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intramuscular paraldehyde
intramuscular paraldehyde is a Barbiturate Small molecule drug developed by Kamuzu University of Health Sciences. It is currently in Phase 3 development for Alcohol withdrawal, Seizure disorders.
Paraldehyde is a sedative and anticonvulsant that acts by inhibiting the activity of GABA transaminase, leading to increased levels of GABA in the brain.
Intramuscular paraldehyde has been studied as a treatment for pediatric convulsions and status epilepticus. It has been compared to intranasal lorazepam in clinical trials, specifically in the treatment of pediatric convulsions.
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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 | intramuscular paraldehyde |
|---|---|
| Sponsor | Kamuzu University of Health Sciences |
| Drug class | Barbiturate |
| Target | GABA transaminase |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
This results in a calming effect on the nervous system, reducing anxiety and seizure activity. Paraldehyde's mechanism of action is complex and not fully understood, but it is thought to involve the inhibition of GABA transaminase, leading to increased GABA levels and a subsequent decrease in neuronal excitability.
Approved indications
- Alcohol withdrawal
- Seizure disorders
Common side effects
- Drowsiness
- Nausea
- Headache
Key clinical trials
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:
- intramuscular paraldehyde CI brief — competitive landscape report
- intramuscular paraldehyde updates RSS · CI watch RSS
- Kamuzu University of Health Sciences portfolio CI
Frequently asked questions about intramuscular paraldehyde
What is intramuscular paraldehyde?
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What is intramuscular paraldehyde used for?
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What drug class is intramuscular paraldehyde in?
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Related
- Drug class: All Barbiturate drugs
- Target: All drugs targeting GABA transaminase
- Manufacturer: Kamuzu University of Health Sciences — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Alcohol withdrawal
- Indication: Drugs for Seizure disorders
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing