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sterofundin
sterofundin is a Small molecule drug developed by Mahidol University. It is currently in Phase 1 development. Also known as: balance salt solution.
Sterofundin is a solution used in medical resuscitation, particularly in the treatment of Acute Kidney Injury and Shock, as well as in procedures such as Bariatric Surgery. It has been compared to normal saline and balanced solutions in clinical trials, including a study on its effect on kidney function in patients undergoing resuscitation.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | sterofundin |
|---|---|
| Also known as | balance salt solution |
| Sponsor | Mahidol University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Clinical Effects of Ringers Lactate Versus Sterofundin/ Plasmalyte Solution in Patients With Sepsis (NA)
- Gelatin in ICU and Sepsis (PHASE4)
- Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis (NA)
- Fluid Optimization With Crystalloids and Colloids in Neurosurgery (NA)
- Study on the Efficacy and Safety of Gelaspan (PHASE3)
- Continuous Non-invasive Assessment of Blood Pressure in Bariatric Surgery (NA)
- Non-invasive Assessment of Cardiac Output and Fluid Responsiveness in Bariatric Surgery (NA)
- Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators (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:
- sterofundin CI brief — competitive landscape report
- sterofundin updates RSS · CI watch RSS
- Mahidol University portfolio CI
Frequently asked questions about sterofundin
What is sterofundin?
Who makes sterofundin?
Is sterofundin also known as anything else?
What development phase is sterofundin in?
Related
- Manufacturer: Mahidol University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: balance salt solution
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing