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Ratutrelvir non-randomised

Phase 2

COVID - 19 | Small molecule | Infectious Disease |Traws Pharma, Inc.|Last Updated: Jan 21, 2026

Target and mechanism

ModalitySmall molecule

Also known as Ratutrelvir (83-0060) non-randomised

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Ratutrelvir non-randomised · 1 trial · 1 indication

Phase 2 1
NCT07157007Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19COVID - 19
RECRUITING90 Analytics
PHASE2RECRUITING
Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19
COVID - 19Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety based on adverse events incidence
28 days

Adverse events incidence will be described using descriptive statistics methods

Safety based on adverse events severity
28 days

Adverse events severity will be assessed by current version of CTCAE

Secondary Endpoints

Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28
28 days
Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28.
28 days
PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax)
11 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ratutrelvir (83-0060) non-randomisedEXPERIMENTAL -
PaxlovidACTIVE_COMPARATORStandard of care
Ratutrelvir (83-0060)EXPERIMENTAL -

Interventions

NameTypeDescription
Ratutrelvir (83-0060) non-randomisedDRUG83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
PaxlovidDRUGPaxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
Ratutrelvir (83-0060)DRUG83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Confirmed SARS-CoV-2 infection for 120 h prior to randomization. 2. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to randomization. 3. At least one of the symptoms attributable to COVID-19 present within 24 hours prior to the Day 1 with the seve...

Countries:AustraliaSouth KoreaTaiwanUzbekistan
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Frequently asked questions about Ratutrelvir non-randomised

What is Ratutrelvir used for?

Ratutrelvir is an investigational small molecule being developed for the treatment of COVID-19. It is currently in Phase 2 clinical development for patients with mild to moderate COVID-19. The drug is being studied to determine a safe and effective dose in this patient population.

Who is developing Ratutrelvir?

Ratutrelvir is being developed by Traws Pharma, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol TRAW. Traws Pharma is conducting clinical trials to evaluate the safety and efficacy of Ratutrelvir for the treatment of COVID-19.

What phase is Ratutrelvir in?

Ratutrelvir is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is recruiting patients with mild to moderate COVID-19 to determine a safe and effective dose of the drug.

What clinical trials is Ratutrelvir in?

Ratutrelvir is being studied in a Phase 2 clinical trial registered as NCT07157007. This trial is titled 'Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19'. The study is currently recruiting participants and aims to enroll 90 patients.

Is Ratutrelvir the same as Ratutrelvir (83-0060) non-randomised?

Yes, Ratutrelvir is also known as Ratutrelvir (83-0060) non-randomised. These names refer to the same investigational drug being developed by Traws Pharma, Inc. for the treatment of COVID-19. The drug is currently in Phase 2 clinical trials.