NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE (nicardipine hydrochloride)
Nicardipine hydrochloride helps patients with chronic stable angina, particularly when chest pain is triggered by physical effort. It also treats hypertension and can be used as a standalone therapy or alongside other medications like beta-blockers. Because the drug's effect on blood pressure can vary significantly between doses, careful monitoring is necessary during use.
How NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE Works
This drug works by blocking the movement of calcium ions into cardiac and vascular smooth muscle cells through specific channels. It is more selective for vascular smooth muscle than the heart muscle itself. By inhibiting this calcium influx, the medication relaxes coronary blood vessels without significantly affecting the strength of heart contractions.
Details
- Status
- Prescription
- First Approved
- 2024-04-17
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE Approval History
What NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE Treats
2 indicationsNICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Angina
- Hypertension
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE Competitive Set
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What's emerging in NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03098680 PRIME | PRIME (A094136) | Ph 1 | terminated | A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
| NCT01810302 results posted | 034-2013 | Ph 2 | terminated | Safety Study of Nicardipine to Treat Cerebral Vasospasm |
Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE FDA Label Details
Indications & Usage
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE is indicated for the treatment of Angina; Hypertension.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.