Keenova Unveils Real-World Data on TERLIVAZ for HRS-AKI at SHM Conference
Event summary
- Keenova Therapeutics will present new clinical analysis on TERLIVAZ (terlipressin) for hepatorenal syndrome-acute kidney injury (HRS-AKI) at the SHM Converge conference (March 29-April 1, 2026).
- TERLIVAZ is the first and only FDA-approved therapy for HRS-AKI, indicated to improve kidney function in adults with rapid kidney function decline.
- The retrospective cohort study examines real-world utilization patterns and outcomes in U.S. adults treated with terlipressin.
- HRS-AKI cases in the U.S. increased from 42,930 in 2018 to 63,381 in 2023, highlighting the growing unmet need.
The big picture
Keenova's presentation underscores the strategic importance of real-world evidence in rare disease markets, particularly for therapies with complex safety profiles. The growing incidence of HRS-AKI positions TERLIVAZ as a critical asset in Keenova's portfolio, though its long-term success hinges on managing regulatory and clinical adoption challenges. The biopharmaceutical sector continues to prioritize specialized treatments for high-morbidity conditions, with nephrology emerging as a key growth area.
What we're watching
- Clinical Adoption
- How the real-world data will influence physician prescribing patterns and payer coverage decisions for TERLIVAZ.
- Competitive Positioning
- Whether Keenova can maintain its first-mover advantage in the HRS-AKI space as competitors develop similar therapies.
- Regulatory Scrutiny
- The pace at which the FDA may require additional safety data given TERLIVAZ's black box warning for respiratory failure.