Last reviewed · How we verify
Isotonic sodium chloride 0.9 percent
Isotonic sodium chloride 0.9 percent is a Crystalloid fluid / Electrolyte replacement solution Small molecule drug developed by Rigshospitalet, Denmark. It is currently FDA-approved for Fluid and electrolyte replacement in dehydration, Vehicle for intravenous drug administration, Maintenance of vascular access patency. Also known as: Isotonic saline.
Isotonic sodium chloride 0.9% restores and maintains fluid and electrolyte balance by providing a physiologically balanced saline solution that matches blood osmolarity.
Isotonic sodium chloride 0.9 percent is a small molecule modality used in various clinical trials for conditions such as Acute Kidney Injury, Skin Care, Postoperative Pain, Chronic Pain, and Analgesics. It is also known by synonyms including 0.9% NACL, 0.9% SALINE, and 0.9% SALINE SOLUTION.
At a glance
| Generic name | Isotonic sodium chloride 0.9 percent |
|---|---|
| Also known as | Isotonic saline |
| Sponsor | Rigshospitalet, Denmark |
| Drug class | Crystalloid fluid / Electrolyte replacement solution |
| Modality | Small molecule |
| Therapeutic area | Fluid and Electrolyte Management |
| Phase | FDA-approved |
Mechanism of action
This solution contains sodium and chloride ions in concentrations (0.9% w/v) that are isotonic with human blood plasma, preventing osmotic shifts across cell membranes. It is used for fluid replacement, electrolyte supplementation, and as a vehicle for drug administration. The solution does not exert a pharmacological effect but rather serves as a physiological support agent.
Approved indications
- Fluid and electrolyte replacement in dehydration
- Vehicle for intravenous drug administration
- Maintenance of vascular access patency
- Perioperative fluid management
Common side effects
- Hyperchloremic acidosis (with prolonged or excessive use)
- Fluid overload / Hypervolemia
- Hypokalemia (with chronic use without potassium supplementation)
- Local phlebitis at infusion site
Key clinical trials
- A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma (PHASE3)
- Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery (PHASE2)
- Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure (PHASE3)
- Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns (PHASE2, PHASE3)
- Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders (PHASE1)
- A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion (NA)
- To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products (NA)
- Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Isotonic sodium chloride 0.9 percent CI brief — competitive landscape report
- Isotonic sodium chloride 0.9 percent updates RSS · CI watch RSS
- Rigshospitalet, Denmark portfolio CI
Frequently asked questions about Isotonic sodium chloride 0.9 percent
What is Isotonic sodium chloride 0.9 percent?
How does Isotonic sodium chloride 0.9 percent work?
What is Isotonic sodium chloride 0.9 percent used for?
Who makes Isotonic sodium chloride 0.9 percent?
Is Isotonic sodium chloride 0.9 percent also known as anything else?
What drug class is Isotonic sodium chloride 0.9 percent in?
What development phase is Isotonic sodium chloride 0.9 percent in?
What are the side effects of Isotonic sodium chloride 0.9 percent?
Related
- Drug class: All Crystalloid fluid / Electrolyte replacement solution drugs
- Manufacturer: Rigshospitalet, Denmark — full pipeline
- Therapeutic area: All drugs in Fluid and Electrolyte Management
- Indication: Drugs for Fluid and electrolyte replacement in dehydration
- Indication: Drugs for Vehicle for intravenous drug administration
- Indication: Drugs for Maintenance of vascular access patency
- Also known as: Isotonic saline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing