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Drug

Clonazepam

Established medicine
ClassGABA-A receptor; anion channel positive allosteric modulatorResearchActive indication expansion
Also known as KlonoPIN, KlonoPIN Wafer, 1,3-dihydro-7-nitro-5-(2-chlorophenyl)-2H-1,4.benzodiazepin-2-one, 5-(o-chlorophenyl)-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-one+1 more

KlonoPIN, KlonoPIN Wafer, 1,3-dihydro-7-nitro-5-(2-chlorophenyl)-2H-1,4.benzodiazepin-2-one, 5-(o-chlorophenyl)-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-one, Clonazepamum.

3
Active clinical trials
16
Protein targets
11
Regulatory events
Latest activity
beta

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

Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

Clinical trial2026-07-28Status changed to Withdrawn · ClinicalTrials.gov

Recall (Class I): CLONAZEPAM

Regulatory2024-11-18FDA

Detoxification From the Lipid Tract by Cocktail Design

Clinical trial2024-03-20Completed · ClinicalTrials.gov

Burning Mouth Syndrome - Optimized Diagnostic Criteria and Treatment

Clinical trial2023-12-31Primary completion · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Clonazepam
Aliases & brands
KlonoPINKlonoPIN Wafer1,3-dihydro-7-nitro-5-(2-chlorophenyl)-2H-1,4.benzodiazepin-2-one5-(o-chlorophenyl)-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-oneClonazepamum
RxNorm CUI
2598
ChEMBL ID
CHEMBL452
ATC codes
N03AE01
UNII
5PE9FDE8GB
Primary mechanism
GABA-A receptor; anion channel positive allosteric modulator
Regulatory jurisdictions
fda

Pharmacology & targets

16 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator

Regulatory timeline

11 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 on record (generic/biosimilar)
2000-10-06
Latest approval
2026-06-12
Authorities
FDA
Total events
11
fdaU.S. Food and Drug Administration· 11 events
2026-06-12Supplemental approval
Supplemental approval: CLONAZEPAM (ANDA075468)
Evidence ↗
2024-11-18RecallSafety
Recall (Class I): CLONAZEPAM
Evidence ↗
2016-07-18Label change
Label change: CLONAZEPAM (ANDA075468)
Evidence ↗

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

Clinical trials

29 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
29
registered trials across all phases
LATEST COMPLETION 2024
3
Active studies
2
Recruiting
18
Late-stage (III+)
18
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 29
Early Phase 11Phase 14Phase 1 / 21Phase 25Phase 2 / 31Phase 34Phase 47Phase N / A6

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.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.