Cardioxil

Dual action protection for the heart and vessels

  • First-in-class selective PPAR-α/γ modulator
  • 30% reduction in major adverse cardiovascular events (MACE) vs standard of care
  • Once-daily oral tablet with no titration required
  • Favorable safety profile with <2% discontinuation due to adverse events
Abstract visualization of cardiovascular protection showing heart and vascular elements
30%
MACE Reduction
7,200
Patients in ARMOR Trial

Mechanism of Action

Dual PPAR-α/γ modulation for comprehensive cardiovascular protection

3D molecular structure showing PPAR alpha and gamma receptors

Targeted Dual Action

Cardioxil™ binds selectively to PPAR-α receptors in hepatocytes, promoting β-oxidation of fatty acids and reducing plasma triglycerides. Simultaneously, partial PPAR-γ modulation in endothelial cells suppresses NF-κB signaling, lowering vascular inflammation without significant adipogenesis.

PPAR-α Activation

Enhances fatty acid oxidation in hepatocytes, reducing triglyceride levels and improving lipid metabolism

PPAR-γ Modulation

Suppresses vascular inflammation via NF-κB pathway inhibition without promoting adipogenesis

Endothelial Protection

Improves endothelial function and reduces markers of vascular inflammation

Proven Clinical Efficacy

Results from the Phase III ARMOR trial demonstrate significant cardiovascular risk reduction

ARMOR Trial Design

Phase III, randomized, double-blind, placebo-controlled study in 7,200 adults with atherosclerotic cardiovascular disease (ASCVD) inadequately controlled on high-intensity statins. Patients were followed for 36 months to assess cardiovascular outcomes.

MACE Reduction
30%

Relative risk reduction in major adverse cardiovascular events vs placebo

CV Death Reduction
37%

Significant reduction in cardiovascular mortality

MI Reduction
35%

Lower incidence of non-fatal myocardial infarction

Stroke Reduction
26%

Reduced risk of non-fatal stroke events

Primary Endpoint: MACE at 36 Months

Endpoint Cardioxil™ + SOC
(n=3,600)
Placebo + SOC
(n=3,600)
Relative Risk Reduction
MACE (CV death, MI, stroke) 6.5% 9.3% 30%
CV Death 2.0% 3.2% 37%
Non-fatal MI 3.1% 4.8% 35%
Non-fatal Stroke 1.4% 1.9% 26%

Key Secondary Endpoints

LDL-C Reduction
−22

mg/dL mean reduction vs placebo at 12 weeks (P<0.001)

hs-CRP Reduction
−35%

Mean reduction in high-sensitivity C-reactive protein (P<0.001)

Endothelial Function
+4.2%

Improvement in flow-mediated dilation (FMD) vs +0.9% placebo (P<0.01)

Favorable Safety Profile

Comprehensive safety data from pooled analysis of 4,000 patients

Common Adverse Events (≥5%)

Adverse Event Cardioxil™ (%) Placebo (%)
Headache 8.5 6.2
Diarrhea 6.7 5.1
Nasopharyngitis 6.3 4.9
ALT ↑ >3× ULN 1.9 1.4
Edema 1.8 1.6

Contraindications

  • Severe Hepatic Impairment
    Child-Pugh C classification
  • Uncontrolled Heart Failure
    NYHA class III-IV
  • 🛑
    Hypersensitivity
    To any component of Cardioxil™

Warnings & Precautions

  • 📊
    Liver Enzyme Monitoring
    Monitor at baseline and 12 weeks; withhold if ALT/AST >3× ULN with symptoms
  • 🔍
    Renal Function
    Use caution in patients with eGFR <30 mL/min/1.73 m²
  • 💧
    Fluid Retention
    Observe for edema in patients with history of fluid retention

Dosing & Administration

Standard Dosing

50 mg tablet taken once daily, with or without food

Dose Modifications for Adverse Events

Adverse Event Grade Recommended Action
ALT/AST >3× ULN with symptoms Grade 2-3 Withhold until recovery; resume at 25 mg daily
Peripheral Edema Grade 2 Initiate diuretic; continue treatment
Severe Edema Grade 3 Withhold; resume at 25 mg after resolution
Creatinine ↑ >2× baseline Grade 3 Interrupt until ≤1.5× baseline; resume at 25 mg
Life-threatening AE Grade 4 Permanently discontinue

Comprehensive Patient Support

We're committed to making Cardioxil™ accessible and affordable for all eligible patients

💳

Copay Assistance

Eligible patients pay as little as $25/month with our copay savings program

Learn More →
📦

Starter Packs

30-day free supply for newly prescribed patients to help begin treatment without delay

Request Now →
📋

Insurance Coverage

Tier 2 on 68% of commercial formularies at launch. Medicare Part D coverage anticipated Q4 2025

Check Coverage →

24/7 Support Hotline

Dedicated support team available around the clock

1-800-CARDIOX

Resources & Materials

Comprehensive clinical and educational materials for healthcare providers

Cardioxil detailed brochure cover page
Product Brochure

Detailed Product Brochure

Complete product information including mechanism of action, clinical efficacy, safety profile, and dosing guidelines

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Healthcare professional consultation scene
Clinical Data

ARMOR Trial Results

Full Phase III trial data with detailed efficacy and safety analysis from 7,200 patients

View Data →
Prescribing information page
Prescribing Info

Full Prescribing Information

Complete prescribing information including indications, contraindications, warnings, and precautions

View Info →
Important Safety Information: Cardioxil™ is indicated as an adjunct to diet and maximally tolerated statin therapy to reduce the risk of cardiovascular death, myocardial infarction, and stroke in adult patients with established atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors. Contraindicated in severe hepatic impairment (Child-Pugh C), uncontrolled heart failure NYHA III-IV, and hypersensitivity to any component. Monitor liver enzymes at baseline and 12 weeks. For complete safety information, see full prescribing information. For medical professionals only.