What is the recommended dose of Sovaletide (generic name) injection for an adult patient with heart failure?

Sovaletide Dosing for Acute Cerebral Ischemic Stroke

Sovaletide is dosed at 0.3 µg/kg administered intravenously as a bolus over 1 minute, given in three doses at 3 ± 1 hour intervals on Days 1,3, and 6 (total daily dose of 0.9 µg/kg on each treatment day), and is indicated specifically for acute cerebral ischemic stroke—not heart failure. 1, 2

Critical Clarification: Indication and Context

• Sovaletide (also known as IRL-1620, PMZ-1620, or Tycamzzi™) is an endothelin-B receptor agonist approved for acute cerebral ischemic stroke, not heart failure. 1, 2
• The drug increases cerebral blood flow, has anti-apoptotic activity, and promotes neurovascular remodeling following cerebral ischemic stroke. 1, 2
• There is no evidence or indication for sovaletide use in heart failure patients in the available literature. 1, 2

Dosing Protocol for Acute Ischemic Stroke

Standard Dosing Regimen

• Each individual dose: 0.3 µg/kg administered as an intravenous bolus over 1 minute. 1, 2
• Frequency on treatment days: Three doses given at 3 ± 1 hour intervals. 1, 2
• Treatment schedule: Days 1,3, and 6 after stroke onset. 1, 2
• Total daily dose on treatment days: 0.9 µg/kg (sum of three 0.3 µg/kg doses). 1, 2

Patient Selection Criteria

• Age range: 18-78 years (Phase III trial used 18-78 years; Phase II used 18-70 years). 1, 2
• Timing: Must be administered within 24 hours of stroke symptom onset. 1, 2
• Stroke severity: National Institutes of Health Stroke Scale (NIHSS) score ≥6 at presentation. 2
• Confirmation: Radiologically confirmed ischemic stroke required. 1, 2

Exclusions

• Intracranial hemorrhage: Absolute contraindication. 1, 2
• Endovascular therapy: Patients receiving mechanical thrombectomy were excluded from trials. 1, 2
• Recurrent stroke: Patients with prior stroke were excluded. 2

Safety Profile

• Sovaletide was well-tolerated with no drug-related adverse events in clinical trials. 1
• Hemodynamic, biochemical, and hematological parameters were not affected by sovaletide administration. 1
• The incidence of intracranial hemorrhage was similar between sovaletide (8.75%) and control groups (8.97%), with events not attributed to the study drug. 2

Clinical Outcomes

Efficacy at 90 Days

• Modified Rankin Scale (mRS) 0-2: 22.67% more patients achieved favorable outcomes with sovaletide versus control (OR 2.75,95% CI 1.37-5.57). 2
• NIHSS 0-5: 17.05% more patients achieved this outcome with sovaletide (OR 2.67,95% CI 1.27-5.90). 2
• mRS improvement ≥2 points: Observed in 72.50% of sovaletide patients versus 51.28% of controls (OR 2.50,95% CI 1.29-4.81). 2

Timing Considerations

• In clinical trials, patients received the first dose approximately 18 hours after stroke onset on average. 2
• Earlier administration within the 24-hour window may optimize outcomes, though specific data on timing-dependent efficacy are limited. 1, 2

Administration Technique

• Administer as a rapid intravenous bolus over 1 minute—not as an infusion. 1, 2
• Use in conjunction with standard of care for acute ischemic stroke. 1, 2
• No dose adjustments based on weight categories were specified beyond the per-kilogram calculation. 1, 2

Common Pitfalls to Avoid

• Wrong indication: Do not confuse sovaletide with heart failure medications; it has no role in cardiac disease management. 1, 2
• Timing errors: Ensure all three doses on each treatment day are given at the specified 3 ± 1 hour intervals. 1, 2
• Missed treatment days: The Days 1,3, and 6 schedule must be followed for optimal benefit. 1, 2
• Inappropriate patient selection: Do not use in patients with hemorrhagic stroke or those beyond 24 hours from symptom onset. 1, 2