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 138 indications[4].[1]

Versed is one of 2288 small molecule programs targeting Glioma. It is currently in Approved.

138

Indications

805

Total Trials

Active Trials

2,287

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

Coronary Artery DiseaseActive, not recruiting

HIV InfectionApproved

Cirrhosis of LiverApproved

MetastasisApproved

Nicotine DependenceApproved

Prostate AdenocarcinomaApproved

Low Back PainApproved

Neck PainApproved

Depressive DisorderActive, not recruiting

GliomaPreclinical

Active, not recruiting

Coronary Artery DiseasePreclinical

Active, not recruiting

HIV InfectionApproved

Approved

Cirrhosis of LiverApproved

Approved

MetastasisApproved

Approved

Nicotine DependenceApproved

Approved

Prostate AdenocarcinomaApproved

Approved

Low Back PainApproved

Approved

Neck PainApproved

Approved

Depressive DisorderPhase 1

Active, not recruiting

Showing 10 of 129 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Versed

CConrado Roberto Hoffmann Filho

Approved

3 2

Tykerb

GSK

Preclinical

80 3

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 4

Zolymbus

AbbVie

Preclinical

1 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

Zinecard

CChildren's Oncology Group

Preclinical

2 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1/2Active, not recruiting

Prostate Cancer

NCT03436485

Q4 2026

Phase 1Recruiting

TED

NCT06916702

Post-ApprovalActive, not recruiting

Anesthesia

NCT00577200

Q3 2027

Phase 3Not yet recruiting

Sedation

NCT07155265

Q3 2028

Post-ApprovalNot yet recruiting

Status Epilepticus

NCT07177235

Clinical

Trials by Indication[1]

Midazolam25 trials

A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT05258110·15 enrolled

Nasogastric Tube Insertion Using Midazolam in the Emergency Department

Completed·UUniversity of Vermont·Phase 4·NCT01375634·49 enrolled

A Study to Assess Effect of BV100 on the Pharmacokinetics of Midazolam in Healthy Participants

Completed·BBioVersys AG·Phase 1·NCT05537090·16 enrolled

Show 22 more trials

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986120 in Healthy Subjects and the Effects of Co-Administration of Midazolam and BMS-986120

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02208882·24 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

Ketamine and Midazolam Infusions for CRPS: Feasibility Study

Withdrawn·SStanford University·Phase 2·NCT05945147

Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

Completed·UUniversity of Alabama at Birmingham·N/A·NCT02396537·77 enrolled

A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01069822·46 enrolled

A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06547164·40 enrolled

Comp Granisetron Midazolam Comb in Lap Children

Unknown status·—·Phase 3·NCT03483350·90 enrolled

A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin

Recruiting·KKaruna Therapeutics·Phase 1·NCT07118215·60 enrolled

A Study to Learn If the Study Medicine Called PF-08049820 Changes How the Body Processes the Other Study Medicines Called Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult Female Participants

Active, not recruiting· Pfizer logo

Pfizer·Phase 1·NCT07190430·16 enrolled

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

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

Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

Completed· Pfizer logo

Pfizer·Phase 4·NCT00952653·28 enrolled

To Evaluate the Effect of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers

Completed·AArdelyx·Phase 1·NCT02140268·65 enrolled

Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam

Completed·SSecuraBio·Phase 1·NCT01925911·14 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

The Study is to Evaluate the Effect of Multiple Doses PF-06751979 on the Pharmacokinetics of Midazolam in Healthy Adults

Completed· Pfizer logo

Pfizer·Phase 1·NCT03126721·12 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

This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03325712·60 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 of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants

Completed·AAgios Pharmaceuticals, Inc.·Phase 1·NCT06648824·20 enrolled

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

Completed·SSanthera Pharmaceuticals·Phase 1·NCT06689527·18 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

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

Sedation22 trials

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

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

Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

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

Show 19 more trials

Sedation During Spinal Anesthesia

Completed·—·Phase 2·NCT03133780·80 enrolled

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

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

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

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

Evaluation of Ketamine/Midazolam Sedation vs. Fentanyl/Midazolam Sedation for Image-Guided Percutaneous Procedures in Interventional Radiology

Active, not recruiting·—·Phase 1·NCT07040163·276 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

