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
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 | 2024-10-25 |
| 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
284 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 | HP_0001369 | M05-M14 | 10 | 19 | 28 | 17 | 41 | 114 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 10 | 16 | 17 | 16 | 38 | 97 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | 2 | 6 | 7 | 19 | 35 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | 3 | 6 | 7 | 18 | 35 |
| Ulcer | D014456 | MPATH_579 | — | 1 | 2 | 6 | 4 | 17 | 30 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | 2 | 7 | 1 | 7 | 17 |
| Spondylitis | D013166 | — | M46.9 | — | 5 | 2 | 4 | 3 | 13 |
| Spondylarthritis | D025241 | — | — | — | 5 | 2 | 4 | 2 | 12 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | 1 | 4 | 1 | 1 | 3 | 10 |
| Alopecia | D000505 | HP_0002293 | L64 | 1 | 4 | 1 | 1 | 3 | 10 |
Show 26 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 6 | 7 | — | 1 | 16 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | 1 | 1 | 4 | — | 1 | 6 |
| Covid-19 | D000086382 | — | — | — | 4 | 1 | — | 1 | 6 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 5 | 1 | — | — | 6 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | 2 | 1 | — | 2 | 5 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | 1 | 1 | — | — | 2 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | — | 1 | 1 | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | — | 1 | — | — | 1 |
| Cutaneous leishmaniasis | D016773 | — | B55.1 | — | 1 | 1 | — | — | 1 |
| Leishmaniasis | D007896 | EFO_0005044 | B55 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 23 | 1 | — | — | — | 24 |
| Kidney transplantation | D016030 | — | — | 1 | 5 | — | — | 1 | 7 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | 4 | 1 | — | — | — | 4 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | 1 | 3 | — | — | — | 3 |
| Dry eye syndromes | D015352 | — | H04.12 | 1 | 3 | — | — | — | 3 |
| Inflammation | D007249 | MP_0001845 | — | 1 | 2 | — | — | 1 | 3 |
| Granuloma | D006099 | — | — | 3 | 1 | — | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | — | 3 | — | — | — | 3 |
| Sclerosis | D012598 | — | — | 2 | 2 | — | — | — | 3 |
| Depression | D003863 | — | F33.9 | 1 | 1 | — | — | 1 | 2 |
Show 31 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | 2 | — | — | — | — | 2 |
| Granuloma annulare | D016460 | — | L92.0 | 2 | — | — | — | — | 2 |
| Stevens-johnson syndrome | D013262 | EFO_0004276 | L51.1 | 1 | — | — | — | 1 | 2 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | 1 | — | — | — | — | 1 |
| Muscle weakness | D018908 | HP_0001324 | — | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 1 | — | — | — | — | 1 |
| Mesothelioma | D008654 | — | C45 | 1 | — | — | — | — | 1 |
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | — | — | — | — | 1 |
Show 10 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | — | — | 1 | 1 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 1 | 1 |
| Rheumatic diseases | D012216 | — | M79.0 | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 1 | 1 |
| Treatment adherence and compliance | D000074822 | — | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Vasculitis | D014657 | HP_0002633 | — | — | — | — | — | 1 | 1 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | — | — | — | 1 | 1 |
| Recreational drug use | D000084783 | — | — | — | — | — | — | 1 | 1 |
Show 7 more
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
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Xeljanz – Pfizer
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Additional graphs summarizing 12,420 documents
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Safety
Black-box Warning
Black-box warning for: Xeljanz, Xeljanz xeljanz
Adverse Events
Top Adverse Reactions
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144,532 adverse events reported
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