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Sevirumab

Phase 1

Cytomegalovirus Infections | Small molecule | Infectious Disease |Novartis AG|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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002268A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or ViruriaPHASE1 COMPLETED - - -Jun 24, 20052 United States
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Study Design & Arms
PurposeTREATMENT
Interventions
NameTypeDescription
SevirumabDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria Concurrent Medication: Allowed: * Zidovudine (AZT). * Acyclovir. * Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection. * Trimethoprim / sulfamethoxazole (TMP / SMX). * Pyrimethamine / sulfadoxine. * Inhale...

Countries:United States
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