Zidovudine - PharmaKB

Retrovir, Combivir(zidovudine)

/ Lamivudine / Zidovudine, Combivir, Lamivudine / Zidovudine, Retrovir, Trizivir, Zidovudine (zidovudine) is a small molecule pharmaceutical. Zidovudine was first approved as Retrovir on 1987-03-19. It is used to treat acquired immunodeficiency syndrome and HIV infections in the USA. It has been approved in Europe to treat HIV infections.

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Commercial

Therapeutic Areas

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

Trade Name

FDA

EMA

Retrovir, Zidovudine (discontinued: Retrovir, Zidovudine)

Combinations

Abacavir sulfate, lamivudine zidovudine, Lamivudine zidovudine (discontinued: Combivir, Lamivudine zidovudine, Lamivudine, nevirapine zidovudine, Trizivir)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Zidovudine

Tradename	Company	Number	Date	Products
RETROVIR	ViiV Healthcare	N-019655 RX	1987-03-19	1 products, RLD, RS
RETROVIR	ViiV Healthcare	N-019910 RX	1989-09-28	1 products, RLD, RS
RETROVIR	ViiV Healthcare	N-019951 RX	1990-02-02	1 products, RLD, RS

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Lamivudine

Nevirapine

Zidovudine

Tradename	Company	Number	Date	Products
LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE	Micro Laboratories	N-205626 DISCN	2018-08-13	1 products, RLD

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Lamivudine

Zidovudine

Tradename	Company	Number	Date	Products
LAMIVUDINE AND ZIDOVUDINE	PharmaCare	N-022018 DISCN	2017-03-17	1 products
COMBIVIR	ViiV Healthcare	N-020857 DISCN	1997-09-26	1 products, RLD

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Abacavir sulfate

Lamivudine

Zidovudine

Tradename	Company	Number	Date	Products
TRIZIVIR	ViiV Healthcare	N-021205 DISCN	2000-11-14	1 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
abacavir sulfate, lamivudine and zidovudine	ANDA	2013-12-17
abacavir, lamivudine and zidovudine	ANDA	2023-10-31
azactam	New Drug Application	2025-01-09
aztreonam	ANDA	2024-06-03
cayston	New Drug Application	2025-03-17
combivir	New Drug Application	2023-08-22
compound w	C200263	2025-08-08
compound w for kids one step strips	C200263	2025-10-23
compound w one step pads	C200263	2025-10-23
compound w one step plantar foot pads	C200263	2025-10-23

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hiv infections	EFO_0000764	D015658	B20
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20
hepatitis b	—	D006509	—

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

— J05AF01: Zidovudine

— J05AR: Antivirals for treatment of hiv infections, combinations

— J05AR01: Zidovudine and lamivudine

— J05AR04: Zidovudine, lamivudine and abacavir

— J05AR05: Zidovudine, lamivudine and nevirapine

HCPCS

Code	Description
J3485	Injection, zidovudine, 10 mg
S0104	Zidovudine, oral, 100 mg

Clinical

Clinical Trials

598 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	77	117	97	45	124	448
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	42	42	40	13	63	199
Infections	D007239	EFO_0000544	—	9	10	13	6	17	55
Hiv	D006678	—	O98.7	7	12	7	17	5	42
Communicable diseases	D003141	—	—	6	3	3	1	8	21
Lymphoma	D008223	—	C85.9	1	10	1	1	3	15
Lipodystrophy	D008060	—	E88.1	—	3	—	7	—	10
Tuberculosis	D014376	EFO_0000774	A15-A19	3	1	1	2	3	9
Hepatitis c	D006526	—	B19.2	3	2	—	1	3	7
Immunologic deficiency syndromes	D007153	—	D84.9	1	1	1	2	2	7

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Aids-related complex	D000386	EFO_0007137	B20	26	25	13	—	32	96
Pregnancy	D011247	EFO_0002950	Z33.1	7	2	8	—	2	18
Aids-related opportunistic infections	D017088	—	—	1	2	6	—	4	13
Anemia	D000740	EFO_0004272	D64.9	—	6	1	—	7	13
Kaposi sarcoma	D012514	—	C46	6	2	2	—	—	9
Aids dementia complex	D015526	EFO_0002608	—	2	2	3	—	1	8
Acne vulgaris	D000152	EFO_0003894	L70	—	3	3	—	1	7
Infectious pregnancy complications	D011251	—	—	4	—	3	—	—	7
Pneumocystis pneumonia	D011020	EFO_0007448	B59	—	—	4	—	3	7
Covid-19	D000086382	—	U07.1	3	1	2	—	—	6

