This section highlights FDA-related milestones and regulatory updates for drugs developed by Tenax Therapeutics (TENX).
Over the past two years, Tenax Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TNX-103 and Levosimendan. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
TNX-103 FDA Regulatory Events
TNX-103 is a drug developed by Tenax Therapeutics for the following indication: Treatment of PH-HFpEF.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TNX-103
- Announced Date:
- November 6, 2025
- Indication:
- Treatment of PH-HFpEF
Announcement
Tenax Therapeutics, Inc. announced that the Company will host a conference call and webcast on Thursday, November 13, 2025, at 4:30 p.m. ET.
AI Summary
Tenax Therapeutics, Inc., a clinical-stage pulmonology company, will host a conference call and live webcast on Thursday, November 13, 2025, at 4:30 p.m. ET to update investors on its progress.
The management team will be joined by leading cardiology experts Dr. Barry A. Borlaug of the Mayo Clinic and Dr. Sanjiv J. Shah of Northwestern University. They will discuss the current treatment landscape for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) and late-stage development of TNX-103.
Tenax is advancing TNX-103 (oral levosimendan) in two registrational Phase 3 studies: LEVEL, with enrollment ongoing in North America, and LEVEL-2, a global study set to start in 2025, both targeting PH-HFpEF.
To join the call, dial +1-877-317-6789 (US) or +1-412-317-6789 (international) and ask for the Tenax Therapeutics call. A live and archived webcast will also be available on the company’s investor relations webpage.
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Levosimendan FDA Regulatory Events
Levosimendan is a drug developed by Tenax Therapeutics for the following indication: Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Levosimendan
- Announced Date:
- March 5, 2025
- Indication:
- Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF)
Announcement
Tenax Therapeutics, announced the U.S. Food and Drug Administration (FDA) has completed their review of Tenax Therapeutics' updated Phase 3 development plan for TNX-103 (oral levosimendan), including an Amendment to expand enrolment and increase the power of the ongoing Phase 3 LEVEL study, and the protocol for LEVEL-2, Tenax Therapeutics' second registrational Phase 3 study.
AI Summary
Tenax Therapeutics announced that the FDA has completed its review of the company's updated Phase 3 development plan for TNX-103 (oral levosimendan). This plan includes an amendment to expand enrollment in the ongoing Phase 3 LEVEL study from 152 to at least 230 patients, boosting its statistical power to over 95%. The increased enrollment is expected to be completed around the end of 2025, which should help produce robust data for demonstrating the drug’s efficacy and safety in patients with PH-HFpEF.
Additionally, the FDA approved the protocol for LEVEL-2, Tenax Therapeutics’ second registrational Phase 3 study. This global study will begin enrolling patients later this year and is designed to meet rigorous safety and benefit/risk assessment requirements. These parallel studies mark a significant step in advancing TNX-103 as a potential new treatment option for PH-HFpEF.
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