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 13h 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)
A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
400 enrolled
HIV Infections
A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
180 enrolled
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
Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
200 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.