolus, Inc. | Results Evolus Announces Publication of Independent Study in JAMA Dermatology Demonstrating Jeuveau® as a Top Performer Among Leading Neurotoxins evolus.com ↗
Jeuveau ® achieved the highest peak effect at Day 30, with a median strain reduction of 93%, highlighting its robust performance profile. |
| 2024-05-03 | AEON Biopharma, Inc. | Results AEON Biopharma Announces Preliminary Top-Line Results from Phase 2 Interim Analysis of ABP-450 in the Preventive Treatment of Chronic Migraine aeonbiopharma.com ↗
While we were surprised and disappointed that ABP-450 did not demonstrate statistically significant superiority over placebo in this interim readout, both active arms showed a reduction in monthly migraine days directly in-line with our expectations. |
| 2024-04-17 | Evolus, Inc. | Results Evolus Announces Publication of Safety and Duration Data from Phase 2 Study for “Extra-Strength” 40U Formulation of Jeuveau® evolus.com ↗
Data showed duration effect of 26 weeks, or 6 months, based on a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to baseline value using the Global Aesthetic Improvement Scale |
| 2024-01-18 | AEON Biopharma, Inc. | Results AEON Biopharma Presents Positive Clinical and Pre-clinical Data for ABP-450 (prabotulinumtoxinA) in Treating Cervical Dystonia and PTSD, Respectively, at a Leading Neurotoxin Conference aeonbiopharma.com ↗
Peak efficacy for all ABP-450 doses and cycles occurred early, within 4 weeks, and durability of effect was demonstrated from 12 to 16 weeks post treatment. |
| 2023-11-07 | Evolus, Inc. | Results Evolus Reports Record Third Quarter 2023 Financial Results and Phase II Data for Extra-Strength 40U Formulation of Jeuveau® evolus.com ↗
“We are incredibly pleased to report the results of the completed Phase II trial, which provides important insights about the role of this formulation in achieving longer-lasting results,” |
| 2023-11-06 | Evolus, Inc. | Results “Extra-Strength” 40U Formulation of Jeuveau® Demonstrates Effects Lasting 26 Weeks in Phase II Data Presented at 2023 ASDS Annual Meeting evolus.com ↗
Final data were presented at the 2023 American Society for Dermatologic Surgery (ASDS) Annual Meeting on November 3, 2023, in Chicago, and demonstrated 26 weeks, or 6 months of duration with the extra-strength dose of 40U across multiple measurements. |
| 2023-01-28 | Evolus, Inc. | Results "Extra-Strength" Formulation of Jeuveau® Demonstrates Effects Lasting 26 Weeks in Interim Phase II Data Results, Representing Prolonged 6-Month Performance evolus.com ↗
The data indicated that the “extra-strength” formulation of Jeuveau ® at 40U (units) achieved a duration profile of 6 months or 26 weeks. |
| 2023-01-23 | Evolus, Inc. | Regulatory Evolus Receives Regulatory Approval for Nuceiva® in Australia evolus.com ↗
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that the Australian Therapeutic Goods Administration (TGA) has provided regulatory approval for Nuceiva ® (prabotulinumtoxinA)▼, a neurotoxin dedicated exclusively to aesthetics. |
| 2022-08-24 | Evolus, Inc. | Results Newly Published Post Hoc Analysis Evaluates Efficacy of Jeuveau® in Adult Males Compared to BOTOX® evolus.com ↗
Results demonstrated percentages of male responders treated with Jeuveau ® achieved approximately 10% higher results across all visits |
| 2022-06-02 | Evolus, Inc. | Results Peer-Reviewed Post Hoc Analysis Shows Jeuveau® is Highly Effective for Millennials by All Measures and at All Time Points Assessed evolus.com ↗
The data showed Jeuveau ® (prabotulinumtoxinA-xvfs) was well tolerated in both millennial and non-millennial patient populations, and highly effective for millennials with moderate-to-severe glabellar lines. |
| 2022-02-08 | Evolus, Inc. | Regulatory Evolus Receives Acceptance of Submission in Australia, a Pivotal Step in Approval Process for Nuceiva® evolus.com ↗
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company, today announced the acceptance of its submission to the Australian Therapeutics Good Administration (TGA) for regulatory approval of Nuceiva ® (prabotulinumtoxinA), the first and only neurotoxin dedicated exclusively to aesthetics. |
