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Normal saline irrigation
Normal saline irrigation is a Wound irrigation solution Small molecule drug developed by Hospital General Universitario Elche. It is currently in Phase 3 development for Wound irrigation and cleansing, Surgical site irrigation, Post-operative wound management. Also known as: Intraperitoneal Normal saline irrigation, Saline irrigation.
Normal saline irrigation mechanically cleanses and flushes wounds or surgical sites with sterile 0.9% sodium chloride solution to remove debris, bacteria, and foreign material.
Normal saline irrigation is used in the treatment of various conditions, including Ulcerative Colitis, Pulpitis, Peri-Implantitis, and Surgical Site Infection, as per ClinicalTrials.gov. Normal saline, also known as Potassic Saline, is a type of solution used for irrigation, with its modality being unknown according to ChEMBL.
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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 | Normal saline irrigation |
|---|---|
| Also known as | Intraperitoneal Normal saline irrigation, Saline irrigation |
| Sponsor | Hospital General Universitario Elche |
| Drug class | Wound irrigation solution |
| Modality | Small molecule |
| Therapeutic area | Surgery / Wound Care |
| Phase | Phase 3 |
Mechanism of action
Normal saline (0.9% NaCl) is an isotonic solution that matches physiological osmolarity, making it safe for direct tissue contact. When used for irrigation, it physically removes contaminants, necrotic tissue, and microorganisms from wounds or surgical fields without causing cellular damage or electrolyte imbalance. The mechanical flushing action promotes wound healing and reduces infection risk.
Approved indications
- Wound irrigation and cleansing
- Surgical site irrigation
- Post-operative wound management
Common side effects
- Minimal systemic adverse events expected with topical use
Key clinical trials
- Effects of Bronchial Segmental Endotoxin Instillation in Humans (PHASE2)
- Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease (NA)
- New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
- Volume Reduction for Open Fracture Irrigation (PHASE4)
- Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity (PHASE2, PHASE3)
- The Impact of Saline Temperature and Local Anesthetic Adjuvants on Postoperative Shoulder Pain and Inflammatory Marker Levels Following Laparoscopic Cholecystectomy (NA)
- Evaluating Postoperative Pain and Antibacterial Effect of Ultrasonic and 980 nm Diode Laser Combination (NA)
- Autogenous Periosteal Pedicle Graft Versus Pericardium Membrane in Management of Periodontal Intrabony Defects in Stage III Periodontitis (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:
- Normal saline irrigation CI brief — competitive landscape report
- Normal saline irrigation updates RSS · CI watch RSS
- Hospital General Universitario Elche portfolio CI
Frequently asked questions about Normal saline irrigation
What is Normal saline irrigation?
How does Normal saline irrigation work?
What is Normal saline irrigation used for?
Who makes Normal saline irrigation?
Is Normal saline irrigation also known as anything else?
What drug class is Normal saline irrigation in?
What development phase is Normal saline irrigation in?
What are the side effects of Normal saline irrigation?
Related
- Drug class: All Wound irrigation solution drugs
- Manufacturer: Hospital General Universitario Elche — full pipeline
- Therapeutic area: All drugs in Surgery / Wound Care
- Indication: Drugs for Wound irrigation and cleansing
- Indication: Drugs for Surgical site irrigation
- Indication: Drugs for Post-operative wound management
- Also known as: Intraperitoneal Normal saline irrigation, Saline irrigation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing