TERLIVAZ (terlipressin acetate)
Terlivaz helps adults with hepatorenal syndrome who are experiencing a rapid decline in their kidney function. It is used to improve how well the kidneys work in these patients, though it is less likely to be effective for those with very high serum creatinine levels above 5 mg/dL. Doctors prescribe this medication to stabilize renal performance during acute episodes of this syndrome.
How TERLIVAZ Works
This medication works by targeting vasopressin V1 receptors more specifically than V2 receptors, acting both as a direct agent and a precursor to lysine-vasopressin. By reducing pressure and blood flow within the portal vessels, it increases overall arterial volume and blood pressure. These changes help restore blood flow to the kidneys, which supports improved organ function.
Details
- Status
- Prescription
- First Approved
- 2022-09-14
- Patent Cliff
- 2037
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
TERLIVAZ Approval History
What TERLIVAZ Treats
1 indicationsTERLIVAZ is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatorenal Syndrome
TERLIVAZ Boxed Warning
SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk [see References (15) ]. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinu...
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk [see References (15) ]. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO 2 decreases below 90% [see Dosage and Administration (2.1) , Contraindications (4) , and Warnings and Precautions (5.1) ]. WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with ACLF Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO 2 decreases below 90% ( 2.1 , 4 , 5.1 ).
TERLIVAZ Competitive Set
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MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 TERLIVAZ
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01640964 results posted | CRLX030X2201 2012-000236-26 | Ph 2 | completed | An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension |
Active Pipeline
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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.
TERLIVAZ FDA Label Details
Indications & Usage
FDA Label (PDF)TERLIVAZ is indicated for the treatment of Hepatorenal Syndrome.
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk [see References (15) ]. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERL...
TERLIVAZ Patents & Exclusivity
Patents (1 active)
Exclusivity
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Deep insights for TERLIVAZ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.