TheraRadar
Data updated: Jun 28, 2026

PLENDIL (felodipine) · AstraZeneca

Trial Activity: Declining
Cardiovascular Approved 1991-07-25

PLENDIL is FDA-approved to treat 1 condition (same as FELODIPINE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's conducting 1 trials (33%)
3 indications explored (Focused)
→ food-drug interactions (1 trials)
→ disorder related to lung transplantation (1 trials)
→ healthy (1 trials)
2
Indications
--
Phase 3 Trials
34
Years on Market

Details

Status
Discontinued
First Approved
1991-07-25
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

AstraZeneca
Active Ingredient: FELODIPINE

PLENDIL Approval History

1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
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2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
60 FDA actions from 1991 to 2012 · 1 indication expansions
Oct 2012 SUPPL
Label · Labeling
FDA Letter Label
Jun 2004 SUPPL
Label · Labeling
FDA Letter Label
Sep 2002 SUPPL
Mfg · Manufacturing (CMC)

What PLENDIL Treats

1 indications

PLENDIL is approved for 1 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as FELODIPINE (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT02232269 R-11-655 NA-7122 Ph 1 completed Coffee Interaction With the Antihypertensive Drug Felodipine
NCT02744872 CARCATS 2008-004771-22 Ph 4 completed Copenhagen Acute Renal Complications After Transplantations Study Group
NCT00905333 D2452L00021 IMPACT 15381 Ph 1 completed Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

PLENDIL FDA Label Details

Indications & Usage

FDA Label (PDF)

PLENDIL is FDA-approved to treat 1 condition — same approved indications as FELODIPINE.

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Data Sources

FDA Approval: NDA019834 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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