TheraRadar
Data updated: May 26, 2026

CORLANOR (ivabradine)

Trial Activity: Mature 5 active trials
Cardiovascular Approved 2015-04-15
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Assistance Publique - Hôpitaux de Paris conducting 2 trials (6%)
44 indications explored (Broad Platform)
→ heart failure (4 trials)
→ coronary artery disease (3 trials)
→ septic shock (2 trials)
2
Indications
--
Phase 3 Trials
2
Priority Reviews
11
Years on Market

Details

Status
Discontinued
First Approved
2015-04-15
Patent Cliff
2027

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SOLUTION, TABLET

Companies

Amgen
Active Ingredient: IVABRADINE

CORLANOR Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2015 to 2021
Aug 2021 SUPPL
Label · Labeling
FDA Letter Label
May 2019 SUPPL
Label · Labeling
FDA Letter Label
Apr 2019 ORIGINAL Priority
New Form · Type 3 - New Dosage Form
FDA Letter Label

What CORLANOR Treats

2 FDA approvals

Originally approved for its first indication in 2015 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

34 trials
Trial Sponsor ID Phase Status Title
NCT05882708 2022-LCYJ-YYDZX-02 Ph 4 recruiting Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis
NCT02584439 BRADYVASC 2015/077/HP 2015-002060-17 Ph 3 completed Effect of Pharmacological Heart Rate Reduction on Visco-elastic Properties of the Arterial Wall (BRADYVASC)
NCT04031573 IRISS P160925J 2018-003801-24 Ph 3 active not recruiting Ivabradine for Heart Rate Control In Septic Shock
NCT06305806 Pro00112597_B OTA-21-015G Ph 2 completed RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)
NCT07268170 HEART-BEAT 2025-522741-21-00 2025-522741-21-00 Ph 2, Ph 3 enrolling by invitation Heart Rate Control Before Cardiac Computed Tomography in Adults for the Evaluation of Coronary Artery Disease
NCT05279651 PREVENT-MINS PREVENT-MINS Ph 3 active not recruiting Ivabradine for Prevention of Myocardial Injury After Noncardiac Surgery Trial (PREVENT-MINS)
NCT03168529 OBSERVE-IVA results posted 1701000235 Ph 4 terminated Trial Assessing the Effectiveness of Ivabradine Started at Discharge From the Observation Unit
NCT03631654 HP-00080414 Ph 4 withdrawn Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes
NCT04285736 CL1200 Ph 2, Ph 3 completed Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI
NCT02446990 SIGNIFY results posted CL3-16257-083 2009-011360-10 Ph 3 completed Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure
NCT06371222 BSMMU/2023/6502 Ph 4 completed Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm
NCT02973594 PROBE-IT 16-1363 Ph 4 completed Pulse Reduction On Beta-blocker and Ivabradine Therapy
NCT03718273 BRAKE-AF BRAKE-AF 2018-001936-23 Ph 3 completed IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE-AF Study).
NCT04436016 PROTECTIN PROTECTIN Pilot SNCTP000003728 Ph 4 completed PeRiOperaTivE CardioproTection With Ivabradine in Non-cardiac Surgery
NCT03137537 results posted 17-022 Ph 2 terminated Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation Therapy.
NCT03456856 results posted 20160231 Ph 4 completed A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction.
NCT03987204 2000022064 Ph 1 completed Ivabradine for Rate Control in Permanent Atrial Fibrillation
NCT03182725 POTS results posted 170694 Ph 3 completed Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
NCT03105219 BENCH NFH20170403 Ph 3 withdrawn IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease
NCT00825123 141/07 bayside health Ph 4 terminated Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals
NCT00815100 Riviera/09 Ph 4 completed Effects of the Ivabradine on Reduction of Inflammatory Markers in Patients With Acute Coronary Syndrome
NCT02827500 PRIME-HF results posted Pro00071309 Ph 4 completed Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF)
NCT03866395 04091990 Ph 4 completed Effects of Ivabradine on Residual Myocardial Ischemia After PCI
NCT03619187 20180037 Ph 3 withdrawn An Interventional Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients
NCT02507050 MICRO-PCI 1060 Ph 4 withdrawn Ivabradine and Post-revascularisation Microcirculatory Dysfunction
NCT03485482 PHCL36 Ph 3 completed Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers
NCT01657136 CIBIST Casilino0001 0001 Ph 3 completed Ivabradine Versus Beta-blockers in the Treatment of Inappropriate Sinus Tachycardia
NCT02681978 RIVENDEL RIVENDEL Ph 4 completed Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease
NCT00757055 N2008/Iva/DD Ph 2 withdrawn If Channel Blockade With Ivabradine in Patients With Diastolic Heart Failure
NCT01178528 CARVIVA-HF results posted CTG001-07 Ph 3 completed Heart Rate Reduction in Heart Failure
NCT01699776 Dig&Iva CG&PJ-Dig-Iva 2009-2012 Ph 4 completed Efficacy Study of Digoxin & Ivabradine to Treat Heart Failure
NCT01373619 HFNEF-IVA-DIAL Ph 4 completed Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
NCT01029223 141/07 Ph 4 withdrawn The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
NCT01022463 IVA-MS F-2/IEC/MAMC/09/No.192 Ph 3 completed Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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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

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.

CORLANOR FDA Label Details

View full patent landscape →
8 OB patents · 2 families · 123 international docs across 45 countries

CORLANOR Patents & Exclusivity

Latest Patent: Jun 2027
Exclusivity: Oct 2026

Patents (8 active)

US7867996*PED Expires Jun 12, 2027
US7867996 Expires Dec 12, 2026
US7879842*PED Expires Aug 22, 2026
US7361649*PED Expires Aug 22, 2026
US7361650*PED Expires Aug 22, 2026
US7361650 Expires Feb 22, 2026
US7361649 Expires Feb 22, 2026
US7879842 Expires Feb 22, 2026

Exclusivity

ODE-234 Until Apr 2026
PED Until Oct 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for CORLANOR

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2027
  • • 36 active patents

Trial Analysis

  • • 35 total trials
  • • Stage: Mature

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA209964 → 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