| 2021-06-24 | Evolus, Inc. | Results Peer Reviewed Article Highlights Efficacy and Safety of Jeuveau® in Patients with Skin of Color evolus.com ↗
This important study of pooled data provides information for Dermatologists of a non-statistical difference in responder rates and headache in SOC as compared to non-SOC patients for this neurotoxin. |
| 2021-05-12 | Evolus, Inc. | Results Aesthetic Surgery Journal Publishes Long Term Safety and Efficacy Data of Jeuveau® for the Treatment of Moderate to Severe Frown Lines evolus.com ↗
The two Phase II studies, conducted to support the registration and regulatory approval of Jeuveau ® in the United States , Canada and Europe , demonstrate that prolonged use of Jeuveau is safe and effective with repeat treatments. |
| 2021-01-04 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s Nabota proves its efficacy in hair loss through clinical trials daewoong.co.kr ↗
As a result, the amount of hair significantly increased statistically at week 24 compared to the start of the study. |
| 2020-08-05 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s Nabota Confirmed Its Palliative Effect on Bruxism in Clinical Trial Findings daewoong.co.kr ↗
The results showed that the Nabota group had improved symptoms of bruxism as the masseter weakened compared to the placebo group and this effect was maintained for 12 weeks. |
| 2020-06-24 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s Nabota Beginning to Make Inroads into Greater China with Marketing Authorization in Taiwan daewoong.co.kr ↗
Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced on June 23 that the company obtained marketing approval for Nabota’s indication of glabellar wrinkles from the Taiwan Food and Drug Administration (TFDA). |
| 2020-02-20 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s Nabota Advances into Brazil, the Largest Market in Latin America, with Marketing Authorization daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Sengho Jeon) announced on March 20 that it has obtained marketing authorization for Nabota in Brazil, the largest market in Latin America on March 17 (local time). |
| 2020-01-27 | Evolus, Inc. | Results Positive Results from Phase III, Split-Face, Head-to-Head Study Comparing OnabotulinumtoxinA and PrabotulinumtoxinA in the Treatment of Crow’s Feet Lines Published in Dermatologic Surgery evolus.com ↗
The primary endpoint of non-inferiority was achieved with responder rates* of 65.02% for prabotulinumtoxinA and 62.56% for onabotulinumtoxinA at Week 4. |
| 2019-12-19 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s Nabota Acquires Marketing Authorization in the UAE and Indonesia… Advancing into the Halal Market daewoong.co.kr ↗
Daewoong (CEO Sengho Jeon) announced on March 19 that the company has obtained marketing authorization for Nabota in the UAE and Indonesia, two halal countries. |
| 2019-11-11 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical, established a difference in scar care effects by a medication timing based on a clinical research, ‘NABOTA.’ daewoong.co.kr ↗
This was the first comparative research on ‘a point in time’ when injecting botulinum toxin on the surgical lesions and highly effective to heal scars when it was administered on the day of surgery. |
| 2019-10-02 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong pharmaceutical, announces Nuceiva™ Approval by Evolus in Europe daewoong.co.kr ↗
Daewoong pharmaceutical announced Evolus, the exclusive partner of Daewoong pharmaceutical, received market approval for Nuceiva from European Commission (EC) on 1st Oct. |
| 2019-10-01 | Evolus, Inc. | Regulatory Evolus Receives Approval for Nuceiva™ in the European Union evolus.com ↗
Evolus , Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that the European Commission (EC) has approved the marketing of Nuceiva™ (prabotulinumtoxinA). |
| 2019-10-01 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s NABOTA proves exceptional ‘potency retention’ in clinical and non-clinical studies. daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Sengho Jeon) announced on the 1st that its original Botulinum Toxin ‘NABOTA’ proved exceptional ‘potency retention’ through non-clinical and clinical tests. |
| 2019-07-11 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s ‘Nabota’ enters IMCAS Asia 2019… Announces its excellence to medical practitioners from all over the world. daewoong.co.kr ↗
In this respect, Daewoong Pharmaceutical’s Botulinum Toxin has proven its efficacies and safety through U.S. FDA approval and equivalence compared to Botox in all aspects, including improvement of frown lines and safety, through the global clinical studies. |
| 2019-06-24 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s ‘Nabota’ secured application to blepharospasm. daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Sengho Jeon) announced on the 24th that the KFDA added application to blepharospasm to the list of possible application of ‘Nabota Unit 100’ last 20th. |
| 2019-06-10 | Evolus, Inc. | Regulatory Evolus Provides Update on Nuceiva™ Marketing Authorization Application in Europe evolus.com ↗
Evolus was informed by the EMA that the EC has requested supplementary information from the EMA/CHMP as part of their review of the Nuceiva™ MAA. |
| 2019-05-08 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical hosted a symposium titled ‘NABOTA Sparkling Night’ in Thailand daewoong.co.kr ↗
Nabota has proven non-inferiority in terms of improvement of frown lines and safety through a comparative clinical study with Allergan’s Botox, |
| 2019-04-29 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s botulinum toxin about to be released in Europe with European CHMP’s recommendation for approval daewoong.co.kr ↗
Received ‘recommendation for approval’ from EMA-affiliated CHMP. |
| 2019-04-26 | Evolus, Inc. | Regulatory Evolus Receives Positive CHMP Opinion for Nuceiva™ in the European Union evolus.com ↗
today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the Nuceiva™ marketing authorization application. |
| 2019-04-12 | Daewoong Pharmaceutical Co. LTD. | Results The clinical findings of Botulinum Toxin manufactured by Daewoong have been published on international journal regarding the comparison with Botox daewoong.co.kr ↗
As a result, 87.2% of the JEUVEAU group and 82.8% of the Botox group showed improvement of Glabellar Line to GLS 0 or 1. |
| 2019-04-08 | Evolus, Inc. | Results Evolus Announces Publication of Largest Aesthetic Head-to-Head Pivotal Trial Comparing Jeuveau™ and BOTOX® in Aesthetic Surgery Journal evolus.com ↗
Primary Endpoint of Non-Inferiority Achieved with Responder Rates* of 87.2% for Jeuveau™, 82.8% for BOTOX ® and 4.2% for Placebo at Day 30 |
| 2019-03-25 | Daewoong Pharmaceutical Co. LTD. | Results The U.S. 3-phase clinical results of ‘Jeuveau’ is published on an SCI-level international journal daewoong.co.kr ↗
The same rate of the placebo group was 1.2% and 1.3%, respectively, and clearly different to prove Jeuveau’s excellence in wrinkle improvement compared to the placebo. |
| 2019-03-21 | Evolus, Inc. | Results Evolus Announces Publication of U.S. Phase III Pivotal Trial Results for Jeuveau™ in Dermatologic Surgery evolus.com ↗ |
| 2019-03-13 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical ‘Nabota’ enters phase 3 clinical studies in China during the second half. daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Sengho Jeon) announced on the 13th that the application to change the manufacture facilities for Nabota’s Clinical Trial Application (CTA) was finally approved on the 6th by China Food and Drug Administration (CFDA). |
| 2019-02-19 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong’s ‘NABOTA’ submitted the form to change clinical test plans in China. daewoong.co.kr ↗
Daewoong’s ‘NABOTA’ submitted the form to change clinical test plans in China. |
| 2019-02-19 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s botulinum toxin becomes the first Korea-made Botulinum Toxin to obtain US FDA approval daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Sengho Jeon) announced last 1st (US time) that Jeuveau has finally been approved by the U.S. FDA for the treatment of frown lines. |
| 2019-02-01 | Evolus, Inc. | Regulatory Evolus Receives FDA Approval for Jeuveau™ prabotulinumtoxinA-xvfs for Injection evolus.com ↗ |
