Cardiozen
cardiozepam
ApprovedStatus: Approved
Therapeutic Area: Cardiovascular•Manufacturer: HeartMed Labs
Overview
Description
A selective SGLT2 inhibitor for the treatment of heart failure with reduced ejection fraction.
Mechanism of Action
Inhibits sodium-glucose co-transporter 2 (SGLT2) in the kidney, reducing glucose reabsorption and providing cardiovascular benefits.
Indication
Heart failure with reduced ejection fraction (HFrEF) in adults.
Market Projections
Financial outlook and market data
$1800M
Estimated Revenue
$12.0B
Market Size
6.2%
Growth Rate
2026
Peak Sales Year
Projected Revenue Growth
20242030
Clinical Development Timeline
Progress through clinical trial phases
✓
Preclinical
Completed
✓
Phase I
Completed
✓
Phase II
Completed
✓
Phase III
Completed
✓
Approved
Completed
| Phase | Status | Timeline | Participants | Primary Endpoint | Results |
|---|---|---|---|---|---|
| Preclinical | Completed | 2015-03 - 2016-08 | - | - | Favorable safety profile in animal models |
| Phase I | Completed | 2016-11 - 2017-09 | 60 | Safety and PK | Linear PK, well tolerated |
| Phase II | Completed | 2018-01 - 2019-06 | 250 | Change in NT-proBNP | 35% reduction in NT-proBNP |
| Phase III | Completed | 2019-09 - 2022-03 | 4,500 | CV death or HF hospitalization | 26% reduction in primary endpoint |
| Approved | Completed | 2022-09 | - | - | - |
Regulatory Approval Status
Approval status across different regions
U
United States
ApprovedAgency: FDA
Date: 2022-09
Approved for HFrEF
E
European Union
ApprovedAgency: EMA
Date: 2022-11
J
Japan
ApprovedAgency: PMDA
Date: 2023-02
C
China
ApprovedAgency: NMPA
Date: 2023-06