Esaxerenone
- Generic Name
- Esaxerenone
- Drug Type
- Small Molecule
- Chemical Formula
- C22H21F3N2O4S
- CAS Number
- 1632006-28-0
- Unique Ingredient Identifier
- N62TGJ04A1
- Background
Esaxerenone is under investigation in clinical trial NCT02722265 (Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension).
- Indication
用于治疗高血压等。
CDSCO Panel Asks Sun Pharma to Conduct Phase III Trial of Esaxerenone for Resistant Hypertension
• The CDSCO's Subject Expert Committee (SEC) has advised Sun Pharmaceutical Industries to conduct a Phase III clinical study on esaxerenone for resistant hypertension.
• This recommendation followed Sun Pharma's proposal to manufacture and market esaxerenone tablets (2.5 mg and 5 mg) and a request to conduct a Phase III clinical trial.
• The SEC noted that esaxerenone is not indicated for essential hypertension and that another applicant has been recommended for a Phase III trial in resistant hypertension.
• The committee also requested Sun Pharma to submit bioequivalence study data for review, alongside a revised Phase III protocol focusing on resistant hypertension.
Esaxerenone Shows Promise as Second-Line Hypertension Treatment, Especially with ARBs
• Esaxerenone demonstrates non-inferiority to trichlormethiazide in lowering blood pressure when added to either ARBs or CCBs.
• In patients on CCBs, esaxerenone was superior to trichlormethiazide in lowering systolic blood pressure, indicating a potential advantage.
• The study suggests esaxerenone may be particularly effective when combined with ARBs due to factors like aldosterone breakthrough.
• Monitoring serum potassium is crucial when using esaxerenone, especially with ARBs, to manage potential hyperkalemia.
Drug Development Updates
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