| 2018-11-28 | Daewoong Pharmaceutical Co. LTD. | Regulatory FDA resumes review of Daewoong Pharmaceutical’s Nabota daewoong.co.kr ↗
On Aug. 30, Daewoong Pharrmaceutical (CEO Sengho Jeon) announced that it received an acceptance letter for resubmission of Biologic License Application for Nabota. |
| 2018-11-28 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s Nabota, Exposed latest clinical study result and treatment regimen at IMCAS ASIA 2018 daewoong.co.kr ↗
The safety and efficacy of Nabota has been proved by clinical studies conducted in Korea and other advanced nations. |
| 2018-11-28 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical successfully held ‘NABOTA SEOUL 2018’ daewoong.co.kr ↗
Nabota(DWP-450) proved its non-inferiority compared to Botox in various clinical studies conducted in Korea, US, Canada and Europe. |
| 2018-11-28 | Daewoong Pharmaceutical Co. LTD. | Regulatory The Nuceiva Manufacturing Facility acquires GMP Approval from Health Canada daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Sengho Jeon) announced that the Nuceiva manufacturing facility acquired GMP approval from Health Canada on May 18, after acquiring US FDA cGMP approval on May 15. |
| 2018-08-29 | Evolus, Inc. | Regulatory Evolus Receives Acceptance of FDA BLA Resubmission for DWP-450 evolus.com ↗
Evolus, Inc. (NASDAQ: EOLS), a company dedicated to aesthetic medicine, today announced the acceptance of its resubmission of its Biologics License Application for its lead product candidate, prabotulinumtoxinA (DWP-450), by the U.S. Food and Drug Administration (“FDA”). |
| 2018-08-17 | Evolus, Inc. | Regulatory Evolus Granted Approval of DWP-450 by Health Canada evolus.com ↗
IRVINE, Calif. , Aug. 17, 2018 (GLOBE NEWSWIRE) -- Evolus, Inc. (NASDAQ: EOLS), a company dedicated to aesthetic medicine, today announced that Health Canada has granted approval of DWP-450 (prabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows seen at maximum frown) in adult patients under 65 years of age. |
| 2018-08-02 | Evolus, Inc. | Regulatory Evolus Reports Second Quarter 2018 Financial Results evolus.com ↗
Announced early resubmission to the U.S. Food and Drug Administration (“FDA”) of its Biologics License Application (“BLA”) for its product candidate, DWP-450. |
| 2018-08-02 | Evolus, Inc. | Regulatory Evolus Announces Early Resubmission to the FDA of its Biologics License Application for DWP-450 evolus.com ↗
Evolus, Inc. (NASDAQ:EOLS), a company dedicated to aesthetic medicine, announced that today it is resubmitting its Biologics License Application (“BLA”) for its lead product candidate, DWP-450 (prabotulinumtoxinA), to the U. S Food and Drug Administration (“FDA”). |
| 2018-06-22 | Evolus, Inc. | Results Clinical Overview of PrabotulinumtoxinA for the Investigational Treatment of Frown Lines to Be Featured During Summer Cosmetic Bootcamp 2018 evolus.com ↗
Dr. Beer will present top-line results of the Company’s three Phase III studies, all of which met their respective primary endpoints. |
| 2018-05-16 | Evolus, Inc. | Regulatory Evolus Announces Progress with DWP-450 Regulatory Submissions evolus.com ↗
Additionally, the FDA has issued a Complete Response Letter (“CRL”) to Evolus related to its BLA for DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients. |
| 2018-04-23 | Evolus, Inc. | Results Evolus to Present at the Inaugural Aesthetics Innovation Summit and ASAPS’ The Aesthetic Meeting evolus.com ↗
Our Phase III EVB-003 head-to-head comparative trial in the EU and Canada demonstrates that DWP-450 clearly met its primary endpoint at Day 30 in subjects with moderate to severe glabellar lines compared to onabotulinumtoxinA (Botox ® ), |
| 2018-04-05 | Evolus, Inc. | Results Evolus Phase III European - Canadian Head-to-Head Trial of prabotulinumtoxinA Compared to Botox® Meets Primary Endpoint evolus.com ↗ |
| 2018-02-17 | Evolus, Inc. | Results Evolus Announces Presentation of Phase III European - Canadian Comparative Data evolus.com ↗
The study met the primary endpoint of non-inferiority at Day 30 with responder rates of 87.2% in the prab |
| 2017-10-26 | Evolus, Inc. | Regulatory Evolus Announces Health Canada Acceptance For Review Of The New Drug Submission For PrabotulinumtoxinA evolus.com ↗
