Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TRX-100 · 2 trials · 1 indication
Defined as at least 2 quantifiable (≥LLOQ) qRT-PCR samples reported over 4 planned consecutive assessments within 48 hours.
At least one incidence of a symptom from the symptom diary card of grade ≥2.
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Number of participants with abnormal laboratory tests results
| Arm | Type | Description |
|---|---|---|
| TRX-100 Timing 1 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 2 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 3 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 4 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| Placebo Timing 1 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 2 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 3 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 4 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| TRX-100 Dose Level 1 | EXPERIMENTAL | Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100. |
| TRX-100 Dose Level 2 | EXPERIMENTAL | Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100. |
| Standard of Care (SOC) | ACTIVE_COMPARATOR | Participants in this arm will not receive the investigational drug. Instead, they will receive the current standard of care treatment. This arm serves as a comparator to evaluate the effects of the investigational drug. |
| Name | Type | Description |
|---|---|---|
| TRX-100 | DRUG | A single oral dose in capsules |
| Placebo | DRUG | A single oral dose in capsules |
| Influenza A/France/759/2021 (H1N1) virus | BIOLOGICAL | A single dose of challenge agent will be delivered Intranasal |
| Standard of Care (SOC) | DRUG | Standard of Care Influenza Antiviral therapy |
Inclusion Criteria: 1. Written informed consent signed and dated by the participant and the PI/investigator obtained before any assessment is performed. 2. Aged between 18 and 55 years old on the day prior to signing the consent form, inclusive. 3. A total body weight ≥50 kg and body mass index (BM...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
TRX-100 is an investigational small molecule antiviral being developed for the treatment of influenza. It is in Phase 2 clinical development and is not approved for any indication. Traws Pharma, Inc. is studying it in adults with influenza as well as in a human influenza A challenge model.
TRX-100 targets CAP-dependent endonuclease, a viral protein enzyme. Inhibiting this target is intended to interfere with influenza viral replication. The drug is a small molecule directed at that protein target, which places it in the same mechanistic class as other endonuclease inhibitors being developed for influenza.
TRX-100 is being developed by Traws Pharma, Inc., which trades on the Nasdaq under the ticker TRAW. The company is the sponsor of the clinical program studying the drug in influenza. No partnership or licensing arrangement for TRX-100 is disclosed in the available program information.
TRX-100 is in Phase 2 clinical development for influenza. It is investigational and has not been approved by the FDA or any other regulatory agency. Two Phase 2 trials are registered for the program, both currently active, with no completed trials reported to date.
TRX-100 is being studied in two Phase 2 trials. NCT07503405 is a Phase 2a efficacy and safety study in a human influenza A challenge model in the United Kingdom, enrolling 165 healthy volunteers, and is not yet recruiting. NCT07371650 is an early-stage dose-finding trial in patients with mild to moderate influenza in Australia, enrolling 105 participants, and is active but not recruiting.
Yes. TRX-100 is also known as tivoxavir marboxil, and the two names refer to the same investigational influenza antiviral from Traws Pharma. The alternative name appears in the registered title of the Phase 2 dose-finding trial NCT07371650, so readers searching either name are looking at the same asset.