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MNTX

Phase 2

Bowel Dysfunction | Small molecule | Gastrointestinal |Bausch Health Companies Inc.|Last Updated: Nov 27, 2019

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01367574Methylnaltrexone in Patients With Opioid-Induced Bowel DysfunctionPHASE2 COMPLETED 39Apr 1, 2002May 1, 2003Nov 27, 20191 United States
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Study Endpoints
Primary Endpoints
Number of subjects who have a bowel movement within four hours of dosing
Up to 4 weeks

To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.

Secondary Endpoints
Number of subject with Adverse Events
Up to 4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -
Interventions
NameTypeDescription
SC MNTXDRUGDose 1
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care 2. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen 3. Must have constipation 4. Must be 18 yrs or older Exclusion Criteria: 1. Concu...

Countries:United States
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