Drugs / Botox Cosmetic
Regulatory milestones approvals, filings & regulatory actions · 21 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (20) | US (FDA) | BOTOX COSMETIC | — | 2000-12-21 – 2024-10-18 | fda.gov ↗ |
| Approved | US (FDA) | BOTOX COSMETIC | — | 1991-12-09 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04755595 | Mar → May 2021 | — | State University of New York - Downstate Medical Center | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05138835 | Nov 2021 → Nov 2022 | — | Andreas Nikolis | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT03712449 Background | Jan 2019 → Jul 2020 | — | Allergan | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BOTOX Cosmetic | “BOTOX® Cosmetic is approved and commercially available for use in Canada.” NCT05138835 ↗ |
| Known as | BTX | “This is a two cohort, randomized, double blind, single center study to evaluate the effects of Botox Cosmetic (BTX) on sebum protection.” NCT05138835 ↗ |
| Modality | Protein / enzyme biologic | “botulinum toxin” NCT04755595 ↗ |
| Route | Intramuscular | “injected into muscles” NCT05138835 ↗ |