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CJ 0.9% Normal Saline Injection
CJ 0.9% Normal Saline Injection is a Intravenous fluid / Electrolyte replacement Small molecule drug developed by Seoul National 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 drug administration.
Normal saline (0.9% sodium chloride) provides isotonic fluid replacement and electrolyte balance for intravenous administration.
Normal saline (0.9% sodium chloride) provides isotonic fluid replacement and electrolyte balance for intravenous administration. Used for Fluid and electrolyte replacement in dehydration, Maintenance of intravascular volume during surgery or critical illness, Vehicle for intravenous drug administration.
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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).
| 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 name | CJ 0.9% Normal Saline Injection |
|---|---|
| Sponsor | Seoul National University Hospital |
| Drug class | Intravenous fluid / Electrolyte replacement |
| Modality | Small molecule |
| Therapeutic area | Supportive Care / Fluid Management |
| Phase | Phase 3 |
Mechanism of action
Normal saline is a sterile solution of sodium chloride at physiologic concentration (0.9%) that matches the osmolarity of blood plasma. It is used to restore intravascular volume, maintain electrolyte homeostasis, and serve as a vehicle for intravenous drug delivery. The solution has no active pharmacologic mechanism beyond fluid and electrolyte replacement.
Approved indications
- Fluid and electrolyte replacement in dehydration
- Maintenance of intravascular volume during surgery or critical illness
- Vehicle for intravenous drug administration
Common side effects
- Hyperchloremic acidosis (with prolonged high-volume infusion)
- Fluid overload / pulmonary edema (in susceptible patients)
- Hypokalemia (with chronic use without potassium supplementation)
- Local phlebitis at infusion site
Key clinical trials
- Balanced Salt Solution Versus 0.9% Saline Infusion for Prevention of Contrast-induced Acute Kidney Injury (BASIC Trial) (PHASE3)
- Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy (PHASE3)
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:
- CJ 0.9% Normal Saline Injection CI brief — competitive landscape report
- CJ 0.9% Normal Saline Injection updates RSS · CI watch RSS
- Seoul National University Hospital portfolio CI
Frequently asked questions about CJ 0.9% Normal Saline Injection
What is CJ 0.9% Normal Saline Injection?
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Who makes CJ 0.9% Normal Saline Injection?
What drug class is CJ 0.9% Normal Saline Injection in?
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Related
- Drug class: All Intravenous fluid / Electrolyte replacement drugs
- Manufacturer: Seoul National University Hospital — full pipeline
- Therapeutic area: All drugs in Supportive Care / Fluid 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 drug administration
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing