Recent Updates
Recently added Catalysts

Resatorvid

Phase 3

Sepsis | Small molecule | Infectious Disease |Takeda Pharmaceutical Company Limited|Trials Updated: Feb 2, 2012

Resatorvid development status

Highest phase Phase 3
Registered trials 3 across 2 sponsors since Sep 2005

Resatorvid target and mechanism

Molecular targetTLR4
Target classInhibitor
ModalitySmall molecule

Also known as TAK-242

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment277

FDA Designations

No designations recorded

Resatorvid clinical trials

Resatorvid · 1 trial · 1 indication

Phase 3 1
NCT00143611Efficacy & Safety of Resatorvid in Adults With Severe SepsisSepsis
COMPLETED277 Analytics
PHASE3COMPLETED
Efficacy & Safety of Resatorvid in Adults With Severe Sepsis
SepsisUnlock trial analytics

Study Endpoints

Primary Endpoints

28-day All-cause Mortality.
Day 28

Secondary Endpoints

Change from Baseline in Organ Failure Assessment
Day 28
Mean Systemic Inflammatory Response
Day 28
Mean Vasopressor-free days
Day 28
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Resatorvid 1.2 mg/kg/dayEXPERIMENTAL -
Resatorvid 2.4 mg/kg/dayEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ResatorvidDRUGResatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.05 mg/kg/h (1.2 mg/kg/day), injection, subcutaneously over 96 hours.
PlaceboDRUGResatorvid placebo-matching injection, subcutaneously for thirty minutes; then resatorvid placebo-matching injection, subcutaneously over 96 hours.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites144

Inclusion Criteria: * Has clinical evidence of infection defined as the presence of a known or probable source of infection requiring the initiation of parenteral antimicrobial therapy. * Must meet at least 3 of the following 4 criteria for SIRS: * A core temperature greater than 38°C or less th...

Countries:United StatesAustraliaAustriaBelgiumCanadaCzechiaFinlandGermanyIsraelItalyJapanNetherlandsNew ZealandPuerto RicoSpainSwedenUnited Kingdom
Unlock Eligibility Criteria

Competitive Landscape -Sepsis 24 trials

Top 3 of 7 competitors

Unlock Competitive Intelligence

Frequently asked questions about Resatorvid

What is Resatorvid used for?

Resatorvid was developed as a treatment for severe sepsis in adults. It is a small molecule antiviral and anti-inflammatory agent that was studied in a Phase 3 clinical trial in patients with severe sepsis. The drug has not been approved for commercial use and remains an investigational therapy.

What does Resatorvid target?

Resatorvid targets TLR4, also known as Toll-like receptor 4. It acts as an inhibitor of this receptor. TLR4 is involved in the innate immune response to bacterial infections, and inhibiting it was intended to reduce the excessive inflammatory response associated with severe sepsis.

Who makes Resatorvid?

Resatorvid was developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor responsible for the clinical development of the drug, including the Phase 3 trial conducted in patients with severe sepsis.

What phase is Resatorvid in?

Resatorvid reached Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is Resatorvid in?

Resatorvid was studied in one completed Phase 3 trial, NCT00143611, titled Efficacy and Safety of Resatorvid in Adults With Severe Sepsis. The trial enrolled 277 adults aged 18 and older across the United States, Europe, Japan, Australia, Canada, Israel, New Zealand, and Puerto Rico.

Was the Resatorvid trial randomized and placebo controlled?

Yes. The Phase 3 trial of Resatorvid, NCT00143611, was randomized, double blind, and placebo controlled. It enrolled 277 adults with severe sepsis and has been completed. The study included participants of all sexes and did not use biomarker selection for enrollment.