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Hyperosmolar sodium lactate
Hyperosmolar sodium lactate is a Osmotic agent Small molecule drug developed by Innogene Kalbiotech Pte. Ltd. It is currently in Phase 3 development for Elevated intracranial pressure, Traumatic brain injury, Acute ischemic stroke. Also known as: Kalsolac, Totilac.
Hyperosmolar sodium lactate increases serum osmolality to draw fluid from intracellular and interstitial spaces into the intravascular compartment, reducing intracranial pressure and improving cerebral perfusion.
Hyperosmolar sodium lactate increases serum osmolality to draw fluid from intracellular and interstitial spaces into the intravascular compartment, reducing intracranial pressure and improving cerebral perfusion. Used for Elevated intracranial pressure, Traumatic brain injury, Acute ischemic stroke.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | Hyperosmolar sodium lactate |
|---|---|
| Also known as | Kalsolac, Totilac |
| Sponsor | Innogene Kalbiotech Pte. Ltd |
| Drug class | Osmotic agent |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
The drug acts as an osmotic agent that creates an osmotic gradient across the blood-brain barrier. By increasing plasma osmolality, it promotes movement of water from the brain parenchyma into the vasculature, thereby reducing brain edema and intracranial pressure. The lactate component may also provide metabolic substrate and buffer capacity in hypoxic or ischemic conditions.
Approved indications
- Elevated intracranial pressure
- Traumatic brain injury
- Acute ischemic stroke
Common side effects
- Hypernatremia
- Hyperosmolality
- Phlebitis at infusion site
- Renal dysfunction
Key clinical trials
- Effect of Exogenous Lactate on Neurocognitive in Brain Trauma (NA)
- Efficacy, Safety of Solution Containing Hyperosmolar Sodium Lactate Infusion for Resuscitation of Patients With Hemorrhagic Shock (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:
- Hyperosmolar sodium lactate CI brief — competitive landscape report
- Hyperosmolar sodium lactate updates RSS · CI watch RSS
- Innogene Kalbiotech Pte. Ltd portfolio CI
Frequently asked questions about Hyperosmolar sodium lactate
What is Hyperosmolar sodium lactate?
How does Hyperosmolar sodium lactate work?
What is Hyperosmolar sodium lactate used for?
Who makes Hyperosmolar sodium lactate?
Is Hyperosmolar sodium lactate also known as anything else?
What drug class is Hyperosmolar sodium lactate in?
What development phase is Hyperosmolar sodium lactate in?
What are the side effects of Hyperosmolar sodium lactate?
Related
- Drug class: All Osmotic agent drugs
- Manufacturer: Innogene Kalbiotech Pte. Ltd — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Elevated intracranial pressure
- Indication: Drugs for Traumatic brain injury
- Indication: Drugs for Acute ischemic stroke
- Also known as: Kalsolac, Totilac
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing