TheraRadar
Data updated: Jun 28, 2026

KLONOPIN RAPIDLY DISINTEGRATING (clonazepam) · Roche

Trial Activity: Declining 1 active trials
CNS Approved 1997-12-23

KLONOPIN RAPIDLY DISINTEGRATING is FDA-approved to treat 7 conditions (same as CLONAZEPAM).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Icahn School of Medicine at Mount Sinai conducting 1 trials (8%)
20 indications explored (Broad Platform)
→ epilepsy (2 trials)
→ schizophrenia (2 trials)
→ suicide crisis syndrome (1 trials)
1
Indication
--
Phase 3 Trials
28
Years on Market

Details

Status
Discontinued
First Approved
1997-12-23
Routes
ORAL
Dosage Forms
TABLET, ORALLY DISINTEGRATING

Companies

Roche
Active Ingredient: CLONAZEPAM

KLONOPIN RAPIDLY DISINTEGRATING Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
45 FDA actions from 1997 to 2016
Dec 2016 SUPPL
Label · Labeling
FDA Letter Label
Oct 2013 SUPPL
Label · Labeling
FDA Letter Label
Nov 2011 SUPPL
Update · REMS
FDA Letter

What KLONOPIN RAPIDLY DISINTEGRATING Treats

7 indications

KLONOPIN RAPIDLY DISINTEGRATING is approved for 7 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Seizure Disorder
  • Lennox-Gastaut Syndrome
  • Akinetic Seizures
  • Myoclonic Seizures
  • Absence Seizures
  • Panic Disorder
  • Agoraphobia

Same approved indications as CLONAZEPAM (same active ingredient).

Source: FDA Label
📋

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 RAPIDLY DISINTEGRATING FDA Label Details

Indications & Usage

FDA Label (PDF)

KLONOPIN RAPIDLY DISINTEGRATING is FDA-approved to treat 7 conditions — same approved indications as CLONAZEPAM.

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Data Sources

FDA Approval: NDA020813 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment