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Drug

Clobazam

Approved · FDA
Emerging researchLate-stage development

Also known as Onfi, Sympazan, 1-phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-dioxo-3H-1,5-benzodiazepine, Clobazamum.

1
Research papers
3
Regulatory events
Latest activity
beta

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

Approval: CLOBAZAM (ANDA213039)

Regulatory2021-05-06FDA

Use of Clobazam in Treating Anxiety Comorbid With Pediatric Epilepsy

Clinical trial2021-03-04Results posted · ClinicalTrials.gov

Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome

Clinical trial2018-03-21Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Clobazam
Aliases & brands
OnfiSympazan1-phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-dioxo-3H-1,5-benzodiazepineClobazamum
RxNorm CUI
21241
ChEMBL ID
CHEMBL70418
UNII
2MRO291B4U
Regulatory jurisdictions
fda

Regulatory timeline

3 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.

Earliest approval
2021-05-06
Latest approval
2021-05-06
Authorities
FDA
Total events
3
fdaU.S. Food and Drug Administration· 3 events
2025-02-19Label change
Label change: CLOBAZAM (ANDA213039)
Evidence ↗
2023-04-26Label change
Label change: CLOBAZAM (ANDA213039)
Evidence ↗
2021-05-06Approval
Approval: CLOBAZAM (ANDA213039)
Evidence ↗

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

Clinical trials

17 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
17
registered trials across all phases
LATEST COMPLETION 2025
13
Late-stage (III+)
10
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 17
Phase 1 / 21Phase 23Phase 38Phase 44Phase N / A1

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

1 papers

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

Journals, researchers & institutions
Top journals
  • Epilepsy & behavior : E&B1
Leading researchers
  • Conry J1
  • Drummond R1
  • Isojarvi J1
  • Kernitsky L1
  • Lee D1
  • Mitchell W1
  • Ng YT1
  • Owen R1
Leading institutions
free-text, unnormalised
  • University of Oklahoma Health Sciences Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.