Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TNX-103 · 3 trials · 2 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
| Arm | Type | Description |
|---|---|---|
| TNX-103 | EXPERIMENTAL | Open-label oral levosimendan 1-3mg |
| Placebo | PLACEBO_COMPARATOR | Matching placebo (oral) |
| Name | Type | Description |
|---|---|---|
| TNX-103 | DRUG | Open-label oral levosimendan 1-3mg |
| Placebo | DRUG | Matching placebo (oral) |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag |
| Merck & Co., Inc. | MRK | 6 | PHASE3 | Riociguat |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Johnson & Johnson | JNJ | 4 | PHASE3 | Selexipag |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | TNX-103 |
| Inhibikase Therapeutics, Inc. | IKT | 1 | PHASE3 | IKT-001 |
| Gossamer Bio, Inc. | GOSS | 2 | PHASE3 | Seralutinib |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| Tectonic Therapeutic Inc | TECX | 1 | PHASE2 | TX000045- Dose A, TX000045- Dose B |
| Abbott Laboratories | ABT | 1 | N/A | Undisclosed |
TNX-103 is an investigational small molecule being developed for pulmonary hypertension, specifically pulmonary hypertension associated with heart failure with preserved ejection fraction (HFpEF). It is currently in Phase 3 clinical trials to evaluate its effect on exercise limitation in patients with these conditions.
TNX-103 is oral levosimendan, a calcium sensitizer that enhances cardiac contractility without increasing oxygen demand. It also opens ATP-sensitive potassium channels, leading to vasodilation. These actions are being studied in the context of pulmonary hypertension associated with HFpEF.
TNX-103 is being developed by Tenax Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol TENX. The company is conducting Phase 3 clinical trials to assess the drug's efficacy in treating pulmonary hypertension.
TNX-103 is in Phase 3 clinical development. It is not yet approved by regulatory authorities and remains investigational. There are two active Phase 3 trials and one additional Phase 3 open-label extension study, all focused on pulmonary hypertension associated with HFpEF.
TNX-103 is being studied in two active Phase 3 trials: NCT05983250 (LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF) and NCT07288398 (LEVEL-2). Additionally, there is an open-label extension study, NCT07436689, enrolling patients who completed prior trials.
Yes, TNX-103 is oral levosimendan. The drug is being developed under the brand name TNX-103 by Tenax Therapeutics. Clinical trials refer to it as oral levosimendan, and it is being investigated for the treatment of pulmonary hypertension associated with HFpEF.