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Data updated: May 26, 2026

CARTIA XT (diltiazem hydrochloride)

Cardiovascular Approved 1998-07-09

CARTIA XT is indicated for the treatment of Hypertension; Angina.

1
Indication
--
Phase 3 Trials
27
Years on Market

Details

Status
Prescription
First Approved
1998-07-09
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

Active Ingredient: DILTIAZEM HYDROCHLORIDE

CARTIA XT Approval History

1999
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Original
New Indication
New Form
Label Update
92 FDA actions from 1998 to 2026
Jan 2026 SUPPL
Label · Labeling
Oct 2011 SUPPL
Label · Labeling
May 2007 SUPPL
Label · Labeling

What CARTIA XT Treats

2 indications

CARTIA XT is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Angina
Source: FDA Label

CARTIA XT Competitive Set

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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.

Drugs Similar to CARTIA XT

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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
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

CARTIA XT FDA Label Details

Indications & Usage

FDA Label (PDF)

CARTIA XT is indicated for the treatment of Hypertension; Angina.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.