Drugs / Botulinum Toxins, Type A
Botulinum Toxins, Type A
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed disorder of neck of urinary bladder 1 milestone | |||||
| Filed | US (FDA) | BOTOX | disorder of neck of urinary bladder | 2020-06-22 | “FDA) has accepted the company's supplemental biologics license application (sBLA) to expand the BOTOX ® prescribing information for the treatment of signs and symptoms of detrusor” abbvie.com ↗ |
| Filed Indication not stated 3 milestones | |||||
| Filed | Other | — | glabellar lines | 2017-10-26 | “Health Canada accepted for review the Company’s New Drug Submission (NDS) for DWP-450 for treatment of glabellar lines in adult patients.” evolus.com ↗ |
| Filed | EU (EMA) | — | glabellar lines | 2017-07-20 | “European Medicines Agency (EMA) acceptance for review of the Company’s Marketing Authorization Application (MAA) for DWP-450” evolus.com ↗ |
| Filed | US (FDA) | — | glabellar lines | 2017-07-19 | “Received U.S. Food and Drug Administration ( FDA ) acceptance for review of Biologics License Application (BLA) for DWP-450 for treatment of glabellar lines in adult patients;” evolus.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03054610 | Jan 2015 → Mar 2020 | plantar fasciitis, salivary substance, Clostridium botulinum type | Autonomous University of Nuevo León | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT02184988 | Aug 2014 → Dec 2015 | — | Evolus, Inc. | Completed | Met primary |
| Phase not applicable1 trial · 1 met primary | ||||||
| — | NCT01226706 | Jun 2008 → Sep 2010 | urinary bladder disorder | Saskatchewan Health Authority - Regina Area | Completed | Met primary |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2026-05-19 | Ipsen | Results Ipsen announces late-breaking data from first head-to-head study comparing Dysport® and Botox® in adults with upper limb spasticity ipsen.com ↗
The DIRECTION trial results show the safety profile for Dysport® (abobotulinumtoxinA) was non-inferior to Botox® (onabotulinumtoxinA) in adult patients with upper limb spasticity |
| 2026-04-13 | Cutia Therapeutics（Wuxi）Co.,Ltd | Results VOLUNTARY ANNOUNCEMENT - COMPLETION OF PHASE III CLINICAL TRIAL OF CU-20101 (BOTULINUM TOXIN TYPE A FOR INJECTION) FOR IMPROVING MODERATE TO SEVERE GLABELLAR LINES IN CHINA cutiatx.com ↗
COMPLETION OF PHASE III CLINICAL TRIAL OF CU-20101 (BOTULINUM TOXIN TYPE A FOR INJECTION) FOR IMPROVING MODERATE TO SEVERE GLABELLAR LINES IN CHINA |
| 2026-03-26 | AbbVie | Results Allergan Aesthetics Reinforces Scientific Differentiation and Leadership with 21 Evidence-Based E-Posters at the 2026 Aesthetic & Anti-Aging Medicine World Congress (AMWC) abbvie.com ↗ |
| 2026-01-09 | Huons Biopharma | Regulatory Huons BioPharma Secures NMPA Approval for Type A Botu-linum Toxin in China huonsbiopharma.com ↗
Huons BioPharma Co., Ltd. (CEO: Yeong-Mok Kim) announced on the 9th that its Chinese partner, IMeik Technology, has received marketing authorization from the National Medical Products Administration (NMPA) of China for Hutox (domestic brand name: LIZTOX). |
| 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 ® and Dysport ® demonstrated significantly faster visible effects at Day 3 compared to Botox ® and Xeomin ® . |
| 2024-12-20 | Merz Aesthetics Inc. | Results MERZ AESTHETICS ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 2 STUDY OF XEOMIN® (incobotulinumtoxinA) FOR TREATMENT OF PLATYSMA PROMINENCE merzaesthetics.com ↗
The study met its primary endpoint. |
| 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 |
| 2024-01-17 | Galderma R&D | Results TOXINS 2024: Galderma’s phase III RelabotulinumtoxinA results demonstrate positive efficacy and long duration of effect when treating frown lines and crow’s feet simultaneously galderma.com ↗
Galderma announced today positive topline results from the phase III READY-3 clinical trial investigating the use of RelabotulinumtoxinA for the treatment of glabellar lines (frown lines) and lateral canthal lines (crow’s feet), either alone (single-area) or simultaneously. |
| 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. |
| 2023-10-03 | Ipsen | Regulatory Ipsen updates on QM-1114 regulatory process ipsen.com ↗
Galderma has confirmed receipt from the FDA of a Complete Response Letter related to its Biologics License Application for liquid botulinum toxin type A (QM-1114) |
| 2023-06-12 | Merz Aesthetics Inc. | Results MERZ AESTHETICS ANNOUNCES POSITIVE PHASE 3 DATA DEMONSTRATING EFFICACY AND SAFETY OF XEOMIN® (incobotulinumtoxinA) IN TREATING UPPER FACIAL LINES merzaesthetics.com ↗
Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today topline results from two pivotal phase 3 clinical studies demonstrating the efficacy and safety of Xeomin® (incobotulinumtoxinA) in the simultaneous treatment of upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral canthal lines). |
| 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. |
| 2022-10-07 | Galderma R&D | Results New data from Galderma's aesthetics portfolio to be presented at 2022 ASDS Annual Meeting galderma.com ↗
Results showed rapid onset of action, with 39% patients seeing results on Day 1 for frown lines and 34% on Day 1 for crow's feet and demonstrated long duration of action through six months |
| 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. |
| 2021-08-31 | Merz Pharmaceuticals GmbH | Regulatory XEOMIN® (incobotulinumtoxinA) Receives European Approval for the Treatment of Chronic Sialorrhea in Children merz.com ↗ |
| 2020-07-09 | AbbVie | Regulatory FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity abbvie.com ↗ |
| 2020-05-23 | Ipsen | Results New surveys show over 80% of patients with spasticity and cervical dystonia treated with botulinum toxin-A experience debilitating symptom recurrence ipsen.com ↗
The results show that over 80% of respondents experienced debilitating symptom recurrence, and revealed that a lack of long-lasting symptom control between injections has a profound impact on the personal and professional lives of patients. |
| 2020-01-06 | Ipsen | Regulatory Dysport® (clostridium botulinum type A toxin-haemagglutinin complex) now approved in the UK for symptomatic treatment of upper limb spasticity in children with cerebral palsy ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence update for Dysport® for the symptomatic treatment of focal spasticity of upper limbs in pediatric cerebral palsy patients, two years of age and older. |
| 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. |
| 2019-06-10 | 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, |
| 2019-04-12 | 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 |
| 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. |
| 2018-06-22 | 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. |
| 2018-04-05 | 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. |
| 2017-07-20 | Evolus, Inc. | Regulatory Evolus Announces European Medicines Agency Acceptance for Review of the Marketing Authorization Application for DWP-450 Neuromodulator evolus.com ↗
The MAA acceptance for review under the Centralized Procedure is a significant milestone achievement for the DWP-450 development program. |
| 2017-07-19 | Evolus, Inc. | Regulatory Evolus Announces FDA Acceptance For Review Of The Biologics License Application For DWP-450 Neuromodulator evolus.com ↗
Evolus Inc. ( www.Evolus.com ) received confirmation from the U.S. Food and Drug Administration (FDA) that their Biologics License Application (BLA) for DWP-450, a new 900 kDa Botulinum toxin Type A, has been accepted for review. |
| 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 |
All press releases naming this drug 47 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Botulinum Toxins, Type A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03054610 ↗ |
| Known as | Botox | “Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond to standard therapy.” NCT01226706 ↗ |
| Known as | Botulinum purified neurotoxin, Type A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02184988 ↗ |
| Known as | Botulinum toxin A | “Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond to standard therapy.” NCT01226706 ↗ |
| Known as | botulinum toxin Type A | “followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.” NCT01226706 ↗ |
| Known as | BTA | “Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond to standard therapy.” NCT01226706 ↗ |
| Known as | DWP-450 (Botulinum purified neurotoxin, Type A) Injection | “DWP-450 (Botulinum purified neurotoxin, Type A) Injection” NCT02184988 ↗ |
| Known as | DWP450 | “Efficacy and safety of a new botulinum toxin type A, NABOTA (DWP450) in post-stroke upper limb spasticity was evaluated in comparison with Botox (onabotulinum toxin A).” PMID 26233808 ↗ Jul 2015 |
| Known as | NABOTA | “Efficacy and safety of a new botulinum toxin type A, NABOTA (DWP450) in post-stroke upper limb spasticity was evaluated in comparison with Botox (onabotulinum toxin A).” PMID 26233808 ↗ Jul 2015 |
| Modality | Protein / enzyme biologic | “Biological: Botulinum purified neurotoxin, Type A” NCT02184988 ↗ |
| Route | Intramuscular | “The subject is to be injected intra-muscularly into a total of five sites” NCT02184988 ↗ |