Drug · Small Molecule

Tofacitinib

CI-DRUG-00000596Explore in graph →NCIt C95800 CHEMBL221959 CIViC Approved

Regulatory

Approvals (22)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory22 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2026-03-06 (see label)	approved	Mar 6, 2026	openfda
US FDA	—	Efficacy supplement 2026-03-06 (see label)	approved	Mar 6, 2026	openfda
US FDA	—	Efficacy supplement 2026-03-06 (see label)	approved	Mar 6, 2026	openfda
US FDA	—	Efficacy supplement 2025-10-16 (see label)	approved	Oct 16, 2025	openfda
US

Data updated 16 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	2	2	8	14	22	US	Nov 6, 2012	2009-10
Malignant Central Nervous System Neoplasm	Phase3	Phase 3	0	0	1	1	0	—	—	Oct 7, 2022
Non-Hodgkin Lymphoma	Phase2	Phase 2	1	1	0	2	0	—	—	Jan 1, 2019
Malignant Mesothelioma	Phase1	Phase 1	0	0	0	1	0

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
JAK3 M511I1
Tofacitinib	T Acute Lymphoblastic Leukemia

Clinical trials

Trials with this intervention (16)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–16 of 16 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06698822	A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA	recruiting	Phase 2	20	M.D. Anderson Cancer CenterOTHER	1	Jul 13, 2026	clinicaltrials
NCT05326464	Tofacitinib in Recurrent GBM Patients	completed	Phase 3

Molecule

Record

Kind: Small Molecule
Mechanism: Janus Kinase (JAK) inhibitor
Targets: 4 genes
UNII: O1FF4DIV0D
Aliases: 3-((3R,4R)-4-Methyl-3-(Methyl(7H-Pyrrolo(2,3-D)Pyrimidin-4-yl)Amino)Piperidin-1-yl)-3-Oxopropanenitrile, 550, CP-690, CP 690550, CP- 690 550, CP690,550, CP690550, CP-690550-10, CP-690,550 Free Base, CP-690,550 FREE BASE, CP-690550 FREE BASE, Cp-690 free base, JAK Inhibitors: Tofacitinib, PFE-PKIS 25, Tasocitinib, TASOCITINIB CITRATE, Tofacitinib, TOFACITINIB CITRATE, TOFACITINIB (CONTROLLED RELEASE), TOFACITINIB (CP-690550), TOFACITINIB SOLUTION, TOFACITINIB XR, XELJANZ, XELJANZ XR

Data updated 23 hours agoSource updated unknown

Identifiers

Codes (0)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

Data not yet available

No cross-reference code recorded yet beyond the record identifiers above.

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.