Versed

(Midazolam)

ApprovedSmall molecule

Midazolam is used to calm patients before medical procedures and surgeries, and to help control seizures. It works by slowing down brain activity to reduce anxiety and help people relax or fall asleep.[2] Versed is currently approved and in use across 111 indications[4].[1]

Versed is one of 1659 small molecule programs targeting Interaction. It is currently in Approved.

111

Indications

831

Total Trials

Active Trials

1,658

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

InteractionWithdrawn

ARTRecruiting

SunburnActive, not recruiting

AbortionActive, not recruiting

Aggressive BehaviorApproved

HypotensionApproved

Urinary Tract InfectionApproved

Nicotine DependenceApproved

Fluoride PoisoningApproved

HypertensionApproved

InteractionApproved

Withdrawn

ARTPhase 1

Recruiting

SunburnApproved

Active, not recruiting

AbortionApproved

Active, not recruiting

Aggressive BehaviorApproved

Approved

HypotensionApproved

Approved

Urinary Tract InfectionApproved

Approved

Nicotine DependenceApproved

Approved

Fluoride PoisoningApproved

Approved

HypertensionApproved

Approved

Showing 10 of 105 indications

Competition

Competitive Landscape

254 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Phase 3

25 2

Adrucil

EElorac, Inc.

Phase 3

86 3

Versed

CConrado Roberto Hoffmann Filho

Approved

1 4

Bayer Aspirin

Bayer

Phase 3

7 5

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

8 6

Decadron

AAspen Global Incorporated

Phase 3

7 7

XL092

Roche

Phase 3

1 8

Botensilimab

AAgenus Inc.

Phase 3

9 9

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Phase 3

2 10

Iron Isomaltoside

TThomas Jefferson University

Phase 3

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Atrial Fibrillation

NCT05891145

Post-ApprovalNot yet recruiting

Extracorporeal Membrane Oxygenation

NCT06934811

Q1 2027

N/ANot yet recruiting

Cesarean Section

NCT07386054

Phase 2Not yet recruiting

Treatment

NCT06228391

Q2 2027

Phase 1/2Recruiting

Sedation

NCT07443254

Q2 2028

Phase 3Not yet recruiting

Suicidal Ideation

NCT06957704

Clinical

Trials by Indication[1]

Sedation37 trials

Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department

Withdrawn·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT03399838

Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction

Unknown status·TTel-Aviv Sourasky Medical Center·N/A·NCT03041506·90 enrolled

Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT06878703·380 enrolled

Show 34 more trials

Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)

Not yet recruiting·OOman Medical Speciality Board·N/A·NCT07166666·128 enrolled

Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Unknown status·HHospital Sao Domingos·Phase 4·NCT01256866·146 enrolled

Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy

Completed·—·Phase 4·NCT01934088·130 enrolled

The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

Completed·—·N/A·NCT01444976·76 enrolled

Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Unknown status·UUllevaal University Hospital·Phase 3·NCT01091818·40 enrolled

Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children

Unknown status·—·Phase 4·NCT02408302·90 enrolled

Remimazolam Versus Midazolam for Sedation During Upper GI Endoscopy: a Randomized Controlled Trial

Recruiting·KKoen Munters·Phase 4·NCT06614036·148 enrolled

Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP

Unknown status·HHanyang University·N/A·NCT01900938·210 enrolled

Sedation During Spinal Anesthesia

Completed·—·Phase 2·NCT03133780·80 enrolled

Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

Completed·SSeoul National University Hospital·N/A·NCT03055663·37 enrolled

A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration

Completed·SSeoul National University Hospital·N/A·NCT02157818·110 enrolled

The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy

Completed·UUfuk University·Phase 4·NCT02486328·103 enrolled

Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation

Completed·GGuangzhou Institute of Respiratory Disease·Phase 4·NCT03901716·60 enrolled

Prospective IR-led Sedation Feasibility

Recruiting·—·Phase 1/2·NCT07443254·40 enrolled

Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

Unknown status·GGovind Ballabh Pant Hospital·Phase 4·NCT01356121·120 enrolled

Sedation and Pain (The Effect of IV Sedation on Pain Perception)

Completed·UUniversity of Alabama at Birmingham·N/A·NCT00853333·86 enrolled

Lorazepam Sedation for Critically Ill Children

Completed·TThe Emmes Company, LLC·Phase 2/3·NCT00109395·179 enrolled

Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for Dental Extractions.

