Drugs / Clonazepam
Clonazepam
also known as
Klonopin · Rivotril · Clonazepam civ · Klonopin rapidly disintegrating · NSC-179913 · Ravotril · Rivatril · RO 5-4023
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | KLONOPIN | — | 1997-04-09 | fda.gov ↗ |
| Approved | US (FDA) | KLONOPIN | — | 1975-06-04 | fda.gov ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT00810316 | Oct → Nov 2008 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00652912 | Mar → Apr 2004 | — | Par Pharmaceutical, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00652639 | Feb → Mar 2004 | — | Par Pharmaceutical, Inc. | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT04884503 | Jan 2019 → Apr 2020 | burning mouth syndrome, glossodynia | Wroclaw Medical University | Completed | No outcome recorded |
| Phase 2 | NCT02913924 | Dec 2016 → Jun 2020 | cannabis dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT02789592 | Jul 2016 → Dec 2019 | Parkinson disease, REM sleep behavior disorder | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02312908 | Mar 2015 → Mar 2016 | REM sleep behavior disorder | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00594945 | Dec 2007 → Dec 2008 | epilepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00118417 | Mar 1999 → Oct 2007 | panic disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT02134366 | Jul 2014 → Jul 2017 | epilepsy syndrome | The Cooper Health System | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01011036 | Dec 2009 → Apr 2010 | — | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT06133114 | Mar 2024 → Oct 2026 expected | — | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 4 | NCT06357104 | Feb → Mar 2024 | — | Pachankis, Yang I., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT06040190 | Nov 2023 → Jul 2026 overdue | burning mouth syndrome | Federal University of Minas Gerais | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03061136 | Oct 2016 → Oct 2017 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Palo Alto Veterans Institute for Research | Withdrawn | No outcome recorded |
| Phase 4 | NCT02690844 | Apr → May 2016 | burning mouth syndrome | University of Alberta | Withdrawn | No outcome recorded |
| Phase 4 | NCT01083784 | Mar 2010 → Dec 2012 | cardiac arrest | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00859872 | Aug 2008 → Mar 2009 | schizophrenia | Central South University | Completed | No outcome recorded |
| Phase 4 | NCT00282828 | Mar 2006 → Dec 2011 | social phobia | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00025740 | Oct 2001 → Aug 2004 | post-traumatic stress disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07498387 | Jan → Aug 2026 overdue | autism spectrum disorder, catatonia | Tanta University | Active not recruiting | No outcome recorded |
| — | NCT06056349 | May 2023 → Dec 2024 | epilepsy | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez | Unknown | No outcome recorded |
| — | NCT06217731 | Jan → Feb 2022 | burning mouth syndrome | Universidad de Murcia | Completed | No outcome recorded |
| — | NCT04364321 | May 2020 → Jun 2023 | febrile seizures, familial | Queen Sirikit National Institute of Child Health | Unknown | No outcome recorded |
| Comparator or background therapy17 trials | ||||||
| Phase 0 | NCT02382029 Comparator | Mar → Nov 2014 | burning mouth syndrome | University of Zagreb | Completed | No outcome recorded |
| Phase 1 | NCT03375034 Comparator | Mar → Dec 2017 | neuropathy, painful | Jules Desmeules | Completed | No outcome recorded |
| Phase 1/2 | NCT01291316 Comparator | Apr 2010 → Nov 2011 | neuropathy, painful | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 3 | NCT04189367 Background | Jun 2020 → Jul 2022 | burning mouth syndrome | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01870024 Comparator | Jun 2013 → Feb 2018 | epilepsy | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT01713946 Background | Apr 2013 → Oct 2017 | tuberous sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01150331 Background | Jul 2009 → May 2013 | epilepsy with generalized tonic-clonic seizures | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 4 | NCT07313371 Comparator | Jan → Jul 2026 overdue | substance dependence | University of Sao Paulo General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07047651 Background | Jun 2025 → Dec 2027 expected | treatment-refractory schizophrenia | Dr. Stavroula Rakitzi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04313907 Comparator | Aug 2019 → Jun 2020 | burning mouth syndrome | Universidad Nacional Autonoma de Mexico | Unknown | No outcome recorded |
| Phase 4 | NCT02205931 Comparator | Jan 2015 → Jun 2018 | epilepsy | University College, London | Unknown | No outcome recorded |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04523935 Comparator | Dec 2005 → Aug 2020 | cerebral palsy | Sathbhavana Brain Clinic | Completed | No outcome recorded |
| Phase 4 | NCT02852577 Comparator | Jan 2000 → Aug 2012 | agoraphobia, panic disorder | Federal University of Rio de Janeiro | Completed | No outcome recorded |
| — | NCT06611202 Background | Jan → Nov 2025 overdue | dementia | Oxleas NHS Foundation Trust | Not yet recruiting | No outcome recorded |
| — | NCT05059418 Comparator | Nov 2021 → Dec 2023 | burning mouth syndrome | Malmö University | Unknown | No outcome recorded |
| — | NCT03255642 Comparator | Nov 2017 → Dec 2020 | REM sleep behavior disorder | Kyung Hee University Hospital at Gangdong | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2008-01-07 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate jazzpharma.com ↗
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its JZP-8 product candidate for the treatment of recurrent acute repetitive seizures. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2008-01-07 | Jazz Pharmaceuticals | Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate jazzpharma.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clonazepam | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗41“List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin” NCT01713946 ↗ “risperidone oral solution combination clonazepam oral and haloperidol IM injection” NCT00859872 ↗ “clonazepam 0.5mg every day before sleep or twice a day for 12 weeks” NCT04189367 ↗ “Clonazepam” NCT02205931 ↗ |
| Known as | Clonazepam civ | ChEMBL registry synonym — accepted as the source's own label CHEMBL452 ↗ |
| Known as | Klonopin | “Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),...” NCT04523935 ↗2“Clonazepam (Klonopin®) treatment arm - 1 mg clonazepam (Klonopin® tablet) TID, dissolved in mouth for 3 minutes then expectorated” NCT02690844 ↗ “To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1 mg” NCT00652639 ↗ |
| Known as | Klonopin rapidly disintegrating | ChEMBL registry synonym — accepted as the source's own label CHEMBL452 ↗ |
| Known as | NSC-179913 | ChEMBL registry synonym — accepted as the source's own label CHEMBL452 ↗ |
| Known as | Ravotril | ChEMBL registry synonym — accepted as the source's own label CHEMBL452 ↗ |
| Known as | Rivatril | ChEMBL registry synonym — accepted as the source's own label CHEMBL452 ↗ |
| Known as | Rivotril | “Participants rinsed with a clonazepam solution (Rivotril® 2.5 mg/mL; 10 drops = 1 mg) diluted in 10 mL of water” NCT06040190 ↗1“Rivotril ( clonazepam) 0.25mg once every 24 hours for a month” NCT06217731 ↗ |
| Known as | RO 5-4023 | ChEMBL registry synonym — accepted as the source's own label CHEMBL452 ↗ |
| Action | Activate | “Two agonists at the benzodiazepine-binding site of GABAA-receptors (clobazam and clonazepam) were studied using multiple experimental pain tests.” PMID 23554851 ↗ Mar 2013 |
| Modality | Small molecule | “traditional 1,4-benzodiazepines such as diazepam, lorazepam, and clonazepam” NCT02134366 ↗ |
| Route | Intranasal | “intranasal Clonazepam” NCT00594945 ↗ |