Decitabine - PharmaKB

Dacogen(decitabine)

Dacogen, 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

Combinations

Inqovi

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Cedazuridine

Decitabine

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

Decitabine

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

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Labels

FDA

EMA

Brand Name	Status	Last Update
coditussin dac	OTC monograph final	2016-05-10
cosmegen	New Drug Application	2024-01-18
dacarbazine	ANDA	2022-10-20
dacogen	New Drug Application	2023-11-30
dactinomycin	NDA authorized generic	2024-01-18
decitabine	ANDA	2023-12-14
inqovi	New Drug Application	2022-05-05
vizimpro	New Drug Application	2023-10-13
zodryl dac 25	OTC monograph final	2009-09-22
zodryl dac 30	OTC monograph final	2009-09-22

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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

484 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	93	98	30	2	9	192
Myelodysplastic syndromes	D009190	—	D46	58	81	17	2	11	138
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	9	3	—	1	1	12
Large b-cell lymphoma diffuse	D016403	—	C83.3	4	4	1	1	—	9

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myelomonocytic leukemia chronic	D015477	—	C93.1	14	16	3	—	1	31
Leukemia	D007938	—	C95	15	19	3	—	1	30
Neoplasms	D009369	—	C80	18	6	3	—	1	22
Hodgkin disease	D006689	—	C81	2	6	1	—	—	7
Anemia	D000740	HP_0001903	D64.9	3	2	2	—	—	6
Myeloid leukemia	D007951	—	C92	2	2	1	—	—	5
Monocytic leukemia acute	D007948	—	—	—	3	1	—	—	4
Myelomonocytic leukemia acute	D015479	—	C92.5	—	3	1	—	—	4
Hematologic diseases	D006402	EFO_0005803	D75.9	1	—	1	—	1	3
Thrombocytopenia	D013921	HP_0001873	D69.6	1	2	1	—	—	3

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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	—	1	7	—	—	—	8
Melanoma	D008545	—	—	8	4	—	—	—	8
Breast neoplasms	D001943	EFO_0003869	C50	5	3	—	—	—	7
Primary myelofibrosis	D055728	—	D47.4	4	2	—	—	—	6
Non-hodgkin lymphoma	D008228	—	C85.9	6	2	—	—	—	6
Non-small-cell lung carcinoma	D002289	—	—	5	3	—	—	—	6
Lymphoma	D008223	—	C85.9	2	2	—	—	1	5
Castration-resistant prostatic neoplasms	D064129	—	—	4	2	—	—	—	4
Ovarian neoplasms	D010051	EFO_0003893	C56	3	3	—	—	—	4
Fallopian tube neoplasms	D005185	—	—	3	2	—	—	—	4

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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	3	—	—	—	—	3
Neuroblastoma	D009447	EFO_0000621	—	3	—	—	—	—	3
Hematopoietic stem cell transplantation	D018380	—	—	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
Sarcoma	D012509	—	—	2	—	—	—	—	2
Gata2 deficiency	D000077428	—	—	1	—	—	—	—	1
Ependymoma	D004806	—	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Colonic neoplasms	D003110	—	C18	—	—	—	—	1	1
Pulmonary hypertension	D006976	EFO_0001361	I27.20	—	—	—	—	1	1
Osteoporosis	D010024	HP_0000939	M81.0	—	—	—	—	1	1
Beta-thalassemia	D017086	Orphanet_848	D56.1	—	—	—	—	1	1
Iron overload	D019190	—	—	—	—	—	—	1	1
Infections	D007239	EFO_0000544	—	—	—	—	—	1	1

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