From the FDA Drug Label
Sotatercept-csrk is a homodimeric recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA (ActRIIA) linked to the human IgG1 Fc domain. The molecular weight based on the amino acid sequence of sotatercept-csrk is approximately 78 kDa as a homodimer Sotatercept (ACE-011) is a recombinant activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein, which acts as an activin signaling inhibitor 1. It is used to improve the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation.
- Mechanism of Action: Sotatercept-csrk binds to activin A and other TGF- β superfamily ligands to modulate vascular proliferation.
- Key Characteristics: Homodimeric recombinant fusion protein with a molecular weight of approximately 78 kDa.
From the Research
Sotatercept (ACE-011) is an activin receptor type IIA-Fc fusion protein that acts as a ligand trap to neutralize negative regulators of late-stage erythropoiesis, and it has been shown to increase hemoglobin levels and improve anemia in patients with various conditions, including end-stage kidney disease and myelodysplastic syndromes. The medication works by trapping activin receptor type IIA ligands, which are negative regulators of erythropoiesis, and has been found to be well-tolerated and effective in clinical trials 2. Some of the key benefits of sotatercept include:
- Increased hemoglobin levels and improved anemia
- Improved bone mineral density
- Slowed vascular calcification
- Well-tolerated with common side effects including hypertension, muscle spasm, and headache The most recent and highest quality study on sotatercept was published in 2019, which found that the medication exhibited a favorable safety profile and was associated with trends in dose-related slowing of vascular calcification in patients with end-stage kidney disease 3. Overall, sotatercept has shown promise as a treatment for anemia and other conditions, and further research is needed to fully understand its effects and potential benefits. It is worth noting that sotatercept has been studied in various patient populations, including those with myelodysplastic syndromes, and has been found to be effective in improving anemia and reducing transfusion burden in these patients 2. Additionally, sotatercept has been found to have a favorable safety profile, with common side effects being mild and manageable 3, 2. In terms of dosing, sotatercept has been administered subcutaneously at various doses, ranging from 0.1 to 2.0 mg/kg, and has been found to be well-tolerated at these doses 2. Overall, sotatercept is a promising medication that has shown efficacy and safety in clinical trials, and further research is needed to fully understand its potential benefits and risks.