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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR MIDAZOLAM HYDROCHLORIDE


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505(b)(2) Clinical Trials for Midazolam Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01275547 ↗ The Analgesic Effect of Combined Treatment With Intranasal S-ketamine and Intranasal Midazolam Completed University Hospital, Basel, Switzerland Phase 2/Phase 3 2011-01-01 Introduction Ketamine is an old and generally well accepted analgesic used in the intra- and perioperative setting. Several studies demonstrated the effectiveness of ketamine in the postoperative setting. A new formulation of S-ketamine as an intranasal spray device was tested in our hospital in 8 healthy volunteers (unpublished data, EKBB 351/08). 20 mg of S-ketamine were administered intranasally and compared with S-ketamine i.v. and i.m.. None of the volunteers had serious adverse effects or complications. A preliminary data analysis shows a clear analgesic effect and good absorption of the intranasal S-ketamine. As a next step we would like to investigate the effect of S-ketamine intranasal spray combined with midazolam intranasal spray in a group of postoperative spinal surgery patients. The rational for the combination of intranasal S-ketamine and midazolam is the well known midazolam antagonising effect of ketamine induced psychomimetic adverse effects. Furthermore we know from other studies (EKBB 106/06) that midazolam intranasal spray has relaxant and anxiolytic effects. As far as we know, this is the first study which will examine the combination of S-ketamine and midazolam intranasal sprays in adult patients. Study work plan This prospective, randomized, double-blinded non inferiority study will address pain ratings and patient satisfaction in a postoperative setting in two treatment scenarios: 1. Alternating S-ketamine intranasal unit-dose spray (6 mg per dose) with midazolam intranasal spray (0.75 mg per dose) patient controlled application with a lock-out interval of 20 minutes between two applications and placebo patient controlled analgesia (PCA) with a lock-out interval of 12 minutes with saline 0.9% i.v. for 72 hours or until 40 unit-dose sprays are delivered 2. PCA with 2 mg morphine with a lock-out interval of 12 minutes i.v. with placebo intranasal spray (saline 0.9% + chitosan) with a minimum lock-out interval of 20 minutes for 72 hours or until 40 unit-dose sprays are delivered Patient number We will examine 36 patients, 18 patients in each group. The study duration for an individual patient will be at latest 72 hours, the total study duration is 4 to 5 months. Study importance An intranasal spray is an ideal application form for surgery patients, either in- or outpatients. On the other hand, ketamine and S-ketamine is quite often used in the perioperative setting as a rescue analgesic. In higher doses it could be used as an emergency tool in emergency prehospital medicine. In the perioperative setting it is important to evaluate the efficacy and safety of S-ketamine intranasal spray combined with midazolam intranasal spray in patients. If our study shows that S-ketamine intranasal spray is effective as an analgesic and has good patient acceptance, S-ketamine intranasal spay could be considered as an alternative, completely non-invasive analgesic procedure in a postoperative outpatient setting. As a consequence development of a nasal multidose-applicator combining S-ketamine and midazolam would be of interest.
New Formulation NCT01349140 ↗ EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks Completed Pacira Pharmaceuticals, Inc Phase 1 2012-02-01 EXPARELâ„¢, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation NCT01349140 ↗ EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks Completed University of California, San Diego Phase 1 2012-02-01 EXPARELâ„¢, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
OTC NCT01691690 ↗ Analgesic Effect of IV Acetaminophen in Tonsillectomies Completed Nationwide Children's Hospital Phase 2 2012-10-01 Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).
New Formulation NCT01754116 ↗ A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects Completed GlaxoSmithKline Phase 1 2013-01-01 This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This study will evaluate LAP formulations of GSK1265744 with different particle sizes. Following a 14 day lead in period with oral GSK1265744, forty-five subjects will receive 400 mg of one of three GSK1265744 formulations which vary in particle size from 200 nm to 5 um by intramuscular injection. Samples for determination of GSK1265744 concentrations will be collected for 12 weeks post-injection. Safety will be evaluated by adverse event recording and laboratory values at frequent intervals throughout the trial. A subgroup of 12 subjects will receive a 3 mg dose of oral midazolam at baseline on Day-29 and then again on the last day of the oral GSK1265744 lead in period to evaluate the effect of GSK1265744 on CYP3A enzymes. The subjects will undergo follow-up evaluations for a minimum of 12 weeks.
New Formulation NCT01754116 ↗ A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects Completed ViiV Healthcare Phase 1 2013-01-01 This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This study will evaluate LAP formulations of GSK1265744 with different particle sizes. Following a 14 day lead in period with oral GSK1265744, forty-five subjects will receive 400 mg of one of three GSK1265744 formulations which vary in particle size from 200 nm to 5 um by intramuscular injection. Samples for determination of GSK1265744 concentrations will be collected for 12 weeks post-injection. Safety will be evaluated by adverse event recording and laboratory values at frequent intervals throughout the trial. A subgroup of 12 subjects will receive a 3 mg dose of oral midazolam at baseline on Day-29 and then again on the last day of the oral GSK1265744 lead in period to evaluate the effect of GSK1265744 on CYP3A enzymes. The subjects will undergo follow-up evaluations for a minimum of 12 weeks.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Midazolam Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001570 ↗ A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer Completed National Cancer Institute (NCI) Phase 1 1997-02-01 Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days. To ensure the safety of a 7 day infusion of PSC 833, one patient is treated for 5 days and a second for 6 days, before the first cohort is enrolled. Vinblastine is administered in escalating doses on days 2-5. At least 3 patients are entered at each dose level. The MTD will be defined as the dose immediately below that at which 2 patients experience dose limiting toxicity. Treatment continues every 28 days.
NCT00004424 ↗ Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy Completed Case Western Reserve University N/A 1996-07-01 OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00004424 ↗ Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy Completed FDA Office of Orphan Products Development N/A 1996-07-01 OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00006299 ↗ Celebrex for Pain Relief After Oral Surgery Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1999-12-01 This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on relieving pain after oral surgery. It is also designed to assess the drug's selective inhibition of a chemical called cyclooxygenase-2 and not its closely related form, cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs. Healthy volunteers who require removal of their third molars are eligible for this study. Participants will have oral surgery for tooth extraction after receiving a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening before and 1 hour before surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill with no active ingredient). After surgery, a small piece of tubing will be placed in each extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol 3), if needed, for pain. The tubing then will be removed and the patient discharged with standard pain medication.
NCT00026819 ↗ Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 2001-11-01 This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID) called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis, menstrual cramps, and pain. Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be screened with a medical history and oral examination, including dental x-rays as needed to confirm the need for third molar removal. Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind the lower wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously (through a vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol with codeine and the study drug) and instructions for their use. They will also be given a pain diary to record pain ratings and medications taken at home. A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed. Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic.
NCT00027014 ↗ Herb-Opioid Interactions Completed National Center for Complementary and Integrative Health (NCCIH) Phase 4 2001-09-01 This is a series of studies in healthy volunteers to assess the potential for adverse interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of standard doses of oxycodone in treating pain problems. For the fentanyl study, we will investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other dietary and environmental toxins.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Midazolam Hydrochloride

Condition Name

Condition Name for Midazolam Hydrochloride
Intervention Trials
Healthy 100
Pain 49
Anesthesia 47
Sedation 41
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Condition MeSH

Condition MeSH for Midazolam Hydrochloride
Intervention Trials
Pain, Postoperative 95
Delirium 39
Depression 37
Depressive Disorder 33
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Clinical Trial Locations for Midazolam Hydrochloride

Trials by Country

Trials by Country for Midazolam Hydrochloride
Location Trials
Egypt 148
China 123
Germany 75
Canada 74
Korea, Republic of 62
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Trials by US State

Trials by US State for Midazolam Hydrochloride
Location Trials
Texas 97
California 87
New York 70
Florida 59
Pennsylvania 51
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Clinical Trial Progress for Midazolam Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Midazolam Hydrochloride
Clinical Trial Phase Trials
Phase 4 397
Phase 3 127
Phase 2/Phase 3 45
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Clinical Trial Status

Clinical Trial Status for Midazolam Hydrochloride
Clinical Trial Phase Trials
Completed 844
Recruiting 194
Not yet recruiting 166
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Clinical Trial Sponsors for Midazolam Hydrochloride

Sponsor Name

Sponsor Name for Midazolam Hydrochloride
Sponsor Trials
Boehringer Ingelheim 29
Pfizer 27
Assiut University 25
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Sponsor Type

Sponsor Type for Midazolam Hydrochloride
Sponsor Trials
Other 1497
Industry 518
NIH 48
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Midazolam Hydrochloride: Clinical Trials, Market Analysis, and Projections

Overview of Midazolam Hydrochloride

Midazolam hydrochloride is a versatile benzodiazepine derivative widely used in medical settings for its sedative, anxiolytic, muscle relaxant, anticonvulsant, and amnesic properties. It is a short-acting hypnotic-sedative drug that has been approved by the US FDA for various indications since 1985[1].

Clinical Trials

Midazolam hydrochloride has been extensively studied in various clinical trials across different phases.

Phase Distribution

  • Phase 0: 22 clinical trials
  • Phase 1: 431 clinical trials
  • Phase 2: 129 clinical trials
  • Phase 3: 103 clinical trials
  • Phase 4: 270 clinical trials[1].

