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 116 indications[4].[1]

Versed is one of 1764 small molecule programs targeting Interaction. It is currently in Approved.

116

Indications

816

Total Trials

Active Trials

1,763

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

InteractionWithdrawn

Advanced CancerCompleted

ARTRecruiting

SunburnActive, not recruiting

AbortionActive, not recruiting

Aggressive BehaviorApproved

HypotensionApproved

Urinary Tract InfectionApproved

Nicotine DependenceApproved

Fluoride PoisoningApproved

InteractionApproved

Withdrawn

Advanced CancerPhase 1

Completed

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

Showing 10 of 110 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Versed

CConrado Roberto Hoffmann Filho

Approved

3 2

Adenocard

Astellas

Preclinical

2 3

Zolymbus

AbbVie

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Spravato

WWim Janssens

Preclinical

2 9

Duragesic

CCephalon

Preclinical

1 10

Nubain

AAultman Health Foundation

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Sedation

NCT07184801

Q2 2027

Post-ApprovalNot yet recruiting

Sedation

NCT06736938

Recruiting

Status Epilepticus

NCT05313308

Q3 2027

Post-ApprovalNot yet recruiting

Delirium

NCT07265128

Phase 3Not yet recruiting

Sedation

NCT07155265

Q4 2029

Phase 3Recruiting

Sedation

NCT06878703

Clinical

Trials by Indication[1]

Sedation30 trials

A Single-centre Study of Entonox Versus Midazolam Sedation in Gastroscopy

Terminated·—·Phase 4·NCT01744184·62 enrolled

Intranasal Dexmedetomidine Versus Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging

Unknown status·—·Phase 3·NCT05192629·250 enrolled

The Effect of Sedation on Eye Movements

Completed·UUniversity of Alabama at Birmingham·N/A·NCT00646646·65 enrolled

Show 27 more trials

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

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

Completed·—·Phase 4·NCT01934088·130 enrolled

Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction

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

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

Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy

Recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT07184801·56 enrolled

The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas

Completed·—·N/A·NCT03984240·38 enrolled

Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation

Unknown status·—·Phase 3·NCT02801201·200 enrolled

Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy

Completed·—·Phase 4·NCT06181188·66 enrolled

Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine

Not yet recruiting·FFondazione Andrea Cesalpino Arezzo ONLUS·Phase 4·NCT06736938·530 enrolled

Effects of Two Different Sedation Regimes on Auditory Evoked Potentials and Electroencephalogram (EEG)

Completed·IInsel Gruppe AG, University Hospital Bern·N/A·NCT00641563·10 enrolled

Dexmedetomidine vs Midazolam for Intraoperative Sedation

Completed·IInstituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo·Phase 4·NCT02878837·120 enrolled

Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years

Completed·UUniversity of Washington·Phase 4·NCT04068948·37 enrolled

Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam

Unknown status·ZZhujiang Hospital·N/A·NCT05160987·440 enrolled

Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy

Completed·FFDA Office of Orphan Products Development·N/A·NCT00004424·120 enrolled

Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy

Completed·HHospital Universitario La Fe·N/A·NCT01038882·238 enrolled

Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: Study Comparing Midazolam and Propofol With Midazolam

Terminated·YYonsei University·N/A·NCT01617707·11 enrolled

Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation

Unknown status·TTehran University of Medical Sciences·Phase 4·NCT01749579·60 enrolled

Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy

Recruiting·QQassim Health Cluster·Phase 4·NCT06763705·157 enrolled

REMIMID-ICU: Remimazolam vs Midazolam for Deep Sedation in Hemodynamically Unstable, Mechanically Ventilated Adults

Not yet recruiting·—·Phase 3·NCT07155265·180 enrolled

Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old

Completed·SSedana Medical·Phase 3·NCT04684238·94 enrolled

Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation

Terminated·AART Fertility Clinics LLC··NCT04397393·26 enrolled

Study of Comparison of the Effectiveness of Three Diagrams for Sedation in Spinal Anesthesia

Completed·UUniversidad de Cartagena·Phase 4·NCT02136641·75 enrolled

Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

Completed·PPeking University·Phase 4·NCT04602845·81 enrolled

Effect of Remazolam Besylate Combined With Remifentanil Analgesic Sedation on the Prognosis of Patients With Sepsis

