Decitabine - PharmaKB

Dacogen(decitabine)

Dacogen, Decitabine, Inaqovi, Inqovi (decitabine) is a small molecule pharmaceutical. Decitabine was first approved as Dacogen on 2006-05-02. It is used to treat myelodysplastic syndromes in the USA. It has been approved in Europe to treat myeloid leukemia. It is known to target cytidine deaminase.

Download report

Favorite

FDA Novel Drug Approvals 2020

SARS-CoV-2 Interaction

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

Trade Name

FDA

EMA

Decitabine (discontinued: Dacogen, Decitabine)

Combinations

Inqovi

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Decitabine

Tradename	Company	Number	Date	Products
DECITABINE	Sun Pharmaceutical Industries	N-205582 RX	2014-01-28	1 products, RLD, RS

Show 1 discontinued

Cedazuridine

Decitabine

Tradename	Company	Number	Date	Products
INQOVI	Taiho Oncology	N-212576 RX	2020-07-07	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w...	Biologic Licensing Application	2011-03-11
center-al - acacia longifolia pollen center-al - acer negundo pollen center-al - acer saccharum pollen center-al - agrostis gigantea center-al - al...	Biologic Licensing Application	2009-06-12
coditussin dac	OTC monograph final	2016-05-10
dacarbazine	ANDA	2025-07-28
dactinomycin	ANDA	2024-06-18
decitabine	ANDA	2025-08-05
inqovi	New Drug Application	2024-11-29
standardized bermuda grass pollen standardized kentucky bluegrass pollen standardized meadow fescue grass pollen standardized orchard grass pollen ...	Biologic Licensing Application	2010-03-27
standardized bermuda grass standardized kentucky blue (june) grass standardized meadow fescue grass standardized orchard grass standardized perenni...	Biologic Licensing Application	2025-06-03
vizimpro	New Drug Application	2025-08-15

Show 7 more

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
myelodysplastic syndromes	—	D009190	D46

Agency Specific

FDA

EMA

Expiration	Code
CEDAZURIDINE / DECITABINE, INQOVI, OTSUKA
2027-07-07	ODE-316
2025-07-07	NCE

Patent Expiration

Patent	Expires	Flag	FDA Information
Cedazuridine / Decitabine, Inqovi, Otsuka
8268800	2030-08-22	DP	U-2864, U-2865, U-2866, U-2867
8618075	2028-10-16		U-2864, U-2867
9567363	2028-10-16	DP

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01B: Antimetabolites

— L01BC: Pyrimidine analogues, antineoplastic antimetabolites

— L01BC08: Decitabine

HCPCS

Code	Description
J0893	Injection, decitabine (sun pharma) not therapeutically equivalent to j0894, 1 mg
J0894	Injection, decitabine, 1 mg

Clinical

Clinical Trials

594 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	115	129	37	2	12	248
Leukemia	D007938	—	C95	104	131	36	2	11	239
Myeloid leukemia	D007951	—	C92	90	106	32	2	10	203
Myelodysplastic syndromes	D009190	—	D46	75	104	17	3	11	173
Preleukemia	D011289	—	—	58	77	12	3	9	131
Syndrome	D013577	—	—	48	60	9	3	10	107
Lymphoma	D008223	—	C85.9	19	31	6	2	1	46
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	10	10	1	1	1	21
Large b-cell lymphoma diffuse	D016403	—	C83.3	6	10	2	1	—	17
B-cell lymphoma	D016393	—	—	8	11	2	1	—	17

Show 2 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	43	27	4	—	2	56
Recurrence	D012008	—	—	23	16	5	—	1	38
Myelomonocytic leukemia chronic	D015477	—	C93.1	17	20	4	—	1	38
Myelomonocytic leukemia juvenile	D054429	—	C93.3	15	16	4	—	2	34
Myeloproliferative disorders	D009196	—	D47.1	13	13	1	—	1	23
Myelomonocytic leukemia acute	D015479	—	C92.5	4	11	2	—	—	15
Myelodysplastic-myeloproliferative diseases	D054437	—	—	7	8	1	—	—	13
Anemia	D000740	EFO_0004272	D64.9	4	4	2	—	1	10
T-cell lymphoma	D016399	—	—	3	4	3	—	—	9
Classical conditioning	D003214	—	—	—	9	9	—	—	9

