Videx

(Didanosine)

ApprovedSmall molecule

Didanosine is used to treat HIV (the virus that causes AIDS) by slowing down the virus's ability to reproduce in the body, usually taken as part of a combination treatment with other HIV medications.[2] Videx is currently approved and in use across 7 indications[4].[1]

Videx is one of 204 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

122

Total Trials

Active Trials

203

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Viral DiseaseActive, not recruiting

ImmunodeficiencyActive, not recruiting

Hepatitis BActive, not recruiting

TuberculosisActive, not recruiting

HemophiliaActive, not recruiting

AIDSCompleted

HIV InfectionCompleted

Viral DiseaseApproved

Active, not recruiting

ImmunodeficiencyPreclinical

Active, not recruiting

Hepatitis BPreclinical

Active, not recruiting

TuberculosisPreclinical

Active, not recruiting

HemophiliaApproved

Active, not recruiting

AIDSPreclinical

Completed

HIV InfectionApproved

Completed

Competition

Competitive Landscape

123 competitors in HIV Infection

#DrugCompanyPhaseTrials

Retrovir

BBp Consulting, Inc

Approved

36 2

Epivir

GGlaxo Dba Glaxosmithkline

Approved

16 3

Ziagen

GSK

Approved

4 4

Videx

Bristol-Myers Squibb

Approved

14 5

Viramune

Boehringer Ingelheim

Approved

11 6

Olumiant

Eli Lilly

Approved

1 7

Vemlidy

Gilead

Approved

1 8

Lialda

Takeda

Approved

1 9

Invirase

Roche

Approved

4 10

Hepsera

Gilead

Approved

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Effectiveness18 trials

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

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00002420·25 enrolled

The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001057·105 enrolled

A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000939·150 enrolled

Show 15 more trials

A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000922·1,710 enrolled

The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00002376·540 enrolled

The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001063·200 enrolled

The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001074·140 enrolled

Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00007202·55 enrolled

Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00016718·43 enrolled

Safety and Effectiveness of Giving Combinations of Three or Four Anti-HIV Drugs to HIV-Infected Patients

Completed·PPharmacia and Upjohn·N/A·NCT00002211·160 enrolled

Safety and Effectiveness of a Combination Anti-HIV Drug Treatment

Completed· GSK logo

GSK·Phase 4·NCT00005018·150 enrolled

A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000916·399 enrolled

Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients

Completed· Gilead logo

Gilead·Phase 2·NCT00002234·25 enrolled

A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001108·6 enrolled

Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults

Completed·—·Phase 1·NCT00002427·225 enrolled

The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001087·300 enrolled

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

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00008866

The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00002418·25 enrolled

HIV infection14 trials

Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00013520·1,125 enrolled

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

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00000652·85 enrolled

A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002177

Show 11 more trials

Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00102960·377 enrolled

A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000870·200 enrolled

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Completed·KKirby Institute·Phase 4·NCT00192660·80 enrolled

A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000760·96 enrolled

A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000671·750 enrolled

A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000669·25 enrolled

A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002176

A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00006154·165 enrolled

A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000919·900 enrolled

Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00006339

The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001035·10 enrolled

Drug11 trials

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00074581·3,526 enrolled

A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002168·200 enrolled

A Study of MKC-442 in Combination With Other Anti-HIV Drugs

Completed·TTriangle Pharmaceuticals·Phase 2·NCT00002412

Show 8 more trials

Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00002240

A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

Completed·WWeill Medical College of Cornell University·N/A·NCT00002407

Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00014937·240 enrolled

A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

Unknown status·TTriangle Pharmaceuticals·Phase 3·NCT00006208

Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001045·300 enrolled

A Study to Compare Two Different Anti-HIV Drug Regimens

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000924·120 enrolled

A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002411

Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00002429·500 enrolled

Children7 trials

Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000851·198 enrolled

The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000865·32 enrolled

A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001066·740 enrolled

Show 4 more trials

Bioequivalence Study of Didanosine in Children Treated for HIV

Suspended·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT00668356·26 enrolled

A Study of ddI in Children With AIDS Who Have Not Had Success With Zidovudine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002280

A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000963·300 enrolled

A Study of Azidothymidine in HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000982·75 enrolled

HIV7 trials

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000656·116 enrolled

A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002207

A Study Comparing Two Forms of Didanosine in HIV-infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00002360·30 enrolled

Show 4 more trials

A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001022·1,200 enrolled

Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00002224·120 enrolled

Study of Anti-HIV Therapy Intensification

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00034086·22 enrolled

Comparison of ddI Versus Zidovudine in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000979·1,500 enrolled

41 more indications

Double-blind5 trials

A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000781·1,292 enrolled

A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000770·400 enrolled

Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002035·300 enrolled

Show 2 more trials

Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy

Completed·IImmunobiology Research Institute·Phase 3·NCT00002109

A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

Completed·PPharmacia and Upjohn·Phase 3·NCT00002123

Treatment3 trials

Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

Unknown status·AAgouron Pharmaceuticals·Phase 4·NCT00005000·200 enrolled

A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001029·654 enrolled

Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000885·440 enrolled

Immunodeficiency3 trials

The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease

Completed· GSK logo

GSK·N/A·NCT00002001

A Phase I Study to Evaluate the Pharmacokinetics, Safety and Antiviral Effects of Concurrent Administration of Zidovudine (AZT) and 2'3'-Dideoxyinosine (ddI) in Patients With Human Immunodeficiency Virus (HIV)

