Diazepam

also known as Valium · Valtoco · NRL-1 · Alupram 10 · Alupram 2 · Alupram 5 · Ansiolisina · Apozepam · +38 more

Developed for: epilepsy · alcohol withdrawal · epilepsy syndrome · focal epilepsy · generalized epilepsy · schizophrenia · alcohol dependence · antibody mediated epilepsy
+20 more
· anxiety disorder · benign non-familial infantile seizures · burning mouth syndrome · complex partial epilepsy · constipation disorder · delirium · dystocia · palsy · peripheral vertigo · post-traumatic stress disorder · rotator cuff syndrome · vertebral column disorder · alcohol withdrawal delirium · anismus · anxiety · chronic pancreatitis · febrile seizures, familial · Landau-Kleffner syndrome · levator syndrome · pelvis syndrome
Investigated by: Acorda Therapeutics · Aquestive Therapeutics · Henry Ford Health System · Neurelis, Inc. · Covance · TriHealth Inc.
+41 more
· Mayo Clinic · National Institute of Neurological Disorders and Stroke (NINDS) · Syneos Health · Arooj Khan · Assiut University · Belgium Health Care Knowledge Centre · Canadian Institutes of Health Research (CIHR) · Centre for Addiction and Mental Health · Edin Mešanović · Erasme University Hospital · Hadassah Medical Organization · Hamilton Health Sciences Corporation · Hannover Medical School · Jason Gilleran · King's College London · McMaster University · Minamihanno Hospital · Montefiore Medical Center · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of Nursing Research (NINR) · Navy General Hospital, Beijing · Ontario Ministry of Health and Long Term Care · Pfizer · Shaheed Zulfiqar Ali Bhutto Medical University · The Royal Society · UCB Biopharma SRL · University Hospital Brussels · University Hospital Tuebingen · University Hospital, Lille · University Hospital, Strasbourg, France · University of Brasilia · University of California, San Francisco · University of Catania · University of Cincinnati · University of Minnesota · University of Monastir · University of Twente · Wei Zhao · Wellcome Trust · ZonMw: The Netherlands Organisation for Health Research and Development · inVentiv Health Clinical

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed simple partial epilepsy 6 milestones
Filed	US (FDA)	Libervant	simple partial epilepsy	2023-09-11	“today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film” aquestive.com ↗
Filed	US (FDA)	Libervant	simple partial epilepsy	2023-06-29	“submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Libervant™ (diazepam) Buccal Film” aquestive.com ↗
Filed	US (FDA)	Libervant	simple partial epilepsy	2021-06-24	“The FDA accepted Aquestive's New Drug Application (NDA) for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity” aquestive.com ↗ “In September 2023, the FDA accepted Aquestive's NDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity” aquestive.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film” aquestive.com ↗ “resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Libervant™ (diazepam) Buccal Film” aquestive.com ↗
Rejected (CRL)	US (FDA)	Libervant	simple partial epilepsy	2020-09-25	“the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film” aquestive.com ↗
Filed	US (FDA)	Libervant	simple partial epilepsy	2019-12-02	“The Company also initiated a rolling New Drug Application (NDA) submission for Libervant in May 2019 with the U.S. Food and Drug Administration ( FDA ).” aquestive.com ↗ “submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for its therapeutic candidate Libervant™ (diazepam)” aquestive.com ↗
Filed	US (FDA)	VALTOCO	simple partial epilepsy	2018-09-24	“today announced that the company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for VALTOCO TM (diazepam nasal spray)” neurelis.com ↗
Approved Indication not stated 2 milestones
Label expansion	US (FDA)	VALTOCO	—	2025-04-15	fda.gov ↗
Approved	US (FDA)	VALIUM	—	1963-11-15	fda.gov ↗

Trials 49

today

US approved 1963

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Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 04 trials
Phase 0	NCT07012148	Jan 2026 → Dec 2028 expected	focal epilepsy, generalized epilepsy	Mayo Clinic	Recruiting	No outcome recorded
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 Stop: Enrollment
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	NCT03825809	Jan 2019 → Jan 2020 overdue	substance-related disorder	Henry Ford Health System	Recruiting	No outcome recorded
Phase 2/3	NCT03818932	Jan 2019 → Jan 2020	—	Henry Ford Health System	Completed	Mixed
Phase 2/3	NCT02646124	Jun 2015 → Feb 2016	—	Montefiore Medical Center	Completed	No outcome recorded
Phase 36 trials · 1 met primary
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	Met primary
Phase 3	NCT00004297	Nov 1995 → Feb 1999	—	National Institute of Neurological Disorders and Stroke (NINDS)	Completed	No outcome recorded
