Utilization of injection Sovateltide for acute ischemic stroke

G. Rengaraj

Physician Assistant, Kauvery Hospital, Cantonment, Trichy

Case Presentation

Chief Complaint

Sudden onset of weakness in left upper and lower limbs and facial deviation.

History of Present Illness

Patient had an episode of giddiness followed by fall from a 2-wheeler around noon on 04 /02/25. He was treated at a local hospital and went home. The patient developed a sudden onset of weakness in the left upper and lower limbs, along with facial deviation since 1.00 pm on same day. Outside CT brain scan showed no evidence of acute ischemic stroke. He had worsening weakness and sensorium the next day and hence was referred here for further management.

Past Medical History

Hypertension on Telmisartan 40 and amlodipine 5 combination OD.

Family History

No H/o stroke, cardiovascular disease, neurological disorders, TIA, no similar events in the past.

Social History

Chronic smoker, alcoholic

General Examination

On 05 /02/25 at 1.50 pm

On arrival at the ER, he was conscious and responded to words.

Vitals

Right-hand BP: 140/90, Left-hand BP: 130/80

HR – 70/min, SPO2 – 100% with RA

GRBS – 100 mg/dl

On Examination

CNS – GCS: E4 V5 M6
Right gaze preferences present
Left hemiparesis 3/5
Left UMN facial palsy
Left hemineglect
CVS – S1 S2
RR – BAE (+)
NIHSS – 6
P/A – Soft

The patient was not eligible for thrombolysis/thrombectomy due to delayed arrival (>24 hr since onset).

Fig (1): Outside CT shows normal and no evidence of acute ischemic stroke

Investigation

Blood investigation	Renal function test	Liver function test
HB: 13.1	Urea: 21.40	Total bilirubin: 2.57
Platelets: 9890	Creatinine: 0.68	Direct bilirubin: 0.79
WBC: 261000		Indirect bilirubin: 1.78
Homocysteine: 13.17		SGOT: 27 .4
		SGOT: 18.3
		GGT: 44

Lipid profile	Electrolysis	Serology
Total cholesterol: 166	Sodium: 138	Negative
Triglycerides: 95	Potassium: 0.68
HDL: 49.8
LDL: 97.20

Management

Started with Single antiplatelet (Aspirin) and Atorvastatin.
Target BP maintained.
MRI brain with MRA or CT Angio could not be done due to restlessness.
Patient admitted in Neuro ICU for close monitoring

Fig (2): CT shows acute right MCA infarct (Kauvery Hospital)

Carotid and vertebral Doppler ultrasound done to rule out significant atherosclerosis, stenosis and embolic sources.
Cardiology opinion was obtained to rule out cardio embolic stroke.
ECG – Normal sinus rhythm
Echo – Good LV function

Pharmacological Management

Drug	Dose	Frequency
Inl. Tyvalzi (Sovateltide)	20 MCQ	TDS on Day 1, 3 and 6
Single Antiplatelet-Asprin	150 mg	OD
Antiedema-Mannitol	100ml	TDS
Statin Aztor	40mg	Hs
Inj. Pan	40mg	OD

Fig (3): CT brain and neck angiogram showed large vessel occlusion

Post CT Management

Aggressive Physiotherapy was done.
Repeat CT brain done showed Right MCA infarct with area of reperfusion mass effect and minimal midline shift to left side.
Speech and swallow assessment done after oral feeds were initiated.
Symptomatically improving after he was shifted to ward, power improved +4/5 , mobilized hence discharge with stable in a state.

Fig (4): CT shows Right MCA infarct with area of reperfusion mass effect

Discussion

Inj. Sovateltide – Drug Profile

Sovateltide, a novel injectable formulation, is a highly selective endothelin-B receptor agonist and synthetic analog of endothelin-1, is a neural progenitor cell therapeutic agent for the treatment of acute cerebral ischemic stroke (ACIS), hypoxic-ischemic encephalopathy (HIE), spinal cord injuries and Alzheimer’s disease. In May 2023, sovateltide was approved in India for the treatment of cerebral ischemic stroke within 24 hr of stroke onset.

Dose	0.3 Mcg/kg of body weight/dose
Reconstitution solution	Sodium Chloride Injection IP (0.9 %w/v)
Dosing interval	3 hr ± 1 hr
Total doses in a day	3 doses
Total doses	9 (3 doses on each day- Day 1, 3, 6)
1st dose	Within 24 hr of the onset of the stroke

Conclusion

The drug demonstrates significant therapeutic potential for managing Acute Ischemic Stroke, with a favourable safety profile. The result suggests that it may offer an effective and well tolerated option for patients with inadequate responses.

Literature review

Gulati A, Agrawal N, Vibha D, Misra UK, Paul B, Jain D, Pandian J et al. Safety and Efficacy of Sovateltide (IRL-1620) in a Multicenter Randomized Controlled Clinical Trial in Patients with Acute Cerebral Ischemic Stroke. CNS Drugs.

Highlights

Utilization of injection Sovateltide for acute ischemic stroke

Utilization of injection Sovateltide for acute ischemic stroke

G. Rengaraj

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