Tuesday, March 17, 2015 3:27:42 AM
Levosimendan is a novel, first-in-class calcium sensitizer/K-ATP activator that provides:
oxygen sparing improvements in myocardial contractility
reductions in afterload
potential cardioprotective effects
Unmet medical need
Currently there are no drugs indicated for the prevention or the treatment of LCOS.
The FDA has granted fast track status for the “development of levosimendan to reduce morbidity and mortality in cardiac surgery patients at risk for developing low cardiac output syndrome.”
Low LVEF cardiac surgery patients represent a high risk population who experience a higher incidence of LCOS and worse outcomes.
Levosimendan has the potential to improve outcomes in these high risk patients.
FDA fast track status
The FDA has granted fast track status based on the drug’s potential to fill a serious unmet medical need, and has agreed to the Phase 3 trial protocol under a Special Protocol Assessment (SPA). FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in the U.S.
Recent TENX News
- Tenax Therapeutics to Host KOL Event: “LEVEL Setting: the Scientific Rationale for Levosimendan as a Potential First Treatment for PH-HFpEF, and the Ongoing Phase 3 LEVEL Study” • GlobeNewswire Inc. • 04/09/2024 12:30:00 PM
- Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results • GlobeNewswire Inc. • 03/28/2024 12:30:00 PM
- Tenax Therapeutics to Present at the 36th Annual Roth Conference • GlobeNewswire Inc. • 03/12/2024 12:30:00 PM
- Tenax Therapeutics Announces Oral Presentation of Levosimendan for the Treatment of PH-HFpEF at THT 2024 • GlobeNewswire Inc. • 02/29/2024 02:00:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/26/2024 09:31:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/23/2024 09:30:34 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/20/2024 09:01:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 01:33:49 PM
- Tenax Therapeutics Announces Global License Amendment that Significantly Expands Rights to Levosimendan • GlobeNewswire Inc. • 02/20/2024 01:30:00 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/16/2024 04:28:52 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/16/2024 12:36:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/12/2024 09:46:29 PM
- Tenax Therapeutics Announces Pricing of Approximately $9 Million Public Offering • GlobeNewswire Inc. • 02/08/2024 01:16:41 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/08/2024 05:15:17 AM
- Tenax Therapeutics Enrolls First Patient in Phase 3 LEVEL Study Evaluating TNX-103 (Oral Levosimendan) for the Treatment of Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF) • GlobeNewswire Inc. • 02/08/2024 01:01:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/06/2024 01:56:32 PM
- Tenax Therapeutics Announces USPTO Grants Notice of Allowance for U.S. Patent Application, Significantly Broadening IP Protection for Use of Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) • GlobeNewswire Inc. • 02/06/2024 01:30:00 PM
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