Unknown status·GGuy's and St Thomas' NHS Foundation Trust·Phase 3·NCT05220462·128 enrolled

A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department

Completed·UUniversity of Colorado, Denver·Phase 4·NCT03085563·63 enrolled

Efficacy, Safety and Pharmacokinetic Study of Intravenous Clonidine Versus Midazolam for Sedation in Paediatric Patients

Terminated·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT02509273·28 enrolled

Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery

Recruiting·RRomanian Society for Enteral and Parenteral Nutrition·Phase 3·NCT07113483·120 enrolled

Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine

Terminated·UUniversity of Louisville·N/A·NCT02129426·21 enrolled

Comparison of Intubation With Nerve Block and With Sedation in Awake Patients

Unknown status·TTehran University of Medical Sciences·Phase 3·NCT01768377·70 enrolled

Dexmedetomidine Sedation in Orthopedic Surgery

Unknown status·—·Phase 2·NCT04149626·60 enrolled

A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty

Unknown status·TThe University of The West Indies·Phase 3·NCT02444260·180 enrolled

Efficacy of Moderate Sedation for Dental Treatment of Young Children

Completed·UUniversidade Federal de Goias·Phase 4·NCT00902395·41 enrolled

Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

Completed·SSamsung Medical Center·Phase 3·NCT05836545·132 enrolled

The Effect of Midazolam Sedation on Diagnostic Medial Branch Blocks

Completed·HHenry Ford Health System··NCT04453449·95 enrolled

Midazolam With Meperidine and Dexmedetomidine vs. Midazolam With Meperidine and Propofol for Sedation During ERCP

Completed·—·Phase 4·NCT02475824·258 enrolled

Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 3·NCT00481312·501 enrolled

Sedation Strategies for Diagnostic Bronchoscopy

Terminated·—·N/A·NCT03406533·28 enrolled

Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia

Unknown status·HHallym University Medical Center·N/A·NCT03399019·45 enrolled

Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

Completed·LLena Nilsson·N/A·NCT03357393·150 enrolled

Sevoflurane- Safety in Long-term Sedation Procedures

Withdrawn·FF Javier Belda·Phase 3·NCT01802255

Midazolam17 trials

A Study in Healthy Female Participants to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03111511·18 enrolled

A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05901714·65 enrolled

Intranasal Midazolam in Children as a Pre-Operative Sedative

Completed·BBassett Healthcare·Phase 4·NCT02314546·15 enrolled

Show 14 more trials

Comparison Between Dexmeditomidine, Midazolam and Ketamine as a Sedative to Help Cannula Insertion in Pediatric Patient

Completed·—·Phase 2/3·NCT04704622·150 enrolled

A Study to Investigate the Effect of Single and Repeated Oral Doses of ACT-539313 on What the Body Does to Flurbiprofen, Omeprazole, Midazolam in Healthy Subjects

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05254548·22 enrolled

Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Midazolam in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02256748·20 enrolled

Phase I Trail for Intramuscular Administration of Midazolam Using An Autoinjector

Completed·UU.S. Army Office of the Surgeon General·Phase 1·NCT00534378·39 enrolled

A Phase I Study With LEO 32731 and Midazolam in Healthy Male Subjects

Terminated· LEO Pharma logo

LEO Pharma·Phase 1·NCT02753218·12 enrolled

DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan

Completed·DDrugs for Neglected Diseases·Phase 1·NCT05947604·20 enrolled

A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06327256·40 enrolled

Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam

Completed·—·Phase 2·NCT04072328·30 enrolled

A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05480488·18 enrolled

Effect of Ridaforolimus on the Pharmacokinetics of Midazolam (Study MK-8669-044)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01071304·16 enrolled

Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

Completed·SSanthera Pharmaceuticals·Phase 1·NCT06689527·18 enrolled

Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children

Completed·TTishreen University·Phase 2/3·NCT03725995·63 enrolled

Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants

Completed·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT04545944·20 enrolled

Study to Assess the Effect of Multiple Doses of Tradipitant on CYP3A4 Using Midazolam as a Substrate in Healthy Subjects