Show 39 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	8	9	—	—	—	15
Lymphoid leukemia	D007945	—	C91	7	7	—	—	1	13
Carcinoma	D002277	—	C80.0	8	8	—	—	—	12
Hematologic neoplasms	D019337	—	—	8	5	—	—	1	12
Primary myelofibrosis	D055728	—	D47.4	4	5	—	—	1	10
Blast crisis	D001752	—	—	4	7	—	—	—	10
Lung neoplasms	D008175	—	C34.90	8	4	—	—	—	10
Non-small-cell lung carcinoma	D002289	—	—	7	5	—	—	—	9
Breast neoplasms	D001943	EFO_0003869	C50	6	4	—	—	—	9
Melanoma	D008545	—	—	8	4	—	—	—	8

Show 85 more

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	4	—	—	—	—	4
Neuroblastoma	D009447	EFO_0000621	—	3	—	—	—	—	3
Promyelocytic leukemia acute	D015473	—	C92.4	2	—	—	—	—	2
Mantle-cell lymphoma	D020522	—	C83.1	2	—	—	—	—	2
Burkitt lymphoma	D002051	—	C83.7	2	—	—	—	—	2
Leukemia myeloid chronic atypical bcr-abl negative	D054438	—	C92.2	2	—	—	—	—	2
Small cell lung carcinoma	D055752	—	—	2	—	—	—	—	2
Squamous cell carcinoma of head and neck	D000077195	—	—	2	—	—	—	—	2
Bone marrow diseases	D001855	—	—	1	—	—	—	—	1
Osteosarcoma	D012516	—	—	1	—	—	—	—	1

Show 25 more

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Infections	D007239	EFO_0000544	—	—	—	—	—	2	2
Frailty	D000073496	—	R53.1	—	—	—	—	1	1
Liver transplantation	D016031	EFO_0010682	—	—	—	—	—	1	1
Colonic neoplasms	D003110	—	C18	—	—	—	—	1	1
Pulmonary hypertension	D006976	EFO_0001361	I27.20	—	—	—	—	1	1
Osteoporosis	D010024	EFO_0003882	M81.0	—	—	—	—	1	1
Iron overload	D019190	—	—	—	—	—	—	1	1
Hiv infections	D015658	EFO_0000764	B20	—	—	—	—	1	1
Hepatitis c	D006526	—	B19.2	—	—	—	—	1	1
Hepatitis	D006505	—	K75.9	—	—	—	—	1	1

Show 8 more

Epidemiology

Epidemiological information for investigational and approved indications

View more details

Drug

General

Drug common name	Decitabine
INN	decitabine
Description	5-aza-2'-deoxycytidine is a 2'-deoxyribonucleoside.
Classification	Small molecule
Drug class	nucleoside antiviral or antineoplastic agents, cytarabine or azarabine derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1

Identifiers

PDB	—
CAS-ID	2353-33-5
RxCUI	—
ChEMBL ID	CHEMBL1201129
ChEBI ID	50131
PubChem CID	451668
DrugBank	DB01262
UNII ID	776B62CQ27 (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

CDA

Organism

Homo sapiens

Gene name

CDA

Gene synonyms

CDD

NCBI Gene ID

978

Protein name

cytidine deaminase

Protein synonyms

Cytidine aminohydrolase, cytosine nucleoside deaminase, small cytidine deaminase

Uniprot ID

P32320

Mouse ortholog

Cda (72269)

cytidine deaminase (Q9D7V3)

Variants

No data

Financial

No data

Trends

PubMed Central

Top Terms for Disease or Syndrome:

Mock data
Subscribe for the real data

Additional graphs summarizing 32,554 documents

View more details

Safety

Black-box Warning

Black-box warning for: 2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w..., Center-al - acacia longifolia pollen center-al - acer negundo pollen center-al - acer saccharum pollen center-al - agrostis gigantea center-al - al..., Dacarbazine, Standardized bermuda grass pollen standardized kentucky bluegrass pollen standardized meadow fescue grass pollen standardized orchard grass pollen ..., Standardized bermuda grass standardized kentucky blue (june) grass standardized meadow fescue grass standardized orchard grass standardized perenni...

Adverse Events

Top Adverse Reactions

Mock data
Subscribe for the real data

110,589 adverse events reported

View more details