What is the recommended dosing regimen for sovatiltide?

Sovateltide Dosing

Sovateltide is administered at 0.3 µg/kg 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) for acute cerebral ischemic stroke within 24 hours of symptom onset. 1, 2

Standard Dosing Regimen

The approved dosing protocol for sovateltide in acute cerebral ischemic stroke follows a specific schedule:

• Individual dose: 0.3 µg/kg administered as an intravenous bolus over 1 minute 1, 2
• Frequency on treatment days: Three doses separated by 3 ± 1 hour intervals 1, 2
• Treatment days: Day 1, Day 3, and Day 6 after randomization 1, 2
• Total daily dose: 0.9 µg/kg on each of the three treatment days 1

Timing of Administration

Sovateltide must be initiated within 24 hours of stroke onset, with clinical trial data showing median administration at approximately 18 hours post-stroke. 2 The drug demonstrated efficacy when given to patients presenting up to 24 hours after symptom onset. 1, 2

Patient Selection Criteria

Sovateltide is indicated for patients meeting the following criteria:

• Age: 18-78 years 2
• Stroke severity: National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 at presentation 2
• Radiologic confirmation: Documented ischemic stroke on imaging 1, 2
• Time window: Within 24 hours of symptom onset 2, 3

Exclusions

Do not administer sovateltide to patients with:

• Intracranial hemorrhage 1, 2
• Recurrent stroke 2
• Patients receiving endovascular therapy 1, 2

Administration Details

Route: Intravenous bolus injection 1, 2

Infusion rate: Administered over 1 minute 1, 2

Concomitant therapy: Sovateltide is given as an addition to standard of care for stroke management 1, 2

Safety Profile

Sovateltide demonstrated excellent tolerability with no drug-related adverse events in clinical trials. 1 Hemodynamic, biochemical, and hematological parameters remained unaffected by treatment. 1 The incidence of intracranial hemorrhage was similar between sovateltide (8.75%) and control groups (8.97%), indicating no increased bleeding risk. 2

Clinical Context

This dosing regimen achieved regulatory approval in India in May 2023 for treatment of cerebral ischemic stroke within 24 hours of onset. 3 The phase III trial demonstrated that 72.50% of sovateltide-treated patients achieved ≥2-point improvement on the modified Rankin Scale compared to 51.28% in controls (OR 2.50). 2 Additionally, 22.67% more patients achieved favorable outcomes (mRS 0-2) at 90 days with sovateltide versus placebo (OR 2.75). 2