Completed·VVanda Pharmaceuticals·Phase 1·NCT02621385·24 enrolled

Interaction16 trials

Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT04498741·89 enrolled

A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT06392659·42 enrolled

Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam

Completed· LEO Pharma logo

LEO Pharma·Phase 1·NCT03126578·32 enrolled

Show 13 more trials

Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe Drugs

Completed· GSK logo

GSK·Phase 1·NCT00920088·24 enrolled

Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

Completed·Ppharmaand GmbH·Phase 1·NCT02740712·17 enrolled

A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects

Completed·FF-star Therapeutics, Inc.·Phase 1·NCT03493698·17 enrolled

A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT03988907·35 enrolled

Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer Subjects

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT01517399·28 enrolled

A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects

Completed·AAntios Therapeutics, Inc·Phase 1·NCT05137600·36 enrolled

A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872

Completed·AAlios Biopharma Inc.·Phase 1·NCT02888327·68 enrolled

A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers

Completed·BBiota Scientific Management Pty Ltd·Phase 1·NCT02204501·24 enrolled

A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT06917508·24 enrolled

Drug-drug Interaction Study With GLPG3667 and Midazolam in Healthy Subjects

Completed·GGalapagos NV·Phase 1·NCT04736927·14 enrolled

Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

Completed· Bayer logo

Bayer·Phase 1·NCT02975440·12 enrolled

Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT05032950·12 enrolled

Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of CTX 4430 and Midazolam

Completed·CCeltaxsys, Inc.·Phase 1·NCT02233244·20 enrolled

Dexmedetomidine7 trials

Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy

Completed·UUniversity of Patras·Phase 3·NCT06185127·50 enrolled

Dexmedetomidine Premedication in Hypertensive Patients

Completed·—·Phase 3·NCT02058485·162 enrolled

Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

Completed·NNational Cancer Institute, Egypt·N/A·NCT04597268·75 enrolled

Show 4 more trials

Dexmedetomidine Facilitate Analgesia

Completed·CChina International Neuroscience Institution·Phase 4·NCT04675372·181 enrolled

The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction

Completed·YYonsei University·N/A·NCT02929095·70 enrolled

Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization

Enrolling by invitation·MMinia University·Phase 3·NCT07013955·144 enrolled

Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Premedication in Pediatric Dental Surgeries

Completed·ZZagazig University·N/A·NCT04226885·39 enrolled

Anxiety6 trials

Ketamine Infusion for Adolescent Depression and Anxiety

Completed·YYale University·Phase 4·NCT02579928·17 enrolled

Comparative Evaluation of Three Anxiety Control Protocols in Third Molar Extraction

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

Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children

Completed·HHôpital d'enfants Béchir-Hamza·N/A·NCT04049201·112 enrolled

Show 3 more trials

Comparison Between Efficacy of Music Therapy and Intravenous Midazolam 0.02 mg/kgBW in Reducing Preoperative Anxiety

Completed·IIndonesia University·N/A·NCT03269929·60 enrolled

Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children

Completed·—·N/A·NCT05469412·84 enrolled

Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial

Unknown status·UUniversidad de Valparaiso·N/A·NCT03531359·112 enrolled

91 more indications

Tics5 trials

First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants

Completed· GSK logo

GSK·Phase 1·NCT05393271·73 enrolled

Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01766050·45 enrolled

Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers

Completed·AAeovian Pharmaceuticals, Inc.·Phase 1·NCT06205381·89 enrolled

Show 2 more trials

Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00689780·60 enrolled

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT04475848·88 enrolled

Delirium5 trials

The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia

Completed·UUniversity of Baghdad·N/A·NCT05236907·36 enrolled

Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam

Completed·—··NCT05456230·11,927 enrolled

Is Dexmedetomidine Associated With a Lower Incidence of Postoperative Delirium When Compared to Propofol or Midazolam in Cardiac Surgery Patients

Completed·SStanford University··NCT00417664·90 enrolled

Show 2 more trials

Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients

Unknown status·FFuling Central Hospital of Chongqing City·Phase 4·NCT02225210·80 enrolled

The Role of Remazolam in Reducing the Incidence of Postoperative Delirium in Elderly Patients

Completed·FFang Jun·N/A·NCT05466279·131 enrolled

Remimazolam3 trials

A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT01970072·79 enrolled

Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

Unknown status·YYeungnam University Hospital·Phase 2·NCT06275594·330 enrolled

Remimazolam in the Extraction of Impacted Wisdom Teeth

Unknown status·PPeking Union Medical College Hospital·N/A·NCT05350085·150 enrolled

