Didanosine - PharmaKB

Didanosine

Videx (didanosine) is a small molecule pharmaceutical. Didanosine was first approved as Videx on 1991-10-09. It is used to treat acquired immunodeficiency syndrome and HIV infections in the USA.

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Events

FDA approval date

EMA approval date

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Study first post date

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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
urogenital diseases	D000091642
immune system diseases	D007154

Trade Name

FDA

EMA

No data

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Didanosine

Tradename	Company	Number	Date	Products
VIDEX	Bristol Myers Squibb	N-020156 DISCN	1991-10-09	1 products, RLD
VIDEX	Bristol Myers Squibb	N-020154 DISCN	1991-10-09	5 products, RLD
VIDEX	Bristol Myers Squibb	N-020155 DISCN	1991-10-09	4 products
VIDEX EC	Bristol Myers Squibb	N-021183 DISCN	2000-10-31	4 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
didanosine	ANDA	2012-05-02

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hiv infections	EFO_0000764	D015658	B20
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors

— J05AF02: Didanosine

HCPCS

Code	Description
S0137	Didanosine (ddi), 25 mg

Clinical

Clinical Trials

380 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	44	53	30	15	28	166
Healthy volunteers/patients	—	—	—	87	—	—	1	1	89
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	19	12	12	4	9	55
Infections	D007239	EFO_0000544	—	19	13	6	2	4	43
Hiv	D006678	—	—	3	—	2	2	—	7
Lipodystrophy	D008060	HP_0009125	E88.1	—	—	—	3	—	3
Cardiovascular diseases	D002318	HP_0001626	—	—	—	—	1	—	1
Hiv-associated lipodystrophy syndrome	D039682	EFO_1001348	—	—	—	—	1	—	1
Hemophilia a	D006467	EFO_0007267	D66	—	—	—	1	—	1
Vasovagal syncope	D019462	—	R55	—	—	—	1	—	1

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Communicable diseases	D003141	—	—	8	5	3	—	4	19
Neoplasms	D009369	—	C80	16	2	1	—	1	18
Immunologic deficiency syndromes	D007153	HP_0002721	D84.9	—	1	4	—	2	6
Aids-related complex	D000386	EFO_0007137	B20	1	1	1	—	3	6
Tuberculosis	D014376	EFO_0000774	A15-A19	1	—	2	—	1	4
Gastrointestinal stromal tumors	D046152	EFO_0000505	C49.A	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv seropositivity	D006679	—	—	2	1	—	—	1	4
Sarcoma	D012509	—	—	2	1	—	—	—	3
Fibrosis	D005355	—	—	3	1	—	—	—	3
Myeloid leukemia acute	D015470	—	C92.0	2	2	—	—	—	2
Myeloproliferative disorders	D009196	—	D47.1	2	1	—	—	—	2
Prostatic neoplasms	D011471	—	C61	2	1	—	—	—	2
Kaposi sarcoma	D012514	—	C46	1	1	—	—	—	2
Non-hodgkin lymphoma	D008228	—	C85.9	1	1	—	—	—	2
Lymphoma	D008223	—	C85.9	1	1	—	—	—	2
Cystic fibrosis	D003550	EFO_0000390	E84	2	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Drug interactions	D004347	—	—	17	—	—	—	4	21
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	8	—	—	—	—	8
Pharmacokinetics	D010599	—	—	5	—	—	—	—	5
Malaria	D008288	EFO_0001068	B54	4	—	—	—	—	4
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	4	—	—	—	—	4
Colorectal neoplasms	D015179	—	—	3	—	—	—	—	3
Atopic dermatitis	D003876	EFO_0000274	L20	3	—	—	—	—	3
Dermatitis	D003872	HP_0011123	L30.9	3	—	—	—	—	3
Fatty liver	D005234	EFO_0003934	—	3	—	—	—	—	3
Diabetes mellitus	D003920	HP_0000819	E08-E13	3	—	—	—	—	3

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Osteoarthritis	D010003	EFO_0002506	M15-M19	—	—	—	—	1	1
Blood coagulation disorders	D001778	EFO_0009314	D68.9	—	—	—	—	1	1
Hemostatic disorders	D020141	—	—	—	—	—	—	1	1
Heart failure	D006333	HP_0001635	I50	—	—	—	—	1	1
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	1	1
Virus diseases	D014777	—	B34	—	—	—	—	1	1
Irritable bowel syndrome	D043183	EFO_0000555	K58	—	—	—	—	1	1
Syndrome	D013577	—	—	—	—	—	—	1	1
Skin neoplasms	D012878	EFO_0004198	C44	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Didanosine
INN	didanosine
Description	Didanosine is a purine 2',3'-dideoxyribonucleoside that is inosine in which the hydroxy groups at both the 2' and the 3' positions on the sugar moiety have been replaced by hydrogen. An antiviral drug, it is used as a medication to treat HIV/AIDS. It has a role as an antimetabolite, a HIV-1 reverse transcriptase inhibitor, an antiviral drug, an EC 2.4.2.1 (purine-nucleoside phosphorylase) inhibitor and a geroprotector.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	O=c1[nH]cnc2c1ncn2[C@H]1CC[C@@H](CO)O1