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Chlorure de sodium

Centre Hospitalier Universitaire Dijon · Phase 3 active Small molecule

Chlorure de sodium is a Electrolyte replacement agent Small molecule drug developed by Centre Hospitalier Universitaire Dijon. It is currently in Phase 3 development for Hyponatremia (low sodium levels), Dehydration and fluid loss, Electrolyte imbalance correction.

Sodium chloride replaces lost electrolytes and restores osmotic balance in body fluids.

Sodium chloride replaces lost electrolytes and restores osmotic balance in body fluids. Used for Hyponatremia (low sodium levels), Dehydration and fluid loss, Electrolyte imbalance correction.

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 nameChlorure de sodium
SponsorCentre Hospitalier Universitaire Dijon
Drug classElectrolyte replacement agent
ModalitySmall molecule
Therapeutic areaElectrolyte/Fluid Management
PhasePhase 3

Mechanism of action

Sodium chloride is an essential electrolyte that maintains proper fluid balance, nerve conduction, and muscle contraction. It is used clinically to correct hyponatremia, dehydration, and electrolyte imbalances by restoring sodium and chloride ions to normal physiological levels. The drug works osmotically to regulate water distribution between intracellular and extracellular compartments.

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 Chlorure de sodium

What is Chlorure de sodium?

Chlorure de sodium is a Electrolyte replacement agent drug developed by Centre Hospitalier Universitaire Dijon, indicated for Hyponatremia (low sodium levels), Dehydration and fluid loss, Electrolyte imbalance correction.

How does Chlorure de sodium work?

Sodium chloride replaces lost electrolytes and restores osmotic balance in body fluids.

What is Chlorure de sodium used for?

Chlorure de sodium is indicated for Hyponatremia (low sodium levels), Dehydration and fluid loss, Electrolyte imbalance correction, Saline solution for intravenous or oral rehydration.

Who makes Chlorure de sodium?

Chlorure de sodium is developed by Centre Hospitalier Universitaire Dijon (see full Centre Hospitalier Universitaire Dijon pipeline at /company/centre-hospitalier-universitaire-dijon).

What drug class is Chlorure de sodium in?

Chlorure de sodium belongs to the Electrolyte replacement agent class. See all Electrolyte replacement agent drugs at /class/electrolyte-replacement-agent.

What development phase is Chlorure de sodium in?

Chlorure de sodium is in Phase 3.

What are the side effects of Chlorure de sodium?

Common side effects of Chlorure de sodium include Hypernatremia (excessive sodium), Fluid overload, Phlebitis (at IV injection site), Nausea.

Related

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