Overview
DaxibotulinumtoxinA is an acetylcholine release inhibitor and neuromuscular blocking agent. It is a botulinum toxin without accessory proteins purified from the bacterium Clostridium botulinum type A, the gram-positive anaerobic bacterium primarily present in soil. C. botulinum is known to produce toxins that can cause botulism in humans. DaxibotulinumtoxinA was first approved by the FDA on September 8, 2022, for the temporary improvement of glabellar lines. On August 14, 2023, the drug was also approved for the treatment of cervical dystonia. DAXI or DAXXIFY, a product of daxibotulinumtoxinA, incorporates RTP004, a proprietary synthetic stabilizing peptide for enhanced product stability.
Background
DaxibotulinumtoxinA is an acetylcholine release inhibitor and neuromuscular blocking agent. It is a botulinum toxin without accessory proteins purified from the bacterium Clostridium botulinum type A, the gram-positive anaerobic bacterium primarily present in soil. C. botulinum is known to produce toxins that can cause botulism in humans. DaxibotulinumtoxinA was first approved by the FDA on September 8, 2022, for the temporary improvement of glabellar lines. On August 14, 2023, the drug was also approved for the treatment of cervical dystonia. DAXI or DAXXIFY, a product of daxibotulinumtoxinA, incorporates RTP004, a proprietary synthetic stabilizing peptide for enhanced product stability.
Indication
DaxibotulinumtoxinA is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. It is also used for the treatment of cervical dystonia in adult patients.
Associated Conditions
- Cervical Dystonia
- Moderate Glabellar Frown Lines (GL)
- Severe Glabellar Frown Lines (GL)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/12 | Phase 3 | Not yet recruiting | |||
2025/06/12 | Phase 3 | Not yet recruiting | |||
2025/05/29 | Phase 3 | Not yet recruiting | |||
2025/02/21 | Phase 3 | Completed | Innopharm LLC | ||
2025/02/21 | Phase 3 | Recruiting | |||
2025/01/20 | Phase 2 | Recruiting | |||
2025/01/01 | Phase 2 | Not yet recruiting | |||
2024/08/14 | Not Applicable | Recruiting | |||
2024/07/03 | N/A | Completed | Swissmed Hospital | ||
2024/07/03 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DAXXIFY daxibotulinumtoxinA 100 units powder for Injection vial | 420430 | Medicine | A | 12/17/2024 |