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Lobradimil

Phase 1

Meningitis, Cryptococcal | Small molecule | Infectious Disease |Alkermes plc|Last Updated: Jun 24, 2005

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
Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002316The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal MeningitisPHASE1 COMPLETED - - -Jun 24, 200511 United States
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Study Design & Arms
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
LobradimilDRUG -
Amphotericin BDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria Concurrent Medication: Allowed: * Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis. Patients must have: * HIV infection. * Acute cryptococcal meningitis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or condit...

Countries:United States
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