Phase 48 trials · 1 missed
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	Missed primary
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 · 1 missed
—	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	Missed primary
—	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
Comparator or background therapy36 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 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 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 2/3	NCT02904265 Comparator	Sep 2016 → Jul 2019	Landau-Kleffner syndrome	Mayo Clinic	Terminated	No outcome recorded Stop: Enrollment
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 3	NCT06103188 Comparator	Oct 2023	anxiety	University of Jordan	Completed	Missed primary
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 overdue	—	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 Stop: Enrollment
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 Stop: Enrollment
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	Missed primary
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 Stop: Enrollment
Phase 4	NCT04523935 Comparator	Dec 2005 → Aug 2020	cerebral palsy	Sathbhavana Brain Clinic	Completed	No outcome recorded
—	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

News releases announcing trial results or a regulatory action · 41

Date	Issuer	Release
2026-07-31	Lupin Limited	Regulatory Lupin Announces the Approval of Diazepam Injection, USP in the United States lupin.com ↗ Mumbai, India, Naples, Fla, July 31, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received approval under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for its Abbreviated New Drug Application for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes.
2026-04-16	Neurelis, Inc.	Results NEURELIS TO PRESENT ANALYSES OF IMMEDIATE-USE SEIZURE TREATMENT AT THE AMERICAN ACADEMY OF NEUROLOGY ANNUAL MEETING neurelis.com ↗ outpatient visits were lower among patients in the diazepam nasal spray cohort.
2025-04-16	Neurelis, Inc.	Regulatory NEURELIS ANNOUNCES FDA APPROVAL FOR IMMEDIATE USE SEIZURE MEDICATION VALTOCO® (DIAZEPAM NASAL SPRAY) IN AGES 2 TO 5 neurelis.com ↗
2024-05-01	Alembic Pharmaceuticals Ltd.	Regulatory Press Release USFDA Products Approval dated 9th May, 2024 alembicpharmaceuticals.com ↗ This is to inform the exchanges that the Company has received various US Food & Drug Administration (USFDA) (Tentative or Final) Product Approvals.
2024-04-11	Neurelis, Inc.	Results NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS AT THE 76TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY neurelis.com ↗ Sustained DZP levels were observed in plasma and brain, akin to human levels, suggesting potential long-acting effects.
2023-11-02	Lupin Limited	Regulatory Lupin Launches Diazepam Rectal Gel in the United States lupin.com ↗ Novel Laboratories Inc., based in Somerset, New Jersey received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA).
2023-09-11	XenoPort, Inc.	Regulatory Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients and Assignment of Prescription Drug User Fee Act (PDUFA) Date aquestive.com ↗ The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,
2023-06-29	XenoPort, Inc.	Regulatory Aquestive Therapeutics Provides Business Update and Announces Chief Medical Officer Appointment aquestive.com ↗ Aquestive submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Libervant™ (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age.
2023-06-01	Lupin Limited	Regulatory Lupin Receives Approval from U.S. FDA for Diazepam Rectal Gel lupin.com ↗ Global pharma major Lupin Limited (Lupin) today announced that its wholly-owned subsidiary, Novel Laboratories Inc., based in Somerset, New Jersey, has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System, a generic equivalent of Diastat® AcuDialTMRectal Delivery System, 10 mg and 20 mg, of Bausch Health US, LLC.
2023-04-25	Neurelis, Inc.	Results NEURELIS ANNOUNCES FOUR POSTER PRESENTATIONS AT THE 75TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY neurelis.com ↗ No change was observed in the ove
2022-12-02	Neurelis, Inc.	Results NEURELIS TO PRESENT NINE POSTERS AT THE 76th AMERICAN EPILEPSY SOCIETY ANNUAL MEETING neurelis.com ↗ Investigational Phase 3 study of VALTOCO ® (diazepam nasal spray) CIV shows double the time between seizure clusters when administered over a 12-month period
2022-10-13	Neurelis, Inc.	Results NEURELIS PRESENTS NOVEL, INVESTIGATIONAL ANALYSIS OF VALTOCO® (DIAZEPAM NASAL SPRAY) CIV DEMONSTRATING INCREASED TIME BETWEEN SEIZURE CLUSTERS AT THE 51ST CHILD NEUROLOGY SOCIETY ANNUAL MEETING neurelis.com ↗ Findings indicate a significant increase in these intervals, or SEIzure interVAL (SEIVAL) data, over a 12-month period.