Cesarean Section3 trials

The Effectiveness of Binaural Beats on Midazolam Requirement During Cesarean Section With Spinal Anesthesia

Not yet recruiting·YYonsei University·N/A·NCT07386054·100 enrolled

Intrathecal Nalbuphine Versus Midazolam in Cesarean Section

Completed·ZZagazig University·Phase 1·NCT03918187·90 enrolled

Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section

Completed·QQazvin University Of Medical Sciences·Phase 1/2·NCT01404442·90 enrolled

Colonoscopy2 trials

Compare Propofol to Fentanyl and Midazolam for Colonoscopy

Completed·TTrinity Health Michigan·N/A·NCT01488045·289 enrolled

Comparison of Post Anesthetic Recovery Time in Sedated Patients for Colonoscopy

Completed·FFederal University of Minas Gerais·Phase 4·NCT03813303·50 enrolled

Advanced Cancer2 trials

Pilot Study Comparing Treatment With Dexmedetomidine to Midazolam for Symptom Control in Advanced Cancer Patients

Withdrawn·FFraser Health·Phase 2·NCT01687751

A Study of LY3023414 in Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01655225·156 enrolled

Premedication2 trials

Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-blind, Placebo-controlled Trial

Unknown status·HHospital Authority, Hong Kong·N/A·NCT00563069·120 enrolled

Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty

Completed·—·Phase 4·NCT05369819·120 enrolled

Clinical Trial2 trials

Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy

Completed·—·Phase 4·NCT02909049·100 enrolled

Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Completed·TTabriz University·Phase 4·NCT00636428·50 enrolled

Drug2 trials

Modeling and Application of Triple Drug Response Surface Models

Completed·TTaipei Veterans General Hospital, Taiwan··NCT03813875·100 enrolled

Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.

Completed· Bayer logo

Bayer·Phase 1·NCT04027192·50 enrolled

Treatment Resistant Depression2 trials

Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression

Completed·TThe Cleveland Clinic·N/A·NCT02522377·15 enrolled

Optimization of IV Ketamine for Treatment Resistant Depression

Completed·—·Phase 2·NCT00768430·73 enrolled

Intensive Care Unit2 trials

Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.

Unknown status·KKing Abdullah International Medical Research Center·Phase 3·NCT05485519·430 enrolled

Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)

Terminated·UUniversity of Chicago·Phase 4·NCT01059929·41 enrolled

Treatment2 trials

Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

Completed·UUniversidade Federal de Goias·Phase 4·NCT01795222·18 enrolled

Ketamine Treatment for PTSD and MDD in TBI

Not yet recruiting·MMinneapolis Veterans Affairs Medical Center·Phase 2·NCT06228391·40 enrolled

Safety and Efficacy2 trials

a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

Unknown status·KKing Faisal Specialist Hospital & Research Center·Phase 3·NCT04356638·80 enrolled

Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy

Completed·PPaion UK Ltd.·Phase 3·NCT02532647·79 enrolled

Agitation2 trials

Olanzapine Versus Midazolam for Agitation

Terminated·HHennepin Healthcare Research Institute··NCT03899506·206 enrolled

Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU

Terminated·—·Phase 4·NCT02903407·7 enrolled

Headache2 trials

Bedside Sedation for the Prevention of Post Dural Puncture Headache

Unknown status·TTel-Aviv Sourasky Medical Center·Phase 2·NCT01503788·100 enrolled

Diclofenac Administered Before Skull Operations Reduces the Severity of Headache After the Intervention

Completed·UUniversity of Debrecen·Phase 4·NCT01907984·200 enrolled

Depression2 trials

Ketamine for Treatment Resistant Late-Life Depression

Completed·VVA Office of Research and Development·Phase 3·NCT02556606·33 enrolled

Ketamine in the Treatment of Suicidal Depression

Completed·NNew York State Psychiatric Institute·Phase 4·NCT01700829·82 enrolled

Suicidal Ideation2 trials

Evaluation of the Efficacy and Safety of Subcutaneous Ketamine in the Treatment of Depressive Episode With Suicidal Ideation and/or Behavior in Adolescents

Not yet recruiting·FFederal University of São Paulo·Phase 3·NCT06957704·60 enrolled

Ketamine For Suicidal Ideation

Completed·JJames Murrough·Phase 4·NCT01507181·24 enrolled

Liver Disease1 trial

Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.

Unknown status·SSherief Abd-Elsalam·Phase 4·NCT03063866·100 enrolled

Adult Subject1 trial

A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects

Completed·SSyndax Pharmaceuticals·Phase 1·NCT03187015·26 enrolled

Obesity1 trial

Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity

Completed· Pfizer logo

Pfizer·Phase 1·NCT04621227·16 enrolled

Depressive Disorder1 trial

Ketamine for Relapse Prevention in Recurrent Depressive Disorder

Terminated·SSt Patrick's Hospital, Ireland·Phase 1·NCT02661061·9 enrolled

Chronic Renal Failure1 trial

Effects of Dexmedetomidine Premedication on Geriatric Patients With Chronic Renal Failure Undergoing Hip Surgery

Completed·—·Phase 3·NCT01837290·60 enrolled

Bone Fracture1 trial

Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT00416039·60 enrolled

Cataract1 trial

Oral vs IV Sedation for Cataract Surgery in Older Adults

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT07154147·20 enrolled

Sevoflurane1 trial

Sevoflurane in Subarachnoidal Haemorrhage

Withdrawn·UUniversity of Zurich·Phase 2·NCT02946437

Breast Surgery1 trial

Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00542542·89 enrolled

Critically Ill Patients1 trial

Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients

Completed·—·Phase 4·NCT03030911·30 enrolled

Metabolism1 trial

Resveratrol and Midazolam Metabolism

Completed·UUniversity of Washington·N/A·NCT01173640·6 enrolled

Acute Myeloid Leukemia1 trial

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

Recruiting·KKura Oncology, Inc.·Phase 1/2·NCT04067336·263 enrolled

Adult1 trial

A Study to Learn How Different Amounts of the Study Medicine Called PF-07976016 Are Tolerated and Act in The Body in Healthy Adults

Completed· Pfizer logo

Pfizer·Phase 1·NCT06106009·117 enrolled

Prostate Cancer1 trial

CYP3A4 Activity in Patients With Prostate Cancer Versus Male Patients With Other Solid Tumours

Completed·TThe Netherlands Cancer Institute·N/A·NCT05518799·18 enrolled

Peripheral Nerve Block1 trial

Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks

Terminated·UUniversity of Pennsylvania·Phase 1/2·NCT05610969·36 enrolled

Phase 11 trial

A Phase 1 Dose Escalation Study of VX-973 in Healthy Adults

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT05866055·30 enrolled

Ketamine1 trial

Effect of Ketamine on Laboratory-induced Stress in Healthy Subjects

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT04173962·24 enrolled

Borderline personality disorder1 trial

Ketamine in Borderline Personality Disorder

Terminated·YYale University·Phase 2·NCT03395314·22 enrolled

Double-blind1 trial

Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia

Suspended·PPharmaTher Inc.·Phase 2·NCT04912115·30 enrolled

Schizophrenia1 trial

Multiple Ascending Dose Study on Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective

Completed· Amgen logo

Amgen·Phase 1·NCT02504476·52 enrolled

Status Epilepticus1 trial

Ketamine for the Treatment of Refractory Status Epilepticus

Not yet recruiting·TThomas Jefferson University·Phase 4·NCT07177235·50 enrolled

Advanced/Metastatic Cancer1 trial

A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02857270·210 enrolled

Fatigue1 trial

Effect of Ketamine on Fatigue Following Cancer Therapy

Terminated·NNational Institute of Nursing Research (NINR)·Phase 1·NCT02317341·2 enrolled

Bronchoscopy1 trial

A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

Completed·PPaion UK Ltd.·Phase 3·NCT02296892·446 enrolled

Efficacy and Safety1 trial

A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients

Completed·PPaion UK Ltd.·Phase 3·NCT02290873·461 enrolled

Loss of consciousness1 trial

Remifentanil and Midazolam on Propofol for Loss of Consciousness

Completed·SSeverance Hospital·N/A·NCT02536690·120 enrolled

Postoperative Recovery1 trial

Psychological Influences on Postoperative Recovery

Completed·UUniversity of California, Irvine·Phase 2·NCT00581139·241 enrolled

Nausea and vomiting1 trial

Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia

Completed·YYonsei University·N/A·NCT05736341·80 enrolled

Glioma1 trial

Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma

Completed·—·N/A·NCT02439164·36 enrolled

Mechanical Ventilation1 trial

The Diversity of Intestinal Microbiota in Patients With Different Sedative-hypnotics Undergoing Mechanical Ventilation

