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Ringer's Lactate Crystalloid Solutions
Ringer's Lactate Crystalloid Solutions is a Crystalloid intravenous solution Small molecule drug developed by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu. It is currently in Phase 3 development for Fluid resuscitation in hypovolemic shock, Perioperative fluid maintenance, Burn management and fluid replacement. Also known as: Fluid challenge.
Ringer's Lactate is a crystalloid intravenous fluid that restores intravascular volume and electrolyte balance by providing water, sodium, potassium, calcium, chloride, and lactate in physiologically balanced concentrations.
Ringer's Lactate Crystalloid Solutions are used to treat conditions such as hypotension and pancreatitis, including acute and chronic pancreatitis, as well as pancreatic duct stones. They are administered intravenously as part of aggressive hydration therapy, often in combination with other treatments like indomethacin suppositories.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | Ringer's Lactate Crystalloid Solutions |
|---|---|
| Also known as | Fluid challenge |
| Sponsor | Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu |
| Drug class | Crystalloid intravenous solution |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Ringer's Lactate solution mimics the electrolyte composition of plasma and is used for fluid resuscitation and maintenance therapy. The lactate component is metabolized by the liver to bicarbonate, providing mild alkalinizing effects. It effectively expands the extracellular fluid compartment and restores perfusion in hypovolemic states.
Approved indications
- Fluid resuscitation in hypovolemic shock
- Perioperative fluid maintenance
- Burn management and fluid replacement
Common side effects
- Hyperchloremic acidosis
- Fluid overload/pulmonary edema
- Hypokalemia
- Phlebitis at infusion site
Key clinical trials
- Effect of Liberal and Restrictive IV Fluids on Recovery After Gallbladder Surgery (PHASE1)
- Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy (PHASE2)
- Gelaspan vs Crystalloid Therapy in Sepsis (PHASE4)
- Precision Resuscitation With Crystalloids in Sepsis (NA)
- Volume Kinetics of Fluid Resuscitation in Early Sepsis
- Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PHASE3)
- Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients (NA)
- Fluids in Septic Shock (FISSH) (PHASE2, 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:
- Ringer's Lactate Crystalloid Solutions CI brief — competitive landscape report
- Ringer's Lactate Crystalloid Solutions updates RSS · CI watch RSS
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu portfolio CI
Frequently asked questions about Ringer's Lactate Crystalloid Solutions
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Related
- Drug class: All Crystalloid intravenous solution drugs
- Manufacturer: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Fluid resuscitation in hypovolemic shock
- Indication: Drugs for Perioperative fluid maintenance
- Indication: Drugs for Burn management and fluid replacement
- Also known as: Fluid challenge
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing