Azacitidine - PharmaKB

Vidaza(azacitidine)

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.

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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

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Commercial

Therapeutic Areas

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

Trade Name

FDA

EMA

Azacitidine, Onureg, Vidaza (discontinued: Azacitidine)

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	2025-09-16
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
sideroblastic anemia	—	D000756	D64.3
refractory anemia	—	D000753	D46.4

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

1189 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia acute	D015470	—	C92.0	258	324	77	6	54	607
Leukemia	D007938	—	C95	229	296	62	5	39	531
Myeloid leukemia	D007951	—	C92	187	232	57	5	39	440
Myelodysplastic syndromes	D009190	—	D46	201	246	40	6	25	426
Preleukemia	D011289	—	—	149	176	30	4	20	317
Syndrome	D013577	—	—	111	141	20	4	13	240
Myelomonocytic leukemia chronic	D015477	—	C93.1	58	64	9	1	5	110
Myelomonocytic leukemia juvenile	D054429	—	C93.3	51	53	8	1	5	94
Lymphoma	D008223	—	C85.9	42	49	7	2	3	82
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	24	24	—	1	1	43

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	75	47	5	—	3	97
Recurrence	D012008	—	—	42	34	4	—	3	65
Myeloproliferative disorders	D009196	—	D47.1	26	26	1	—	1	42
Myelomonocytic leukemia acute	D015479	—	C92.5	19	27	3	—	—	38
Hematologic neoplasms	D019337	—	—	26	13	2	—	2	34
T-cell lymphoma peripheral	D016411	—	—	11	19	5	—	2	30
T-cell lymphoma	D016399	—	—	13	14	5	—	2	28
Myelodysplastic-myeloproliferative diseases	D054437	—	—	15	12	1	—	—	21
Refractory anemia with excess of blasts	D000754	—	D46.2	6	12	4	—	1	18
Hodgkin disease	D006689	—	C81	8	10	1	—	—	17

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoid leukemia	D007945	—	C91	15	16	—	—	1	27
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	14	13	—	—	1	24
Non-small-cell lung carcinoma	D002289	—	—	12	11	—	—	1	20
Carcinoma	D002277	—	C80.0	11	10	—	—	—	18
Lung neoplasms	D008175	—	C34.90	11	9	—	—	1	18
Multiple myeloma	D009101	—	C90.0	13	6	—	—	1	17
Residual neoplasm	D018365	—	—	5	11	—	—	3	16
Primary myelofibrosis	D055728	—	D47.4	10	9	—	—	—	16
Melanoma	D008545	—	—	13	7	—	—	—	14
Breast neoplasms	D001943	EFO_0003869	C50	6	9	—	—	1	13

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ependymoma	D004806	—	—	5	—	—	—	—	5
Osteosarcoma	D012516	—	—	3	—	—	—	—	3
Neuroblastoma	D009447	EFO_0000621	—	3	—	—	—	—	3
T-cell lymphoma cutaneous	D016410	—	C84.A	2	—	—	—	—	2
Renal insufficiency	D051437	—	N19	2	—	—	—	—	2
Squamous cell neoplasms	D018307	—	—	2	—	—	—	—	2
Burkitt lymphoma	D002051	—	C83.7	2	—	—	—	—	2
Systemic mastocytosis	D034721	—	C96.21	2	—	—	—	—	2
Mastocytosis	D008415	—	D47.09	2	—	—	—	—	2
Hairy cell leukemia	D007943	—	C91.4	1	—	—	—	—	1

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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
Carcinogenesis	D063646	—	—	—	—	—	—	1	1
Methylation	D008745	—	—	—	—	—	—	1	1
Pulmonary hypertension	D006976	EFO_0001361	I27.20	—	—	—	—	1	1
Osteoporosis	D010024	EFO_0003882	M81.0	—	—	—	—	1	1
Iron overload	D019190	—	—	—	—	—	—	1	1
Infections	D007239	EFO_0000544	—	—	—	—	—	1	1
Gastrointestinal microbiome	D000069196	—	—	—	—	—	—	1	1
Eye abnormalities	D005124	—	Q15.9	—	—	—	—	1	1
Stomach neoplasms	D013274	EFO_0003897	C16	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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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