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-hodgkin lymphoma	D008228	—	C85.9	—	3	—	—	3	6
Cytomegalovirus infections	D003586	EFO_0001062	B25	1	1	—	—	2	4
Lymphoproliferative disorders	D008232	Orphanet_2442	D47.9	—	3	—	—	—	3
Progressive multifocal leukoencephalopathy	D007968	EFO_0007455	A81.2	—	1	—	—	2	3
Lymphadenopathy	D000072281	—	R59.1	—	2	—	—	—	2
Non-small-cell lung carcinoma	D002289	—	—	1	1	—	—	—	2
Lung neoplasms	D008175	—	C34.90	1	1	—	—	—	2
Human herpesvirus 8	D019288	—	—	—	2	—	—	—	2
Inflammation	D007249	MP_0001845	—	2	1	—	—	—	2
Leukemia	D007938	—	C95	—	1	—	—	1	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancytopenia	D010198	—	D61.81	2	—	—	—	10	12
Cytopenia	D000095542	—	—	2	—	—	—	10	12
Healthy volunteers/patients	—	—	—	5	—	—	—	2	7
Neutropenia	D009503	—	D70	2	—	—	—	1	3
Psoriasis	D011565	EFO_0000676	L40	1	—	—	—	1	2
Polycystic ovary syndrome	D011085	EFO_0000660	E28.2	1	—	—	—	—	1
Hiv seronegativity	D018023	—	—	1	—	—	—	—	1
Newborn infant diseases	D007232	—	—	1	—	—	—	—	1
Mycobacterium avium-intracellulare infection	D015270	EFO_0007386	—	1	—	—	—	—	1
Mycobacterium infections	D009164	—	A31.9	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cytomegalovirus retinitis	D017726	EFO_1001302	—	—	—	—	—	4	4
Retinitis	D012173	—	H30.9	—	—	—	—	4	4
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	—	—	—	1	1
Chronic hepatitis b	D019694	EFO_0004239	B18.1	—	—	—	—	1	1
Chemical and drug induced liver injury	D056486	EFO_0004228	—	—	—	—	—	1	1
Meningeal tuberculosis	D014390	—	A17.0	—	—	—	—	1	1
T-cell lymphoma	D016399	—	—	—	—	—	—	1	1
Brain neoplasms	D001932	EFO_0003833	C71	—	—	—	—	1	1
Myasthenia gravis	D009157	EFO_0004991	G70.0	—	—	—	—	1	1
Bone fractures	D050723	EFO_0003931	T14.8	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Zidovudine
INN	zidovudine
Description	Zidovudine is a pyrimidine 2',3'-dideoxyribonucleoside compound having a 3'-azido substituent and thymine as the nucleobase. It has a role as an antiviral drug, an antimetabolite and a HIV-1 reverse transcriptase inhibitor. It is a pyrimidine 2',3'-dideoxyribonucleoside and an azide.
Classification	Small molecule
Drug class	antineoplastics; antivirals (zidovudine group) (exception: edoxudine)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cc1cn([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)c(=O)[nH]c1=O

Identifiers

PDB	—
CAS-ID	30516-87-1
RxCUI	—
ChEMBL ID	CHEMBL129
ChEBI ID	10110
PubChem CID	35370
DrugBank	DB00495
UNII ID	4B9XT59T7S (ChemIDplus, GSRS)

Target

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Variants

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Financial

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Azactam – Elan Corporation

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Estimated US medical usage

Zidovudine

Lamivudine

Abacavir

Total medical expenditures per year (USD, in millions)

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Zidovudine

Lamivudine

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Zidovudine

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Trends

PubMed Central

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Additional graphs summarizing 1,448,362 documents

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Safety

Black-box Warning

Black-box warning for: Abacavir sulfate, lamivudine and zidovudine, Abacavir, lamivudine and zidovudine, Combivir, Direct rx, Lamivudine and zidovudine, Lamivudine zidovudine, Retrovir, Trizivir, Zidovudine

Adverse Events

Top Adverse Reactions

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30,930 adverse events reported

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