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Sular (NISOLDIPINE)
Sular (generic name: NISOLDIPINE) is a Dihydropyridine Calcium Channel Blocker [EPC] Small molecule drug developed by Azurity. It is currently FDA-approved (first approved 1995) for Hypertensive disorder.
Sular works by blocking calcium channels in blood vessel walls, which relaxes the blood vessels and lowers blood pressure.
Sular is a small molecule that belongs to the drug class of blockers, specifically targeting the voltage-gated L-type calcium channel. It is used to treat conditions such as hypertension and diabetic nephropathy, as well as healthy individuals, and is available in extended-release tablet form.
At a glance
| Generic name | NISOLDIPINE |
|---|---|
| Sponsor | Azurity |
| Drug class | Dihydropyridine Calcium Channel Blocker [EPC] |
| Target | Voltage-dependent L-type calcium channel subunit alpha-1C |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 1995 |
Mechanism of action
Mechanism of Action. Nisoldipine is member of the dihydropyridine class of calcium channel antagonists (calcium ion antagonists or slow channel blockers) that inhibit the transmembrane influx of calcium into vascular smooth muscle and cardiac muscle. It reversibly competes with other dihydropyridines for binding to the calcium channel. Because the contractile process of vascular smooth muscle is dependent upon the movement of extracellular calcium into the muscle through specific ion channels, inhibition of the calcium channel results in dilation of the arterioles. In vitro studies show that the effects of nisoldipine on contractile processes are selective, with greater potency on vascular smooth muscle than on cardiac muscle. Although, like other dihydropyridine calcium channel blockers, nisoldipine has negative inotropic effects. In vitro studies conducted in intact anesthetized animals have shown that the vasodilating effect occurs at doses lower than those that affect cardiac contr
Approved indications
- Hypertensive disorder
Common side effects
- Peripheral Edema
- Headache
- Dizziness
- Pharyngitis
- Vasodilation
- Sinusitis
- Palpitation
- Chest Pain
- Nausea
- Rash
- Abnormal liver function tests
- Anorexia
Drug interactions
- clarithromycin
- erythromycin
- telithromycin
Key clinical trials
- ACEI or ARB and COVID-19 Severity and Mortality in US Veterans
- Bioequivalence Study of Nisoldipine Extended-Release Tablets, 30 mg (PHASE1)
- Single-Dose Fed Bioequivalence Study of Nisoldipine Extended-Release Tablets (40 mg; Mylan) and Sular® Extended-Release Tablets (40 mg; First Horizon) in Healthy Volunteers (PHASE1)
- Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg (PHASE1)
- Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension (NA)
- Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sular CI brief — competitive landscape report
- Sular updates RSS · CI watch RSS
- Azurity portfolio CI
Frequently asked questions about Sular
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Related
- Drug class: All Dihydropyridine Calcium Channel Blocker [EPC] drugs
- Target: All drugs targeting Voltage-dependent L-type calcium channel subunit alpha-1C
- Manufacturer: Azurity — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertensive disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing