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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.

4
Active clinical trials
16
Protein targets
11
Regulatory events
Latest activity
beta

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

Management of Catatonic Features in Adolescents With Profound Autism: A Prospective Uncontrolled Trial

Clinical trial2026-03-27Results expected Q3 2026 · ClinicalTrials.gov

Recall (Class I): CLONAZEPAM

Regulatory2024-11-18FDA

Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

Clinical trial2024-06-07Results expected Q4 2026 · ClinicalTrials.gov

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
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
4
Active studies
3
Recruiting
18
Late-stage (III+)
18
Completed
7
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.