OPTISON (albumin human)
ALBUMINEX 25% is a concentrated human albumin solution indicated for the restoration and maintenance of circulating blood volume in adult and pediatric patients with hypovolemia due to shock, trauma, sepsis, or surgery. It is indicated for the prevention of central volume depletion following large-volume paracentesis in patients with ascites (liver cirrhosis), and as an adjuvant treatment for spontaneous bacterial peritonitis or type I hepatorenal syndrome. Additionally, it is used to manage hypoalbuminemia resulting from severe burns (after the initial 12–24 hours), acute nephrosis (in combination with diuretics), Acute Respiratory Distress Syndrome (ARDS), and to maintain hemodynamics during cardiopulmonary bypass surgery.
How OPTISON Works
Human albumin is the primary protein responsible for maintaining plasma colloid oncotic pressure (COP), accounting for approximately 80% of the oncotic force of plasma. ALBUMINEX 25% is a hyperoncotic solution; when injected intravenously, it draws interstitial fluid into the intravascular compartment, effectively expanding the circulating blood volume. Beyond volume stabilization, albumin serves as a vital transport protein for hormones, enzymes, and medicinal products. It also exhibits antioxidant properties, free radical scavenging capabilities, and helps maintain capillary membrane integrity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1997-12-31
- Patent Cliff
- 2028
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OPTISON Approval History
What OPTISON Treats
12 indicationsOPTISON is approved for 12 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypovolemia
- Ascites
- Hypoalbuminemia
- Burns
- Acute Nephrosis
- Acute Respiratory Distress Syndrome
- Cardiopulmonary Bypass
- Liver Cirrhosis
OPTISON Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to OPTISON
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04216784 results posted | 19092507-IRB01 | Ph 4 | terminated | Compare the Diuretic Effect With Furosemide vs Furosemide and Albumin Combined in Cirrhotic Patients |
| NCT02440334 results posted | 15P.039 JT 7277 | Ph 2 | completed | Two and Three Dimensional Contrast-enhanced Ultrasound for Screening of Renal Cell Carcinoma Recurrence Following Cryoablation |
| NCT05613946 CASTLE | 22-006006 | Ph 1 | completed | Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema |
| NCT03740997 results posted | GE-191-008 | Ph 4 | completed | Study to Determine Safety and Dosage of OPTISON in Pediatric Participants |
| NCT04071041 ALBUCAP | HUB-INF-ALBUCAP-402 2018-003117-18, PI17/01332 | Ph 3 | terminated | Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia. |
| NCT02625428 results posted | 14-009240 | Ph 4 | completed | IRB 14-009240, Does CEUS Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys? |
| NCT02204917 ceVUS results posted | IRB 13-010618 | Ph 1, Ph 2 | completed | CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children |
| NCT02061163 | HUM00080030 | Ph 1, Ph 2 | withdrawn | Contrast-Enhanced Ultrasound in Human Crohn's Disease |
| NCT01394926 results posted | GE-191-001 | Ph 2 | terminated | Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OPTISON FDA Label Details
Indications & Usage
FDA Label (PDF)OPTISON is indicated for the treatment of Hypovolemia; Ascites; Hypoalbuminemia; Burns; Acute Nephrosis; Acute Respiratory Distress Syndrome; Cardiopulmonary Bypass; Liver Cirrhosis; Chronic Liver Disease; Hepatorenal Syndrome; Spontaneous Bacterial Peritonitis; Infection.
OPTISON Patents & Exclusivity
Exclusivity
Track OPTISON with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment