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Normal Saline 0.9% Infusion Solution

Fayoum University Hospital · Phase 3 active Small molecule Under review

Normal Saline 0.9% Infusion Solution is a Crystalloid fluid / Electrolyte replacement solution Small molecule drug developed by Fayoum University Hospital. It is currently in Phase 3 development for Fluid and electrolyte replacement in dehydration, Maintenance of intravascular volume during surgery or critical illness, Vehicle for intravenous medication administration. Also known as: NORSI.

Normal saline restores and maintains fluid and electrolyte balance by providing isotonic sodium chloride solution for intravenous administration.

Normal Saline 0.9% Infusion Solution is a solution used in medical settings, with conditions studied including cardiopulmonary arrest, acute coronary syndrome, and hypothermia. It is classified as an oligosaccharide modality, with synonyms including anticoagulant heparin solution.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameNormal Saline 0.9% Infusion Solution
Also known asNORSI
SponsorFayoum University Hospital
Drug classCrystalloid fluid / Electrolyte replacement solution
ModalitySmall molecule
Therapeutic areaSupportive Care / Fluid Management
PhasePhase 3

Mechanism of action

Normal saline (0.9% sodium chloride) is an isotonic crystalloid solution that matches the osmolarity of blood plasma, allowing safe intravenous infusion without causing cell lysis or crenation. It replaces lost fluids and electrolytes, maintains intravascular volume, and supports cellular function. It is a fundamental supportive therapy rather than a disease-modifying agent.

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 Normal Saline 0.9% Infusion Solution

What is Normal Saline 0.9% Infusion Solution?

Normal Saline 0.9% Infusion Solution is a Crystalloid fluid / Electrolyte replacement solution drug developed by Fayoum University Hospital, indicated for Fluid and electrolyte replacement in dehydration, Maintenance of intravascular volume during surgery or critical illness, Vehicle for intravenous medication administration.

How does Normal Saline 0.9% Infusion Solution work?

Normal saline restores and maintains fluid and electrolyte balance by providing isotonic sodium chloride solution for intravenous administration.

What is Normal Saline 0.9% Infusion Solution used for?

Normal Saline 0.9% Infusion Solution is indicated for Fluid and electrolyte replacement in dehydration, Maintenance of intravascular volume during surgery or critical illness, Vehicle for intravenous medication administration, Treatment of hypovolemic shock.

Who makes Normal Saline 0.9% Infusion Solution?

Normal Saline 0.9% Infusion Solution is developed by Fayoum University Hospital (see full Fayoum University Hospital pipeline at /company/fayoum-university-hospital).

Is Normal Saline 0.9% Infusion Solution also known as anything else?

Normal Saline 0.9% Infusion Solution is also known as NORSI.

What drug class is Normal Saline 0.9% Infusion Solution in?

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

What development phase is Normal Saline 0.9% Infusion Solution in?

Normal Saline 0.9% Infusion Solution is in Phase 3.

What are the side effects of Normal Saline 0.9% Infusion Solution?

Common side effects of Normal Saline 0.9% Infusion Solution include Hyperchloremic acidosis, Fluid overload / pulmonary edema, Hypernatremia, Phlebitis at infusion site.

Related

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