Enrolling by invitation·FFirst Affiliated Hospital of Ningbo University·Phase 4·NCT06731088·100 enrolled

Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study

Unknown status·RRabin Medical Center·N/A·NCT03635398·300 enrolled

Hypnosis vs Midazolam for Sedation for TEE

Completed·—··NCT01749475·98 enrolled

Etomidate vs. Midazolam for Sedation During ERCP

Completed·—·Phase 4·NCT02027311·63 enrolled

Interaction24 trials

Drug-drug Interaction Study of Gepotidacin

Completed· GSK logo

GSK·Phase 1·NCT04493931·64 enrolled

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

Show 21 more trials

A Drug-drug Interaction Study of Avapritinib and Midazolam

Completed·BBlueprint Medicines·Phase 1·NCT04908176·10 enrolled

Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam

Completed·GGlobal Alliance for TB Drug Development·Phase 1·NCT01768273·14 enrolled

PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates

Completed·MMirati Therapeutics Inc.·Phase 1·NCT04887194·40 enrolled

A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam

Completed·JJiangsu Kanion Pharmaceutical Co., Ltd·Phase 4·NCT02233972·15 enrolled

A Preliminary Drug Drug Interaction Study With TA-8995

Completed·XXention Ltd·Phase 1·NCT02124954·18 enrolled

A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06704763·27 enrolled

TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam

Completed·TToray Industries, Inc·Phase 1·NCT03043248·48 enrolled

Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants

Completed·IInstitut de Recherches Internationales Servier (I.R.I.S.)·Phase 1·NCT07235748·28 enrolled

Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation

Completed· GSK logo

GSK·Phase 1·NCT00964106·87 enrolled

Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT03363984·20 enrolled

A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05573230·32 enrolled

Drug-Drug Interaction Study: ASP2151 and Midazolam

Completed·MMaruho Europe Limited·Phase 1·NCT02403635·27 enrolled

Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam

Completed· Takeda logo

Takeda·Phase 1·NCT02370615·34 enrolled

Drug Interaction Study of Isavuconazole and Midazolam

Completed· Astellas logo

Astellas·Phase 1·NCT01406171·24 enrolled

A Drug Interaction Study of ACH-0145228

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04709081·38 enrolled

Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin

Completed·GGuangdong Raynovent Biotech Co., Ltd·Phase 1·NCT06031454·56 enrolled

HCV-796 and Midazolam Drug Interaction Study in Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00410254·38 enrolled

Drug Interaction Study of CT1812 in Healthy Volunteers

Completed·CCognition Therapeutics·Phase 1·NCT03716427·16 enrolled

Drug-drug Interaction Study of Evobrutinib With Midazolam in Healthy Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT04697511·16 enrolled

A Drug-Drug Interaction Study of LY3537982 on Midazolam, Digoxin, and Rosuvastatin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06111521·35 enrolled

A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT03017495·20 enrolled

Midazolam21 trials

This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 1358894 Affects the Way the Body Breaks Down Midazolam

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03754959·50 enrolled

Intranasal Midazolam in Children as a Pre-Operative Sedative

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

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

Show 18 more trials

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

A Study to Determine the Effects of PF-04965842 on Midazolam PK in Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT03647670·25 enrolled

A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants

Completed· Bayer logo

Bayer·Phase 1·NCT06360211·15 enrolled

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03139500·47 enrolled

A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT05550636·15 enrolled

The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02254148·24 enrolled

A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02477514·18 enrolled

A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04187456·14 enrolled

Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib

Completed· Sanofi logo

Sanofi·Phase 1·NCT01544140·16 enrolled

Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2

Completed·JJennifer Victory, RN, CCRC·Phase 4·NCT02356705·42 enrolled

A Study to Assess the Effect of Multiple-Dose Administration of JNJ-42847922 on Midazolam and Warfarin in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02617810·18 enrolled

PREMIX vs PREMED Intranasal Lidocaine and Midazolam

Completed·—·Phase 2·NCT03054844·55 enrolled

The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam

Completed· Amgen logo

Amgen·Phase 1·NCT01221727·30 enrolled

Effects of PQ912 on the Pharmacokinetics of Midazolam and Omeprazole

Completed·VVivoryon Therapeutics N.V.·Phase 1·NCT02190708·18 enrolled

Effect of Tepotinib on PK of CYP3A Substrate Midazolam

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03628339·12 enrolled

A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06367153·18 enrolled

Study to Assess the Effect of AZD4831 on the Pharmacokinetics (Drug Behavior in the Body) of Midazolam

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05052710·14 enrolled

Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and Digoxin

Withdrawn· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02345304

Dexmedetomidine7 trials

Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT01159262·36 enrolled

Effect of Midazolam and Dexmedetomidine on Heart Function - A Randomized MRI-based Study.

Completed·—·Phase 4·NCT04529187·30 enrolled

Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

Completed·TTanta University·Phase 4·NCT04652661·60 enrolled

Show 4 more trials

Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy

Unknown status·—·Phase 4·NCT06181682·70 enrolled

Intranasal Dexmedetomidine Premedication in Children

Completed·UUniversity of Mississippi Medical Center·Phase 3·NCT02250703·75 enrolled

Effect of Dexmedetomidine Upon Sleep Postoperatively

Withdrawn·—·Phase 4·NCT00333632

Effects of Dexmedetomidine on the Postoperative Experience in Children

Completed·IInonu University·Phase 4·NCT01748630·42 enrolled

Anxiety4 trials

Effects of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in Children and Adolescents

Unknown status·VValley Anesthesiology Consultants·N/A·NCT03239743·80 enrolled

A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients

Completed·MMelbourne Health·Phase 4·NCT01866605·120 enrolled

Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?

Completed·UUniversity of Medicine and Dentistry of New Jersey·N/A·NCT00932685·119 enrolled

Show 1 more trial

Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department

Completed·—·N/A·NCT03420911·180 enrolled

86 more indications

Drug Interactions4 trials

An Open-label Study in Healthy Participants to Evaluate AZD0780 as an Object or Precipitant of CYP3A4-mediated Drug-drug Interactions

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06671405·59 enrolled

Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride

Completed·AAhon Pharmaceutical Co., Ltd.·Phase 1·NCT06822166·68 enrolled

Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects

Completed·BBridge Biotherapeutics, Inc.·Phase 1·NCT04138836·48 enrolled

Show 1 more trial

Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin

Completed·TTenNor Therapeutics Inc.·Phase 1·NCT06551623·32 enrolled

Status Epilepticus3 trials

Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)

Recruiting·SSohag University·Phase 2/3·NCT07095842·668 enrolled

Effectiveness of Combined Levetiracetam and Midazolam in Generalized Convulsive Status Epilepticus in Children

Completed·SSohag University·Phase 2·NCT04926844·144 enrolled

A Survey of Midazolam in People With Status Epilepticus

Recruiting·CClinigen K.K.··NCT05313308·50 enrolled

Tics3 trials

A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02211079·16 enrolled

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

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RO6889678 and the Combination of RO6889678 With Ritonavir in Healthy Participants

Terminated· Roche logo

Roche·Phase 1·NCT02321384·100 enrolled

ART3 trials

A First-In-Human Study of LY3839840 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06153355·140 enrolled

A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants

Terminated· Eli Lilly logo

Eli Lilly·Phase 1·NCT04586920·104 enrolled

A Study of Lazertinib (JNJ-73841937) in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05076877·20 enrolled

Adult Subject3 trials

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

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

Effect of GSK376501 on CYP450 Activity in Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT00615212·23 enrolled

Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects

Completed·CClementia Pharmaceuticals Inc.·Phase 1·NCT04829773·48 enrolled

Intensive Care Unit3 trials

Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00875550·175 enrolled

Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit

Unknown status·MMinia University·Phase 1·NCT05903963·40 enrolled

Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

Completed· GSK logo

GSK·Phase 4·NCT00158873·224 enrolled

Overweight3 trials

A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults

Completed· Pfizer logo

Pfizer·Phase 1·NCT01707082·69 enrolled

Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01807377·15 enrolled

Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01757756·12 enrolled

Single Dose3 trials

ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ

Completed· Pfizer logo

Pfizer·Phase 1·NCT03762928·12 enrolled

Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam

Completed·TTobira Therapeutics, Inc.·Phase 1·NCT01827540·20 enrolled

A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05932277·22 enrolled

Obesity2 trials

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

Effect of Obesity on Proton Pump Inhibitors

Completed·—·Phase 4·NCT04248335·150 enrolled

Solid Tumors2 trials

Study of Cobimetinib in Participants With Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT00467779·119 enrolled

A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement

Terminated· Pfizer logo

Pfizer·Phase 1·NCT04543188·65 enrolled

Treatment2 trials

Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients

Completed·MMarkus Joerger·Phase 4·NCT01402089·54 enrolled

Intensive 7-day Treatment for PTSD Combining Ketamine With Exposure Therapy

Terminated·YYale University·Phase 2·NCT02727998·28 enrolled

Intravenous2 trials

The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

Unknown status·TTel-Aviv Sourasky Medical Center·Phase 1/2·NCT04242914·30 enrolled

Predictors of Intravenous Ketamine Response in TRD

Unknown status·AAbraham Nunes·Phase 3·NCT05625555·40 enrolled

Treatment Resistant Depression2 trials

Synaptic Imaging and Network Activity in Treatment Resistant Depression

Completed·KKing's College London·N/A·NCT05870501·56 enrolled

Action of Ketamine in Treatment-Resistant Depression

Completed·UUniversity of Ottawa·Phase 2/3·NCT01945047·46 enrolled

Strabismus2 trials

Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery

Completed·YYeditepe University··NCT03806270·45 enrolled

Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

Completed·YYao Yusheng·Phase 4·NCT01895023·156 enrolled

Female2 trials

A Study of Milvexian in Healthy Adult Females

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05706753·20 enrolled

A Study of LY3484356 in Healthy Female Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04840888·82 enrolled

Heart Failure2 trials

Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation

Unknown status·HHeidelberg University··NCT04934410·50 enrolled

A Study to Assess the Effect of Danicamtiv on the Drug Levels of Midazolam in Participants With Stable Heart Failure

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05952089·13 enrolled

Anesthesia2 trials

Epidural Anesthesia for Gynecological Surgeries

Completed·—·Phase 4·NCT04174872·150 enrolled

Measurement of Psychomotor Recovery After Anesthesia Using 4CRT

Completed·UUniversity Medicine Greifswald·Phase 2·NCT02232139·124 enrolled

Agitation2 trials

Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

Completed·IInje University·N/A·NCT02256358·68 enrolled

Sevoflurane Induced Emergence Agitation

Completed·YYeditepe University Hospital·Phase 4·NCT02022488·78 enrolled

Psoriasis1 trial

Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02397382·16 enrolled

Advanced Cancer1 trial

A Study of LY2228820 in Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01393990·89 enrolled

Chronic Cough1 trial

Repeat Doses of BAY1902607 in Healthy Males and Proof of Concept in Chronic Cough Patients

Completed· Bayer logo

Bayer·Phase 1/2·NCT03535168·59 enrolled

AIN1 trial

Project 4A: Inspiratory Muscle Training and Diaphragm Strength

Terminated·UUniversity of Florida·Phase 1/2·NCT02367170·1 enrolled

Hand Surgery1 trial

Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery

Completed·—·Phase 3·NCT02658721·60 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

Chronic Renal Failure1 trial

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

Completed·—·Phase 3·NCT01837290·60 enrolled

Colonoscopy1 trial

Compare Propofol to Fentanyl and Midazolam for Colonoscopy

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

Lip1 trial

The Effect of MDZ on Movement During UIA Clipping

Unknown status·SSeoul National University Hospital·Phase 4·NCT05553678·64 enrolled

Women1 trial

A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT04537897·70 enrolled

Multiple Myeloma1 trial

A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma

Completed· Novartis logo

Novartis·Phase 1·NCT01456689·79 enrolled

Fatigue1 trial

Ketamine for Treatment of MS Fatigue

Completed·JJohns Hopkins University·Phase 1/2·NCT03500289·18 enrolled

Septic Shock1 trial

Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients

Completed·—·Phase 3·NCT03844984·43 enrolled

Acute Myeloid Leukemia1 trial

Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed· Astellas logo

Astellas·Phase 1/2·NCT02014558·265 enrolled

Prophylaxis1 trial

Prophylaxis Against Metoclopramide-Induced Akathisia

Completed·PPamukkale University·N/A·NCT01051271·225 enrolled

Advanced Solid Tumors1 trial

Phase 1 Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam in Subjects With Advanced Solid Tumors

