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dirucotide

Phase 2

Relapsing Remitting Multiple Sclerosis | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Sep 9, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment218

FDA Designations

No designations recorded

Clinical trial landscape

dirucotide · 2 trials · 2 indications

Phase 2 2
NCT00869986A Study for Patients With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple Sclerosis
COMPLETED218 Analytics
NCT00869726A Study for Patients With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis
COMPLETED596 Analytics
PHASE2COMPLETED
A Study for Patients With Relapsing Remitting Multiple Sclerosis
Relapsing Remitting Multiple SclerosisUnlock trial analytics
PHASE2COMPLETED
A Study for Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Annualized relapse rate
15 months
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos

Secondary Endpoints

Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)
baseline, 15, 24 and 27 months
Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)
baseline, 15, 24 and 27 months
Proportion of patients relapse-free
15, 24, and 27 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DirucotideEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
dirucotideDRUG500mg, intravenous, every 6 months for 15 months
placeboDRUGintravenous, once every six months for 15 months
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Male or female subjects, 18-50 years of age 2. Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846) 3. At least 2 years history of MS before trial ent...

Countries:BulgariaPolandRussiaSerbiaSlovakiaUkraineCanadaDenmarkEstoniaFinlandGermanyLatviaNetherlandsSpainSwedenUnited Kingdom
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Frequently asked questions about dirucotide

What is dirucotide used for?

Dirucotide is an investigational small molecule being studied for the treatment of relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis. It is in Phase 2 clinical development and has not been approved by regulatory authorities.

Who is developing dirucotide?

Dirucotide is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 2 clinical trials for multiple sclerosis indications.

What phase is dirucotide in?

Dirucotide is in Phase 2 clinical development. It has completed two Phase 2 trials, one in secondary progressive multiple sclerosis and one in relapsing remitting multiple sclerosis. The drug remains investigational and has not received regulatory approval.

What clinical trials has dirucotide been in?

Dirucotide has been studied in two completed Phase 2 trials. NCT00869726 enrolled 596 participants with secondary progressive multiple sclerosis across multiple countries. NCT00869986 enrolled 218 participants with relapsing remitting multiple sclerosis in Eastern European countries. Both trials were randomized, double-blind, and placebo-controlled.

Is dirucotide FDA approved?

Dirucotide is not FDA approved. It is an investigational drug that has completed Phase 2 clinical trials for multiple sclerosis. The drug is still in clinical development and has not been authorized for commercial use.