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ELAD treatment
ELAD treatment is a Extracorporeal liver support device Biologic drug developed by Vital Therapies, Inc.. It is currently in Phase 3 development for Acute liver failure (fulminant hepatic failure) as a bridge to transplantation or recovery. Also known as: ELAD.
ELAD is an extracorporeal liver assist device that uses hepatocyte-based bioreactor technology to provide liver support and detoxification functions in patients with acute liver failure.
ELAD is an extracorporeal liver assist device that uses hepatocyte-based bioreactor technology to provide liver support and detoxification functions in patients with acute liver failure. Used for Acute liver failure (fulminant hepatic failure) as a bridge to transplantation or recovery.
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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).
| 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 | ELAD treatment |
|---|---|
| Also known as | ELAD |
| Sponsor | Vital Therapies, Inc. |
| Drug class | Extracorporeal liver support device |
| Modality | Biologic |
| Therapeutic area | Hepatology / Critical Care |
| Phase | Phase 3 |
Mechanism of action
ELAD contains human hepatocytes within a bioreactor cartridge that performs synthetic, metabolic, and detoxification functions of the liver when connected extracorporeally. The device bridges patients with acute liver failure toward either spontaneous recovery or transplantation by maintaining critical liver functions and reducing hepatic encephalopathy and other complications of liver failure.
Approved indications
- Acute liver failure (fulminant hepatic failure) as a bridge to transplantation or recovery
Common side effects
- Thrombocytopenia
- Coagulopathy
- Infection
- Device-related complications
Key clinical trials
- Evaluating Liraglutide in Alzheimer's Disease (PHASE2)
- To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure (PHASE3)
- Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure (PHASE3)
- Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF) (PHASE2)
- Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD (PHASE3)
- Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery
- Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency (PHASE1, PHASE2)
- Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis (PHASE2, 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:
- ELAD treatment CI brief — competitive landscape report
- ELAD treatment updates RSS · CI watch RSS
- Vital Therapies, Inc. portfolio CI
Frequently asked questions about ELAD treatment
What is ELAD treatment?
How does ELAD treatment work?
What is ELAD treatment used for?
Who makes ELAD treatment?
Is ELAD treatment also known as anything else?
What drug class is ELAD treatment in?
What development phase is ELAD treatment in?
What are the side effects of ELAD treatment?
Related
- Drug class: All Extracorporeal liver support device drugs
- Manufacturer: Vital Therapies, Inc. — full pipeline
- Therapeutic area: All drugs in Hepatology / Critical Care
- Indication: Drugs for Acute liver failure (fulminant hepatic failure) as a bridge to transplantation or recovery
- Also known as: ELAD
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing