Didanosine

Overview

A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. Didanosine is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA by binding to reverse transcriptase; ddI is then metabolized to dideoxyadenosine triphosphate, its putative active metabolite.

Indication

For use, in combination with other antiretroviral agents, in the treatment of HIV-1 infection in adults.

Associated Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Bioequivalence Study of Didanosine in Children Treated for HIV	2008/04/29	NCT00668356	Phase 2	Suspended	Assistance Publique - Hôpitaux de Paris
Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya	2007/01/29	NCT00427297	Phase 3	Terminated	University of Washington
Antiretroviral Therapy for Advanced HIV Disease in South Africa	2006/06/21	NCT00342355	Phase 4	Completed	National Institutes of Health Clinical Center (CC)
Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC	2006/06/20	NCT00338390	Phase 3	Completed	Hospital de Granollers
Once a Day (QD) - Twice a Day (BID) Clinical Trial: Didanosine, Lamivudine and Efavirenz Versus Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of HIV	2005/11/22	NCT00256828	Phase 4	Completed	Clinical Trial Agency of HIV Study Group
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)	2005/09/19	NCT00192660	Phase 4	Completed	Kirby Institute
Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)	2005/09/12	NCT00158470	Phase 3	Completed	French National Agency for Research on AIDS and Viral Hepatitis
One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine	2005/09/02	NCT00142337	Phase 2	Completed	Institut de Recherche pour le Developpement
Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen	2005/08/26	NCT00135382	Phase 3	Completed	Bristol-Myers Squibb
Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)	2005/07/22	NCT00122538	Phase 2	Completed	French National Agency for Research on AIDS and Viral Hepatitis

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Didanosine	Physicians Total Care, Inc.	54868-5464	ORAL	250 mg in 1 1	5/2/2012
Didanosine	State of Florida DOH Central Pharmacy	53808-0236	ORAL	250 mg in 1 1	8/11/2010
Didanosine	State of Florida DOH Central Pharmacy	53808-0353	ORAL	400 mg in 1 1	8/11/2010

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
VIDEX EC	bristol-myers squibb canada	02244596	Capsule (Enteric-Coated) - Oral	125 MG	1/2/2002
VIDEX CHEWABLE DISPERSIBLE TAB 150MG	bristol-myers squibb canada	01940554	Tablet - Oral	150 MG	12/31/1991
VIDEX CHEWABLE DISPERSIBLE TAB 50MG	bristol-myers squibb canada	01940538	Tablet - Oral	50 MG	12/31/1991
VIDEX EC	bristol-myers squibb canada	02244598	Capsule (Enteric-Coated) - Oral	250 MG	1/2/2002
VIDEX PEDIATRIC POWDER SOL 4G/BOTT	bristol-myers squibb canada	01940635	Powder For Solution - Oral	4 G / BOTTLE	7/1/1999
VIDEX CHEWABLE DISPERSIBLE TAB 100MG	bristol-myers squibb canada	01940546	Tablet - Oral	100 MG	12/31/1991
VIDEX EC	bristol-myers squibb canada	02244597	Capsule (Enteric-Coated) - Oral	200 MG	1/2/2002

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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