Withdrawn·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·N/A·NCT03401736

Septic Shock1 trial

Dexmedetomidine in Modifying Immune Paralysis In Patient With Septic Shock

Completed·KKasr El Aini Hospital·Phase 2·NCT03989609·24 enrolled

Nitrous Oxide1 trial

Nitrous Oxide for PTSD

Terminated·VVA Office of Research and Development·Phase 2·NCT04378426·1 enrolled

Solid Tumors1 trial

A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors

Completed· Takeda logo

Takeda·Phase 1·NCT03420742·24 enrolled

Hyperalgesia1 trial

The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers

Unknown status·MMedical University of Vienna·Phase 4·NCT00886106·24 enrolled

Overweight1 trial

A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06564441·34 enrolled

Single Dose1 trial

Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects

Completed·CConcert Pharmaceuticals·Phase 1·NCT05467709·20 enrolled

Alpha-1 Antitrypsin Deficiency1 trial

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD)

Completed·UUniversity of Florida··NCT01810458·109 enrolled

Multimodal Analgesia1 trial

PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

Completed·WWashington University School of Medicine·Phase 2·NCT03084536·134 enrolled

Lung Cancer1 trial

Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic

Completed·—·Phase 4·NCT00440960

Women1 trial

A Study of Imlunestrant (LY3484356) in Healthy Women

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05509816·20 enrolled

Oocyte Retrieval1 trial

A Non-inferiority Trial on Pain Relief During Oocyte Retrieval

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

Extracorporeal Membrane Oxygenation1 trial

Ciprofol's Impact on Oxygenator Function in Extracorporeal Membrane Oxygenation (ECMO) Patients

Not yet recruiting·FFirst Affiliated Hospital of Wannan Medical College·Phase 4·NCT06934811·30 enrolled

Sunburn1 trial

The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)

Unknown status·MMedical University of Vienna·Phase 4·NCT01015482·24 enrolled

Atrial Fibrillation1 trial

Remimazolam for Postoperative Atrial Fibrillation

Recruiting·YYangzhou University·N/A·NCT05891145·50 enrolled

Remimazolam Besylate1 trial

Sedative Effect and Safety of Remimazolam Besylate in ARDS Patients

Recruiting·ZZhiming Jiang·Phase 4·NCT05758597·100 enrolled

Bupivacaine1 trial

Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

Completed·—·Phase 2/3·NCT03592537·90 enrolled

Endoscopy1 trial

Effect of the Antihistamine Injection to Prevent Paradoxical Reaction During Sedative Endoscopy

Unknown status·SSeoul National University Hospital·N/A·NCT03940391·220 enrolled

Post-Traumatic Stress Disorder1 trial

Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2/3·NCT02397889·30 enrolled

Preoperative1 trial

Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication

Completed·—·Phase 4·NCT01976845·139 enrolled

Remifentanil1 trial

Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy

Completed·KKonkuk University Medical Center·Phase 4·NCT01693185·60 enrolled

Major Depressive Disorder1 trial

Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression.

Completed·SSunnybrook Health Sciences Centre·Phase 1·NCT02593643·9 enrolled

Outcome1 trial

The Effect of Etomidate on Outcomes of Trauma Patients

Withdrawn·—·N/A·NCT00938990

Single Ascending Dose1 trial

First-in-human: Single Ascending Dose, Food Effect, Drug-drug Interaction, Multiple Ascending Dose, Proof of Pharmacology

Completed· Astellas logo

Astellas·Phase 1·NCT02420782·116 enrolled

Resistance1 trial

Changes of Skin Resistance After Midazolam and After the End of Anaesthesia

Completed·—·Phase 4·NCT03791424·28 enrolled

Drug Interactions1 trial

Study of Potential for Drug Interactions Mediated by CYP3A4 Inhibition With Aramchol in Healthy Volunteers