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 Using Virtual Reality During Surgery Under Spinal Anesthesia

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

Sedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis

Completed· Pfizer logo

Pfizer··NCT03632330·6,963 enrolled

The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

Unknown status·—·Phase 4·NCT02296073·120 enrolled

Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy

Completed·—·Phase 4·NCT06181188·66 enrolled

Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children

Unknown status·DDouglas Fraser·Phase 3·NCT04082767·120 enrolled

the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation

Unknown status·TThe First Affiliated Hospital of Zhengzhou University·Phase 4·NCT02635802·1,500 enrolled

Nitrous Oxide Prior to Intranasal Midazolam for Moderate Dental Sedation in Pediatric Patients

Unknown status·—·Phase 4·NCT04083105·150 enrolled

Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam

Withdrawn·UUniversity of Sao Paulo·Phase 2·NCT01402596

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

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

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

Interaction21 trials

A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05445232·32 enrolled

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

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 18 more trials

A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02406261·82 enrolled

Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02783040·13 enrolled

A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects

Completed·GGalapagos NV·Phase 1·NCT02562950·24 enrolled

Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

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

Voxelotor CYP and Transporter Cocktail Interaction Study

Completed· Pfizer logo

Pfizer·Phase 1·NCT05981365·44 enrolled

Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers

Completed· Bayer logo

Bayer·Phase 1·NCT03237416·15 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

Pharmacokinetic Interaction of Darapladib and CYP 3A4 in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT01873339·26 enrolled

Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT05594615·24 enrolled

Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates

Completed· Astellas logo

Astellas·Phase 1·NCT01911728·14 enrolled

A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06092931·28 enrolled

28-day Repeat Dose and Drug Interaction Study With Orvepitant (GW823296)

Completed· GSK logo

GSK·Phase 1·NCT00511654·36 enrolled

A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole

Completed·PPresidio Pharmaceuticals, Inc.·Phase 1·NCT01786382·24 enrolled

Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam

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

Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction of Multiple Oral Doses of BAY1830839 in Healthy Male Participants

Completed· Bayer logo

Bayer·Phase 1·NCT03965728·67 enrolled

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

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

Drug-drug Interaction Study of Gepotidacin

Completed· GSK logo

GSK·Phase 1·NCT04493931·64 enrolled

Dexmedetomidine8 trials

Dexmedetomidine Premedication in Hypertensive Patients

Completed·—·Phase 3·NCT02058485·162 enrolled

Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy

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

Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

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

Show 5 more trials

Dexmedetomidine Facilitate Analgesia

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

Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair

Completed·UUniversity of Pittsburgh·Phase 4·NCT02168439·40 enrolled

Oral Dexmedetomidine vs Midazoam For Premedication

Completed·—·Phase 4·NCT03357718·52 enrolled

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

Dexmedetomidine Versus Midazolam for Facilitating Extubation

Completed·UUniversity of Colorado, Denver·N/A·NCT00744380·23 enrolled

Anxiety6 trials

Ketamine Infusion for Adolescent Depression and Anxiety

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

Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

Completed·—·N/A·NCT03388957·60 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

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

Efficacy of Virtual Reality Distraction Technique for Anxiety and Pain Control in Orthopedic Forearm Surgeries Performed Under Supraclavicular Brachial Plexus Block

Unknown status·—·N/A·NCT05512728·30 enrolled

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

93 more indications

Adult4 trials

Study of BLU-808 in Healthy Adult Participants

Completed·BBlueprint Medicines·Phase 1·NCT06948032·95 enrolled

A Study to Learn How Different Amounts of the Study Medicine Called PF-07941944 Are Tolerated in the Body of Healthy Adults.

