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Albutein 20%
Albutein 20% is a Small molecule drug developed by Grifols Therapeutics LLC. It is currently in Phase 3 development.
Albutein 20% is a solution used in medical treatments, specifically in conditions such as cirrhosis, ascites, and acute kidney injury, as per ClinicalTrials.gov. It is administered through albumin administration, which is compared to normal saline in some clinical trials, such as the randomized controlled trial "Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites".
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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 | Albutein 20% |
|---|---|
| Sponsor | Grifols Therapeutics LLC |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
- Anaemia
- Procedural pain
- Urinary tract infection
- Arthralgia
- Joint swelling
- Nasopharyngitis
- Muscle spasms
- Hypotension
- Diarrhoea
- Joint stiffness
- Pruritus
- Headache
Key clinical trials
- Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy (PHASE2)
- Recombinant Human Serum Albumin in Healthy Subjects (PHASE1)
- Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects (PHASE1)
- Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites (PHASE2, PHASE3)
- Phase II/III of Recombinant Human Serum Albumin (PHASE2, PHASE3)
- Modulation of Cerebral Ischemia by Albumin (PHASE2)
- Strong Albumin Solutions in Patients With Septic Shock (PHASE2, PHASE3)
- Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites (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:
- Albutein 20% CI brief — competitive landscape report
- Albutein 20% updates RSS · CI watch RSS
- Grifols Therapeutics LLC portfolio CI
Frequently asked questions about Albutein 20%
What is Albutein 20%?
Who makes Albutein 20%?
What development phase is Albutein 20% in?
What are the side effects of Albutein 20%?
Related
- Manufacturer: Grifols Therapeutics LLC — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing