FDA Events for Tenax Therapeutics (TENX)
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
Levosimendan. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Levosimendan - FDA Regulatory Timeline and 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.
Read Announcement
Tenax Therapeutics FDA Events - Frequently Asked Questions
As of now, Tenax Therapeutics (TENX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Tenax Therapeutics (TENX) has reported FDA regulatory activity for Levosimendan.
The most recent FDA-related event for Tenax Therapeutics occurred on March 5, 2025, involving Levosimendan. The update was categorized as "Provided Update," with the company reporting: "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."
Currently, Tenax Therapeutics has one therapy (Levosimendan) targeting the following condition: Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:TENX) was last updated on 7/10/2025 by MarketBeat.com Staff
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