Xeljanz(tofacitinib)
Tofacitinib, Xeljanz (tofacitinib) is a small molecule pharmaceutical. Tofacitinib was first approved as Xeljanz on 2012-11-06. 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 JAK3, tyrosine-protein kinase JAK1, and tyrosine-protein kinase JAK2. In addition, it is known to target serine/threonine-protein kinase N1 and non-receptor tyrosine-protein kinase TYK2.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Tofacitinib, Xeljanz (discontinued: Tofacitinib)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xeljanz | New Drug Application | 2026-01-30 |
| xeljanz xeljanz | New Drug Application | 2022-06-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TOFACITINIB CITRATE, XELJANZ, PF PRISM CV | |||
| 2024-12-14 | I-879 | ||
| 2023-09-25 | NPP | ||
TOFACITINIB CITRATE, XELJANZ XR, PFIZER | |||
| 2024-12-14 | I-879 | ||
TOFACITINIB CITRATE, XELJANZ, PFIZER | |||
| 2023-09-25 | NP | ||
HCPCS
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Clinical
Clinical Trials
307 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 6 | 12 | 9 | 4 | 23 | 54 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 7 | 12 | 14 | 2 | 18 | 52 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | 6 | 1 | 10 | 18 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | 5 | 1 | 6 | 13 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | 5 | 1 | 6 | 13 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | 5 | 1 | 5 | 11 |
| Spondylarthritis | D025241 | — | — | — | 1 | 1 | 2 | — | 4 |
| Spondylitis | D013166 | — | M46.9 | — | 1 | 1 | 2 | — | 4 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | — | 1 |
| Rheumatic fever | D012213 | EFO_1001160 | I00-I02 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 5 | 7 | — | 1 | 15 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | 1 | 1 | 3 | — | 1 | 5 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | 1 | 1 | — | 1 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 1 | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 1 | 1 | — | — | 2 |
| Pruritus | D011537 | — | L29 | — | — | 1 | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | — | — | 1 | — | — | 1 |
| Amyloid plaque | D058225 | — | — | — | — | 1 | — | — | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | — | — | 1 | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | 1 | 5 | — | — | 1 | 7 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 4 | — | — | — | 4 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 2 | 1 | — | — | — | 2 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | 1 | 2 | — | — | — | 2 |
| Dry eye syndromes | D015352 | — | H04.12 | 1 | 2 | — | — | — | 2 |
| Cutaneous lupus erythematosus | D008178 | EFO_0003834 | L93.1 | 1 | 1 | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | 1 | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | 1 | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | 1 | — | — | — | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 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 | — | — | — | 18 | — | — | — | — | 18 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | 2 | — | — | — | — | 2 |
| Granuloma | D006099 | — | — | 1 | — | — | — | — | 1 |
| Granuloma annulare | D016460 | — | L92.0 | 1 | — | — | — | — | 1 |
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | — | — | — | — | 1 |
| Discoid lupus erythematosus | D008179 | — | L93.0 | 1 | — | — | — | — | 1 |
| Dermatomyositis | D003882 | EFO_0000398 | M33 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Immunomodulation | D056747 | — | — | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Necrosis | D009336 | — | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 1 | 1 |
| Intestinal diseases | D007410 | — | K63.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tofacitinib |
| INN | tofacitinib |
| Description | Tofacitinib is a pyrrolopyrimidine that is pyrrolo[2,3-d]pyrimidine substituted at position 4 by an N-methyl,N-(1-cyanoacetyl-4-methylpiperidin-3-yl)amino moiety. Used as its citrate salt to treat moderately to severely active rheumatoid arthritis. It has a role as an EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor and an antirheumatic drug. It is a pyrrolopyrimidine, a N-acylpiperidine, a nitrile and a tertiary amino compound. |
| 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) | C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12 |
Identifiers
| PDB | — |
| CAS-ID | 477600-75-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL221959 |
| ChEBI ID | 71200 |
| PubChem CID | 9926791 |
| DrugBank | DB08895 |
| UNII ID | 87LA6FU830 (ChemIDplus, GSRS) |
Target
Agency Approved
JAK3
JAK3
Alternate
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Variants
No data
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Xeljanz – Pfizer
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Tabular view
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Xeljanz, Xeljanz xeljanz
Adverse Events
Top Adverse Reactions
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153,737 adverse events reported
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