Completed· Pfizer logo

Pfizer·Phase 1·NCT06920498·25 enrolled

A Study to Understand the Effect of Multiple Ascending Doses of PF-07293893 in Healthy Adult Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT06177457·88 enrolled

Show 1 more trial

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

Completed· Pfizer logo

Pfizer·Phase 1·NCT06033612·50 enrolled

Tics4 trials

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

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

Anesthetics in Rhytidoplasty - A Comparison Study

Completed·MMercy Facial Plastic Surgery Center·N/A·NCT02410460·30 enrolled

Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03291288·32 enrolled

Show 1 more trial

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

Prostate Cancer3 trials

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

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

Prothrombotic Factors and Anaesthesia in Prostate Cancer

Completed·RRegina Elena Cancer Institute·N/A·NCT01998685·200 enrolled

Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

Active, not recruiting· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 1/2·NCT03436485·204 enrolled

Status Epilepticus2 trials

Ketamine for the Treatment of Refractory Status Epilepticus

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

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

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

Breast Surgery2 trials

Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

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

Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

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

Spinal Anesthesia2 trials

Perioperative Music in Obese Patients Under Spinal Anesthesia

Not yet recruiting·—·Phase 2·NCT06835101·40 enrolled

Premedication and Haemodynamics After Spinal Anesthesia

Completed·MMedical University of Gdansk·N/A·NCT01066247·60 enrolled

Tobacco Use Disorder2 trials

The Effects of Sedatives on Tobacco Use Disorder

Completed·WWake Forest University Health Sciences·Phase 1/2·NCT03813121·10 enrolled

The Effects of Sedatives on Tobacco Use Disorder Version 2

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

Major Depressive Disorder2 trials

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

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03185819·147 enrolled

Cystic Fibrosis2 trials

Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis

Recruiting· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT06154447·255 enrolled

A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis

Completed· AbbVie logo

AbbVie·Phase 1·NCT05530278·24 enrolled

Atorvastatin2 trials

STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS

Completed· Pfizer logo

Pfizer·Phase 1·NCT05093205·35 enrolled

ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants

Completed·EEccogene·Phase 1·NCT06293742·48 enrolled

Ketamine2 trials

Effect of Ketamine on Laboratory-induced Stress in Healthy Subjects

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

Pro-Epileptic Effects of IV Ketamine

Completed·HHaseki Training and Research Hospital·Phase 4·NCT06741930·300 enrolled

Female2 trials

A Study of Elenestinib in Healthy Adult Female Participants

Recruiting·BBlueprint Medicines·Phase 1·NCT07388511·20 enrolled

A Study of Milvexian in Healthy Adult Females

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05706753·20 enrolled

Oxidative Stress2 trials

Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients

Unknown status·ZZhujiang Hospital·Phase 4·NCT02202239·60 enrolled

Comparing the Effect of Dexmedetomidine With Midazolam on Sedation, Oxidative Stress, and Microcirculation in Intensive Care Unit

Completed·NNational Taiwan University Hospital·Phase 4·NCT00886275·33 enrolled

Intensive Care Unit2 trials

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

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

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

Post-Traumatic Stress Disorder2 trials

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

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

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

Completed·DDennis Charney·Phase 2·NCT00749203·41 enrolled

Septic Shock2 trials

Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients

Unknown status·—·Phase 3·NCT03640468·36 enrolled

Dexmedetomidine in Modifying Immune Paralysis In Patient With Septic Shock

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

Drug Interactions2 trials

A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults

Completed·AAssembly Biosciences·Phase 1·NCT04142762·80 enrolled

A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT03782662·82 enrolled

ART2 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

Psoriasis2 trials

Investigate Effect of Secukinumab on the PK of Midazolam in Patients With Mod to Sev Plaque Psoriasis

Completed· Novartis logo

Novartis·Phase 1·NCT02607774·25 enrolled

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

Premedication1 trial

The Effect of Midazolam Premedication on Copeptine Concentration in Blood

Completed·MMedical University of Warsaw·Phase 4·NCT03474939·40 enrolled

Bronchoscopy1 trial

A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

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

Metabolism1 trial

Resveratrol and Midazolam Metabolism

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

Chronic Neck Pain1 trial

Pilot Study of Spinal Manipulation for Chronic Neck Pain

Terminated·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 1·NCT00030004·30 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

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

NAC1 trial

PanACEA Sutezolid Dose-finding and Combination Evaluation

Completed·MMichael Hoelscher·Phase 2·NCT03959566·75 enrolled

Seizure1 trial

Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center

Recruiting·EEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez·N/A·NCT06056349·150 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

Nitrous Oxide1 trial

Nitrous Oxide for PTSD

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

Safety and Efficacy1 trial

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

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

Clinical Trial1 trial

Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Completed·TTabriz University·Phase 4·NCT00636428·50 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