Completed·GGalmed Pharmaceuticals Ltd·Phase 1·NCT03760848·15 enrolled

Inguinal hernia1 trial

Comparison of Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair

Unknown status·SSheikh Zayed Medical College·Phase 1·NCT05337085·185 enrolled

Solid Tumor1 trial

Drug Interaction Study of SAR302503 in Patients With Solid Tumor

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01585623·16 enrolled

Pilot Study1 trial

Audiovisual Aid Pilot Study

Completed·HHospital for Special Surgery, New York·N/A·NCT02506673·26 enrolled

Bipolar Depression1 trial

Ketamine for Suicidality in Bipolar Depression

Completed·NNew York State Psychiatric Institute·Phase 1/2·NCT01944293·16 enrolled

Cancer1 trial

The Influence of Phenotype, Grapefruit Juice and Orange Juice on the Pharmacokinetics of Sunitinib in Cancer Patients

Completed·LLeiden University Medical Center·Phase 1·NCT01743300·15 enrolled

Monitored Anaesthesia Care1 trial

Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care During Vertebroplasty and Kyphoplasty

Completed·HHallym University Medical Center·N/A·NCT02476981·75 enrolled

Cocaine Dependence1 trial

The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence

Terminated·NNew York State Psychiatric Institute·Phase 1/2·NCT01535937·55 enrolled

Nerve Block1 trial

Music vs Midazolam During Preop Nerve Block Placement

Completed·UUniversity of Pennsylvania·Phase 3·NCT03069677·160 enrolled

Stroke1 trial

Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions

Terminated·UUniversity Hospitals Cleveland Medical Center·Phase 2·NCT01845441·7 enrolled

Pediatric Patients1 trial

Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients

Unknown status·SSecond Affiliated Hospital of Wenzhou Medical University·Phase 4·NCT04135014·138 enrolled

Mechanically Ventilated Patients1 trial

Pilot Study Evaluating Stress Response and Immune Function in Mechanically Ventilated Patients With Alcohol Use Disorders Treated With Propofol or Midazolam

Withdrawn·VVirginia Commonwealth University·Phase 4·NCT00871039

Major Depression1 trial

Ketamine As an Adjunctive Therapy for Major Depression (2)

Completed·UUniversity of Dublin, Trinity College·Phase 3·NCT04939649·63 enrolled

Memory1 trial

Memory Modulation by Pain During Anesthesia

Completed·UUniversity of Pittsburgh·Phase 1·NCT02515890·32 enrolled

Abuse Potential1 trial

Abuse Potential of Intravenous Remimazolam Compared to Midazolam and Placebo in Recreational CNS Depressant Users

Completed·PPaion UK Ltd.·Phase 1·NCT04110535·83 enrolled

Local Infiltration1 trial

Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery

Withdrawn·UUniversity of Pennsylvania·N/A·NCT02970097

Intravenous1 trial

To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients

Completed· GSK logo

GSK·Phase 1·NCT00258050·24 enrolled

Children1 trial

Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

Unknown status·SShaare Zedek Medical Center·N/A·NCT00886314·80 enrolled

Non-Small Cell Lung Cancer1 trial

Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

Completed· Takeda logo

Takeda·Phase 1·NCT04051827·26 enrolled

Unspecified2 trials

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ODM-108: in Healthy Male Volunteers

Terminated· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 1·NCT02432664·85 enrolled

Influence of the MDR1 Genotype on Blood Levels of Indinavir and Saquinavir in Healthy Volunteers

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 4·NCT00050180·81 enrolled

Regulatory

FDA Approval Timeline[5]

May 26, 1987

VERSED

NDA NDA018654

Oct 15, 1998

VERSED

NDA NDA020942

Sep 14, 2018

SEIZALAM

NDA NDA209566

May 17, 2019

NAYZILAM

NDA NDA211321

Mar 22, 2021

MIDAZOLAM IN 0.9% SODIUM CHLORIDE

NDA NDA211844

Jul 20, 2022

MIDAZOLAM IN 0.8% SODIUM CHLORIDE

NDA NDA215868

Aug 8, 2022

MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)

NDA NDA216359

Sources

References

[1]
ClinicalTrials.gov — 831 trial records for Midazolam. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Versed drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Midazolam compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Midazolam. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216359). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Versed. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Conrado Roberto Hoffmann Filho 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: CConrado Roberto Hoffmann Filho

Patent Landscape[6]

Patent Cliff

Jan 18, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9687495Jan 18, 2028

9289432Jan 18, 2028

8217033Jan 18, 2028

8809322Jan 18, 2028

10966990Jun 20, 2038