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DR-2001a

Phase 2

Endometriosis | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: May 9, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00117481Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic PainPHASE2 COMPLETED 90Jun 1, 2005Dec 1, 2007May 9, 201441 United States
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Study Endpoints
Primary Endpoints
Mean change in nonmenstrual pelvic pain at end of treatment
Baseline to Week 12/Early Withdrawal Visit
Secondary Endpoints
Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms
Weeks 4, 8 and 12
Safety and tolerability of DR-2001
Throughout study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DR-2001aDRUGDR-2001a administered vaginally each month
DR-2001bDRUGDR-2001b administered vaginally each month
PlaceboOTHERPlacebo administered vaginally each month
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * Surgically sterilized (patient or partner), willing to use condoms throughout the study, or otherwise not at risk for pregnancy * Diagnosis of endometriosis within the last 5 years * Moderate or severe nonmenstrual pelvic pain * Premenopausal * Not pregnant or breastfeeding * ...

Countries:United States
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