Data updated: May 26, 2026
DEXTROSE 5% (dextrose)
Trial Activity: Mature 3 active trials
Other
Approved 2024-04-08
Development Insights
Assiut University conducting 3 trials (50%)
11 indications explored (Broad Platform)
→ carpal tunnel syndrome (cts) (2 trials)
→ anesthesia; functional (2 trials)
→ gynecological abdominal surgeries (1 trials)
1
Indication
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2024-04-08
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DEXTROSE 5% Approval History
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Apr 2024 ORIGINAL
Update
What DEXTROSE 5% Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 2024)
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Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07494084 | R01HL177106 R01HL177106 | Ph 4 | not yet recruiting | Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance |
| NCT04895358 | 3475-B49 MK-3475-B49, KEYNOTE-B49 | Ph 3 | active not recruiting | Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) |
| NCT05264727 | 22-000306 R01DK116231 | Ph 4 | active not recruiting | Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion |
| NCT07283874 | volume of injectate CTS | Ph 4 | not yet recruiting | Does it Matter the Volume of Injectate on the Outcome of Ultrasound-guided Perineural Injection for Carpal Tunnel Syndrome |
| NCT06726980 | Dextrose vs Saline Gyn surg | Ph 4 | not yet recruiting | Effects of Dextrose Versus Saline Infusion on Intrathecal Morphine-Induced Postoperative Nausea and Vomiting During Gynecological Abdominal Surgeries: Randomized Controlled Double-blind Study |
| NCT04020601 | Pro00092897 | Ph 2, Ph 3 | terminated | The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty |
| NCT02471690 | MDCO-ORI-15-01 | Ph 1 | completed | Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers |
| NCT01482559 HIP | HIP-FP7-BrePco 2010-023988-17 | Ph 3 | terminated | Management of Hypotension In the Preterm Infant |
| NCT03095651 results posted | 5160-002 MK-5160-002 | Ph 1 | completed | Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002) |
| NCT02269735 | 2640-001 | Ph 1 | completed | A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) |
| NCT00578669 results posted | PHI0710-002 1R01DA023190 | Ph 3 | completed | Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms |
| NCT01547364 | SweetCaudal | Ph 2 | completed | Caudal Epidural Injection of Dextrose For Low Back Pain |
| NCT02984098 40%D-N-PP | POSDRU/159.5/S/133377 | Ph 4 | completed | 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose |
| NCT02185729 TPN1 results posted | IRB00007543 | Ph 2, Ph 3 | completed | Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers |
| NCT00878878 results posted | GE-191-004 | Ph 4 | completed | Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR). |
| NCT01326611 | rö05053781128 | Ph 4 | completed | Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants |
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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.
DEXTROSE 5% 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