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Resuscitation (Saline)
Resuscitation (Saline) is a Crystalloid fluid / Electrolyte replacement Small molecule drug developed by Universidad Nacional de La Plata. It is currently in Phase 3 development for Hypovolemic shock and hemorrhagic shock resuscitation, Severe dehydration and fluid loss, Perioperative fluid management.
Saline resuscitation restores circulating blood volume and tissue perfusion by administering isotonic sodium chloride solution intravenously.
Saline is a fluid used in resuscitation, specifically in the treatment of conditions such as Out-Of-Hospital Cardiac Arrest and Postcardiac Arrest Syndrome. It is administered through various techniques, including the Push-Pull technique, as part of fluid therapy interventions.
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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 | Resuscitation (Saline) |
|---|---|
| Sponsor | Universidad Nacional de La Plata |
| Drug class | Crystalloid fluid / Electrolyte replacement |
| Modality | Small molecule |
| Therapeutic area | Critical Care / Emergency Medicine |
| Phase | Phase 3 |
Mechanism of action
Saline solution replaces lost intravascular fluid during hemorrhage, shock, or severe dehydration, thereby restoring adequate perfusion pressure and oxygen delivery to vital organs. The isotonic formulation (0.9% NaCl) maintains osmotic balance and prevents cellular edema while expanding the extracellular fluid compartment.
Approved indications
- Hypovolemic shock and hemorrhagic shock resuscitation
- Severe dehydration and fluid loss
- Perioperative fluid management
Common side effects
- Hyperchloremic acidosis
- Fluid overload / pulmonary edema
- Electrolyte imbalance
Key clinical trials
- Management of Pain in Lumbar Arthrodesis (PHASE4)
- Precision Resuscitation With Crystalloids in Sepsis (NA)
- CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial (PHASE2)
- Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PHASE3)
- Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia (PHASE4)
- Effect of Oral Water on the Quality of Volume Expansion in Resuscitation Patients (NA)
- A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients (PHASE4)
- Crystalloid Fluid Choice and Neurological Outcome in Patients After Subarachnoid Haemorrhage (NA)
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:
- Resuscitation (Saline) CI brief — competitive landscape report
- Resuscitation (Saline) updates RSS · CI watch RSS
- Universidad Nacional de La Plata portfolio CI
Frequently asked questions about Resuscitation (Saline)
What is Resuscitation (Saline)?
How does Resuscitation (Saline) work?
What is Resuscitation (Saline) used for?
Who makes Resuscitation (Saline)?
What drug class is Resuscitation (Saline) in?
What development phase is Resuscitation (Saline) in?
What are the side effects of Resuscitation (Saline)?
Related
- Drug class: All Crystalloid fluid / Electrolyte replacement drugs
- Manufacturer: Universidad Nacional de La Plata — full pipeline
- Therapeutic area: All drugs in Critical Care / Emergency Medicine
- Indication: Drugs for Hypovolemic shock and hemorrhagic shock resuscitation
- Indication: Drugs for Severe dehydration and fluid loss
- Indication: Drugs for Perioperative fluid management
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing