Baricitinib - PharmaKB

Olumiant(baricitinib)

Baricitinib, Olumiant (baricitinib) is a small molecule pharmaceutical. Baricitinib was first approved as Olumiant on 2017-02-13. It is used to treat rheumatoid arthritis in the USA. It has been approved in Europe to treat rheumatoid arthritis. The pharmaceutical is active against tyrosine-protein kinase JAK1 and tyrosine-protein kinase JAK2. In addition, it is known to target cyclin-G-associated kinase, non-receptor tyrosine-protein kinase TYK2, BMP-2-inducible protein kinase, AP2-associated protein kinase 1, and tyrosine-protein kinase JAK3.

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Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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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
musculoskeletal diseases	D009140
skin and connective tissue diseases	D017437
immune system diseases	D007154

Trade Name

FDA

EMA

Olumiant (discontinued: Baricitinib)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Baricitinib

Tradename	Company	Number	Date	Products
OLUMIANT	Eli Lilly	N-207924 RX	2018-05-31	3 products, RLD

Labels

FDA

EMA

Brand Name	Status	Last Update
baricitinib	Use Authorization	2022-05-10
olumiant	New Drug Application	2024-11-13

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
rheumatoid arthritis	EFO_0000685	D001172	M06.9

Agency Specific

FDA

EMA

Expiration	Code
BARICITINIB, OLUMIANT, ELI LILLY AND CO
2025-06-13	I-890
2025-05-10	I-891
2023-05-31	NCE

Patent Expiration

Patent	Expires	Flag	FDA Information
Baricitinib, Olumiant, Eli Lilly And Co
9089574	2032-11-30		U-3372
11045474	2032-11-30		U-3372
9737469	2031-11-02		U-3500
8158616	2030-06-08	DS, DP
8420629	2029-03-10		U-247

ATC Codes

L: Antineoplastic and immunomodulating agents

— L04: Immunosuppressants

— L04A: Immunosuppressants

— L04AA: Selective immunosuppressants

— L04AA37: Baricitinib

HCPCS

No data

Clinical

Clinical Trials

171 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Arthritis	D001168	EFO_0005856	M05-M14	—	2	10	3	—	15
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	1	2	7	3	—	13
Alopecia areata	D000506	EFO_0004192	L63	—	2	3	1	—	5
Alopecia	D000505	—	L64	—	2	3	1	—	5
Psoriatic arthritis	D015535	EFO_0003778	L40.5	—	—	—	1	—	1
Spondylarthritis	D025241	—	—	—	—	—	1	—	1
Spondylitis	D013166	—	M46.9	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Atopic dermatitis	D003876	EFO_0000274	L20	—	1	8	—	1	10
Eczema	D004485	—	L30.9	—	1	8	—	1	10
Dermatitis	D003872	—	L30.9	—	1	8	—	1	10
Systemic lupus erythematosus	D008180	EFO_0002690	M32	—	1	3	—	—	4
Skin diseases	D012871	—	L00-L99	—	2	2	—	1	4
Syndrome	D013577	—	—	—	3	1	—	1	4
Juvenile arthritis	D001171	EFO_1002007	M08	—	—	3	—	—	3
Fever	D005334	—	R50.9	—	1	1	—	1	2
Lipodystrophy	D008060	—	E88.1	—	1	1	—	1	2
Hyperthermia	D000084462	—	—	—	1	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Giant cell arteritis	D013700	EFO_1001209	M31.6	—	2	—	—	—	2
Polymyalgia rheumatica	D011111	EFO_0008518	M35.3	—	2	—	—	—	2
Kidney diseases	D007674	EFO_0003086	N08	—	2	—	—	—	2
Myositis	D009220	EFO_0000783	G72.49	—	1	—	—	—	1
Muscular diseases	D009135	EFO_0002970	G72.9	—	1	—	—	—	1
Autoimmune diseases of the nervous system	D020274	—	—	—	1	—	—	—	1
Nervous system malformations	D009421	—	Q00-Q07	—	1	—	—	—	1
Biliary liver cirrhosis	D008105	—	K74.3	—	1	—	—	—	1
Cholangitis	D002761	HP_0030151	K83.0	—	1	—	—	—	1
Arteritis	D001167	EFO_0009011	I77.6	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	15	—	—	—	—	15
Liver diseases	D008107	EFO_0001421	K70-K77	1	—	—	—	—	1
Liver failure	D017093	—	K72.9	1	—	—	—	—	1
Hepatic insufficiency	D048550	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Dermatomyositis	D003882	EFO_0000398	M33	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Baricitinib
INN	baricitinib
Description	Baricitinib is a pyrrolopyrimidine that is 7H-pyrrolo[2,3-d]pyrimidine substituted by a 1-[3-(cyanomethyl)-1-(ethanesulfonyl)azetidin-3-yl]-1H-pyrazol-4-yl group at position 5. It is an FDA approved selective Janus Kinase 1 and 2 (JAK1 and JAK2) inhibitor used for the treatment of rheumatoid arthritis. It has a role as an antirheumatic drug, an EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor, an anti-inflammatory agent, an immunosuppressive agent and an antiviral agent. It is a pyrrolopyrimidine, a member of pyrazoles, a member of azetidines, a sulfonamide and a nitrile.
Classification	Small molecule
Drug class	tyrosine kinase inhibitors: tyrosine kinase inhibitors; janus kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1