Drugs / Flumazenil
Flumazenil
also known as
Anexate · CRLS035 · Flumazepil · FMZ · Lanexat · Mazicon · NSC-759193 · RO 15-1788/000 · +4 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ROMAZICON | — | 1991-12-20 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03743805 | Jan 2019 → Jul 2021 | acute opioid poisoning, brain hypoxia - ischemia, cardiac arrest | Prisma Health-Midlands | Withdrawn | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00681746 | Feb → Sep 2008 | anxiety | AstraZeneca | Completed | No outcome recorded |
| Phase 1/26 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT03462641 | Mar 2018 → Jun 2021 | Parkinson disease | University of Michigan | Completed | Met primary |
| Phase 1/2 | NCT02696512 | Mar 2016 → Mar 2017 | brain injury | International Brain Research Foundation | Unknown | No outcome recorded |
| Phase 1/2 | NCT02048969 | Jun 2014 → Oct 2017 | cirrhosis of liver, hepatic encephalopathy | Yale University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01183312 | Sep 2010 → Jan 2012 | idiopathic hypersomnia, narcolepsy without cataplexy | Lynn Marie Trotti | Completed | Missed primary |
| Phase 1/2 | NCT01071889 | May 2010 → Aug 2012 | — | Coeruleus Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT00695630 | Sep 2006 → Dec 2007 | — | University of Washington | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00000246 | Jan 1993 → Dec 1994 | substance-related disorder | Yale University | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT00262639 | Dec 2005 → Feb 2008 | alcohol dependence | Medical University of South Carolina | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07663877 | Jun 2026 → Jun 2028 expected | — | Chung-Ang University Gwangmyeong Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07277881 | Jan 2026 → Oct 2027 expected | delirium | Medical University of Gdansk | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05681377 | Mar → Aug 2023 | — | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06513923 | Feb → Sep 2023 | — | Central South University | Completed | No outcome recorded |
| Phase not applicable7 trials · 2 met primary | ||||||
| — | NCT07619092 | Jan 2026 → Aug 2028 expected | bipolar disorder, major depressive disorder | Anders Jørgensen | Recruiting | No outcome recorded |
| — | NCT07265050 | Jan 2026 → Dec 2027 expected | — | Seoul National University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06563063 | Aug → Dec 2023 | gastric neoplasm | Yonsei University | Completed | No outcome recorded |
| — | NCT05435911 | Aug → Dec 2022 | — | Seoul National University Hospital | Completed | Met primary |
| — | NCT05397886 | Aug 2022 → Apr 2023 | — | Seoul National University Hospital | Completed | Met primary |
| — | NCT04329585 | Mar 2020 → Mar 2021 | — | National Taiwan University Hospital | Unknown | No outcome recorded |
| — | NCT02439164 | May 2015 → Mar 2017 | glioma | Beijing Tiantan Hospital | Completed | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 0 | NCT06205719 Comparator | Jun 2024 → May 2025 | — | Sichuan Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT06531369 Comparator | Jul 2024 → Dec 2025 overdue | — | Qianfoshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT01655914 Comparator | Jul → Dec 2010 | insomnia | Coeruleus Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00681720 Background | Feb → Jul 2008 | anxiety | AstraZeneca | Completed | No outcome recorded |
| Phase 1/2 | NCT03440112 Comparator | Jan 2018 → Dec 2021 | Parkinson disease | Nicolaas Bohnen, MD, PhD | Completed | No outcome recorded |
| Phase 2 | NCT00997087 Comparator | Oct 2009 → Dec 2012 | obsessive-compulsive disorder | Parkway Medical Center | Terminated | No outcome recorded |
| Phase 2/3 | NCT00260481 Comparator | Jan 2006 → Jun 2008 | drug dependence, substance abuse | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT05468671 Background | Jan → Aug 2021 | bronchial neoplasm | Zhejiang Cancer Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02899156 Comparator | Mar 2016 → Apr 2019 | delirium | University of California, Davis | Terminated | No outcome recorded |
| — | NCT05939674 Comparator | Sep 2023 → Feb 2026 overdue | — | Pusan National University Yangsan Hospital | Recruiting | No outcome recorded |
| — | NCT05835713 Background | Apr 2023 → Apr 2024 | bronchial disorder, tracheal stenosis | Samsung Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT05382806 Comparator | Aug 2022 → May 2023 | — | Konkuk University Medical Center | Completed | No outcome recorded |
| — | NCT05047939 Background | Dec 2021 → Aug 2022 | — | Seoul National University Hospital | Completed | Met primary |
| — | NCT02690389 Comparator | Jan → Jun 2015 | — | Dr. Yin Liu | Completed | No outcome recorded |
| — | NCT02157428 Comparator | Jan 2011 → Sep 2012 | — | University of Sao Paulo | Completed | No outcome recorded |
| — | NCT00570388 Comparator | Mar 2007 → Sep 2008 | alcohol dependence | Institute of Addiction Medicine | Unknown | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2004-10-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Flumazenil Injection tevapharm.com ↗ |
| 2004-04-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Flumazenil Injection tevapharm.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Flumazenil | “Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗36“participants assigned to the PROMETA pharmacotherapy condition will receive pre-treatment with hydroxyzine (50mg) followed by intravenous flumazenil (2mg) over a 2-hour period” NCT00260481 ↗ “specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used” NCT02439164 ↗ “After recovering spontaneous respiration during emergence, remimazolam group receive flumazenil injection (0.5 mg)” NCT05835713 ↗ “In the remimazolam group, its antagonist, flumazenil 0.2mg, is administered at the end of surgery.” NCT05047939 ↗ “2 mg flumazenil is given as a slow IV push.” NCT00570388 ↗ |
| Known as | Anexate | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Known as | CRLS035 | “Sublingual Flumazenil (CRLS035)” NCT01655914 ↗ |
| Known as | Flumazepil | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Known as | FMZ | “evaluated a medication combination of intravenous flumazenil (FMZ) and oral gabapentin (GBP) in alcoholics” PMID 19593171 ↗ Aug 2009 |
| Known as | Lanexat | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Known as | Mazicon | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Known as | NSC-759193 | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Known as | RO 15-1788/000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Known as | RO-15-1788 | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Known as | RO-1722 | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Known as | RO-41-8157 | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Known as | Romazicon | ChEMBL registry synonym — accepted as the source's own label CHEMBL407 ↗ |
| Action | Restore | “flumazenil does in fact return the function of the GABA system to normal.” NCT01183312 ↗ |
| Modality | Small molecule | “Flumazenil as a 1, 4-imidazobenzodiazepine” NCT02899156 ↗ |
| Route | Intravenous | “intravenous flumazenil (2mg)” NCT00260481 ↗ |