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Agitated Saline SoC
Agitated Saline SoC is a Small molecule drug developed by Agitated Solutions, Inc.. It is currently in Phase 3 development for Treatment of agitation in patients with dementia.
Agitated Saline SoC is a standard of care treatment that involves administering a saline solution to help calm agitated patients.
Agitated Saline is a standard of care (SoC) intervention being compared to ASI-02 in a clinical trial for suspected Right-To-Left Shunt. Agitated Saline is also known as Potassic Saline or Lactated Saline, but its modality is currently unknown.
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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 | Agitated Saline SoC |
|---|---|
| Sponsor | Agitated Solutions, Inc. |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
The exact mechanism of action is not well understood, but it is thought to work by providing a soothing effect on the patient's nervous system. This can help to reduce agitation and promote a sense of calm. The saline solution may also help to rehydrate the patient and reduce any underlying electrolyte imbalances.
Approved indications
- Treatment of agitation in patients with dementia
Common side effects
- Nausea
- Vomiting
- Headache
Key clinical trials
- Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt (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:
- Agitated Saline SoC CI brief — competitive landscape report
- Agitated Saline SoC updates RSS · CI watch RSS
- Agitated Solutions, Inc. portfolio CI
Frequently asked questions about Agitated Saline SoC
What is Agitated Saline SoC?
How does Agitated Saline SoC work?
What is Agitated Saline SoC used for?
Who makes Agitated Saline SoC?
What development phase is Agitated Saline SoC in?
What are the side effects of Agitated Saline SoC?
Related
- Manufacturer: Agitated Solutions, Inc. — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Treatment of agitation in patients with dementia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing