Last reviewed · How we verify
Saline isotonic
Saline isotonic is a Crystalloid fluid / Electrolyte solution Small molecule drug developed by Daniel Hägi-Pedersen. It is currently FDA-approved for Fluid and electrolyte replacement in dehydration, Maintenance of intravascular volume during surgery or critical illness, Vehicle for intravenous medication administration.
Isotonic saline is a sterile solution of sodium chloride in water that maintains osmotic balance with body fluids, used for hydration and electrolyte replacement.
Saline solution is a type of isotonic solution used in medical interventions, including nerve blocks and injection site irritation treatments. According to ChEMBL, Saline solution is also known as Potassic Saline or Lactated Saline, but its exact mechanism of action is unknown.
At a glance
| Generic name | Saline isotonic |
|---|---|
| Sponsor | Daniel Hägi-Pedersen |
| Drug class | Crystalloid fluid / Electrolyte solution |
| Modality | Small molecule |
| Therapeutic area | Supportive Care / Fluid and Electrolyte Management |
| Phase | FDA-approved |
Mechanism of action
Isotonic saline (0.9% NaCl) has an osmolarity matching that of blood plasma (~308 mOsm/L), preventing fluid shifts across cell membranes. It serves as a physiological replacement for lost fluids and electrolytes, restoring intravascular volume and maintaining electrolyte homeostasis without causing cellular dehydration or edema.
Approved indications
- Fluid and electrolyte replacement in dehydration
- Maintenance of intravascular volume during surgery or critical illness
- Vehicle for intravenous medication administration
Common side effects
- Hyperchloremic acidosis (with prolonged high-volume use)
- Fluid overload / pulmonary edema (in susceptible patients)
- Hypernatremia (rare, with excessive administration)
Key clinical trials
- Effect of Lidocaine Infusion Versus Dexmedemidine Infusion on the Neurocognitive Function of Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography(ERCP): a Randomized, Controlled Trial. (NA)
- Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction (PHASE2)
- Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC) (PHASE2, PHASE3)
- Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
- Repeated Bilateral Greater Occipital Nerve Blockade in Chronic Migraine and Chronic Tension-Type Headache (NA)
- Normal Saline Infusion After Intravenous Thrombolysis in Stroke (PHASE3)
- Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease (NA)
- Effect of Dexmedetomidine on Brain Homeostasis and Neurocognitive Outcome (PHASE4)
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:
- Saline isotonic CI brief — competitive landscape report
- Saline isotonic updates RSS · CI watch RSS
- Daniel Hägi-Pedersen portfolio CI
Frequently asked questions about Saline isotonic
What is Saline isotonic?
How does Saline isotonic work?
What is Saline isotonic used for?
Who makes Saline isotonic?
What drug class is Saline isotonic in?
What development phase is Saline isotonic in?
What are the side effects of Saline isotonic?
Related
- Drug class: All Crystalloid fluid / Electrolyte solution drugs
- Manufacturer: Daniel Hägi-Pedersen — full pipeline
- Therapeutic area: All drugs in Supportive Care / Fluid and Electrolyte Management
- Indication: Drugs for Fluid and electrolyte replacement in dehydration
- Indication: Drugs for Maintenance of intravascular volume during surgery or critical illness
- Indication: Drugs for Vehicle for intravenous medication administration
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing