Sovateltide
Also known as: Endotel, IRL-1620, PMZ-1620
Summary
Sovateltide (IRL-1620) is a synthetic endothelin B receptor agonist under clinical investigation primarily for acute ischemic stroke. It has demonstrated neuroprotective and neurorestorative effects in preclinical models and has completed Phase II/III trials in India, showing improvements in neurological outcomes when administered adjunctively with standard thrombolytic therapy.
Mechanism of Action
Selective agonist of endothelin B (ETB) receptors; promotes neuroregeneration and angiogenesis by stimulating neural stem cell differentiation, oligodendrocyte precursor cell proliferation, and cerebral microvascular remodeling following ischemic injury
Routes of Administration
Goals & Uses
- Reduction of infarct volumeNeuroprotectionLow
- Neurological recovery after acute ischemic strokeNeuroprotection / NeurorestorationModerate
- Promotion of neurogenesisNeuroregenerationModerate
- Cerebral angiogenesisVascular RemodelingLow
Contraindications
- Known hypersensitivity to sovateltide or excipientsAllergy/ImmunologyHigh
- Severe hepatic impairmentOrganModerateLiver function concerns
- Hemorrhagic strokeNeurologicalHigh
Adverse Effects
- Injection site reactionsLocalUncommon
- HeadacheNeurologicCommonPain in the head or upper neck
- NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
- Transient hypotensionCardiovascularUncommon
Drug Interactions
- Tissue plasminogen activator (tPA / alteplase)Low
- Antihypertensive agentsModerate
- Endothelin receptor antagonists (e.g., bosentan, ambrisentan)High
Population Constraints
- Patients with active malignancyOncologyRelative
- Severe renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionInvestigationalNo EMA approval reported as of knowledge cutoff
- United StatesInvestigationalIND-stage; not yet approved by FDA; being evaluated for ischemic stroke
Has received regulatory approval in India (CDSCO) for acute ischemic stroke as an adjunct to standard of care. Designated as an investigational new drug (IND) in the US context. Developed by Pharmazz Inc. Phase III trial results reported from India.
Evidence & Sources
No sources recorded yet.