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Uridine

Phase 2

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

Uridine development status

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

Uridine target and mechanism

ModalitySmall molecule

Also known as RG2417

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment260

FDA Designations

No designations recorded

Uridine clinical trials

Uridine · 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 Uridine

What is Uridine used for in Bipolar Depression?

Uridine is an investigational small molecule being studied for the treatment of Bipolar Depression. It is being developed by Repligen Corporation (NASDAQ: RGEN). The drug is currently in Phase 2 clinical development, meaning it is still being tested in clinical trials and is not yet approved for use.

What does Uridine target?

The specific molecular target of Uridine has not been disclosed. It is a small molecule being investigated for its potential therapeutic effects in Bipolar Depression. The drug is being developed by Repligen Corporation (NASDAQ: RGEN) and is currently in Phase 2 clinical trials.

Who makes Uridine?

Uridine is being developed by Repligen Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol RGEN. The company is conducting clinical research to evaluate the drug as a potential treatment for Bipolar Depression. Uridine is currently in Phase 2 clinical development.

What phase is Uridine in?

Uridine is in Phase 2 clinical development for the treatment of Bipolar Depression. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a completed Phase 2 clinical trial to assess its safety and efficacy in patients with Bipolar I Depression.

What clinical trials is Uridine in?

Uridine has one completed Phase 2 clinical trial registered under NCT00322764, titled "Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression." The trial enrolled 80 participants in the United States and was a randomized, double-blind study. The drug is being developed by Repligen Corporation (NASDAQ: RGEN).

Is Uridine the same as RG2417?

Yes, Uridine is also known as RG2417. The Phase 2 clinical trial NCT00322764, which evaluated the drug for Bipolar I Depression, used the name RG2417 in its title. Repligen Corporation (NASDAQ: RGEN) is the developer of this investigational small molecule.