Baricitinib
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Baricitinib
- Molecular weight
- 371.43
- Structure (SMILES)
- CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
- olumiant
- Olumiant
- 2mg baricitinib
- 2mg Baricitinib
- 3jw
- 3JW
- 4mg Baricitinib
- baricitinib
- Baricitinib
- BARICITINIB
- BARICITINIB (INCB028050)
- Baricitinib (janus kinase inhibitor)
- BARICITINIB (LY3009104)
- Baricitinib (LY3009104) 2 mg
- Baricitinib (LY3009104) 4 mg
- BARICITINIB [EMA EPAR]
- baricitinib [INN]
- BARICITINIB [JAN]
- BARICITINIB [MI]
- BARICITINIB [ORANGE BOOK]
- BARICITINIB [USAN]
- Baricitinib [WHO-DD]
- Baricitinib 2 MG
- Baricitinib 2 MG Oral Tablet
- Baricitinib 2mg
- Baricitinib 4 MG
- Baricitinib 4 MG Oral Tablet
And 35 more, listed on the interactive page.
- CAS registry numbers
- 1187594-09-7
- ChEMBL ID
- CHEMBL2105759
- InChIKey
- XUZMWHLSFXCVMG-UHFFFAOYSA-N
- PubChem compound IDs
- 44205240
- RxNorm IDs (RxCUI)
- 2047232
- FDA ingredient codes (UNII)
- ISP4442I3Y
- L04AA37
- L04AF02
Sources for recorded values
- Applicant
- ELI LILLY AND CO
- Approval date
- 31 May 2018
- Application number
- NDA207924
- Status
- Authorised
- Status date
- 13 Feb 2017
- Authorisation date
- 13 Feb 2017
- Approved indications
- Rheumatoid arthritis Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate. Atopic Dermatitis Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. Alopecia areata Baricitinib is indicated for the treatment of severe alopecia areata in adult and adolescent patients 12 years of age and older. Juvenile idiopathic arthritis Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs: Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), Enthesitis related arthritis, and Juvenile psoriatic arthritis. Baricitinib may be used as monotherapy or in combination with methotrexate.
- Product number
- EMEA/H/C/004085
- Authorisation holder
- Eli Lilly Nederland B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Rheumatoid
European medicines record
- Patents
- 6
- Designations
- 3
- Earliest recorded loss of exclusivity
- 30 Nov 2032
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- baricitinib
- Type
- Synthetic organic
- Drug name stem
- -tinib
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- cyclin G associated kinase
- Gene symbol
- GAK
- Protein identifier
- O14976
- Median affinity
- 6.87
- Affinity units
- pKd
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Janus kinase 2
- Gene symbol
- JAK2
- Protein identifier
- O60674
- Median affinity
- 8.15
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Janus kinase 1
- Gene symbol
- JAK1
- Protein identifier
- P23458
- Median affinity
- 8.23
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- tyrosine kinase 2
- Gene symbol
- TYK2
- Protein identifier
- P29597
- Median affinity
- 7.21
- Affinity units
- pIC50
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Janus kinase 3
- Gene symbol
- JAK3
- Protein identifier
- P52333
- Median affinity
- 6.1
- Affinity units
- pIC50
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- AP2 associated kinase 1
- Gene symbol
- AAK1
- Protein identifier
- Q2M2I8
- Median affinity
- 7.77
- Affinity units
- pKd
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- BMP2 inducible kinase
- Gene symbol
- BMP2K
- Protein identifier
- Q9NSY1
- Median affinity
- 7.4
- Affinity units
- pKd
- Mechanism
- Tyrosine-protein kinase JAK1 inhibitor
- Action type
- Inhibitor
- Target
- Tyrosine-protein kinase JAK1
- Protein identifier
- P23458
- Mechanism
- Tyrosine-protein kinase JAK2 inhibitor
- Action type
- Inhibitor
- Target
- Tyrosine-protein kinase JAK2
- Protein identifier
- O60674
- Mechanism
- Tyrosine-protein kinase JAK1 inhibitor
- Action type
- Inhibitor
- Target
- Tyrosine-protein kinase JAK1
- Mechanism
- Tyrosine-protein kinase JAK2 inhibitor
- Action type
- Inhibitor
- Target
- Tyrosine-protein kinase JAK2
- Action type
- Inhibitor
- Gene symbol
- GAK
- Protein identifier
- O14976
- Organism
- Homo sapiens
- Target development level
- Chemical evidence
- Action type
- Inhibitor
- Gene symbol
- JAK2
- Protein identifier
- O60674
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- JAK1
- Protein identifier
- P23458
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- TYK2
- Protein identifier
- P29597
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- AAK1
- Protein identifier
- Q2M2I8
- Organism
- Homo sapiens
- Target development level
- Chemical evidence
- Action type
- Inhibitor
- Gene symbol
- BMP2K
- Protein identifier
- Q9NSY1
- Organism
- Homo sapiens
- Target development level
- Chemical evidence
