Sovateltide (Soratide) Administration in Acute Ischemic Stroke
Sovateltide should be administered as 0.3 µg/kg intravenously over 1 minute, given in three doses at 3±1 hour intervals on Days 1,3, and 6 (total 0.9 µg/kg/day) within 24 hours of stroke onset, in addition to standard of care, for patients with radiologically confirmed acute cerebral ischemic stroke. 1, 2
Patient Selection Criteria
Inclusion criteria:
- Adults aged 18-78 years presenting within 24 hours of stroke symptom onset 1, 2
- Radiologically confirmed ischemic stroke on CT or MRI 1, 2
- NIHSS score ≥6 (indicating moderate to severe stroke) 2
- Patients receiving standard of care including IV alteplase if eligible 1, 2
Exclusion criteria:
- Intracranial hemorrhage on imaging 1, 2
- Patients receiving endovascular thrombectomy 1, 2
- Recurrent stroke 2
Dosing Schedule and Administration
Day 1 (within 24 hours of onset):
- Administer three doses of sovateltide 0.3 µg/kg IV bolus over 1 minute 1, 2
- Space doses at 3±1 hour intervals 1, 2
- Median time to first dose is approximately 18 hours from stroke onset 2
Day 3:
Day 6:
Monitoring Requirements
During administration:
- Monitor hemodynamic parameters (blood pressure, heart rate) 1
- Assess for adverse events during and after each dose 1
Follow-up assessments:
- NIHSS score on Days 1,6, and at 90 days 1, 2
- Modified Rankin Scale (mRS) on Days 1,6, and at 90 days 1, 2
- Barthel Index on Days 1,6, and at 90 days 1
- Quality of life measures (EQ-5D, SSQoL) at 60 and 90 days 1
Safety monitoring:
- Watch for intracranial hemorrhage (occurred in 8.75% of sovateltide patients, similar to control) 2
- Monitor biochemical and hematological parameters (not affected by sovateltide in trials) 1
Integration with Standard Stroke Care
Sovateltide is administered as an adjunct to standard of care, which includes:
- IV alteplase within 4.5 hours if eligible 3
- Aspirin 160-325 mg within 48 hours (delayed 24 hours if thrombolysis given) 4, 5
- Blood pressure management to maintain <180/105 mmHg in first 24 hours 4
- Stroke unit care with multidisciplinary team 3
Critical timing consideration: While sovateltide can be given up to 24 hours from onset, earlier administration is preferable as 14/18 patients in the phase II trial received treatment within 20 hours 1. The phase III trial showed median administration at 18 hours 2.
Expected Outcomes
At 90 days, sovateltide treatment resulted in:
- 22.67% more patients achieving mRS 0-2 (functional independence) compared to control (OR 2.75) 2
- 17.05% more patients achieving NIHSS 0-5 compared to control (OR 2.67) 2
- 72.50% of patients showing ≥2 point improvement on mRS versus 51.28% in control (OR 2.50) 2
- Significantly greater complete recovery rates (NIHSS 0 and Barthel Index 100) 1
Safety Profile
Sovateltide demonstrated excellent tolerability:
- No drug-related adverse events in phase II trial 1
- Intracranial hemorrhage rate (8.75%) similar to control group (8.97%) 2
- No adverse effects on hemodynamic, biochemical, or hematological parameters 1
- All enrolled patients completed the full treatment course 1
Important Clinical Caveats
Do not withhold standard acute stroke treatments: Sovateltide is given in addition to, not instead of, IV thrombolysis or other evidence-based therapies 1, 2. Patients should still receive IV alteplase within 4.5 hours if eligible 3, and mechanical thrombectomy within 6-24 hours for large vessel occlusions if appropriate 3, 6.
Endovascular therapy exclusion: The clinical trials specifically excluded patients receiving endovascular thrombectomy 1, 2, so safety and efficacy in this population remain unknown.
Regulatory status: Sovateltide (Tycamzzi™) received regulatory approval in India based on the phase III trial 2, but a multinational RESPECT-ETB trial is planned for US FDA approval 2.