Valium

(Diazepam)

ApprovedSmall molecule

Diazepam is used to treat anxiety, muscle spasms, and seizures. It's also used to help people relax before medical procedures or to manage alcohol withdrawal symptoms.[2] Valium is currently approved and in use across 26 indications[4].[1]

Valium is one of 417 small molecule programs targeting Constipation. It is currently in Approved.

Indications

Total Trials

Active Trials

416

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Low Back PainActive, not recruiting

Peripheral VertigoActive, not recruiting

Partial EpilepsyApproved

Cerebral PalsyActive, not recruiting

VertigoApproved

Stiff-Person SyndromeActive, not recruiting

ConvulsionActive, not recruiting

Complex Partial EpilepsyApproved

Rotator Cuff TearApproved

PsychosisActive, not recruiting

Low Back PainPhase 2/Phase 3

Active, not recruiting

Peripheral VertigoPhase 3

Active, not recruiting

Partial EpilepsyApproved

Approved

Cerebral PalsyApproved

Active, not recruiting

VertigoApproved

Approved

Stiff-Person SyndromeApproved

Active, not recruiting

ConvulsionPreclinical

Active, not recruiting

Complex Partial EpilepsyApproved

Approved

Rotator Cuff TearApproved

Approved

PsychosisPreclinical

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Valium

Akero Therapeutics

Approved

52 2

Rituxan

Roche

Preclinical

61 3

Orencia

Bristol-Myers Squibb

Preclinical

47 4

Actemra

Cimzia

30 6

Simponi

Johnson & Johnson

Preclinical

19 7

Enbrel

IImmunex

Preclinical

64 8

Arcoxia

Novartis

Preclinical

4 9

Actos

Takeda

Preclinical

2 10

Zelhou

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Alcohol Withdrawal5 trials

A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal

Completed·SStanford University·N/A·NCT00523185·55 enrolled

Baclofen in Managing Acute Alcohol Withdrawal

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 4·NCT03293017·90 enrolled

Treatment Of Alcohol Withdrawal Syndrome: Dexmedetomidine Vs Diazepam In A Hospital O'horán

Completed·CCentro Medico Nacional La Raza, IMSS·Phase 4·NCT03877120·2 enrolled

Show 2 more trials

Remote Treatment of Alcohol Withdrawal

Completed·CCentre for Addiction and Mental Health·N/A·NCT04858490·30 enrolled

Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

Completed·UUniversity of Pittsburgh··NCT01652326·792 enrolled

Seizure4 trials

Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

Completed·UUniversity of Utah·Phase 2·NCT00326612·358 enrolled

A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode

Completed·AAcorda Therapeutics·Phase 2·NCT01417078·31 enrolled

Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures

Completed·TTanta University·Phase 4·NCT03631901·60 enrolled

Show 1 more trial

Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention

Unknown status·QQueen Sirikit National Institute of Child Health·N/A·NCT04364321·74 enrolled

Opioid Analgesia3 trials

Nonopioid Analgesia After Labral Surgery

Recruiting·HHenry Ford Health System·Phase 2/3·NCT03825809·100 enrolled

Nonopioid Analgesia After Rotator Cuff Repair

Completed·HHenry Ford Health System·Phase 2·NCT03818919·70 enrolled

Nonopioid Analgesia After Arthroscopic Meniscus Surgery

Completed·HHenry Ford Health System·Phase 1·NCT03820193·61 enrolled

Treatment2 trials

Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse

Completed·UUniversity Hospital, Lille·N/A·NCT02242955·26 enrolled

Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome

Withdrawn·SSwedish Medical Center·Phase 4·NCT04216797

Anxiety2 trials

Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

Completed·UUniversidade Estadual Paulista Júlio de Mesquita Filho·Phase 1·NCT03165500·3 enrolled

Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively

Completed·UUniversity of Jordan·Phase 3·NCT06103188·87 enrolled

29 more indications

Epilepsy2 trials

Diazepam Trial in GAD65 Associated Epilepsy

Withdrawn·MMayo Clinic·Phase 1/2·NCT05361447

Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Completed·NNeurelis, Inc.·Phase 1/2·NCT05076838·35 enrolled

Efficacy2 trials

Clinical Efficacy of Diazepam After Whiplash

Completed·EEdin Mešanović·Phase 4·NCT05041985·89 enrolled

Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome

Terminated·MMayo Clinic·Phase 2/3·NCT02904265·3 enrolled

Psychosis2 trials

Investigating the Role of Diazepam on Brain Function and Chemistry in Psychosis Risk

Completed·KKing's College London·N/A·NCT06190483·24 enrolled

Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis

Completed·—·Phase 4·NCT01939093·80 enrolled

Blood Pressure1 trial

Diazepam and Blood Pressure Regulation

Completed·UUniversity of Brasilia·Phase 1·NCT05069779·40 enrolled

Oocyte Retrieval1 trial

A Non-inferiority Trial on Pain Relief During Oocyte Retrieval

Completed·KKwong Wah Hospital·Phase 4·NCT02494180·170 enrolled

Anterior Cruciate Ligament Reconstruction1 trial

Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction

Completed·HHenry Ford Health System·Phase 2/3·NCT03818932·90 enrolled

Status Epilepticus1 trial

Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 3·NCT00004297·210 enrolled

Abdominal pain1 trial

Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain

Completed·RRadboud University Medical Center·Phase 2·NCT01318369·24 enrolled

Convulsion1 trial

Intermittent Levetricetam in Treatment of Febrile Convulsions

Unknown status·—·N/A·NCT05860153·100 enrolled

Nerve Block1 trial

Combined Intravenous Diazepam, Local Periprostatic Nerve Block for Prostate Biopsy

Completed·—·Phase 2/3·NCT02935972·336 enrolled

Post-Traumatic Stress Disorder, PTSD1 trial

Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam

Unknown status·HHadassah Medical Organization·Phase 4·NCT01221883·40 enrolled

Pelvic Pain1 trial

Vaginal Diazepam for the Treatment of Female Pelvic Pain

Completed·RRaymond Foster·Phase 2·NCT01938092·50 enrolled

Post Operative Pain1 trial

Impact of Placement of a Diazepam Suppository on Early Postoperative Pain Following Pelvic Reconstructive Surgery

Unknown status·TTriHealth Inc.·Phase 4·NCT04198233·130 enrolled

Liposomal Bupivacaine1 trial

Liposomal Bupivacaine in Implant Based Breast Reconstruction

Terminated·LLoma Linda University·N/A·NCT02659501·24 enrolled

Sedation1 trial

Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)

Completed·AAvanti Anesthesia·N/A·NCT03653520·651 enrolled

Low back pain1 trial

Diazepam Use With Standard Management for Acute Low Back Pain

Completed·MMontefiore Medical Center·Phase 2/3·NCT02646124·114 enrolled

Multimodal Analgesia1 trial

Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing IUD

Completed·TTriHealth Inc.·N/A·NCT02799641·61 enrolled

Function1 trial

Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.

Completed·TTriHealth Inc.·N/A·NCT01233791·48 enrolled

Hemodynamic Changes1 trial

Comparative Study of Hemodynamic Changes Caused by Diazepam and Midazolam During Third Molar Surgery

Completed·JJimmy Barbalho·Phase 4·NCT02177955·120 enrolled

Peripheral Vertigo1 trial

Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo

Not yet recruiting·UUniversity of Monastir·Phase 3·NCT06293989·1,000 enrolled

Adult1 trial

A Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers

Completed·AAcorda Therapeutics·Phase 1·NCT02663999·15 enrolled

Abuse Potential1 trial

Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience

Completed·VViatris Specialty LLC·Phase 4·NCT04570436·52 enrolled

Chronic1 trial

An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.

Terminated·AAcorda Therapeutics·Phase 2·NCT02316847·126 enrolled

Midazolam1 trial

A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants

Completed· UCB logo

UCB·Phase 1·NCT07020988·55 enrolled

Back pain1 trial

Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department

Completed·SSan Antonio Military Medical Center·N/A·NCT03996564·26 enrolled

Intravenous Administration1 trial

A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers

Completed·UUniversity of Minnesota·Phase 1·NCT01364558·24 enrolled

Drug1 trial

A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users

Completed· Roche logo

Roche·Phase 1·NCT01438749·177 enrolled

Constipation1 trial

Biofeedback for Dyssynergic Constipation

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·N/A·NCT00127257·117 enrolled

Unspecified5 trials

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Lofexidine for Inpatient Opiate Detox in Singapore

Completed·IInstitute of Mental Health, Singapore·Phase 4·NCT01675648·112 enrolled

Exploring the Effects of Diazepam and Lorazepam

Completed·UUniversity Hospital, Strasbourg, France·N/A·NCT00696033·22 enrolled

Show 2 more trials

Effects of Diazepam on RNS Detections

Completed·UUniversity of Cincinnati·Phase 4·NCT05273398·4 enrolled

Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)

Terminated·AAcorda Therapeutics·Phase 2·NCT02474407·78 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

VALRELEASE

NDA NDA018179

Jan 1, 1982

VALIUM

NDA NDA016087

Jan 1, 1982

VALIUM

NDA NDA013263

Dec 5, 1990

DIAZEPAM

NDA NDA020124

Jun 18, 1993

DIZAC

NDA NDA019287

Jul 29, 1997

DIASTAT

NDA NDA020648

Jan 10, 2020

VALTOCO

NDA NDA211635

Sources

References

[1]
ClinicalTrials.gov — 52 trial records for Diazepam. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Valium drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Diazepam compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Diazepam. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211635). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Valium. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Akero Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: GABA-a Receptor; Anion Channel Positive Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Akero Therapeutics

Patent Landscape[6]

Patent Cliff

Mar 27, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11241414Mar 27, 2029

12268664Mar 27, 2029

12521400Mar 27, 2029

11793786Mar 27, 2029

8895546Mar 27, 2029

3 more patents

12337061Jun 13, 2032

12324852Oct 16, 2032

12599611Jun 10, 2042

Valium

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Alcohol Withdrawal5 trials

Seizure4 trials

Opioid Analgesia3 trials

Treatment2 trials

Anxiety2 trials

Epilepsy2 trials

Efficacy2 trials

Psychosis2 trials

Blood Pressure1 trial

Oocyte Retrieval1 trial

Anterior Cruciate Ligament Reconstruction1 trial

Status Epilepticus1 trial

Abdominal pain1 trial

Convulsion1 trial

Nerve Block1 trial

Post-Traumatic Stress Disorder, PTSD1 trial

Pelvic Pain1 trial

Post Operative Pain1 trial

Liposomal Bupivacaine1 trial

Sedation1 trial

Low back pain1 trial

Multimodal Analgesia1 trial

Function1 trial

Hemodynamic Changes1 trial

Peripheral Vertigo1 trial

Adult1 trial

Abuse Potential1 trial

Chronic1 trial

Midazolam1 trial

Back pain1 trial

Intravenous Administration1 trial

Drug1 trial

Constipation1 trial

Unspecified5 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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