Treatment Resistant Depression1 trial

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

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

Cesarean Section1 trial

Intrathecal Nalbuphine Versus Midazolam in Cesarean Section

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

Critically Ill Patients1 trial

Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients

Completed·—·Phase 4·NCT03030911·30 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

Drug1 trial

Modeling and Application of Triple Drug Response Surface Models

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

Preoperative1 trial

Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication

Completed·—·Phase 4·NCT01976845·139 enrolled

Anesthesia1 trial

Safety of Driving After Minor Surgery With Monitored Anesthesia Care

Active, not recruiting·RRush University Medical Center·Phase 4·NCT00577200·625 enrolled

Intrathecal Dexmedetomidine1 trial

Intrathecal Dexmedetomidine vs Midazolame

Completed·NNational Cancer Institute, Egypt·Phase 4·NCT06315634·75 enrolled

Fatigue1 trial

Effect of Ketamine on Fatigue Following Cancer Therapy

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

Clinical Pharmacology1 trial

Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Completed· Pfizer logo

Pfizer·Phase 1·NCT01026415·73 enrolled

Esketamine1 trial

Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02568176·71 enrolled

Mechanically Ventilated Patients1 trial

Midazolam Used Alone or Sequential Use of Midazolam and Propofol/Dexmedetomidine in Mechanically Ventilated Patients

Unknown status·WWest China Hospital·Phase 4·NCT02528513·240 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

Advanced Solid Tumours1 trial

A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04958226·21 enrolled

Intrathecal Anesthesia1 trial

The Use of Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.

Completed·TTanta University·Phase 1·NCT04718259·120 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

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

Treatment1 trial

Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

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

Pulmonary Edema1 trial

MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)

Terminated·AAlberto Dominguez-Rodriguez·Phase 4·NCT02856698·111 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

Remimazolam1 trial

Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy

Completed·PPaion UK Ltd.·Phase 2·NCT00869440·100 enrolled

General Anesthesia1 trial

Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

Completed·—·Phase 4·NCT05567523·200 enrolled

Suicide1 trial

Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide

Unknown status·TTaipei Veterans General Hospital, Taiwan·N/A·NCT03666390·48 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

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

Intranasal Administration1 trial

To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for PTSD

Withdrawn·AAdriana Feder·Phase 2/3·NCT02398136

AML1 trial

An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates

Active, not recruiting· Sanofi logo

Sanofi·Phase 1·NCT06686628·23 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

Agitation1 trial

Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient

Completed·CCatholic Health East·N/A·NCT01501123·10 enrolled

Intensive Care1 trial

Comparison of Lormetazepam and Midazolam Used as Sedatives for Patients That Require Intensive Care

Completed·CClaudia Spies·Phase 4·NCT02022592·84 enrolled

Inflammatory Response1 trial

A Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury

Unknown status·—·Phase 4·NCT02071407·60 enrolled

Depression1 trial

Ketamine for Depression Relapse Prevention Following ECT

Completed·SSt Patrick's Hospital, Ireland·Phase 1·NCT02414932·6 enrolled

Malignancy1 trial

A Study to Evaluate the Effect of Ibrutinib on the Pharmacokinetics of Oral Contraceptives, CYP2B6, and CYP3A4 Substrates in Female Participants With B Cell Malignancy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03301207·25 enrolled

Platelet Aggregation1 trial

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

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

Sepsis1 trial

Effects of Dexmedetomidine vs Propofol in Patients With Intra-abdominal Sepsis

Completed·—·Phase 4·NCT04718714·60 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

Adult Subject1 trial

Effect of GSK376501 on CYP450 Activity in Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT00615212·23 enrolled

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

Orthopedic Surgery1 trial

Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery

Unknown status·—·N/A·NCT01734954·66 enrolled

Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03864042·56 enrolled

Pilot Study1 trial

Audiovisual Aid Pilot Study

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

Heart Failure1 trial

A Double-Blind Pharmacokinetic Interaction Study Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure

Completed·AAcorda Therapeutics·Phase 1·NCT01944683·22 enrolled

TED1 trial

A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06916702·60 enrolled

Memory1 trial

Memory Modulation by Pain During Anesthesia

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

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

Unspecified2 trials

Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA in Healthy Male Volunteers

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02182401·37 enrolled

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

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 — 805 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