ISRADIPINE
ISRADIPINE is indicated for the treatment of Hypertension.
Details
- Status
- Prescription
- First Approved
- 2006-01-05
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, EXTENDED RELEASE
ISRADIPINE Approval History
What ISRADIPINE Treats
1 indicationsISRADIPINE is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
ISRADIPINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 ISRADIPINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ISRADIPINE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ISRADIPINE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02168842 results posted | STEADY-PD III U01NS080818-01A1, U01NS080840-01A1 | Ph 3 | completed | Efficacy of Isradipine in Early Parkinson Disease |
| NCT01895270 results posted | R21DA035325 R21DA035325 | Ph 1, Ph 2 | completed | Improving Buprenorphine Detoxification Outcomes With Isradipine |
| NCT01784666 Isradipine results posted | 2012-P-002449/1 | Ph 2 | terminated | Adjunctive Isradipine for the Treatment of Bipolar Depression |
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.
ISRADIPINE FDA Label Details
Indications & Usage
ISRADIPINE is indicated for the treatment of Hypertension.
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DYNACIRC
Full clinical data, patents, trials, and competitive landscape for isradipine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.