2022-10-12	Neurelis, Inc.	Results NEURELIS ANNOUNCES PRESENTATION OF ANALYSIS OF TIME BETWEEN SEIZURE CLUSTERS WITH VALTOCO® (DIAZEPAM NASAL SPRAY) CIV AT THE 2022 ANNUAL MEETING OF THE ACADEMY OF MANAGED CARE PHARMACY neurelis.com ↗ The poster presentation summarizes results indicating a 2-fold increase in time between treated seizure clusters, or SEIzure interVAL (SEIVAL), associated with use of VALTOCO.
2022-09-08	Neurelis, Inc.	Results STUDY PUBLISHED IN EPILEPSIA SHOWS SIGNIFICANT PROLONGATION OF TIME INTERVALS BETWEEN SEIZURE CLUSTERS TREATED WITH NEURELIS’ VALTOCO® (DIAZEPAM NASAL SPRAY) CIV neurelis.com ↗ The results consistently showed a clinical and statistical increase in the time between use of intranasal diazepam, VALTOCO, over time.
2022-08-31	XenoPort, Inc.	Regulatory Aquestive Therapeutics Receives FDA Tentative Approval for Libervant™ (diazepam) Buccal Film aquestive.com ↗
2022-06-09	Neurelis, Inc.	Results NEURELIS STUDY PUBLISHED IN EPILEPSIA, A WORLD-CLASS JOURNAL DEDICATED TO EPILEPSY neurelis.com ↗ Lack of clinically relevant differences in safety and pharmacokinetics after second-dose administration of intranasal diazepam within 4 h for acute treatment of seizure clusters: A population analysis.
2022-06-08	Neurelis, Inc.	Results NEURELIS PRESENTED CLINICAL DATA SUPPORTING SEIZURE CLUSTER INTERVAL ANALYSIS AT THE EPILEPSY FOUNDATION PIPELINE CONFERENCE neurelis.com ↗ The data indicate that patients using the therapy had a statistical and clinically significant increase in the time between their seizure clusters, or SEIzure cluster interVAL (SEIVAL) over a 12-month period.
2022-05-05	Neurelis, Inc.	Results DATA FROM NOVEL, EXPLORATORY ANALYSIS OF INTERMITTENT VALTOCO® (DIAZEPAM NASAL SPRAY) CIV USE INDICATES MORE THAN TWO-FOLD INCREASE IN MEAN INTERVAL BETWEEN SEIZURE CLUSTERS neurelis.com ↗ The data indicates that patients using the therapy had a significant increase in the time between their seizure clusters, or SEIzure InterVAL data (SEIVAL) over a 12-month period.
2022-04-04	Neurelis, Inc.	Results NEURELIS ANNOUNCES THREE POSTER PRESENTATIONS AT THE 2022 ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY neurelis.com ↗ Patient diary entries from the long-term safety study confirmed that treatment administration occurred after seizure onset within a median time of two minutes.
2021-12-02	Neurelis, Inc.	Results NEURELIS ANNOUNCES 16 POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE AMERICAN EPILEPSY SOCIETY neurelis.com ↗ Subgroup analyses from the long-term safety study of VALTOCO® (diazepam nasal spray) demonstrated favorable safety and tolerability results in children (6-11 years of age), adolescents (12-17 years of age) and adults who experience seizure clusters
2021-09-29	Neurelis, Inc.	Results NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE CHILD NEUROLOGY SOCIETY neurelis.com ↗ The first poster presents analyses from a Phase 3, long-term, open-label, repeat-dose safety study showing that VALTOCO ® (diazepam nasal spray) demonstrated favorable long-term safety and tolerability results in children (aged 6-11) and adolescents (aged 12-17) who have epilepsy.