Completed· GSK logo

GSK·Phase 1·NCT00002014

A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002028

Combination Therapy3 trials

A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000625·2,100 enrolled

A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000803·471 enrolled

A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000833·20 enrolled

Randomized3 trials

Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000810·120 enrolled

A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs

Completed· Roche logo

Roche·Phase 2·NCT00002162·140 enrolled

A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000637·819 enrolled

Unknown status·AAJI Pharma USA·Phase 2·NCT00002099

Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

Completed·AAJI Pharma USA·Phase 1·NCT00002098·50 enrolled

Prospective2 trials

Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT00084136·1,571 enrolled

A Prospective, Randomized, Open-Label, Comparative Trial of Dideoxyinosine (ddI) Versus Dideoxycytidine (ddC) in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine (AZT) Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000969·400 enrolled

AIDS2 trials

The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001024·32 enrolled

A Study of ddI in Patients With AIDS Who Become Sicker While Taking Zidovudine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002274

Drug Therapy2 trials

Treatment With Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000923·110 enrolled

A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000902·217 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals

Completed·CChiron Corporation·N/A·NCT00001997

A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients

Completed·NNorthwestern University·Phase 3·NCT00002230·100 enrolled

Side Effects1 trial

Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults

Unknown status·PPharmaResearch·Phase 3·NCT00008489·200 enrolled

Liver1 trial

Strategies for Delivering Anti-HIV Therapy in South Africa

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00080522·813 enrolled

Adolescent1 trial

A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000814·390 enrolled

Hemophilia1 trial

Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males With Hemophilia

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00002386·55 enrolled

Interaction1 trial

A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000772·15 enrolled

Medication1 trial

A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001122·74 enrolled

Treatment Failure1 trial

A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000918·300 enrolled

Antiretroviral Treatment1 trial

Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00122538·52 enrolled

Pregnancy1 trial

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Single Dose1 trial

One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine

Completed·IInstitut de Recherche pour le Developpement·Phase 2·NCT00142337·244 enrolled

Pregnant Women1 trial

A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000839·12 enrolled

Mycobacterium Avium Complex1 trial

The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS

Completed·AAbbott·Phase 1·NCT00000971·24 enrolled

HIV-1 infection1 trial

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000823·85 enrolled

Infants1 trial

A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001049·180 enrolled

Oral1 trial

A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

Completed· Roche logo

Roche·Phase 1·NCT00002096·24 enrolled

Women1 trial

Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs

Unknown status·PPPD Development, LP·Phase 3·NCT00006397·200 enrolled

Hepatitis B1 trial

Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00051090

AIDS dementia1 trial

Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000657·80 enrolled

Monotherapy1 trial

Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000831·280 enrolled

ESS1 trial

Evaluation of Patients Who Have Not Had Success With Zidovudine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001025·120 enrolled

Tuberculosis1 trial

Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited Settings

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00091936·592 enrolled

Statin1 trial

A Study of Nystatin in HIV-Infected Patients

Completed·AArgus Pharmaceuticals·Phase 1·NCT00002313

Progressive Multifocal Leukoencephalopathy1 trial

Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001048·90 enrolled

Lymphoma1 trial

Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

Unknown status·CCentro di Riferimento Oncologico - Aviano·Phase 2·NCT00002905·20 enrolled

HIV-Infected Individuals1 trial

A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000822·46 enrolled

Unspecified3 trials

Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC

Completed·HHospital de Granollers·Phase 3·NCT00338390·75 enrolled

Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 3·NCT00158470·100 enrolled

A Study of Efavirenz in Combination With Stavudine and Didanosine

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00002225·60 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 9, 1991

VIDEX

NDA NDA020156

Oct 9, 1991

VIDEX

NDA NDA020155

Oct 9, 1991

VIDEX

NDA NDA020154

Oct 31, 2000

VIDEX EC

NDA NDA021183

Sources

References

[1]
ClinicalTrials.gov — 122 trial records for Didanosine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Videx drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Didanosine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Didanosine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021183). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

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Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bristol-Myers Squibb

Videx

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Effectiveness18 trials

HIV infection14 trials

Drug11 trials

Children7 trials

HIV7 trials

Double-blind5 trials

Treatment3 trials

Immunodeficiency3 trials

Combination Therapy3 trials

Randomized3 trials

Efficacy2 trials

Concentration2 trials

Kaposi's sarcoma2 trials

Resistance2 trials

Advanced2 trials

Tolerance2 trials

Prospective2 trials

AIDS2 trials

Drug Therapy2 trials

Safety and Efficacy2 trials

Side Effects1 trial

Liver1 trial

Adolescent1 trial

Hemophilia1 trial

Interaction1 trial

Medication1 trial

Treatment Failure1 trial

Antiretroviral Treatment1 trial

Pregnancy1 trial

Single Dose1 trial

Pregnant Women1 trial

Mycobacterium Avium Complex1 trial

HIV-1 infection1 trial

Infants1 trial

Oral1 trial

Women1 trial

Hepatitis B1 trial

AIDS dementia1 trial

Monotherapy1 trial

ESS1 trial

Tuberculosis1 trial

Statin1 trial

Progressive Multifocal Leukoencephalopathy1 trial

Lymphoma1 trial

HIV-Infected Individuals1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

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