Drugs / PrabotulinumtoxinA

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) JEUVEAU 2019-02-01 fda.gov

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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
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 No outcome recorded
Phase 41 trial
Phase 4 NCT06903975 May 2025 → Aug 2026 overdue 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
Also used as a comparator or background therapy in 7 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05129319 Comparator Dec 2021 → Jun 2023 Clinical Testing of Beverly Hills Completed No outcome recorded
Phase 11 trial
Phase 1 NCT06604832 Comparator Sep 2024 → Aug 2025 Kalpna Kay Durairaj, MD, FACS Completed No outcome recorded
Phase 21 trial
Phase 2 NCT05320393 Comparator Mar 2022 → May 2023 Evolus, Inc. Completed No outcome recorded
Phase 43 trials
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
Phase not applicable1 trial
NCT05167864 Comparator Mar 2022 → Jun 2023 University of Pennsylvania Completed No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as prabotulinumtoxin A “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 2019
11

“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.” NCT04871451

“ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.” NCT04849988

“1 dose of 20 units of prabotulinum toxin A (PBoNT/A);” PMID 40434770 Jul 2025

“PrabotulinumtoxinA 20 units” NCT06448676

NCT04715048

NCT05840445

NCT05167864

NCT07452510

NCT07072806

NCT05129319

Known as ABP-450 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04871451
3

NCT05016661

NCT04845178

NCT04849988

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 2014
4

“Efficacy and Safety of DWP450 Compared With Botox in Moderate to Severe Glabellar Line” NCT01629875

NCT06354127

NCT02428608

NCT04294251

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
3

NCT05320393

NCT05807412

NCT06604832

Modality Protein / enzyme biologic “DWP-450 (Botulinum purified neurotoxin, Type A)” NCT02428608
Route Intramuscular “administered intramuscularly” NCT04294251