NICARDIPINE HYDROCHLORIDE · Sun Pharma
Nicardipine hydrochloride treats chronic stable angina, specifically chest pain triggered by physical exertion. It is also used for patients with high blood pressure and can be taken alone or combined with other medications like beta-blockers. When managing hypertension, it is important to monitor the drug's effect due to variations in blood pressure levels between doses.
How NICARDIPINE HYDROCHLORIDE Works
This drug works by blocking calcium ions from entering cardiac and vascular smooth muscle cells through specific channels. It is more selective for blood vessels than the heart muscle, allowing it to relax coronary vascular smooth muscle without significantly affecting the heart's pumping strength. This process happens without altering the concentration of calcium in the blood.
Details
- Status
- Prescription
- First Approved
- 1988-12-21
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, CAPSULE
Companies
NICARDIPINE HYDROCHLORIDE Approval History
What NICARDIPINE HYDROCHLORIDE Treats
2 indicationsNICARDIPINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
NICARDIPINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NICARDIPINE HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NICARDIPINE HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
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Sun Pharma's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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
Ongoing clinical trials by development phase
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 FDA Label Details
Indications & Usage
FDA Label (PDF)I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (Se...
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NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Full clinical data, patents, trials, and competitive landscape for nicardipine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.