Azacitidine - PharmaKB

Vidaza(azacitidine)

Onureg, Vidaza (azacitidine) is a small molecule pharmaceutical. Azacitidine was first approved as Vidaza on 2004-05-19. It is used to treat myelomonocytic leukemia chronic, refractory anemia, and sideroblastic anemia in the USA. It has been approved in Europe to treat myelodysplastic syndromes, myeloid leukemia acute, and myelomonocytic leukemia chronic.

Download report

Favorite

SARS-CoV-2 Interaction

BMS

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

Mock data
Subscribe for the real data

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
hemic and lymphatic diseases	D006425
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Onureg, Vidaza (generic drugs available since 2013-09-16)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Azacitidine

Tradename	Company	Number	Date	Products
AZACITIDINE	Allergan	N-208216 RX	2016-04-29	1 products
ONUREG	Bristol Myers Squibb	N-214120 RX	2020-09-01	2 products, RLD, RS
VIDAZA	Bristol Myers Squibb	N-050794 RX	2004-05-19	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
azacitidine	ANDA	2024-01-23
azacitidine for	ANDA	2022-09-14
onureg	New Drug Application	2022-10-26
vidaza	New Drug Application	2024-01-29

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
myelomonocytic leukemia chronic	—	D015477	C93.1
refractory anemia	—	D000753	D46.4
sideroblastic anemia	—	D000756	D64.3

Agency Specific

FDA

EMA

Expiration	Code
AZACITIDINE, VIDAZA, BRISTOL-MYERS
2029-05-20	ODE-399
2025-05-20	I-889
AZACITIDINE, ONUREG, BRISTOL
2027-09-01	ODE-320

Patent Expiration

Patent	Expires	Flag	FDA Information
Azacitidine, Onureg, Bristol
8846628	2030-06-03	DP	U-2950
11571436	2029-05-14	DP

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01B: Antimetabolites

— L01BC: Pyrimidine analogues, antineoplastic antimetabolites

— L01BC07: Azacitidine

HCPCS

Code	Description
J9025	Injection, azacitidine, 1 mg

Clinical

Clinical Trials

765 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia acute	D015470	—	C92.0	144	174	40	1	16	312
Myelodysplastic syndromes	D009190	—	D46	120	155	23	3	17	265
Myelomonocytic leukemia chronic	D015477	—	C93.1	42	42	5	1	2	73
Cocaine-related disorders	D019970	—	F14	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938	—	C95	19	33	3	—	2	47
Neoplasms	D009369	—	C80	28	10	2	—	—	32
T-cell lymphoma peripheral	D016411	—	—	5	8	1	—	—	11
Hodgkin disease	D006689	—	C81	8	4	1	—	—	11
Hematologic neoplasms	D019337	—	—	7	6	1	—	—	10
Myeloid leukemia	D007951	—	C92	5	2	3	—	1	10
Large b-cell lymphoma diffuse	D016403	—	C83.3	6	3	2	—	—	9
Erythroblastic leukemia acute	D004915	EFO_1001257	C94.0	3	6	1	—	—	9
Megakaryoblastic leukemia acute	D007947	—	C94.2	4	6	1	—	—	9
Monocytic leukemia acute	D007948	—	—	3	6	1	—	—	9

Show 13 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	18	10	—	—	1	25
Non-hodgkin lymphoma	D008228	—	C85.9	17	7	—	—	—	20
Non-small-cell lung carcinoma	D002289	—	—	8	8	—	—	1	16
Multiple myeloma	D009101	—	C90.0	11	5	—	—	1	14
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	9	3	—	—	—	11
Lymphoma	D008223	—	C85.9	9	5	—	—	—	10
Melanoma	D008545	—	—	7	4	—	—	—	9
Primary myelofibrosis	D055728	—	D47.4	6	5	—	—	—	9
Breast neoplasms	D001943	EFO_0003869	C50	4	6	—	—	1	9
Colorectal neoplasms	D015179	—	—	6	6	—	—	—	8

Show 64 more

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Mantle-cell lymphoma	D020522	—	C83.1	4	—	—	—	—	4
Extranodal nk-t-cell lymphoma	D054391	—	C86.0	3	—	—	—	—	3
Squamous cell carcinoma of head and neck	D000077195	—	—	3	—	—	—	—	3
Adult t-cell leukemia-lymphoma	D015459	—	C91.5	2	—	—	—	—	2
B-cell lymphoma marginal zone	D018442	—	C88.4	2	—	—	—	—	2
Ependymoma	D004806	—	—	2	—	—	—	—	2
Neuroblastoma	D009447	EFO_0000621	—	2	—	—	—	—	2
Burkitt lymphoma	D002051	—	C83.7	2	—	—	—	—	2
Recurrence	D012008	—	—	2	—	—	—	—	2
Hairy cell leukemia	D007943	—	C91.4	1	—	—	—	—	1

Show 31 more

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Atrial fibrillation	D001281	EFO_0000275	I48.0	—	—	—	—	1	1
Infections	D007239	EFO_0000544	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

View more details

Drug

General

Drug common name	Azacitidine
INN	azacitidine
Description	5-azacytidine is an N-glycosyl-1,3,5-triazine that is 4-amino-1,3,5-triazin-2(1H)-one substituted by a beta-D-ribofuranosyl residue via an N-glycosidic linkage. An antineoplastic agent, it is used in the treatment of myeloid leukaemia. It has a role as an antineoplastic agent. It is a N-glycosyl-1,3,5-triazine and a nucleoside analogue. It is functionally related to a beta-D-ribose.
Classification	Small molecule
Drug class	H2-receptor antagonists (cimetidine type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Nc1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)c(=O)n1