Last reviewed · How we verify
IN saline 0.9%
IN saline 0.9% is a Electrolyte solution / Fluid replacement Small molecule drug developed by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. It is currently in Phase 3 development for Fluid resuscitation and electrolyte replacement in clinical trial populations (specific indication unclear from available information).
Normal saline (0.9% sodium chloride solution) is an isotonic fluid that maintains cellular hydration and electrolyte balance when administered intravenously.
Normal saline (0.9% sodium chloride solution) is an isotonic fluid that maintains cellular hydration and electrolyte balance when administered intravenously. Used for Fluid resuscitation and electrolyte replacement in clinical trial populations (specific indication unclear from available information).
-
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 | IN saline 0.9% |
|---|---|
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Drug class | Electrolyte solution / Fluid replacement |
| Modality | Small molecule |
| Therapeutic area | Critical Care / Supportive Care |
| Phase | Phase 3 |
Mechanism of action
Intravenous saline 0.9% is a physiologic solution containing sodium and chloride ions in concentrations matching human plasma osmolality. It serves as a basic fluid replacement therapy to restore intravascular volume, maintain electrolyte homeostasis, and support organ perfusion. As a phase 3 investigational formulation, this may involve novel delivery methods, stabilization, or clinical validation in specific patient populations.
Approved indications
- Fluid resuscitation and electrolyte replacement in clinical trial populations (specific indication unclear from available information)
Common side effects
- Hyperchloremic acidosis
- Fluid overload / pulmonary edema
- Hypernatremia
Key clinical trials
- Effect of Lidocaine Infusion Versus Dexmedemidine Infusion on the Neurocognitive Function of Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography(ERCP): a Randomized, Controlled Trial. (NA)
- PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomized Trial) (NA)
- Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction (PHASE2)
- Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC) (PHASE2, PHASE3)
- Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection (PHASE2)
- Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
- Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies (PHASE1)
- Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function (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:
- IN saline 0.9% CI brief — competitive landscape report
- IN saline 0.9% updates RSS · CI watch RSS
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's portfolio CI
Frequently asked questions about IN saline 0.9%
What is IN saline 0.9%?
How does IN saline 0.9% work?
What is IN saline 0.9% used for?
Who makes IN saline 0.9%?
What drug class is IN saline 0.9% in?
What development phase is IN saline 0.9% in?
What are the side effects of IN saline 0.9%?
Related
- Drug class: All Electrolyte solution / Fluid replacement drugs
- Manufacturer: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's — full pipeline
- Therapeutic area: All drugs in Critical Care / Supportive Care
- Indication: Drugs for Fluid resuscitation and electrolyte replacement in clinical trial populations (specific indication unclear from available information)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing