This section highlights FDA-related milestones and regulatory updates for drugs developed by Traws Pharma (TRAW).
Over the past two years, Traws Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ratutrelvir, rigosertib, and tivoxavir. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ratutrelvir - FDA Regulatory Timeline and Events
ratutrelvir is a drug developed by Traws Pharma for the following indication: An Oral Mpro Inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ratutrelvir
- Announced Date:
- March 25, 2025
- Indication:
- An Oral Mpro Inhibitor
Announcement
Traws Pharma, Inc. announced that positive data supporting the potential for ratutrelvir, a main protease inhibitor, as a treatment for COVID-19, were presented on March 20, 2025 in a poster at the International Conference for Antiviral Research (ICAR 2025), held in Las Vegas, Nevada.
AI Summary
Traws Pharma recently presented positive data at ICAR 2025 in Las Vegas supporting ratutrelvir—a novel main protease inhibitor—as a potential COVID-19 treatment. The data, shared in a poster on March 20, 2025, indicate that ratutrelvir works effectively without needing co-administration with ritonavir, a boosting agent that can cause drug-drug interactions. This key finding could simplify treatment protocols for patients, especially those with complex medical conditions.
The study showed that ratutrelvir maintains effective blood levels over a 10-day course, which may help reduce the likelihood of COVID rebound and lower the risk of long COVID. Traws Pharma is preparing for discussions with the FDA to pave the way for Phase 2 trials, aiming to confirm these encouraging results and further establish ratutrelvir’s safety and efficacy in a larger patient population.
Read Announcement- Drug:
- ratutrelvir
- Announced Date:
- September 30, 2024
- Indication:
- An Oral Mpro Inhibitor
Announcement
Traws Pharma, Inc. announced positive topline Phase 1 results for its potential best-in-class COVID (SARS-CoV-2) candidate, ratutrelvir, an oral inhibitor of the Main protease (Mpro).
AI Summary
Traws Pharma recently announced positive topline Phase 1 results for its promising COVID candidate, ratutrelvir. This potential best-in-class oral antiviral, which targets the SARS-CoV-2 Main protease (Mpro), was well-tolerated over a 10-day period in healthy volunteers, with no treatment-related adverse events. The study showed that ratutrelvir achieved consistent plasma levels within the predicted therapeutic window, reaching concentrations significantly above the level needed to combat the virus, all without the need for ritonavir co-administration. This is a major advantage since avoiding ritonavir reduces the risk of drug-drug interactions and severe side effects. Based on these encouraging results, Traws Pharma is moving forward with the dose selected for a Phase 2a study, expected to begin in the first half of 2025.
Read Announcement
rigosertib - FDA Regulatory Timeline and Events
rigosertib is a drug developed by Traws Pharma for the following indication: In RDEB SCC Patients Treated with Legacy Oncology Drug Rigosertib.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- rigosertib
- Announced Date:
- June 3, 2025
- Indication:
- In RDEB SCC Patients Treated with Legacy Oncology Drug Rigosertib
Announcement
Traws Pharma, Inc. announced the publication of key clinical efficacy data for rigosertib, a legacy Traws Pharma oncology asset for which development and commercialization partners are being actively sought, in patients with RDEB SCC.
AI Summary
Traws Pharma, Inc. announced key clinical efficacy data for rigosertib, an oncology asset currently being advanced for potential commercialization, as part of its research in patients with recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma (RDEB SCC). The data, published in the British Journal of Dermatology, is the first clinical trial of an experimental cancer therapeutic conducted in this rare and challenging condition.
The promising results showed an overall response rate of 80% and complete responses in 50% of evaluable patients, suggesting that rigosertib could address a significant unmet need in RDEB SCC treatment. With current therapies offering limited benefits and short-lasting responses, Traws Pharma is actively seeking development and commercialization partners to help further advance and potentially bring this new treatment option to market.
Read Announcement
tivoxavir - FDA Regulatory Timeline and Events
tivoxavir is a drug developed by Traws Pharma for the following indication: for Flu Candidate.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- tivoxavir
- Announced Date:
- June 30, 2025
- Indication:
- for Flu Candidate
Announcement
Traws Pharma, Inc. announced multiple regulatory submissions related to its antiviral pipeline.
AI Summary
Traws Pharma, Inc. announced new regulatory submissions for its antiviral pipeline focusing on tivoxavir marboxil (TXM). The company has submitted a Phase 2 study protocol for a combined seasonal and bird flu study. This proposed study will compare TXM with XOFLUZA® in patients with seasonal flu and will also include a single arm to test TXM’s effects on H5N1 bird flu. The trial is planned for sites in Australia and select Southeast Asian countries where bird flu is common. Additionally, Traws Pharma submitted briefing documents to the FDA for a Type D meeting request. This meeting will help them discuss a potential path to accelerated approval for TXM to treat bird flu. These actions aim to show TXM’s broad potential in fighting different influenza strains.
Read Announcement- Drug:
- tivoxavir
- Announced Date:
- May 27, 2025
- Indication:
- for Flu Candidate
Announcement
Traws Pharma, Inc. announced receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration (FDA, the Agency).
AI Summary
Traws Pharma, Inc. announced that it has received written responses from the U.S. Food and Drug Administration (FDA) following its Type B pre-Investigational New Drug Application meeting. In this meeting, the company asked questions about developing tivoxavir marboxil (TXM), an investigational oral treatment for both bird flu and seasonal flu. The FDA’s responses provided detailed guidance on the development path, including feedback on using the Animal Rule—a pathway designed for situations where human trials are unethical or impractical.
The feedback also mentioned the possibility of conducting a combined clinical study with subjects infected by bird flu and seasonal flu as they occur naturally. Based on this exchange, Traws Pharma now plans to request a Type D meeting with the FDA to define the next steps, marking a key move toward advancing TXM for future regulatory approval.
Read Announcement - Drug:
- tivoxavir
- Announced Date:
- March 21, 2025
- Indication:
- for Flu Candidate
Announcement
Traws Pharma, Inc. 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.
AI Summary
Traws Pharma recently presented promising data on tivoxavir marboxil (TXM) as a potential treatment for bird flu at the International Society for Antiviral Research (ICAR 2025) in Las Vegas, Nevada. The poster highlighted that, in a rodent challenge model, mice treated with TXM achieved a 100% survival rate, while untreated animals did not survive. Additionally, the drug demonstrated potent suppression of multiple influenza viruses, including strains resistant to other antiviral treatments.
The data also included Phase 1 results that suggest a single dose of TXM maintained effective plasma levels for about three weeks, with good tolerability observed in healthy volunteers. Overall, these promising findings support TXM's potential as a safe, effective, and easy-to-administer bird flu treatment, with implications for its broader use against seasonal flu infections.
Read Announcement- Drug:
- tivoxavir
- Announced Date:
- March 3, 2025
- Indication:
- for Flu Candidate
Announcement
Traws Pharma, Inc. 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.
AI Summary
Traws Pharma announced promising topline results from a study using ferrets—an accepted animal model for human influenza—infected with H5N1 bird flu. The study found that a single oral dose of tivoxavir marboxil led to a reduction of disease severity. Notably, the treatment decreased the viral burden in the lungs and nasal tissues, while also increasing the survival rate of the animals. The positive findings in the ferret model support earlier results seen in murine studies, reinforcing the potential of tivoxavir marboxil as a one-time treatment for bird flu. Traws Pharma plans to conduct additional studies in non-human primates to better determine the appropriate dosage for humans. These results mark an important step forward in developing effective antiviral therapies and underscore the need for innovative treatments to address the risks associated with bird flu transmission to humans.
Read Announcement- Drug:
- tivoxavir
- Announced Date:
- January 23, 2025
- Indication:
- for Flu Candidate
Announcement
Traws Pharma, Inc. announced completion of Phase I clinical studies of its investigational one-dose influenza (flu) therapy, tivoxavir marboxil (tivoxavir), for the treatment or prevention of H5N1 bird flu.
AI Summary
Traws Pharma, Inc. announced the successful completion of its Phase I clinical study of its one-dose influenza therapy, tivoxavir marboxil, aimed at treating or preventing H5N1 bird flu. The trial, which involved healthy, influenza-negative adult volunteers, showed that tivoxavir marboxil was safe and well-tolerated across four different dose levels, with pharmacokinetic data supporting its use for therapeutic and preventive purposes against the bird flu virus.
The positive results pave the way for further testing, including additional studies in animal models of bird flu. Company executives emphasized the urgency of developing new antiviral therapies to tackle the growing threat of H5N1, highlighting that these promising findings might accelerate regulatory discussions and development efforts. This advancement marks a significant step in establishing an effective one-dose treatment option for bird flu.
Read Announcement- Drug:
- tivoxavir
- Announced Date:
- December 23, 2024
- Indication:
- for Flu Candidate
Announcement
Traws Pharma, Inc. announced progress in the development of its investigational one-dose influenza (flu) investigational therapy, tivoxavir marboxil for treatment of H5N1 bird flu.
AI Summary
Traws Pharma, Inc. announced promising progress in developing its investigational one-dose flu therapy, tivoxavir marboxil, specifically designed to treat H5N1 bird flu. The Phase 1 study in healthy adult volunteers showed that a single dose maintains plasma drug levels above the effective threshold for more than 23 days, and the treatment was safe and well-tolerated.
In laboratory and animal studies, tivoxavir marboxil proved effective against multiple isolates of the highly pathogenic H5N1 virus. In an in vivo mouse study, the treatment resulted in complete survival and significantly reduced viral levels in the lungs after exposure to an H5N1 strain from a human case. These encouraging results support further clinical development as a one-dose intervention and set the stage for a Phase 2 trial expected to begin in the first half of 2025.
Read Announcement- Drug:
- tivoxavir
- Announced Date:
- October 8, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- Indication:
- for Flu Candidate
Announcement
Traws Pharma, Inc announced that Phase 2 study expected to begin in H1 2025
AI Summary
Traws Pharma, Inc. announced promising Phase 1 results for its one-dose influenza treatment, tivoxavir marboxil. In the study with healthy volunteers, a single dose maintained plasma drug levels above the effective threshold for more than five days, showing a good safety and pharmacokinetic profile. These outcomes support tivoxavir’s potential to treat various strains of influenza, including seasonal and pandemic forms, and even drug-resistant variants and avian flu. Based on these encouraging results, Traws Pharma plans to advance the program by initiating a Phase 2 study in the first half of 2025. This crucial step will help further evaluate the treatment’s effectiveness and safety, bringing the company closer to offering a new best-in-class therapy to ease the public health burden of influenza.
Read Announcement- Drug:
- tivoxavir
- Announced Date:
- October 8, 2024
- Indication:
- for Flu Candidate
Announcement
Traws Pharma, Inc. announced positive topline Phase 1 safety and pharmacokinetic results for its investigational one-dose influenza (flu) therapy, tivoxavir marboxil (tivoxavir).
AI Summary
Traws Pharma, Inc. announced positive Phase 1 safety and pharmacokinetic results for its one-dose investigational influenza therapy, tivoxavir marboxil. In this study, healthy volunteers showed excellent tolerability, and a single dose maintained plasma drug levels above the EC90 for over five days. This pharmacokinetic profile suggests that tivoxavir could be effective as a one-time treatment for both seasonal and pandemic flu.
Preclinical data also indicated that tivoxavir effectively inhibits drug-resistant strains and avian flu viruses. These promising results have supported the selection of a dose for further development. Based on the encouraging data, Traws Pharma plans to begin a Phase 2 study in the first half of 2025, moving closer to offering a potential best-in-class flu therapy that could significantly improve treatment options during flu outbreaks.
Read Announcement
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