Drugs / Diazepam
Diazepam
also known as
Valium · Valtoco · NRL-1 · Alupram 10 · Alupram 2 · Alupram 5 · Ansiolisina · Apozepam · +38 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VALTOCO | — | 2025-04-15 | fda.gov ↗ |
| Approved | US (FDA) | VALIUM | — | 1963-11-15 | fda.gov ↗ |
Trials 48 · a red edge is where a trial was stopped
1962196319641965196619671968196919701971197219731974197519761977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028202920302031
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06271096 | Nov 2019 → Nov 2022 | epilepsy | Arooj Khan | Completed | No outcome recorded |
| Phase 0 | NCT03820193 | Jan 2019 → Jun 2020 | substance-related disorder | Henry Ford Health System | Completed | No outcome recorded |
| Phase 0 | NCT05069779 | Aug 2017 → May 2019 | — | University of Brasilia | Completed | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT07020988 | Jun 2025 → Jan 2026 | — | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT03053869 | Apr 2017 → Sep 2018 | delirium | McMaster University | Completed | No outcome recorded |
| Phase 1 | NCT02724423 | Jun 2016 → Apr 2019 | epilepsy syndrome | Neurelis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02663999 | Jan → Apr 2016 | — | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01696825 | Oct 2012 → May 2014 | thyroid hormone metabolism, abnormal | Jason Gilleran | Terminated | No outcome recorded |
| Phase 1 | NCT01364558 | Feb → Apr 2011 | epilepsy | University of Minnesota | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05361447 | Jan 2023 → Dec 2024 | antibody mediated epilepsy | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05076838 | Nov 2021 → Mar 2025 | epilepsy | Neurelis, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03953820 | Apr → Jul 2019 | epilepsy | Aquestive Therapeutics | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT03818919 | Jan 2019 → Dec 2020 | rotator cuff syndrome | Henry Ford Health System | Completed | No outcome recorded |
| Phase 2 | NCT03222349 | Aug 2017 → Jan 2020 | epilepsy | Aquestive Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03179891 | May 2017 → Jul 2018 | epilepsy | Aquestive Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02474407 | Jun 2015 → May 2016 | epilepsy | Acorda Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT02316847 | Dec 2014 → Jul 2016 | epilepsy | Acorda Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT02232035 | Sep 2014 → Sep 2015 | dystocia | Navy General Hospital, Beijing | Unknown | No outcome recorded |
| Phase 2 | NCT01417078 | Sep 2011 → Feb 2013 | epilepsy | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00121563 | Jul 2005 → Feb 2006 | — | National Institute of Nursing Research (NINR) | Completed | No outcome recorded |
| Phase 2 | NCT00533286 | Aug 2002 → Apr 2007 | palsy | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT03818932 | Jan 2019 → Jan 2020 | — | Henry Ford Health System | Completed | No outcome recorded |
| Phase 2/3 | NCT03825809 | Jan 2019 → Jan 2020 overdue | substance-related disorder | Henry Ford Health System | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02646124 | Jun 2015 → Feb 2016 | — | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06293989 | May 2024 → Dec 2025 | peripheral vertigo | University of Monastir | Unknown | No outcome recorded |
| Phase 3 | NCT03428360 | Jan 2018 → Jun 2020 | epilepsy | Aquestive Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02721069 | Apr 2016 → Jun 2020 | epilepsy syndrome | Neurelis, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT00319501 | Jan 2006 → Jul 2014 | complex partial epilepsy, generalized epilepsy | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00004297 | Nov 1995 → Feb 1999 | — | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT05273398 | Mar → Nov 2022 | focal epilepsy | University of Cincinnati | Completed | No outcome recorded |
| Phase 4 | NCT04885075 | May → Nov 2021 | epilepsy | Shaheed Zulfiqar Ali Bhutto Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT04198233 | Feb 2020 → May 2022 | — | TriHealth Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT05041985 | Jan → Dec 2020 | vertebral column disorder | Edin Mešanović | Completed | No outcome recorded |
| Phase 4 | NCT03960671 | Aug 2018 → Dec 2022 | — | Wei Zhao | Unknown | No outcome recorded |
| Phase 4 | NCT03293017 | Feb 2016 → Feb 2022 | alcohol withdrawal, alcohol-related disorders | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 4 | NCT01221883 | May 2013 → May 2014 | post-traumatic stress disorder | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 4 | NCT00707915 | Jan 2008 → Jul 2010 | — | Minamihanno Hospital | Completed | No outcome recorded |
| Phase not applicable10 trials | ||||||
| — | NCT06549426 | Apr 2025 → Dec 2029 expected | epilepsy | University of Twente | Recruiting | No outcome recorded |
| — | NCT05860153 | Jun 2023 → Jan 2024 | benign non-familial infantile seizures | Assiut University | Unknown | No outcome recorded |
| — | NCT04858490 | Sep 2021 → Oct 2023 | alcohol withdrawal | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| — | NCT05872789 | May 2020 → Sep 2023 | burning mouth syndrome | University of Catania | Completed | No outcome recorded |
| — | NCT06190483 | Jul 2019 → Mar 2023 | schizophrenia | King's College London | Completed | No outcome recorded |