- Condition
- Dermatitis, Atopic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000274
- Subject identifier
- D003876
- Condition
- Dermatomyositis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000398
- Subject identifier
- D003882
- Condition
- Diabetic Nephropathies
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000401
- Subject identifier
- D003928
- Condition
- Dermatomyositis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000557
- Subject identifier
- D003882
- Condition
- Psoriasis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000676
- Subject identifier
- D011565
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Sjogren's Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000699
- Subject identifier
- D012859
- Condition
- Subarachnoid Hemorrhage
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000713
- Subject identifier
- D013345
- Condition
- HIV Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Myositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000783
- Subject identifier
- D009220
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002609
- Subject identifier
- D001171
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Alopecia Areata
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004192
- Subject identifier
- D000506
- Condition
- Vitiligo
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004208
- Subject identifier
- D014820
- Condition
- Neuromyelitis Optica
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004256
- Subject identifier
- D009471
- Condition
- Purpura, Thrombocytopenic, Idiopathic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007160
- Subject identifier
- D016553
- Condition
- Influenza, Human
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007328
- Subject identifier
- D007251
- Condition
- Dermatitis, Allergic Contact
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:1000668
- Subject identifier
- D017449
- Condition
- Lichen Planus
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000726
- Subject identifier
- D008010
- Condition
- Mastitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001034
- Subject identifier
- D008413
- Condition
- Giant Cell Arteritis
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001209
- Subject identifier
- D013700
- Condition
- Uveitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001231
- Subject identifier
- D014605
- Condition
- Liver Cirrhosis, Biliary
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001486
- Subject identifier
- D008105
And 8 more, listed on the interactive page.
- Condition identifier
- EFO_0000180
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000274
- Condition identifier
- EFO_0000398
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000401
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000557
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000699
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000713
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000783
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002609
- Condition identifier
- EFO_0003106
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004192
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004208
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004256
- Condition identifier
- EFO_0006835
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007160
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007948
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008517
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009746
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000668
- Condition identifier
- EFO_1000726
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001034
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001209
- Highest recorded phase
- 2
And 74 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Warning
- Black Box Warning
- Effect
- infectious disease
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Country
- United States
- Event
- alanine aminotransferase increased
- Reports
- 34
- Reporting signal score
- 19.981
- Event
- covid-19
- Reports
- 47
- Reporting signal score
- 63.0175
- Event
- covid-19 pneumonia
- Reports
- 13
- Reporting signal score
- 28.8629
- Event
- deep vein thrombosis
- Reports
- 67
- Reporting signal score
- 80.4554
- Event
- fibrin d dimer increased
- Reports
- 15
- Reporting signal score
- 39.7986
- Event
- herpes zoster
- Reports
- 39
- Reporting signal score
- 38.4892
- Event
- liver function test increased
- Reports
- 19
- Reporting signal score
- 21.8345
- Event
- lumbosacral plexopathy
