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Data updated: May 26, 2026

KLONOPIN (clonazepam)

CNS Approved 1975-06-04
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
50
Years on Market

Details

Status
Discontinued
First Approved
1975-06-04
Routes
ORAL
Dosage Forms
TABLET

Companies

CHEPLAPHARM
Active Ingredient: CLONAZEPAM

KLONOPIN Approval History

1976
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Original
New Indication
New Form
Label Update
255 FDA actions from 1975 to 2023 · 1 indication expansions
Jan 2023 SUPPL
Label · Labeling
FDA Letter Label
Feb 2021 SUPPL
Label · Labeling
FDA Letter Label
Oct 2017 SUPPL
Label · Labeling
FDA Letter Label

What KLONOPIN Treats

2 FDA approvals

Originally approved for its first indication in 1975 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT06133114 STUDY-22-01296 Ph 4 recruiting Psychopharmacological Treatment of Emotional Distress
NCT06357104 SCI-CT-0001 Ph 4 completed Detoxification From the Lipid Tract
NCT02913924 results posted 7343 U54DA037842-01 Ph 2 completed Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients
NCT00810316 A6131015 Ph 1 completed Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
NCT01870024 LORACLOFT P110123 2012-003795-39 Ph 3 completed Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus
NCT02134366 EPC-1 Ph 3 terminated Clobazam Use in Epilepsia Partialis Continua - Pilot Study
NCT02690844 1182108 Ph 4 withdrawn Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome
NCT03061136 KGB YOJ0004ARC Ph 4 withdrawn Clonazepam Effects on Brain Oscillations and Cognition in Schizophrenia
NCT02374567 GAP GAP-2014 Ph 3 terminated Pharmacovigilance in Gerontopsychiatric Patients
NCT02312908 14172EuiYakAn178 Ph 2 completed Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism
NCT01291316 GABA-SPUM Ph 1, Ph 2 completed GABAergic Modulation in Pain Transmission in Human: Effect of the GABAA Agonist Clobazam on Peripheral and Central Sensitisation
NCT01011036 152/09 SNF SPUM no.33CM30_124117 Ph 3 completed Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

KLONOPIN FDA Label Details

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Data Sources

FDA Approval: NDA017533 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.