drugset
Drugs / TNX-103
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TNX-103

also known as levosimendan
Developed for
pulmonary hypertension
Investigated by
Tenax Therapeutics, Inc.

Trials 1

today NCT07436689 · Ph 3
202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 31 trial
Phase 3 NCT07436689 Mar 2026 → Mar 2029 expected pulmonary hypertension Tenax Therapeutics, Inc. Enrolling by invitation No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT05983250 Comparator Jan 2024 → Oct 2026 expected pulmonary hypertension Tenax Therapeutics, Inc. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2026-08-29 Tenax Therapeutics, Inc. Results Tenax Therapeutics Announces Presentation of Phase 3 LEVEL Results in Late-Breaking Scientific Sessions at ESC Congress 2026 tenaxthera.com ↗
In patients with a baseline 6MWD below the trial median of 333 meters, treatment with TNX-103 resulted in a 26.3-meter improvement compared to placebo (p = 0.0112)
2026-08-10 Tenax Therapeutics, Inc. Results Tenax Therapeutics Announces Topline Results from Phase 3 LEVEL Clinical Trial of TNX-103 in Patients with PH-HFpEF tenaxthera.com ↗
Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”) today announced topline results from the Phase 3 LEVEL clinical trial evaluating TNX-103 (oral levosimendan) in patients with PH-HFpEF.
2025-12-17 Tenax Therapeutics, Inc. Results Tenax Therapeutics Announces Result of Prespecified Blinded Sample Size Assessment tenaxthera.com ↗
2025-03-05 Tenax Therapeutics, Inc. Regulatory Tenax Therapeutics Expands Phase 3 LEVEL Program, Advancing Two TNX-103 (Oral Levosimendan) Registrational Studies for the Treatment of PH-HFpEF tenaxthera.com ↗
With the momentum provided from our $100 million financing in August 2024 and alignment with the FDA, we are now able to execute on our plan to advance these two Phase 3 registrational studies for TNX-103 in parallel.
2024-02-06 Tenax Therapeutics, Inc. Regulatory 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) tenaxthera.com ↗
This new patent, once granted, will provide significant added IP protection through December 2040.
2023-11-13 Tenax Therapeutics, Inc. Regulatory Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023 tenaxthera.com ↗
2022-10-10 Tenax Therapeutics, Inc. Results Positive Data Presented at HFSA Annual Meeting Demonstrate Effects of Oral Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF) tenaxthera.com ↗
2016-10-05 Tenax Therapeutics, Inc. Results Tenax Therapeutics Provides Clinical Update for Lead Candidate Levosimendan tenaxthera.com ↗

All press releases naming this drug 39 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as TNX-103 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05983250 ↗
1

NCT07436689 ↗
Known as levosimendan “The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants...” NCT07436689 ↗
1

“This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD;...” NCT05983250 ↗
Route Oral “This is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF.” NCT05983250 ↗