Last reviewed · How we verify

Saline 0.9%

Rigshospitalet, Denmark · FDA-approved active Small molecule Under review Quality 5/100

Saline 0.9% is a Crystalloid fluid / Electrolyte replacement Small molecule drug developed by Rigshospitalet, Denmark. It is currently FDA-approved for Fluid and electrolyte replacement in dehydration, Intravenous fluid maintenance and resuscitation, Wound irrigation and topical cleansing. Also known as: sterile saline, Placebo, placebo, Hydration.

Saline 0.9% is an isotonic sodium chloride solution that restores and maintains fluid and electrolyte balance in the body.

Saline 0.9% is used in clinical trials for conditions such as oral mucositis due to targeted therapy in renal cell carcinoma, hepatocellular carcinoma, and gastrointestinal stromal tumors. The exact mechanism of action of Saline 0.9% is unknown.

At a glance

Generic nameSaline 0.9%
Also known assterile saline, Placebo, placebo, Hydration, Placebo for GLP-1
SponsorRigshospitalet, Denmark
Drug classCrystalloid fluid / Electrolyte replacement
ModalitySmall molecule
Therapeutic areaGeneral/Supportive Care
PhaseFDA-approved

Mechanism of action

Normal saline (0.9% NaCl) is a physiologic solution with osmolarity matching blood plasma, allowing safe intravenous or topical administration without causing cell lysis or crenation. It serves as a fundamental fluid replacement therapy to correct dehydration, maintain intravascular volume, and support electrolyte homeostasis across multiple clinical settings.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Saline 0.9%

What is Saline 0.9%?

Saline 0.9% is a Crystalloid fluid / Electrolyte replacement drug developed by Rigshospitalet, Denmark, indicated for Fluid and electrolyte replacement in dehydration, Intravenous fluid maintenance and resuscitation, Wound irrigation and topical cleansing.

How does Saline 0.9% work?

Saline 0.9% is an isotonic sodium chloride solution that restores and maintains fluid and electrolyte balance in the body.

What is Saline 0.9% used for?

Saline 0.9% is indicated for Fluid and electrolyte replacement in dehydration, Intravenous fluid maintenance and resuscitation, Wound irrigation and topical cleansing, Vehicle for intravenous drug administration.

Who makes Saline 0.9%?

Saline 0.9% is developed and marketed by Rigshospitalet, Denmark (see full Rigshospitalet, Denmark pipeline at /company/rigshospitalet-denmark).

Is Saline 0.9% also known as anything else?

Saline 0.9% is also known as sterile saline, Placebo, placebo, Hydration, Placebo for GLP-1.

What drug class is Saline 0.9% in?

Saline 0.9% belongs to the Crystalloid fluid / Electrolyte replacement class. See all Crystalloid fluid / Electrolyte replacement drugs at /class/crystalloid-fluid-electrolyte-replacement.

What development phase is Saline 0.9% in?

Saline 0.9% is FDA-approved (marketed).

What are the side effects of Saline 0.9%?

Common side effects of Saline 0.9% include Hyperchloremic acidosis (with prolonged high-volume infusion), Fluid overload / pulmonary edema (in susceptible patients), Hypernatremia (rare, with excessive administration).

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing