TheraRadar
Data updated: Nov 8, 2026

DYNACIRC (isradipine) · GSK

Trial Activity: Declining
Cardiovascular Approved 1990-12-20

DYNACIRC is FDA-approved to treat 1 condition (same as ISRADIPINE).

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

Development Insights

University of Rochester conducting 1 trials (33%)
3 indications explored (Focused)
→ parkinson disease (1 trials)
→ opioid dependence (1 trials)
→ bipolar disorder (1 trials)
1
Indication
--
Phase 3 Trials
35
Years on Market

Details

Status
Discontinued
First Approved
1990-12-20
Routes
ORAL
Dosage Forms
CAPSULE

Companies

GSK
Active Ingredient: ISRADIPINE

DYNACIRC Approval History

1991
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Original
New Indication
New Form
Label Update
48 FDA actions from 1990 to 2005
May 2005 SUPPL
Label · Labeling
FDA Letter
Jun 2002 SUPPL
Mfg · Manufacturing (CMC)
Apr 2002 SUPPL
Mfg · Manufacturing (CMC)

What DYNACIRC Treats

1 indications

DYNACIRC is approved for 1 conditions since its original approval in 1990. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ISRADIPINE (same active ingredient).

Source: FDA Label
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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
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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.

DYNACIRC FDA Label Details

Indications & Usage

DYNACIRC is FDA-approved to treat 1 condition — same approved indications as ISRADIPINE.

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Data Sources

FDA Approval: NDA019546 → 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