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Resatorvid

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment277

FDA Designations

No designations recorded

Clinical trial landscape

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
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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.
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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
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Frequently asked questions about Resatorvid

What is Resatorvid used for?

Resatorvid is an investigational small molecule being studied for the treatment of severe sepsis in adults. It is a Phase 3 drug candidate developed by Takeda Pharmaceutical Company Limited. The drug has been evaluated in a completed clinical trial, but it is not approved and remains in clinical development.

What does Resatorvid target?

Resatorvid is a small molecule being developed for sepsis. Its molecular target has not been disclosed in the available information, so its specific mechanism of action is not described here. The drug is being studied for its efficacy and safety in adults with severe sepsis.

Who makes Resatorvid?

Resatorvid is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has conducted a Phase 3 clinical trial of Resatorvid in adults with severe sepsis, which has been completed.

What phase is Resatorvid in?

Resatorvid is in Phase 3 clinical development for sepsis. It has completed one Phase 3 trial, but it is not FDA approved and remains investigational. The drug is not currently in any active clinical trials according to the available data.

What clinical trials is Resatorvid in?

Resatorvid has been studied in one clinical trial, NCT00143611, titled 'Efficacy & Safety of Resatorvid in Adults With Severe Sepsis.' This was a Phase 3, randomized, double-blind, placebo-controlled study with 277 participants, conducted across multiple countries including the United States, Japan, and European nations. The trial is completed.

Is Resatorvid the same as TAK-242?

Resatorvid is also known as TAK-242, a small molecule developed by Takeda. It has been investigated in a Phase 3 trial for severe sepsis, which was completed. The drug is not approved and remains in clinical development.