Drugs / Tivoxavir Marboxil
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed influenza 1 milestone | |||||
| Filed | US (FDA) | — | influenza | 2026-01-13 | “IND application with the U.S. Food and Drug Administration (FDA) for tivoxavir marboxil (TXM)” trawspharma.com ↗ |
| Clinical hold Indication not stated 1 milestone | |||||
| Clinical hold | US (FDA) | — | — | 2026-02-19 | “FDA informed the Company that its US IND for tivoxavir marboxil was being placed on clinical hold” trawspharma.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07503405 | Jun → Nov 2026 expected | influenza | Traws Pharma, Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07371650 | Dec 2025 → Dec 2026 expected | influenza | Traws Pharma, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-06-22 | Traws Pharma, Inc. | Regulatory Traws Pharma Provides Updated Guidance on Influenza Prophylaxis Program trawspharma.com ↗
Following Traws’ announcement on June 12, . 2026, the MHRA provided more detailed feedback that has enabled the Company to prepare additional preclinical safety information for inclusion in the TXM data package. |
| 2026-06-12 | Traws Pharma, Inc. | Regulatory Traws Pharma Provides Regulatory Update on Influenza Program trawspharma.com ↗
Traws Pharma, Inc. (NASDAQ: TRAW, the Company), a clinical-stage biopharmaceutical company developing novel therapies for critical global viral threats, today announced that the planned test of tivoxavir marboxil (TXM) in a Phase 2a human influenza challenge study has been deferred due to a negative review of the program by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). |
| 2026-02-19 | Traws Pharma, Inc. | Regulatory Traws Pharma Completes Analysis of Ratutrelvir Clinical Study in PAXLOVID®-Eligible and Ineligible COVID-19 Patients and Provides Updates for Additional Indication for Tivoxavir Marboxil as a Prophylactic Treatment for Seasonal Influenza trawspharma.com ↗
PK study of compressed tivoxavir marboxil tablets submitted under open IND in Australia |
| 2026-01-13 | Traws Pharma, Inc. | Regulatory Traws Pharma Files Tivoxavir Marboxil Investigational New Drug (IND) Application for Influenza Therapy, and Provides Updated Results from the Ongoing Clinical Study of Ratutrelvir in PAXLOVID®-Eligible and Ineligible COVID-19 Patients trawspharma.com ↗
today announced the filing of a U.S. IND application with the U.S. Food and Drug Administration (FDA) for tivoxavir marboxil (TXM), a potential best in class CAP-dependent endonuclease inhibitor as a single oral tablet administered for the treatment of influenza. |
| 2025-06-30 | Traws Pharma, Inc. | Regulatory Traws Pharma Advances Antiviral Pipeline with Multiple Regulatory Submissions trawspharma.com ↗
The proposed study has been submitted for Human Research Ethics Committee (HREC) review and is expected to enroll subjects in Australia and selected countries in Southeast Asia (SE Asia) with high rates of human bird flu infections. |
| 2025-03-24 | Traws Pharma, Inc. | Results Traws Pharma Antiviral Bird Flu Program, Tivoxavir Marboxil, Shows Positive Data in Non-human Primates trawspharma.com ↗
today announced positive topline results from a study evaluating the use of tivoxavir marboxil (TXM) as a treatment for non-human primates challenged with a non-lethal dose of H5N1 bird flu. |
| 2025-03-21 | Traws Pharma, Inc. | Results Traws Pharma’s Bird Flu Drug Candidate, Tivoxavir Marboxil, Presented at ICAR trawspharma.com ↗
today announced that positive data supporting the potential for tivoxavir marboxil (TXM) as a bird flu treatment was presented yesterday in a poster at the International Society for Antiviral Research (ICAR 2025), being held in Las Vegas, Nevada. |
| 2025-03-03 | Traws Pharma, Inc. | Results Traws Pharma Reports Positive Results from An Accepted Bird Flu Model for Anti-Viral Candidate, Tivoxavir Marboxil trawspharma.com ↗
today announced positive topline results from ferrets infected with H5N1 bird flu, an accepted animal model for human influenza, when treated with tivoxavir marboxil as a single dose. |
| 2024-10-08 | Traws Pharma, Inc. | Results Traws Pharma Announces Positive Topline Phase 1 Data for Flu Candidate, Tivoxavir Marboxil trawspharma.com ↗
Topline data from the Phase 1 healthy volunteer study showed good overall tolerability and a pharmacokinetic profile that appears to support tivoxavir’s potential use as a one-time treatment for flu, including pandemic flu. |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tivoxavir Marboxil | “A Phase 2a, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tivoxavir Marboxil (TRX-100) in Healthy Adults in a Human...” NCT07503405 ↗1“This is an early-stage clinical trial to determine a safe and effective dose for Tivoxavir Marboxil (TRX-100) in patients with mild to moderate Influenza.” NCT07371650 ↗ |
| Known as | TRX-100 | “A Phase 2a, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tivoxavir Marboxil (TRX-100) in Healthy Adults in a Human...” NCT07503405 ↗1“This is an early-stage clinical trial to determine a safe and effective dose for Tivoxavir Marboxil (TRX-100) in patients with mild to moderate Influenza.” NCT07371650 ↗ |
| Route | Oral | “different oral doses of TRX-100” NCT07371650 ↗ |