2021-07-19	XenoPort, Inc.	Regulatory Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant™ (diazepam) Buccal Film aquestive.com ↗
2021-06-24	XenoPort, Inc.	Regulatory Aquestive Therapeutics Resubmits New Drug Application for Libervant™ (diazepam) Buccal Film aquestive.com ↗ Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters in response to the September 25, 2020 Complete Response Letter (CRL) from the FDA.
2021-04-19	Neurelis, Inc.	Results NEURELIS ANNOUNCES FIVE POSTER PRESENTATIONS FOR THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY neurelis.com ↗ Survey data presented at AAN shows that nearly 80% of patients were comfortable doing activities outside the home when carrying VALTOCO with them
2021-04-12	Neurelis, Inc.	Results NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS FOR THE ANNUAL MEETING OF THE ACADEMY OF MANAGED CARE PHARMACY neurelis.com ↗ These data presented at AMCP shows that just a single dose of VALTOCO was needed in 87.4% of seizure clusters, a proxy measurement for efficacy.
2020-12-04	Neurelis, Inc.	Results Neurelis Announces 12 Poster Presentations for the Annual Meeting of the American Epilepsy Society neurelis.com ↗ Data also highlight the ability for patients to self-administer VALTOCO during a seizure episode
2020-11-18	XenoPort, Inc.	Regulatory Aquestive Therapeutics Completes FDA Type A Meeting on Libervant aquestive.com ↗ The FDA also recommended a follow-up meeting to review the final modeling and simulations, as well as the totality of safety information, prior to resubmission.
2020-10-19	Neurelis, Inc.	Regulatory Neurelis Announces FDA Approval of Extended Expiration Dating for VALTOCO® (diazepam nasal spray) neurelis.com ↗ Neurelis, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company’s lead product, VALTOCO ® (diazepam nasal spray).
2020-10-16	Neurelis, Inc.	Results Neurelis Announces Four Poster Presentations for the Joint Meeting of the International Child Neurology Association and Child Neurology Society neurelis.com ↗ Data also highlight that 88 percent of treated seizure episodes used a single dose of VALTOCO
2020-09-25	XenoPort, Inc.	Regulatory Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant™ (diazepam) Buccal Film for Management of Seizure Clusters aquestive.com ↗ Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for management of seizure clusters.
2020-07-30	Xeris Pharmaceuticals	Results Xeris Pharmaceuticals Announces Additional Data From a Phase 1b Comparative Study of Its Novel Concentrated Diazepam Formulation (XP-0863) and an Expedited Clinical Path Forward xerispharma.com ↗ Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced additional data from the Phase 1b study to evaluate a novel diazepam formulation (XP-0863) in healthy adult subjects.
2020-05-20	Neurelis, Inc.	Results NEURELIS ANNOUNCES TOTAL OF NINE POSTER PRESENTATIONS FOR THE AANN, AMCP, AND AAN ANNUAL MEETINGS neurelis.com ↗ Neurelis Chief Medical Officer Enrique Carrazana, M.D., said the poster presentations continue to validate the safety, pharmacokinetic, and tolerability of VALTOCO ® (diazepam nasal spray).
2020-04-20	Xeris Pharmaceuticals	Results Xeris Pharmaceuticals Announces Positive Topline Results From a Study of Its Novel Formulation of Diazepam Injection xerispharma.com ↗ Xeris’ IM diazepam yielded higher drug exposure AUC 0-∞ when compared to Diastat®, over 24 hours.
2020-02-10	XenoPort, Inc.	Regulatory Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film aquestive.com ↗ the U.S. Food and Drug Administration ( FDA ) accepted the Company’s New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters.
2020-01-13	Neurelis, Inc.	Regulatory NEURELIS ANNOUNCES FDA APPROVAL FOR SEIZURE RESCUE TREATMENT VALTOCO® (DIAZEPAM NASAL SPRAY) THAT INCORPORATES THE SCIENCE OF INTRAVAIL® FOR CONSISTENT AND RELIABLE ABSORPTION neurelis.com ↗ Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO ® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older.
2020-01-12	XenoPort, Inc.	Regulatory Aquestive Therapeutics Receives FDA Response to Citizen’s Petition aquestive.com ↗ In the Response, the FDA indicated that it had approved Neurelis’s NDA for Valtoco on January 10 , 2020.
2019-12-02	XenoPort, Inc.	Regulatory Aquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Libervant™ (diazepam) Buccal Film for Management of Seizure Clusters aquestive.com ↗
2019-05-01	Xeris Pharmaceuticals	Results Xeris Pharmaceuticals Announces Results From a Phase 1 Study of Its Novel Formulation of Diazepam xerispharma.com ↗ Xeris’ IM and SC administration of 10 mg diazepam yielded higher exposure as compared to an equivalent dose of diazepam rectal gel as assessed by AUC 0-∞.
2018-09-24	Neurelis, Inc.	Regulatory Neurelis Files New Drug Application With The FDA For VALTOCO™ (Diazepam Nasal Spray), An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy Patients neurelis.com ↗
2017-01-05	Neurelis, Inc.	Regulatory Neurelis Recieves FDA Fast Track Designation for NRL-1 neurelis.com ↗ “We are very excited to have received Fast Track Designation status with the FDA,” said Craig C. Chambliss, President and Chief Executive Officer of Neurelis.
2015-12-22	Neurelis, Inc.	Regulatory Neurelis Receives FDA Orphan Drug Designation for NRL-1 in the Treatment of Acute Repetitive Seizures neurelis.com ↗ Neurelis, Inc. (“Neurelis”) today announced receipt of Orphan Drug Designation from the FDA for their lead program, NRL-1 (intranasal diazepam) for pediatric, adolescent, and adult epilepsy patients who experience acute repetitive seizures.

All press releases naming this drug 71 releases

Date	Issuer	Release
2026-07-31	Lupin Limited	Lupin Announces the Approval of Diazepam Injection, USP in the United States lupin.com ↗
2026-04-16	Neurelis, Inc.	NEURELIS TO PRESENT ANALYSES OF IMMEDIATE-USE SEIZURE TREATMENT AT THE AMERICAN ACADEMY OF NEUROLOGY ANNUAL MEETING neurelis.com ↗
2025-10-08	Neurelis, Inc.	NEURELIS TO HIGHLIGHT DATA FROM A STUDY OF DIAZEPAM NASAL SPRAY IN PEDIATRIC PATIENTS AT THE CHILD NEUROLOGY SOCIETY ANNUAL MEETING neurelis.com ↗
2025-04-16	Neurelis, Inc.	NEURELIS ANNOUNCES FDA APPROVAL FOR IMMEDIATE USE SEIZURE MEDICATION VALTOCO® (DIAZEPAM NASAL SPRAY) IN AGES 2 TO 5 neurelis.com ↗
2025-04-07	Neurelis, Inc.	Neurelis will Highlight Analyses of Seizure Treatment with Diazepam Nasal Spray at the American Academy of Neurology Annual Meeting neurelis.com ↗
2024-12-19	XenoPort, Inc.	Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity for Libervant® (diazepam) Buccal Film in Pediatric Patients with Seizure Clusters Ages Two to Five aquestive.com ↗
2024-11-11	Neurelis, Inc.	NEURELIS TO SHARE CLINICAL STUDY DESIGN INSIGHTS FOR INVESTIGATION OF VALTOCO® (DIAZEPAM NASAL SPRAY) IN AGES 2 TO 5 AT CHILD NEUROLOGY SOCIETY ANNUAL MEETING neurelis.com ↗
2024-05-01	Alembic Pharmaceuticals Ltd.	Press Release USFDA Products Approval dated 9th May, 2024 alembicpharmaceuticals.com ↗
2024-04-29	XenoPort, Inc.	Aquestive Therapeutics Receives U.S. FDA Approval and Market Access for Libervant™ (diazepam) Buccal Film in Pediatric Patients Ages 2 to 5 and Provides Update on Anaphylm™ (epinephrine) Sublingual Film aquestive.com ↗
2024-04-12	XenoPort, Inc.	Aquestive Therapeutics to Present Crossover Study Data for Libervant™ (diazepam) Buccal Film at 76th Annual Meeting of the American Academy of Neurology aquestive.com ↗
2024-04-11	Neurelis, Inc.	NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS AT THE 76TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY neurelis.com ↗
2023-11-02	Lupin Limited	Lupin Launches Diazepam Rectal Gel in the United States lupin.com ↗
2023-09-11	XenoPort, Inc.	Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients and Assignment of Prescription Drug User Fee Act (PDUFA) Date aquestive.com ↗
2023-06-29	XenoPort, Inc.	Aquestive Therapeutics Provides Business Update and Announces Chief Medical Officer Appointment aquestive.com ↗
2023-06-01	Lupin Limited	Lupin Receives Approval from U.S. FDA for Diazepam Rectal Gel lupin.com ↗
2023-04-25	Neurelis, Inc.	NEURELIS ANNOUNCES FOUR POSTER PRESENTATIONS AT THE 75TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY neurelis.com ↗
2023-03-29	XenoPort, Inc.	Aquestive Therapeutics Expands License and Supply Agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film to Additional Global Markets aquestive.com ↗
2022-12-02	Neurelis, Inc.	NEURELIS TO PRESENT NINE POSTERS AT THE 76th AMERICAN EPILEPSY SOCIETY ANNUAL MEETING neurelis.com ↗
2022-11-29	XenoPort, Inc.	Aquestive Therapeutics Announces Publication of Crossover Food Effect Study of Diazepam Nasal Spray in Epilepsia aquestive.com ↗
2022-10-13	Neurelis, Inc.	NEURELIS PRESENTS NOVEL, INVESTIGATIONAL ANALYSIS OF VALTOCO® (DIAZEPAM NASAL SPRAY) CIV DEMONSTRATING INCREASED TIME BETWEEN SEIZURE CLUSTERS AT THE 51ST CHILD NEUROLOGY SOCIETY ANNUAL MEETING neurelis.com ↗
2022-10-12	Neurelis, Inc.	NEURELIS ANNOUNCES PRESENTATION OF ANALYSIS OF TIME BETWEEN SEIZURE CLUSTERS WITH VALTOCO® (DIAZEPAM NASAL SPRAY) CIV AT THE 2022 ANNUAL MEETING OF THE ACADEMY OF MANAGED CARE PHARMACY neurelis.com ↗
2022-09-28	XenoPort, Inc.	Aquestive Therapeutics Enters License and Supply Agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film for European and MENA Markets aquestive.com ↗
2022-09-08	Neurelis, Inc.	STUDY PUBLISHED IN EPILEPSIA SHOWS SIGNIFICANT PROLONGATION OF TIME INTERVALS BETWEEN SEIZURE CLUSTERS TREATED WITH NEURELIS’ VALTOCO® (DIAZEPAM NASAL SPRAY) CIV neurelis.com ↗
2022-08-31	XenoPort, Inc.	Aquestive Therapeutics Receives FDA Tentative Approval for Libervant™ (diazepam) Buccal Film aquestive.com ↗
2022-06-09	Neurelis, Inc.	NEURELIS STUDY PUBLISHED IN EPILEPSIA, A WORLD-CLASS JOURNAL DEDICATED TO EPILEPSY neurelis.com ↗
2022-06-08	Neurelis, Inc.	NEURELIS PRESENTED CLINICAL DATA SUPPORTING SEIZURE CLUSTER INTERVAL ANALYSIS AT THE EPILEPSY FOUNDATION PIPELINE CONFERENCE neurelis.com ↗
2022-05-31	Neurelis, Inc.	NEURELIS TO HIGHLIGHT VALTOCO (DIAZEPAM NASAL SPRAY) CIV DEVELOPMENT PROGRAM Updates AT 16TH EILAT CONFERENCE neurelis.com ↗
2022-05-05	Neurelis, Inc.	DATA FROM NOVEL, EXPLORATORY ANALYSIS OF INTERMITTENT VALTOCO® (DIAZEPAM NASAL SPRAY) CIV USE INDICATES MORE THAN TWO-FOLD INCREASE IN MEAN INTERVAL BETWEEN SEIZURE CLUSTERS neurelis.com ↗
2022-04-26	Neurelis, Inc.	NEURELIS EXPANDS INTELLECTUAL PROPERTY ESTATE FOR VALTOCO®, A PATIENT-CENTRIC NASAL SPRAY FOR ACUTE TREATMENT OF EPISODES OF FREQUENT SEIZURE ACTIVITY neurelis.com ↗
2022-04-04	Neurelis, Inc.	NEURELIS ANNOUNCES THREE POSTER PRESENTATIONS AT THE 2022 ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY neurelis.com ↗
2022-01-25	Neurelis, Inc.	NEURELIS SIGNS EXCLUSIVE LICENSING AGREEMENT WITH ACULYS PHARMA FOR THE DEVELOPMENT AND COMMERCIALIZATION OF VALTOCO® (DIAZEPAM NASAL SPRAY) IN JAPAN AND THE ASIA-PACIFIC REGION neurelis.com ↗
2021-12-20	XenoPort, Inc.	Aquestive Therapeutics Receives Notification from FDA that It Will Not Be Ready to Take Action by December 23, 2021 for the Company’s NDA for Libervant™ (diazepam) Buccal Film aquestive.com ↗
