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 9h 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, an enzyme essential for HIV replication. The drug was a foundational antiretroviral agent in the early HIV treatment era.
LOE Approaching
With LOE approaching, commercial team size is likely contracting; roles focus on maximizing remaining exclusivity and preparing for generic transition.
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)
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
85 enrolled
HIV Infections
A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women
12 enrolled
HIV InfectionsPregnancy
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
A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease
116 enrolled
HIV Infections
Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine
256 enrolled
HIV 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.