Sovateltide for Acute Ischemic Stroke in the United States
Sovateltide cannot currently be used for acute ischemic stroke in the United States as it lacks FDA approval, and American Heart Association/American Stroke Association guidelines explicitly recommend against neuroprotective agents in general for acute ischemic stroke (Class III: No Benefit; Level of Evidence A). 1
Regulatory Status and Guideline Position
Sovateltide (Tycamzzi™) received approval in India in May 2023 for cerebral ischemic stroke within 24 hours of onset, but has no FDA approval in the United States. 2
The AHA/ASA guidelines do not mention sovateltide specifically and state that no pharmacological treatments with putative neuroprotective actions have demonstrated efficacy in improving outcomes after ischemic stroke. 1
The 2018 AHA/ASA guidelines recommend against neuroprotective agents with a Class III: No Benefit rating, meaning they are not helpful and should not be used. 1
Devices or agents to augment cerebral blood flow should only be used in clinical trial settings (Class IIb; Level of Evidence B). 1
Clinical Trial Evidence
While sovateltide shows promise in research settings, this does not translate to clinical use in the U.S.:
A Phase III trial in India (n=158) showed that 22.67% more patients achieved mRS 0-2 at 90 days with sovateltide versus control (OR 2.75,95% CI 1.37-5.57). 3
The dosing schedule used in trials was 0.3 µg/kg intravenously in three doses at 3±1 hour intervals on Days 1,3, and 6, administered to patients within 24 hours of stroke onset. 4, 3
Patient eligibility in trials included adults aged 18-78 years, NIHSS ≥6, radiologically confirmed ischemic stroke, and presentation within 24 hours. 3
Exclusions included recurrent stroke, endovascular therapy recipients, and intracranial hemorrhage. 3
Current Standard of Care in the United States
Instead of sovateltide, U.S. guidelines mandate the following evidence-based treatments:
Intravenous alteplase (tPA) 0.9 mg/kg (maximum 90 mg) within 3-4.5 hours of symptom onset remains the primary pharmacological intervention (Class I; Level of Evidence A). 5
Endovascular thrombectomy with stent retrievers for large vessel occlusions within 6 hours of onset (Class I). 5
Aspirin 160-325 mg within 24-48 hours after stroke onset for patients not receiving thrombolysis (Class I; Level of Evidence A). 5, 6
Aspirin must not be given within 24 hours of tPA administration due to increased hemorrhage risk (Class III; Level of Evidence A). 6
Critical Caveat
Sovateltide should never be considered a replacement for established treatments like intravenous thrombolysis or endovascular therapy when those treatments are indicated. 1 A multinational trial (RESPECT-ETB) is planned for potential U.S. FDA approval, but until that occurs and FDA approval is granted, sovateltide remains unavailable for clinical use in the United States. 3