- Reports
- 6
- Reporting signal score
- 34.6574
- Event
- lung adenocarcinoma
- Reports
- 9
- Reporting signal score
- 20.5798
- Event
- ovarian adenoma
- Reports
- 6
- Reporting signal score
- 25.6568
- Event
- perineal rash
- Reports
- 6
- Reporting signal score
- 33.4301
- Event
- pneumonia bacterial
- Reports
- 12
- Reporting signal score
- 23.1488
- Event
- pneumonia haemophilus
- Reports
- 6
- Reporting signal score
- 22.1614
- Event
- pneumonia staphylococcal
- Reports
- 8
- Reporting signal score
- 22.4711
- Event
- pulmonary embolism
- Reports
- 63
- Reporting signal score
- 62.7311
- Event
- rheumatoid arthritis
- Reports
- 59
- Reporting signal score
- 53.9154
- Event
- sputum culture positive
- Reports
- 9
- Reporting signal score
- 33.6606
- Event
- squamous cell carcinoma of lung
- Reports
- 8
- Reporting signal score
- 27.5678
- Event
- still's disease
- Reports
- 8
- Reporting signal score
- 26.9453
- Event
- therapy interrupted
- Reports
- 35
- Reporting signal score
- 66.0051
- Event
- thrombocytosis
- Reports
- 12
- Reporting signal score
- 26.4548
- Event
- tooth dislocation
- Reports
- 6
- Reporting signal score
- 39.3844
- Event
- volvulus
- Reports
- 9
- Reporting signal score
- 25.4708
- NCT00902486
- NCT01185353
- NCT01398475
- NCT01469013
- NCT01710358
- NCT01711359
- NCT01721044
- NCT01721057
- NCT01885078
- NCT02265705
- NCT03414502
- NCT03701789
- NCT03915964
- NCT04086745
- NCT04870203
- NCT05238896
- NCT05660655
- NCT05827497
- NCT05955066
- NCT01490632
- NCT01683409
- NCT05897372
- NCT02576938
- NCT03334396
- NCT03334422
And 60 more, listed on the interactive page.
- Dose
- 2 mg
- Route
- Oral
- How often
- Once daily
- Hydrogen bond acceptors
- 7
- Hydrogen bond donors
- 1
- Polar surface area
- 120.56
- Calculated partition coefficient (ALogP)
- 1.1
- Calculated partition coefficient (XLogP)
- -0.5
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 5
- Heavy atoms
- 26
- Molecular formula
- C16H17N7O2S
- Monoisotopic mass
- 371.11644398
- Natural product
- Yes
- 0002-4182
- 0002-4479
- 0002-4732
- 0002-6885
- Recorded assays
- 1,013
- Active assays
- 235
- Confirmatory
- Other
- Screening
Distribution coefficient (LogD)
- Median
- 0.72
- Mean
- 0.72
- Minimum
- 0.24
- Maximum
- 1.2
- Unit
- unitless
- Assays
- 2
- Standard deviation
- 0.678823
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- LogD
Solubility
- Median
- 16.3
- Mean
- 16.3
- Minimum
- 16.3
- Maximum
- 16.3
- Unit
- ug/mL
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- Solubility
Oral bioavailability
- Median
- 45.48
- Mean
- 45.48
- Minimum
- 45.48
- Maximum
- 45.48
- Unit
- %
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Related records
Trials (176)
- "Baricitinib for Treating Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype.
- A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
- A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable
- A Moderate to Severe Rheumatoid Arthritis Study
- A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease
- A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas
- A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis
- A Prospective Pilot Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients
- A Relative Bioavailability and Food Effect Study of New Formulations
- A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis
- A Study in Moderate to Severe Rheumatoid Arthritis
- A Study in Moderate to Severe Rheumatoid Arthritis Participants
- A Study in Participants With Moderate to Severe Rheumatoid Arthritis
- A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy
- A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
- A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS
- A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis
- A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
- A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
- A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Approved for (1)
In development for (34)
- Aicardi-Goutieres syndrome Phase 2
- Allergic contact dermatitis Early phase 1
- Alopecia areata Phase 3
- Atopic eczema Phase 3
- Autoimmune thrombocytopenic purpura Phase 2
- Brain injury Phase 2
- Cardiac sarcoidosis Phase 2
- Chronic graft versus host disease Phase 1
- Chronic kidney disease Phase 2
- COVID-19 Phase 3
- Dermatomyositis Phase 3
- Diabetic kidney disease Phase 2
- Graft versus host disease Phase 1
- HIV infectious disease Phase 2
- Influenza Phase 3
- Juvenile dermatomyositis Phase 3
- Juvenile idiopathic arthritis Phase 3
- Lichen planus Phase 2
- Major depressive disorder Phase 2
- Mastitis Phase 2