| — | NCT02799641 | Jul 2016 → Jun 2022 | — | TriHealth Inc. | Completed | No outcome recorded |
| — | NCT02242955 | Jul 2014 → Jul 2016 | alcohol dependence | University Hospital, Lille | Completed | No outcome recorded |
| — | NCT01233791 | Nov 2010 → Dec 2011 | — | TriHealth Inc. | Completed | No outcome recorded |
| — | NCT00696033 | Jul 2007 → Dec 2008 | — | University Hospital, Strasbourg, France | Completed | No outcome recorded |
| — | NCT00127257 | Sep 1999 → Jun 2006 | constipation disorder | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
Also used as a comparator or background therapy in 36 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03088306 Comparator | Jul 2017 → May 2018 | lumbar disk degenerative disorder, lumbar spinal stenosis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 0 | NCT03165500 Comparator | Dec 2015 → Dec 2016 | anxiety disorder | São Paulo State University | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT02033707 Background | Apr 2014 → Feb 2019 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT01438749 Comparator | Oct 2011 → May 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT02044302 Background | Apr 2014 → Jan 2016 | — | Yale University | Terminated | No outcome recorded |
| Phase 2 | NCT01938092 Comparator | Sep 2013 → Mar 2017 | pelvis syndrome | Raymond Foster | Completed | No outcome recorded |
| Phase 2 | NCT01790555 Background | Jul → Oct 2013 | — | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT01318369 Comparator | Oct 2011 → May 2013 | chronic pancreatitis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00326612 Comparator | Jun 2006 → Dec 2008 | epilepsy | University of Utah | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT02904265 Comparator | Sep 2016 → Jul 2019 | Landau-Kleffner syndrome | Mayo Clinic | Terminated | No outcome recorded |
| Phase 2/3 | NCT02935972 Comparator | Nov 2013 → Nov 2014 | — | Assiut University | Completed | No outcome recorded |
| Phase 2/3 | NCT00621478 Comparator | Feb 2008 → May 2012 | — | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06103188 Comparator | Oct 2023 | anxiety | University of Jordan | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT06935331 Background | Oct 2025 → Dec 2026 expected | adolescent idiopathic scoliosis | OrthoCarolina Research Institute, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06346262 Background | Mar 2024 → Dec 2026 expected | epilepsy | University Hospitals Cleveland Medical Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07037888 Background | Dec 2023 → Sep 2026 expected | — | Henry Ford Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT04570436 Comparator | Mar 2021 → Nov 2022 | substance abuse | Viatris Specialty LLC | Completed | No outcome recorded |
| Phase 4 | NCT04216797 Comparator | Jan 2020 → Feb 2023 | levator syndrome | Swedish Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT03877120 Comparator | Nov 2017 → Feb 2018 | alcohol withdrawal delirium | Mexican Social Security Institute | Completed | No outcome recorded |
| Phase 4 | NCT03246620 Comparator | Sep 2017 → Jun 2018 | — | The University of Hong Kong | Terminated | No outcome recorded |
| Phase 4 | NCT03631901 Comparator | Apr 2017 → Sep 2018 | febrile seizures, familial | Tanta University | Completed | No outcome recorded |
| Phase 4 | NCT02494180 Comparator | Mar 2016 → Feb 2018 | infertility disorder | Kwong Wah Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02078336 Comparator | Dec 2013 → Jul 2025 overdue | — | Universitaire Ziekenhuizen KU Leuven | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01675648 Comparator | Aug 2012 → Jul 2015 | — | Institute of Mental Health, Singapore | Completed | No outcome recorded |
| Phase 4 | NCT02177955 Comparator | Jan 2011 → Jul 2012 | anxiety | Jimmy Barbalho | Completed | No outcome recorded |
| Phase 4 | NCT01939093 Background | Mar 2010 → Sep 2011 | methamphetamine-induced psychosis | Chulalongkorn University | Completed | No outcome recorded |
| Phase 4 | NCT01305707 Comparator | Jul 2009 → Jul 2014 | major depressive disorder | Hospital Universitari de Bellvitge | Terminated | No outcome recorded |
| Phase 4 | NCT04523935 Comparator | Dec 2005 → Aug 2020 | cerebral palsy | Sathbhavana Brain Clinic | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT04364321 Comparator | May 2020 → Jun 2023 | febrile seizures, familial | Queen Sirikit National Institute of Child Health | Unknown | No outcome recorded |
| — | NCT03427216 Comparator | Sep → Dec 2018 | anismus | Dr. John A. Thiel Medical Professional Corporation | Unknown | No outcome recorded |
| — | NCT03653520 Comparator | Jun → Nov 2017 | cataract | Avanti Anesthesia | Completed | No outcome recorded |
| — | NCT03996564 Comparator | Feb → Dec 2016 | — | San Antonio Military Medical Center | Completed | No outcome recorded |
| — | NCT02659501 Background | Jul 2015 → Sep 2016 | breast cancer | Loma Linda University | Terminated | No outcome recorded |
| — | NCT02288923 Comparator | Mar 2015 → Jul 2018 | osteoarthritis, knee | Royal Devon and Exeter NHS Foundation Trust | Completed | No outcome recorded |
| — | NCT01759706 Comparator | Oct 2010 → Dec 2012 | pancreatic neoplasm | Vita-Salute San Raffaele University | Completed | No outcome recorded |
| — | NCT00523185 Comparator | May 2003 → Nov 2004 | alcohol withdrawal | Stanford University | Completed | No outcome recorded |
Evidence & citations 50 cited values
Every value below carries the sentence it was read from. 88 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Diazépam | “BZD-derivative hypnotics will include brotizolam, flunitrazepam, etizolam, quazepam, estazolam, nitrazepam, flurazepam, and diazepam.” NCT00707915 ↗77“Sedatives/anxiolytics: alprazolam, diazepam, lorazepam, secobarbital, temazepam, triazolam, zolpidem” NCT02033707 ↗ “Patients may be given anxiolysis using temazepam 10-20mg or diazepam 2-5mg by mouth if required.” NCT02288923 ↗ “a single dose of a parenteral benzodiazepine (lorazepam, midazolam, or diazepam)” NCT06549426 ↗ “Diazepam PO dosed per body weight during stay and discharged home with PO tabs” NCT06935331 ↗ “diazepam 5mg 1-2 tablets q8hrs PRN to start on POD0 15 tablets” NCT07037888 ↗ “Diazépam drug (0,3 mg/kg) on a single oral intake” NCT00696033 ↗ “- Diazepam 2'5-50 mg/d. N05BA01” NCT01305707 ↗ “diazepam (2 x 5 mg)” NCT00533286 ↗ |
| Known as | Alupram 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Alupram 2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Alupram 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Ansiolisina | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Apozepam | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Atensine | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Centrazepam | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | DBF | “Open-label study to assess the pharmacokinetics of a single diazepam buccal film (DBF) dose in 3 age cohorts of pediatric patients with epilepsy” NCT03222349 ↗ |
| Known as | Diacepin | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Dialar | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Dialar fte | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Diastat | “Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.” NCT00326612 ↗ |
| Known as | Diastat acudial | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Diazepam civ | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | DIAZEPAM HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Diazepam intensol | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | diazepam nasal spray | “Age- and weight-based doses of diazepam nasal spray (5-20 mg) were administered to patients (aged 6-65 years) for seizure clusters.” PMID 41809194 ↗ Feb 2026 |
| Known as | Dizac | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | DZP | “one group DZP (n=20) patients received diazepam (doses 5-20mg IV)” PMID 33423824 ↗ Jan 2021 |
| Known as | E-pam | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | LA III | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Libervant | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Nasal diazepam (Valtoco) | “Nasal diazepam (Valtoco)” NCT05273398 ↗ |
| Known as | NRL-1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02724423 ↗ |
| Known as | NSC-169897 | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | NSC-77518 | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Paxel | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | PLUMIAZ (diazepam) Nasal Spray | “PLUMIAZ™ (diazepam) Nasal Spray” NCT02663999 ↗ |
| Known as | Q-pam | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Relanium | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | RO 5-2807 | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Scriptopam | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Serenack | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Servizepam | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Solis | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Stesolid | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Tensium | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Tranimul | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Tranquase | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Valclair | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Valium | “Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),...” NCT04523935 ↗5“Diazepam (Valium®) is used to treat levator ani syndrome in conjunction with other treatments to help relax the pelvic floor muscle group (levator ani).” NCT04216797 ↗ “conventional pain medications including narcotics (like morphine, etc.) and sedatives (like valium)” NCT02044302 ↗ “Xanax, Valium, Ativan” NCT03053869 ↗ |
| Known as | Valrelease | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | Valtoco | “A Phase 3 open-label safety study (NCT02721069) evaluated long-term safety of diazepam nasal spray (Valtoco) in patients with epilepsy and frequent seizure clusters.” PMID 34418086 ↗ Aug 2021 |
| Known as | Vanquix Auto-Injector | “Vanquix Auto-Injector (Diazepam Injection)” NCT00319501 ↗ |
| Known as | Vivol | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Known as | WY-3467 | ChEMBL registry synonym — accepted as the source's own label CHEMBL12 ↗ |
| Action | Activate | “enhances the inhibitory action of gamma-amino butyric acid (GABA) on neuronal excitability” NCT03427216 ↗ |
| Modality | Small molecule | “This work will evaluate the effect of diazepam - a BZ compound - on PTSD symptom trajectory following traumatic event in a randomized controlled design.” NCT01221883 ↗ |
| Route | Intravenous | “Patients receive intravenous diazepam, lorazepam, or placebo during transport.” NCT00004297 ↗ |