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.

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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

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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
DACOGEN	Otsuka	N-021790 DISCN	2006-05-02	1 products, RLD
DECITABINE	Sun Pharmaceutical Industries	N-205582 DISCN	2014-01-28	1 products, RLD

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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	2025-09-22
dactinomycin	ANDA	2024-06-18
decitabine	ANDA	2026-05-06
inqovi	New Drug Application	2025-12-08
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	2025-12-18

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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

619 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	121	135	37	2	14	261
Leukemia	D007938	—	C95	83	114	34	2	11	205
Myeloid leukemia	D007951	—	C92	70	94	31	2	10	174
Myelodysplastic syndromes	D009190	—	D46	73	105	17	3	12	174
Preleukemia	D011289	—	—	42	62	12	3	9	108
Syndrome	D013577	—	—	33	46	9	3	9	86
Lymphoma	D008223	—	C85.9	19	28	4	2	1	42
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	10	9	1	1	1	20
Large b-cell lymphoma diffuse	D016403	—	C83.3	7	11	4	1	—	20
Hematopoietic stem cell transplantation	D018380	—	—	2	13	10	1	—	16

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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	37	19	4	—	2	45
Recurrence	D012008	—	—	25	17	5	—	2	40
Myelomonocytic leukemia chronic	D015477	—	C93.1	16	21	4	—	1	38
Myelomonocytic leukemia juvenile	D054429	—	C93.3	9	11	4	—	2	25
Myeloproliferative disorders	D009196	—	D47.1	13	14	1	—	1	24
Myelodysplastic-myeloproliferative diseases	D054437	—	—	6	7	1	—	—	12
Myelomonocytic leukemia acute	D015479	—	C92.5	2	8	2	—	—	12
Refractory anemia with excess of blasts	D000754	—	D46.2	3	5	3	—	1	10
T-cell lymphoma	D016399	—	—	3	3	3	—	—	9
Ovarian neoplasms	D010051	EFO_0003893	C56	5	8	1	—	—	9

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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
Primary myelofibrosis	D055728	—	D47.4	5	6	—	—	1	11
Hematologic neoplasms	D019337	—	—	8	4	—	—	1	11
Lymphoid leukemia	D007945	—	C91	6	5	—	—	1	10
Breast neoplasms	D001943	EFO_0003869	C50	7	5	—	—	—	10
Non-small-cell lung carcinoma	D002289	—	—	8	6	—	—	—	10
Lung neoplasms	D008175	—	C34.90	8	4	—	—	—	10
Carcinoma	D002277	—	C80.0	6	7	—	—	—	9
Blast crisis	D001752	—	—	4	5	—	—	—	8
Colorectal neoplasms	D015179	—	—	6	5	—	—	1	8

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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
Head and neck neoplasms	D006258	—	—	3	—	—	—	—	3
Squamous cell carcinoma of head and neck	D000077195	—	—	3	—	—	—	—	3
Thrombocytosis	D013922	—	D75.83	2	—	—	—	—	2
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

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Infections	D007239	EFO_0000544	—	—	—	—	—	2	2
Chronic pain	D059350	—	—	—	—	—	—	2	2
Fibromyalgia	D005356	EFO_0005687	M79.1	—	—	—	—	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

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Epidemiology

Epidemiological information for investigational and approved indications

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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

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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

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111,238 adverse events reported

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