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RG2417

Phase 2

Bipolar I Depression | Small molecule | Psychiatry |Repligen Corporation|Trials Updated: Jan 17, 2011

RG2417 development status

Highest phase Phase 2
Registered trials 3 across 2 sponsors since May 2006

RG2417 target and mechanism

ModalitySmall molecule

Also known as Uridine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment260

FDA Designations

No designations recorded

RG2417 clinical trials

RG2417 · 2 trials · 2 indications

Phase 2 2
NCT00812058A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I DepressionBipolar I Depression
COMPLETED180 Analytics
NCT00322764Phase II Study to Assess RG2417 in the Treatment of Bipolar I DepressionBipolar Depression
COMPLETED80 Analytics
PHASE2COMPLETED
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
Bipolar I DepressionUnlock trial analytics
PHASE2COMPLETED
Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression
Bipolar DepressionUnlock trial analytics

Study Endpoints

Primary Endpoints

MADRS Score
Baseline and weekly for 8 weeks
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo

Secondary Endpoints

CGI-BP-S
Baseline and weekly for 8 weeks
Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)
Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RG2417EXPERIMENTALOral RG2417 taken twice daily for 8 weeks
PlaceboPLACEBO_COMPARATOROral placebo taken twice daily for 8 weeks

Interventions

NameTypeDescription
RG2417DRUG1g bid dose escalates to 2g bid for weeks 2-8.
PlaceboDRUGSimilarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.
UridineDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * Bipolar I Disorder, most recent episode depressed * History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms Exclusion Criteria: * Current manic, hypomanic or mixed episode * Rapid cycling bipolar disorder (4 or ...

Countries:United States
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Frequently asked questions about RG2417

What is RG2417 used for in Bipolar I Depression?

RG2417 is an investigational small molecule being studied for the treatment of Bipolar I Depression. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated for its safety, tolerability, and efficacy in patients with this condition.

Who makes RG2417?

RG2417 is being developed by Repligen Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol RGEN. The company is conducting clinical trials to evaluate the drug's potential in treating Bipolar I Depression.

What phase is RG2417 in?

RG2417 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The drug is being studied for its safety and efficacy in patients with Bipolar I Depression, with one Phase 2 trial already completed.

What clinical trials is RG2417 in?

RG2417 has one completed clinical trial registered as NCT00812058, titled 'A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression.' This Phase 2, randomized, double-blind, placebo-controlled study enrolled 180 participants in the United States.

Is RG2417 FDA approved?

RG2417 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Bipolar I Depression. The drug has completed one clinical trial, but it remains under study and has not been authorized for commercial use.