Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TNX-103, Levosimendan
Levosimendan (TNX-103) · 6 trials · 10 indications
The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs will be tabulated by system organ class and preferred term.
Change in 6-minute walk distance
The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5
Composite of all-cause death (at 30 days), or perioperative nonfatal MI \[CK-MB \>10xULN or \>100 ng/mL, CK-MB \>5xULN or 50 ng/mL with new Q wave (\>0.04 seconds wide in two contiguous leads) or new left bundle branch block)\] (through Day 5), or need for renal dialysis (through Day 30), or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) (through Day 5)
Number of Adverse Events per Patient Population
Change from baseline Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise at Week 6
| Arm | Type | Description |
|---|---|---|
| TNX-103 | EXPERIMENTAL | Open-label oral levosimendan 1-3mg |
| Placebo | PLACEBO_COMPARATOR | Matching placebo (oral) |
| Levosimendan | EXPERIMENTAL | levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours |
| Levosimendan Open-Label | OTHER | Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion. Ongoing patients are transitioned to daily oral levosimendan (1mg capsules TID) |
| Levosimendan 2.5mg/mL Injectable Solution | EXPERIMENTAL | 0.075 - 0.1µg/kg/min for 24 hrs (weekly) |
| Matching Placebo | PLACEBO_COMPARATOR | 0.075 - 0.1µg/kg/min for 24 hrs (weekly) |
| Name | Type | Description |
|---|---|---|
| TNX-103 | DRUG | Open-label oral levosimendan 1-3mg |
| Placebo | DRUG | Matching placebo (oral) |
| Levosimendan | DRUG | - |
| Matching Placebo | DRUG | A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion |
Inclusion Criteria: * Completed a TNX-103 parent study * Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103 * Requirements related to childbearing potential, contraception, and egg/sperm donation Exclusion Criteria: * Investigator or Sponsor op...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 5 | PHASE3 | selexipag, Macitentan |
| Merck & Co., Inc. | MRK | 8 | PHASE3 | Sotatercept, Riociguat, Frespaciguat |
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag, Tyvaso (treprostinil) |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606, LIQ861 Treprostinil, LIQ861 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | Levosimendan (TNX-103) |
| Inhibikase Therapeutics, Inc. | IKT | 2 | PHASE3 | IKT-001 |
| Roivant Sciences Ltd. | ROIV | 3 | PHASE3 | Mosliciguat |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Tectonic Therapeutic Inc | TECX | 2 | PHASE2 | TX45 |
| Gossamer Bio, Inc. | GOSS | 1 | PHASE3 | Seralutinib |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| IRulya Therapeutics Inc. | IRLA | 1 | PHASE2 | LAM-001 |
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | HS235 |
Levosimendan (TNX-103) is being developed for pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). Tenax Therapeutics is also studying it in pulmonary hypertension and in coronary artery bypass grafting. It is an investigational small molecule in Phase 3 development.
Levosimendan targets PDE3A and PDE3B, phosphodiesterases that break down cyclic AMP, and it acts as an inhibitor of these enzymes. It also binds the cardiac troponin proteins TNNC1, TNNI3, and TNNT2, which sensitizes the heart muscle to calcium. Both actions support cardiac contraction and vascular relaxation.
Levosimendan (TNX-103) is being developed by Tenax Therapeutics, Inc., which trades on Nasdaq under the ticker TENX. The company is advancing the oral formulation in Phase 3 trials for pulmonary hypertension associated with HFpEF, with studies running in the United States and multiple international sites.
Levosimendan (TNX-103) is in Phase 3 development. It is investigational and is not approved for its pulmonary hypertension indications. The Phase 3 program includes the LEVEL-2 trial and a long-term open-label extension study, and an earlier Phase 2 open-label rollover study has been completed.
Levosimendan (TNX-103) is being studied in Phase 3 trials NCT07288398 (LEVEL-2, active, not recruiting, 540 patients) and NCT07436689 (long-term open-label extension, enrolling by invitation, 800 patients), plus NCT05983250 in pulmonary hypertension. The completed Phase 2 rollover study is NCT03624010. All trials enroll adults aged 18 and older.
Yes, TNX-103 is another name for levosimendan. Tenax Therapeutics uses TNX-103 to refer to its oral levosimendan program for pulmonary hypertension associated with HFpEF. Searches for either name refer to the same investigational small molecule in Phase 3 development.