Completed· Eisai logo

Eisai·Phase 1·NCT02686164·51 enrolled

Breast Surgery1 trial

Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

Completed·CCentro di Riferimento Oncologico - Aviano·N/A·NCT04172220·68 enrolled

Sepsis1 trial

The Effect of Dexmedetomidine on Microcirculation in Severe Sepsis

Terminated·NNational Taiwan University Hospital·Phase 4·NCT02109965·12 enrolled

Breast Cancer1 trial

A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Terminated· Roche logo

Roche·Phase 1·NCT01296555·674 enrolled

Caesarean Section1 trial

Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section

Completed·MMohamed Abdelrady Mohamed·Phase 1·NCT03824314·80 enrolled

Trial1 trial

A First-in-human Trial of GRT7041 in Healthy Participants

Recruiting·GGrünenthal GmbH·Phase 1·NCT07289776·70 enrolled

Target-controlled Infusion1 trial

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

Completed·UUniversità Vita-Salute San Raffaele·Phase 4·NCT02062177·140 enrolled

Brain Injury1 trial

Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury

Unknown status·XXiangya Hospital of Central South University·Phase 4·NCT04006054·82 enrolled

Platelet Aggregation1 trial

The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial (PACIFY)

Completed·JJohns Hopkins University·Phase 4·NCT02683707·212 enrolled

Supraclavicular Brachial Plexus Block1 trial

Midazolam in Supraclavicular Brachial Plexus Block

Completed·—·Phase 2·NCT03185351·90 enrolled

Patients With Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT01596647·39 enrolled

Major Depression1 trial

Ketamine as an Adjunctive Therapy for Major Depression

Completed·SSt Patrick's Hospital, Ireland·Phase 1·NCT03256162·25 enrolled

Cardiac Surgery1 trial

Comparison of the Effects of Sevoflurane and Midazolam Used for the Maintenance of Anaesthesia on the Levels of Postoperative Cardiac Troponin I in Pediatric Cardiac Surgery

Unknown status·—·Phase 4·NCT01548859·50 enrolled

Inflammation1 trial

Effects of SEvoflurane on Gas Exchange and Inflammation in Patients With ARDS (SEGA Study)

Completed·UUniversity Hospital, Clermont-Ferrand·Phase 4·NCT02166853·50 enrolled

Obsessive-Compulsive Disorder1 trial

Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder

Terminated·—·Phase 1/2·NCT01371110·3 enrolled

Nerve Block1 trial

Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique

Completed·HHelios Research Center·N/A·NCT01643616·250 enrolled

Phase 11 trial

A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT06345755·159 enrolled

Tobacco Use Disorder1 trial

The Effects of Sedatives on Tobacco Use Disorder Version 2

Completed·WWake Forest University Health Sciences·Phase 1·NCT05505630·20 enrolled

Seizure1 trial

Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

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

Regional Anesthesia1 trial

Regional Anesthesia Versus General Anesthesia

Completed·IIRCCS Azienda Ospedaliero-Universitaria di Bologna·N/A·NCT03830086·28 enrolled

Type 2 Diabetes Mellitus1 trial

A Study of LY3549492 in Participants With Type 2 Diabetes Mellitus (T2DM)

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05327595·80 enrolled

Intraoperative1 trial

Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption

Completed·—·Phase 4·NCT05371600·80 enrolled

Adult1 trial

Safety, Tolerability, Pharmacokinetics, and Food Effect Study of RV299 in Healthy Adults

Completed· Pfizer logo

Pfizer·Phase 1·NCT06033612·50 enrolled

Coronary Artery Bypass1 trial

Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery

Completed·—·N/A·NCT05290324·60 enrolled

Depression1 trial

Ketamine Interleaved With Electroconvulsive Therapy for Depression

Terminated·SSt Patrick's Hospital, Ireland·Phase 1·NCT04082858·3 enrolled

Cognition1 trial

Ketamine in OCD: Efficacy and Effects on Stress and Cognition

Recruiting·MMedical University of Vienna·N/A·NCT05577585·60 enrolled

Pediatric Patients1 trial

Different Premedication in Pediatric Patients

Completed·EEye & ENT Hospital of Fudan University·N/A·NCT04266340·320 enrolled

Superficial Cervical Plexus Block1 trial

Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery

Unknown status·TTanta University·N/A·NCT05476003·45 enrolled

Randomized1 trial

Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study

Completed·OOspedale San Raffaele·Phase 4·NCT01941888·140 enrolled

Hypertensive1 trial

Effect of Midazolam on White-coat Hypertensive Dental Patients

Completed·OOkayama University·N/A·NCT01528371·40 enrolled

Pruritus1 trial

The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus

Completed·YYangzhou University·Phase 1·NCT04326738·90 enrolled

Gastrointestinal Stromal Tumor1 trial

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Active, not recruiting·CCogent Biosciences, Inc.·Phase 3·NCT05208047·442 enrolled

Bronchoscopy1 trial

Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

Withdrawn·—·Phase 4·NCT03613792

Ultrasound1 trial

Ultrasound-guided Axillary Plexus Block - Dose Reduction of Prilocaine

Completed·HHelios Research Center·Phase 4·NCT01309360·120 enrolled

Double-blind1 trial

Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients

Terminated·UUniversity Hospital, Rouen·Phase 3·NCT00290082·120 enrolled

Olanzapine1 trial

IM Olanzapine Versus Haloperidol or Midazolam

Terminated·TThe University of Hong Kong·Phase 4·NCT02380118·167 enrolled

Cataract1 trial

Remimazolam for Cataract Surgery

Recruiting·UUniversity of California, Los Angeles·Phase 4·NCT05980117·120 enrolled

Weight loss1 trial

CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug

Completed·SSt. Antonius Hospital·Phase 4·NCT01519726·20 enrolled

Obese Patients1 trial

Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask

Withdrawn·MMontefiore Medical Center·N/A·NCT03009877

Methotrexate1 trial

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03131973·26 enrolled

Oxidative Stress1 trial

Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients

Terminated·RRennes University Hospital·Phase 3·NCT00336882·30 enrolled

Advanced Malignancies1 trial

A Phase 1 Study of Oprozomib to Assess Food Effect, Drug-Drug Interaction With Midazolam, and Safety and Tolerability in Patients With Advanced Malignancies

Terminated· Amgen logo

Amgen·Phase 1·NCT02244112·43 enrolled

Delirium1 trial

Remimazolam vs Midazolam to Reduce Delirium in Adults ≥65 Undergoing CPB Valve Surgery

Not yet recruiting·YYonsei University·Phase 4·NCT07265128·300 enrolled

Concentration1 trial

Relation Between Blood Concentration of Colchicine and Response to Colchicine Treatment in Gout Flare

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT03933007·26 enrolled

Pediatric Anesthesia1 trial

The Use of ADV6209 for Premedication in Pediatric Anesthesia

Completed·MMedical University of Vienna·Phase 4·NCT03931057·80 enrolled

Complication1 trial

Sedation Complications in Urology During Spinal Anesthesia With Dexmedetomidine or Midazolam Regarding OSA Risk

Completed·UUniversity Hospital of Split·Phase 4·NCT04817033·115 enrolled

Premedication1 trial

Effect of Midazolam Premedication on Mask Ventilation Difficulty

Completed·—·Phase 4·NCT05368441·120 enrolled

Chronic Hepatitis1 trial

Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01525628·72 enrolled

Psoriatic Arthritis1 trial

This Study Tests the Effect of Risankizumab on the Metabolism in the Liver of Five Additional Drugs to Study Possible Drug Interactions in Patients With Psoriasis With or Without Psoriatic Arthritis

Completed· AbbVie logo

AbbVie·Phase 1·NCT02772601·21 enrolled

Atopic Dermatitis1 trial

Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)

Completed· Regeneron logo

Regeneron·Phase 1·NCT02647086·14 enrolled

Oral1 trial

Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT05117554·70 enrolled

Unspecified2 trials

BAY73-4506 Probe Substrate Study

Completed· Bayer logo

Bayer·Phase 1·NCT01287598·41 enrolled

Pharmacokinetic Evaluation of MDZ028

Completed·—··NCT03639428·37 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 — 816 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