2021-12-02	Neurelis, Inc.	NEURELIS ANNOUNCES 16 POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE AMERICAN EPILEPSY SOCIETY neurelis.com ↗
2021-09-29	Neurelis, Inc.	NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE CHILD NEUROLOGY SOCIETY neurelis.com ↗
2021-09-20	Neurelis, Inc.	NEURELIS INITIATES STUDY OF VALTOCO® (diazepam nasal spray) IN CHILDREN WITH SEIZURE CLUSTERS AGED TWO TO FIVE neurelis.com ↗
2021-08-09	XenoPort, Inc.	Aquestive Therapeutics Negotiates Six Month Extension to June 30, 2022 for Additional Libervant™ Related Capital Under Current Debt Agreement aquestive.com ↗
2021-07-19	XenoPort, Inc.	Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant™ (diazepam) Buccal Film aquestive.com ↗
2021-06-24	XenoPort, Inc.	Aquestive Therapeutics Resubmits New Drug Application for Libervant™ (diazepam) Buccal Film aquestive.com ↗
2021-04-19	Neurelis, Inc.	NEURELIS ANNOUNCES FIVE POSTER PRESENTATIONS FOR THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY neurelis.com ↗
2021-04-12	Neurelis, Inc.	NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS FOR THE ANNUAL MEETING OF THE ACADEMY OF MANAGED CARE PHARMACY neurelis.com ↗
2021-02-25	XenoPort, Inc.	Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission for Libervant™ (diazepam) Buccal Film Following FDA Feedback aquestive.com ↗
2020-12-04	Neurelis, Inc.	Neurelis Announces 12 Poster Presentations for the Annual Meeting of the American Epilepsy Society neurelis.com ↗
2020-11-18	XenoPort, Inc.	Aquestive Therapeutics Completes FDA Type A Meeting on Libervant aquestive.com ↗
2020-11-09	Neurelis, Inc.	Neurelis Announces National Wholesale and Retailer Chains and Independent Pharmacies Are Now Stocking VALTOCO® (diazepam nasal spray) neurelis.com ↗
2020-10-19	Neurelis, Inc.	Neurelis Announces FDA Approval of Extended Expiration Dating for VALTOCO® (diazepam nasal spray) neurelis.com ↗
2020-10-16	Neurelis, Inc.	Neurelis Announces Four Poster Presentations for the Joint Meeting of the International Child Neurology Association and Child Neurology Society neurelis.com ↗
2020-09-25	XenoPort, Inc.	Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant™ (diazepam) Buccal Film for Management of Seizure Clusters aquestive.com ↗
2020-09-23	Neurelis, Inc.	Neurelis Announces Program to Investigate the Safety and Pharmacokinetics of VALTOCO® (diazepam nasal spray) in Children Aged 2 to 5 neurelis.com ↗
2020-08-04	XenoPort, Inc.	Aquestive Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update: AQST-108 Progress Remains On Track; Libervant PDUFA Goal Date Approaches aquestive.com ↗
2020-07-30	Xeris Pharmaceuticals	Xeris Pharmaceuticals Announces Additional Data From a Phase 1b Comparative Study of Its Novel Concentrated Diazepam Formulation (XP-0863) and an Expedited Clinical Path Forward xerispharma.com ↗
2020-06-08	Neurelis, Inc.	NEURELIS ANNOUNCES RAPID AND BROAD PAYER COVERAGE OF THE COMPANY’S FLAGSHIP PRODUCT, VALTOCO® (DIAZEPAM NASAL SPRAY) neurelis.com ↗
2020-05-20	Neurelis, Inc.	NEURELIS ANNOUNCES TOTAL OF NINE POSTER PRESENTATIONS FOR THE AANN, AMCP, AND AAN ANNUAL MEETINGS neurelis.com ↗
2020-05-05	XenoPort, Inc.	Aquestive Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update: AQST-108 and Libervant Remain On Track aquestive.com ↗
2020-04-20	Xeris Pharmaceuticals	Xeris Pharmaceuticals Announces Positive Topline Results From a Study of Its Novel Formulation of Diazepam Injection xerispharma.com ↗
2020-03-02	Neurelis, Inc.	NEURELIS ANNOUNCES COMMERCIAL AVAILABILITY OF VALTOCO® (DIAZEPAM NASAL SPRAY) FOR SEIZURE CLUSTER RESCUE neurelis.com ↗
2020-02-10	XenoPort, Inc.	Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film aquestive.com ↗
2020-01-13	Neurelis, Inc.	NEURELIS ANNOUNCES FDA APPROVAL FOR SEIZURE RESCUE TREATMENT VALTOCO® (DIAZEPAM NASAL SPRAY) THAT INCORPORATES THE SCIENCE OF INTRAVAIL® FOR CONSISTENT AND RELIABLE ABSORPTION neurelis.com ↗
2020-01-12	XenoPort, Inc.	Aquestive Therapeutics Receives FDA Response to Citizen’s Petition aquestive.com ↗
2019-12-04	XenoPort, Inc.	Aquestive Therapeutics to Host Investor & Analyst Libervant™ (diazepam) Buccal Film Update Forum at American Epilepsy Society 2019 Annual Meeting aquestive.com ↗
2019-12-02	XenoPort, Inc.	Aquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Libervant™ (diazepam) Buccal Film for Management of Seizure Clusters aquestive.com ↗
2019-11-26	XenoPort, Inc.	Aquestive Therapeutics Announces Poster Presentations of Data on Libervant™ (diazepam) Buccal Film at American Epilepsy Society 2019 Annual Meeting aquestive.com ↗
2019-08-06	XenoPort, Inc.	Aquestive Therapeutics Announces Positive Topline Results from Libervant™ (Diazepam) Buccal Film Single Dose Crossover Study aquestive.com ↗
2019-06-04	XenoPort, Inc.	Aquestive Therapeutics Completes Enrollment in Libervant™ (diazepam buccal film) Crossover Study aquestive.com ↗
2019-05-01	Xeris Pharmaceuticals	Xeris Pharmaceuticals Announces Results From a Phase 1 Study of Its Novel Formulation of Diazepam xerispharma.com ↗
2019-04-22	Neurelis, Inc.	NEURELIS ANNOUNCES COMPLETION OF SENIOR MANAGEMENT TEAM BUILDOUT TO SUPPORT THE ANTICIPATED COMMERCIAL LAUNCH OF VALTOCO™ neurelis.com ↗
2018-12-03	XenoPort, Inc.	Aquestive Therapeutics Announces Late-Breaking Findings of its Investigational Diazepam Buccal Film (DBF) Formulation in Adults with Epilepsy aquestive.com ↗
2018-10-25	XenoPort, Inc.	Aquestive Therapeutics Announces Completion of Diazepam Buccal Film Adult Epilepsy Monitoring Unit (EMU) Clinical Study with Positive Topline Results aquestive.com ↗
2018-09-24	Neurelis, Inc.	Neurelis Files New Drug Application With The FDA For VALTOCO™ (Diazepam Nasal Spray), An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy Patients neurelis.com ↗
2017-01-05	Neurelis, Inc.	Neurelis Recieves FDA Fast Track Designation for NRL-1 neurelis.com ↗
2016-01-20	Neurelis, Inc.	Neurelis Initiates Pivotal Clinical Program for NRL-1 in the Treatment of Acute Repetitive Seizures neurelis.com ↗
2015-12-22	Neurelis, Inc.	Neurelis Receives FDA Orphan Drug Designation for NRL-1 in the Treatment of Acute Repetitive Seizures neurelis.com ↗

Evidence & citations 50 cited values

Every value below carries the sentence it was read from. 89 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 ↗ 78 “participants take a scheduled dose of VALTOCO (a nasal spray form of the medication diazepam) once a week” NCT07012148 ↗ “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 ↗ NCT01759706 ↗ Show 68 more sources
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 ↗ 1 NCT02721069 ↗
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 ↗ NCT02078336 ↗ NCT03088306 ↗
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 3 “Diazepam Nasal Spray [Valtoco]” NCT05076838 ↗ “Nasal diazepam (Valtoco)” NCT05273398 ↗ NCT06346262 ↗
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 ↗