Recent Approvals and Indications

  • In late 2018, the intramuscular preparation of midazolam was approved by the FDA for the treatment of status epilepticus in adults.
  • In May 2019, the nasal spray formulation of midazolam (NAYZILAM) was approved for the acute treatment of distinctive intermittent, stereotypic seizure episodes in patients 12 years of age and older[1].

Ongoing and Completed Trials

  • For example, SEIZALAM, a midazolam hydrochloride product, has been involved in several Phase 1 clinical trials sponsored by various organizations such as Ology Bioservices and Rafa Laboratories[4].

Market Analysis

The midazolam hydrochloride market is experiencing significant growth driven by several key factors.

Market Size and Growth

  • The midazolam HCl market was valued at USD 1.5 billion in 2023 and is projected to reach USD 2.9 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 8.5% during the forecast period[2][5].

Drivers of Growth

  • Increasing Surgical Procedures: The rise in the number of surgical procedures globally, including endoscopic and laparoscopic surgeries, is driving the demand for midazolam HCl due to its quick onset and clearance, which aligns well with the faster pace of minimally invasive procedures[2].
  • Aging Population: The aging population, which is more prone to medical procedures and co-occurring conditions, is another significant driver. Midazolam HCl is preferred for its convenient administration and good safety profile in geriatric care[2].
  • Technological Advancements: Innovations in drug delivery technologies, such as nasal sprays and intramuscular preparations, are enhancing the market. There is also a growing emphasis on patient-centric methods to avoid side effects and optimize dose accuracy[2][5].

Market Segmentation

  • The midazolam HCl market is segmented based on type, application, and geography. Geographically, it is classified into North America, Europe, Asia Pacific, and the rest of the world[2][5].

Key Players

  • Major players in the market include Roche, Pfizer, Fresenius Kabi, Hikma, Akorn Pharmaceuticals, Precision Dose, Inc, and Perrigo Company. These companies are involved in the production, formulation, and marketing of midazolam HCl, both in brand-name and generic forms[2].

Market Projections

Future Trends

  • The market is expected to continue its upward trend due to the increasing demand for sedatives with shorter half-lives, especially in minimally invasive surgical procedures. The aging population and the need for sedation in diagnostic tests and palliative care will also contribute to the growth[2][5].

Technological Innovations

  • The incorporation of cutting-edge technology into medication delivery systems, such as nasal sprays and intramuscular preparations, will continue to drive the market. There is a growing preference for generic formulations and patient-centric approaches that focus on minimizing side effects and optimizing dosing[2].

Expanding Therapeutic Uses

  • Midazolam HCl is increasingly being used outside the operating room, including in the treatment of status epilepticus, control of seizures, and sedation of critically ill patients requiring mechanical ventilation. This diversification of use cases is opening up new growth opportunities for the drug[2].

Key Takeaways

  • Midazolam hydrochloride is a versatile drug with multiple clinical applications, including sedation, anxiety treatment, and seizure control.
  • The drug has undergone extensive clinical trials and has received recent approvals for new formulations and indications.
  • The market for midazolam HCl is projected to grow significantly, driven by increasing surgical procedures, an aging population, and technological advancements in drug delivery.
  • Key players in the market are focusing on enhancing safety and effectiveness profiles through R&D efforts.

FAQs

What are the primary uses of midazolam hydrochloride?

Midazolam hydrochloride is used for sedation before surgery, treating anxiety and seizures, and has anxiolytic, muscle relaxant, anticonvulsant, sedative, hypnotic, and amnesic properties[1].

What are the recent FDA approvals for midazolam hydrochloride?

Recent approvals include the intramuscular preparation for treating status epilepticus in adults (2018) and the nasal spray formulation for treating distinctive intermittent, stereotypic seizure episodes in patients 12 years and older (2019)[1].

What is the projected market size for midazolam HCl by 2030?

The midazolam HCl market is expected to reach USD 2.9 billion by 2030, with a CAGR of 8.5% during the forecast period[2][5].

Which companies are major players in the midazolam HCl market?

Major players include Roche, Pfizer, Fresenius Kabi, Hikma, Akorn Pharmaceuticals, Precision Dose, Inc, and Perrigo Company[2].

What are the key drivers of growth for the midazolam HCl market?

Key drivers include the increasing number of surgical procedures, the aging population, technological advancements in drug delivery, and the expanding therapeutic uses of midazolam HCl[2][5].

Sources

  1. DrugBank: Midazolam: Uses, Interactions, Mechanism of Action.
  2. Verified Market Reports: Midazolam HCl Market Size, Share and Growth [2030].
  3. PubMed: Clinical comparison of midazolam hydrochloride and midazolam maleate.
  4. DrugPatentWatch: SEIZALAM Drug Patent Profile.
  5. Market Research Intellect: Midazolam Hydrochloride Market Size, Scope And Forecast Report.

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