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Drug

botulinum toxin type A

Approved · FDA / EMA
Emerging researchLate-stage developmentSteady momentum
Also known as BTX - A, BTX A, BTX-A, Botox+12 more

BTX - A, BTX A, BTX-A, Botox, Botox Cosmetic, Botulinum A neurotoxin, Botulinum toxin A, Daxxify, Dysport, Jeuveau, Letybo, Toxina botulínica A, Toxine botulinique A, Xeomin, Botulinum antitoxin type A, Botulinum toxin type-A.

RxNorm1712UNIIE211KPY694
8
Research papers
17
Active clinical trials
26
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Intraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis

Clinical trial2026-06-25Results expected Q4 2026 · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
botulinum toxin type A
Aliases & brands
BTX - ABTX ABTX-ABotoxBotox CosmeticBotulinum A neurotoxinBotulinum toxin ADaxxifyDysportJeuveauLetyboToxina botulínica AToxine botulinique AXeominBotulinum antitoxin type ABotulinum toxin type-A
RxNorm CUI
1712
UNII
E211KPY694
Regulatory jurisdictions
emafda

Regulatory timeline

26 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2018-07-032019-09-27)
Earliest approval
2010-07-30
Latest approval
2026-06-25
Authorities
FDA · EMA
Total events
26
fdaU.S. Food and Drug Administration· 25 events
2026-06-25Indication expansion
Indication expansion: INCOBOTULINUMTOXINA (BLA125360)
Evidence ↗
2026-03-20Label change
Label change: INCOBOTULINUMTOXINA (BLA125360)
Evidence ↗
2026-02-26Label change
Label change: INCOBOTULINUMTOXINA (BLA125360)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2019-09-27ApprovalMulti-authority
Approval: Nuceiva (EMA)
Indication: Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facialShow full indication

Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

181 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
181
registered trials across all phases
LATEST COMPLETION 2026
17
Active studies
10
Recruiting
121
Late-stage (III+)
124
Completed
40
Discontinued
PHASE DISTRIBUTIONn = 181
Early Phase 15Phase 19Phase 1 / 27Phase 239Phase 2 / 38Phase 345Phase 432Phase N / A36

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

8 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20002015
Most influential
Recent papers
Major research themes1
Arthroplasty, Replacement, Knee1
Journals, researchers & institutions
Top journals
  • BMJ open2
  • JAMA dermatology1
  • Journal of neurology, neurosurgery, and psychiatry1
  • Parkinsonism & related disorders1
  • The American journal of gastroenterology1
  • The Clinical journal of pain1
Leading researchers
  • Hefter H2
  • Jost W2
  • Bamford JM1
  • Benecke R1
  • Bhakta BB1
  • Brashear A1
  • Brodsky M1
  • Chamberlain MA1
Leading institutions
free-text, unnormalised
  • University of Düsseldorf2
  • Center for Cancer Research1
  • Laboratory of Pathology1
  • Office of the Clinical Director1
  • Temple University School of Medicine1
  • The Parkinson's and Movement Disorder Institute1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.