The NDS acceptance for review is a significant milestone achievement for the prabotulinumtoxinA development program. |
| 2017-10-09 | Evolus, Inc. | Results Evolus Announces Presentations of Phase II and Phase III Data of PrabotulinumtoxinA evolus.com ↗
Over the course of the one year study, approximately 41.2% of the subjects experienced adverse events, 30.5% were assessed as unrelated to the drug and 10.7% were assessed as related to the drug. |
| 2016-09-22 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceuticals expands entry to new markets with license in Mexico and India on Nabota daewoong.co.kr ↗
On September 21, Daewoong Pharmaceuticals announced their acquisition of approval Nabota, a botulinum toxin medicine developed by Daewoong, in Mexico and India and their plan to disseminate K-Beauty in emerging markets. |
| 2016-04-15 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceuticals announces US clinical trial result on Nabota at Dubai Derma and spurs exportation daewoong.co.kr ↗
In this event, Daewoong Pharmaceuticals announced the US clinical trial result on Nabota and promoted its products from its booth. |
| 2016-04-08 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceuticals announces the result of phase 3 clinical trial in US on Nabota daewoong.co.kr ↗
According his presentation, ‘DWP-450’ successfully achieved its primary effectiveness evaluation variables when conducted two randomized, double blind, placebo-controlled phase 3 clinical trials (EV001 and EV002). |
| 2014-12-05 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s NABOTA completed 3-phase clinical trial on muscle rigidity daewoong.co.kr ↗
NABOTA has proved itself as a safe and effective treatment for stiffness in upper extremity muscles associated with adult stroke |
| 2014-09-22 | Daewoong Pharmaceutical Co. LTD. | Regulatory U.S. FDA approved Investigational New Drug(IND) application for clinical trial on Daewoong Pharmaceutical’s NABOTA daewoong.co.kr ↗ |
| 2014-06-13 | Daewoong Pharmaceutical Co. LTD. | Regulatory NABOTA received approval from Thailand daewoong.co.kr ↗
Daewoong Pharmaceutical Co.,Ltd(President: Lee Jong-wook) announced on June 9 that its NABOTA received approval from the Food and Drug Administration of Thailand last month. |
All press releases naming this drug 102 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 102 releases opens the full record — a long page | ||
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | prabotulinumtoxinA | “BACKGROUND: Prabotulinumtoxin A has been shown to have efficacy for the treatment of upper-limb spasticity and improvement of moderate to severe glabellar lines.” PMID 30893169 ↗ Dec 201911“ABP-450 (prabotulinumtoxinA) contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.” NCT05016661 ↗ “ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.” NCT04849988 ↗ “ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.” NCT04871451 ↗ “1 dose of 20 units of prabotulinum toxin A (PBoNT/A);” PMID 40434770 ↗ Jul 2025 “PrabotulinumtoxinA 20 units” NCT06448676 ↗ |
| Known as | ABP-450 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05016661 ↗ |
| Known as | Botulinum toxin type A | “Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.” NCT04294251 ↗1“DWP-450 (Botulinum toxin, Type A)” NCT02428608 ↗ |
| Known as | DWP450 | “A novel botulinum neurotoxin type A (DWP450; Daewoong Pharmaceutical, Seoul, Korea) has recently been introduced for the treatment of facial wrinkles.” PMID 25311357 ↗ Oct 20144“Efficacy and Safety of DWP450 Compared With Botox in Moderate to Severe Glabellar Line” NCT01629875 ↗ |
| Known as | Nabota | “The aim of this study is to prospectively compare the clinical efficacy of Dry Needling (DN), Nabota (PrabotulinumtoxinA), and Dysport (AbobotulinumtoxinA) treatments on the...” NCT07452510 ↗ |
| Known as | PBoNT/A | “1 dose of 20 units of prabotulinum toxin A (PBoNT/A);” PMID 40434770 ↗ Jul 2025 |
| Known as | prabotulinumtoxinA-xvfs | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06903975 ↗ |
| Modality | Protein / enzyme biologic | “DWP-450 (Botulinum purified neurotoxin, Type A)” NCT02428608 ↗ |
| Route | Intramuscular | “administered intramuscularly” NCT04294251 ↗ |