daxibotulinumtoxinA
Trade name: Daxxify
Recombinant proteinapprovedOrphan Drug FDA
Approved
Sep 7, 2022
Clinical trial activity
11 trials · 6 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
9
Phase 3
2
Phase 4
2
Earliest trial started Sep 1, 2015 (NCT02706795)
Timeline
2010s
- Jan 1, 2015
Revance Therapeutics, Inc. — Earliest Phase 2 Sponsor(trial)
- Nov 16, 2017
Orphan Drug Designation
- Jan 1, 2018
Revance Therapeutics, Inc. — Earliest Phase 3 Sponsor(trial)
2020s
- Jan 1, 2022
Earliest Phase 1 Sponsor(trial)
- Sep 7, 2022
Revance Therapeutics, Inc. — Earliest FDA Approval
- Sep 7, 2022
Revance Therapeutics, Inc. — Marketing Organization
- Sep 7, 2022
Revance Therapeutics, Inc. — NDA Secondary Org
- Sep 7, 2022
Revance Therapeutics, Inc. — NDA Organization
Indications
Approved for
Mechanism of action
- Botulinum neurotoxin type AAGONIST
botA agonist
- Synaptosomal-associated protein 25INHIBITOR
Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor
Approval history
- approvedSep 7, 2022
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3707359 ↗
Also known as
- daxibotulinumtoxina
- daxibotulinumtoxina
- rtt-150
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06195241 | Phase 4 | Nov 30, 2024 | Revance Therapeutics, Inc., Yeshiva University |
| NCT06225492 | Phase 4 | Jan 1, 2024 | Main Line Center for Laser Surgery |
| NCT05158166 | Phase 1/Phase 2 (Phase 2) | Feb 28, 2022 | University of California, San Francisco |
| NCT04259086 | Phase 2 | Dec 6, 2019 | Revance Therapeutics, Inc. |
| NCT03911102 | Phase 2 | Mar 11, 2019 | Revance Therapeutics, Inc. |
| NCT03786770 | Phase 2 | Jan 24, 2019 | Revance Therapeutics, Inc. |
| NCT03825315 | Phase 2 | Dec 31, 2018 | Revance Therapeutics, Inc. |
| NCT03821402 | Phase 2 | Dec 12, 2018 | Revance Therapeutics, Inc. |
| NCT03617367 | Phase 3 | Sep 5, 2018 | Revance Therapeutics, Inc., Syneos Health |
| NCT03608397 | Phase 3 | Jun 20, 2018 | Revance Therapeutics, Inc., Syneos Health |
| NCT02706795 | Phase 2 | Sep 1, 2015 | Revance Therapeutics, Inc., Sponsor GmbH |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Revance Therapeutics, Inc. | For profit | 9 | 8 | 3 | 2015 |
| Syneos Health | For profit | 2 | 0 | 1 | 2018 |
| Main Line Center for Laser Surgery | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Sponsor GmbH | Academic/Hospital | 1 | 0 | 1 | 2015 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Yeshiva University | Academic/Hospital | 1 | 1 | 1 | 2024 |
6 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Revance Therapeutics, Inc. | For profit | MKTG | Sep 7, 2022 |
| Revance Therapeutics, Inc. | For profit | NDA2 | Sep 7, 2022 |
| Revance Therapeutics, Inc. | For profit | NDA | Sep 7, 2022 |