NDAORALFOR SOLUTIONPriority Review
Approved
Oct 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
VIDEX (didanosine) by Bristol Myers Squibb is [ see clinical pharmacology () ]. First approved in 1991.
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIDEX (didanosine) is an oral nucleoside reverse transcriptase inhibitor (NRTI) approved in 1991 for HIV treatment. It works by inhibiting reverse transcriptase, blocking viral replication in HIV-infected patients. The drug represents an early-generation antiretroviral with historical significance in HIV therapy evolution.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating reduced commercial investment and team contraction likely underway.
Mechanism of Action
[ see Clinical Pharmacology () ].
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Effectiveness of Early or Delayed Addition of Hydroxyurea to a Three-Drug Anti-HIV Drug Combination Including Didanosine, in Advanced HIV Patients Who Failed a First or Second Anti-HIV Triple-Drug Therapy
0
HIV Infections
Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine
256 enrolled
HIV Infections
A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
85 enrolled
HIV Infections
The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors
25 enrolled
HIV Infections
Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
80 enrolled
AIDS Dementia ComplexHIV Infections
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.