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Didanosine

Phase 2

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 14, 2011

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
RandomizedUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment715
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00000672An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related ComplexPHASE2 COMPLETED 660 - -Mar 14, 201167 United States, Puerto Rico
NCT00002360A Study Comparing Two Forms of Didanosine in HIV-infected PatientsPHASE1 COMPLETED 30Mar 1, 1999Mar 1, 1999Apr 14, 2011 -
NCT00000669A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV InfectionPHASE1 COMPLETED 25 - -Aug 26, 20085 United States
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Study Design & Arms
PurposeTREATMENT
Interventions
NameTypeDescription
DidanosineDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria Concurrent Medication: Required: * Aerosolized pentamidine (300 mg every 4 weeks). In the event of physiological intolerance, alternative PCP prophylaxis may be trimethoprim/sulfamethoxazole 1 DS tab per day or dapsone 50 - 100 mg per day. Allowed: * Chronic suppressive treat...

Countries:United StatesPuerto Rico
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