prabotulinumtoxinA
Trade name: Jeuveau
Approved
Feb 1, 2019
Botulinum toxin, or botulinum neurotoxin, is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction, thus causing flaccid paralysis. The toxin causes the disease botulism. The toxin is also used commercially for medical and cosmetic purposes. Botulinum toxin is an acetylcholine release inhibitor and a neuromuscular blocking agent. — Wikipedia
Clinical trial activity
9 trials · 10 clinical orgs · 1 marketing orgs
Earliest trial started Jun 15, 2020 (NCT05840445)
Timeline
2010s
- Feb 1, 2019
Evolus, Inc. — Earliest FDA Approval
- Feb 1, 2019
Evolus, Inc. — Marketing Organization
- Feb 1, 2019
Evolus, Inc. — NDA Organization
2020s
- Jan 1, 2021
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2022
Evolus, Inc. — Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Botulinum neurotoxin type AAGONIST
botA agonist
- Synaptosomal-associated protein 25PROTEOLYTIC ENZYME
Synaptosomal-associated protein 25 proteolytic enzyme
Binds to and is taken up by nerves that use acetylcholine. Once internalised, the catalytic domain of PrabotulinumtoxinA cleaves SNAP-25, a SNARE protein, preventing membrane fusion and release of acetlycholine required for nerve signalling.
Toxin A is selective for SNAP-25.
Cleaves the C-terminal SNARE motif
Approval history
- approvedFeb 1, 2019
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaBotulinum toxin ↗
- ChEMBLCHEMBL4297229 ↗
Also known as
- prabotulinumtoxina-xvfs
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06903975 | Phase 4 | May 14, 2025 | Boston University, Evolus, Inc. |
| NCT06604832 | Phase 1 | Sep 3, 2024 | Evolus, Inc., K. Kay Durairaj, MD, FACS, A Medical Corporation |
| NCT05807412 | Early Phase 1 (Phase 1) | May 1, 2023 | Evolus, Inc., Lupo Center for Aesthetic and General Dermatology |
| NCT07072806 | Phase 4 | Jun 14, 2022 | Yonsei University |
| NCT05320393 | Phase 2 | Mar 30, 2022 | ethica Clinical Research Inc., Evolus, Inc. |
| NCT05167864 | N/A | Mar 4, 2022 | University of Pennsylvania |
| NCT05129319 | Early Phase 1 (Phase 1) | Nov 30, 2021 | Evolus, Inc., The Clinical Testing Center of Beverly Hills |
| NCT04715048 | Early Phase 1 (Phase 1) | Jan 31, 2021 | University of Southern California |
| NCT05840445 | Phase 4 | Jun 15, 2020 | University of Valencia |
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Evolus, Inc. | Academic/Hospital | 5 | 1 | 3 | 2021 |
| Boston University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| ethica Clinical Research Inc. | For profit | 1 | 0 | 1 | 2022 |
| K. Kay Durairaj, MD, FACS, A Medical Corporation | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Lupo Center for Aesthetic and General Dermatology | Academic/Hospital | 1 | 1 | 1 | 2023 |
| The Clinical Testing Center of Beverly Hills | For profit | 1 | 1 | 1 | 2021 |
| University of Pennsylvania | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Southern California | Academic/Hospital | 1 | 1 | 1 | 2021 |
| University of Valencia | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Yonsei University | Academic/Hospital | 1 | 1 | 1 | 2022 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Evolus, Inc. | Academic/Hospital | MKTG | Feb 1, 2019 |
| Evolus, Inc. | Academic/Hospital | NDA | Feb 1, 2019 |