PrabotulinumtoxinA
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | JEUVEAU | — | 2019-02-01 | fda.gov ↗ |
Trials 12 · a red edge is where a trial was stopped
| 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 | ||||||
| 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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.
| Field | Value | Cited 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 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.” 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 ↗ |
| Known as | ABP-450 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04871451 ↗ |
| 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 ↗ |