DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE (diltiazem hydrochloride)
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE is indicated for the treatment of Hypertension; Angina; Coronary Artery Spasm.
Details
- Status
- Prescription
- First Approved
- 2025-02-21
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE Approval History
What DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE Treats
3 indicationsDILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Angina
- Coronary Artery Spasm
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
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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 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07456852 | MC250411 NCI-2026-01065, MC250411 | Ph 1, Ph 2 | not yet recruiting | Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy |
| NCT04777045 EDIT-CMD | NL67497.091.19 2018-003518-41 | Ph 3 | active not recruiting | Efficacy of Diltiazem to Improve Coronary Microvascular Dysfunction: a Randomized Clinical Trial |
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.
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE is indicated for the treatment of Hypertension; Angina; Coronary Artery Spasm.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.