Data updated: May 26, 2026
MIDAZOLAM IN 0.8% SODIUM CHLORIDE (midazolam)
Trial Activity: Declining 51 active trials
CNS
Approved 2022-07-20
Development Insights
Pfizer conducting 33 trials (6%)
454 indications explored (Broad Platform)
→ healthy (88 trials)
→ healthy volunteers (26 trials)
→ healthy participants (20 trials)
2
Indications
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2022-07-20
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
MIDAZOLAM IN 0.8% SODIUM CHLORIDE Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2022 to 2025
May 2025 ORIGINAL
Update
What MIDAZOLAM IN 0.8% SODIUM CHLORIDE Treats
2 FDA approvalsOriginally approved for its first indication in 2022 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
503 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07584434 | VX25-433-001 | Ph 1 | not yet recruiting | A Phase 1, First-in-human Study of VX-433 |
| NCT04067336 | KO-MEN-001 | Ph 1, Ph 2 | active not recruiting | First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia |
| NCT07227454 AVENUE | 54135419SUI3003 54135419SUI3003, 2024-518615-19-00 | Ph 3 | recruiting | A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder |
| NCT02365597 results posted | CR105065 42756493BLC2001, 2014-002408-26 | Ph 2 | active not recruiting | An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer |
| NCT07570082 | CRN04894-131 | Ph 1 | recruiting | Drug-Drug Interaction Study of Atumelnant in Healthy Participants |
| NCT05646862 INAVO121 | WO43919 2022-502322-41-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy |
| NCT05355701 | C4761001 BRAF Class 2 | Ph 1 | recruiting | A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. |
| NCT07567781 | M25-744 | Ph 1 | recruiting | A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults. |
| NCT07556523 | IRB2025-0154 | Ph 4 | recruiting | Patient Quality of Recovery After TAVR With Different Sedation Regimens |
| NCT07154147 CatNAPS-2 | 25-43837 | Ph 4 | completed | Oral vs IV Sedation for Cataract Surgery in Older Adults |
| NCT06686628 | INT18404 U1111-1303-3406, 2024-513495-17 | Ph 1 | completed | An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates |
| NCT07542990 PEDIADEX | PEDIADEX | Ph 3 | not yet recruiting | Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care |
| NCT02166853 SEGA | CHU-0195 2013-005389-21 | Ph 4 | completed | Effects of SEvoflurane on Gas Exchange and Inflammation in Patients With ARDS (SEGA Study) |
| NCT07388511 | BLU-263-0104 | Ph 1 | completed | A Study of Elenestinib in Healthy Adult Female Participants |
| NCT02783040 results posted | 1346.22 2015-001371-41 | Ph 1 | completed | Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin |
| NCT06154447 | VX23-828-001 | Ph 1 | recruiting | Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis |
| NCT07525544 | 300109 | Ph 1 | not yet recruiting | A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants |
| NCT07426757 | C6331001 KAT2i | Ph 1 | not yet recruiting | An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers |
| NCT06692192 | 2024-0852 A538900, SMPH/PSYCHIATRY/PSYCHIATRY | Ph 1 | recruiting | The RECAP2 Study: Midazolam and Psilocybin |
| NCT07340190 | CDAK539A12102 2025-521000-22-00 | Ph 1 | not yet recruiting | A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies |
| NCT06679413 | UP0132 | Ph 1 | completed | A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants |
| NCT05258110 results posted | 1346-0035 2021-005585-17 | Ph 1 | completed | A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood |
| NCT06964776 | 27387 J6E-MC-KWAC, MORF-057 | Ph 1 | completed | A Study of LY4268989 (MORF-057) in Healthy Participants |
| NCT07435194 | 2828-007 MK-2828-007 | Ph 1 | recruiting | A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007) |
| NCT05378100 INKLING-MS | IRB00322473 | Ph 2 | active not recruiting | Ketamine for Multiple Sclerosis Fatigue |
| NCT07184801 DEMISE-MT | IEC-INT/2025/DM-2480 | Ph 3 | recruiting | Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy |
| NCT06716190 | 1519-0002 2024-517209-95-00, U1111-1313-5393 | Ph 1 | terminated | A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People |
| NCT03600883 | 20170543 | Ph 1, Ph 2 | active not recruiting | A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) |
| NCT06564441 | 1404-0008 2024-512332-29-00, U1111-1307-0132 | Ph 1 | completed | 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 |
| NCT07443254 | 26-1377 | Ph 1, Ph 2 | recruiting | Prospective IR-led Sedation Feasibility |
| NCT07118215 | CN012-0013 | Ph 1 | recruiting | A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin |
| NCT06979973 | A104_03DDI2501 | Ph 1 | completed | A Drug-drug Interaction Study to Investigate the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants |
| NCT07289776 | HP7041-01 | Ph 1 | recruiting | A First-in-human Trial of GRT7041 in Healthy Participants |
| NCT07020988 | UP0127 | Ph 1 | completed | A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants |
| NCT07235748 | S095032-230 | Ph 1 | completed | Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants |
| NCT06916702 | 1516-0002 2024-516921-29-00, U1111-1311-3555 | Ph 1 | recruiting | A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men |
| NCT04973163 | 1472-0001 2021-000460-29 | Ph 1 | active not recruiting | A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation |
| NCT06575933 | 1084-009 CA43815, MK-1084-009 | Ph 1 | completed | A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009) |
| NCT06878703 DEXPRE | APHP230813 | Ph 3 | recruiting | Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants |
| NCT05208047 | CGT9486-21-301 | Ph 3 | active not recruiting | (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors |
| NCT07357610 SIM0270-104 | SIM0270-104 | Ph 1 | recruiting | An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants |
| NCT07331389 | HDM1002-111 | Ph 1 | recruiting | A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin |
| NCT05631704 | 218803 | Ph 1 | completed | A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity |
| NCT07300826 | Dexmedetomidine VS Midazolam | Ph 4 | not yet recruiting | Intravenous Dexmedetomidine Versus Midazolam in Preventing Shivering in Trauma Patients Undergoing Lower Limb Orthopedic Surgery Under Spinal Anesthesia |
| NCT07226635 DDI | SPI-62-CL-1004 | Ph 1 | completed | Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone |
| NCT06417125 | K2024-01-006 | Ph 4 | completed | Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children |
| NCT00577200 MACDrive | ABuv110507 | Ph 4 | active not recruiting | Safety of Driving After Minor Surgery With Monitored Anesthesia Care |
| NCT06689527 results posted | SNT-I-VAM-025 2024-513845-36-00 | Ph 1 | completed | Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics |
| NCT06741930 Ketamin stdy | 35-2024 | Ph 4 | completed | Pro-Epileptic Effects of IV Ketamine |
| NCT04840888 results posted | 18204 J2J-MC-JZLD | Ph 1 | completed | A Study of LY3484356 in Healthy Female Participants |
Showing 50 of 503 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIDAZOLAM IN 0.8% SODIUM CHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment