ISORDIL (isosorbide dinitrate)
Isosorbide Dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1959-11-09
- Routes
- SUBLINGUAL, ORAL
- Dosage Forms
- TABLET, CAPSULE, EXTENDED RELEASE, TABLET, EXTENDED RELEASE
ISORDIL Approval History
What ISORDIL Treats
2 FDA approvalsOriginally approved for its first indication in 1959 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Nov 1959) Priority
- • Approved indication (Dec 1961)
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05276219 Decongest | 08102021_ver2.5 2022-500035-36-01 | Ph 4 | recruiting | Optimized Treatment of Pulmonary Edema or Congestion |
| NCT06400784 | Uniabuja G 102642 A18971 | Ph 4 | completed | Hypertensive Heart Failure Treatment in SSA |
| NCT06218199 DART-HA | Dart-HA | Ph 4 | recruiting | Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts |
| NCT01516346 results posted | 01340 5R21AG043802-02 | Ph 2 | completed | Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction |
| NCT04297241 NEET results posted | 2018-0020 | Ph 2 | completed | Nitrate Effect on Exercise Capacitance |
| NCT02789033 results posted | 030-2010 | Ph 3 | completed | Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers |
| NCT01478022 ISOFEN1 | ISOFEN1 | Ph 1 | completed | To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20 |
| NCT02488642 INPer | 212250-29021 | Ph 4 | completed | Medical Management of Late Intrauterine Death. |
| NCT01513070 | SUXIAOJIUXIN2010 | Ph 4 | completed | A Clinical Trials of Quick-Acting Heart Reliever for Moderate Coronary Stenosis |
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.
ISORDIL FDA Label Details
Indications & Usage
FDA Label (PDF)Isosorbide Dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment