Drug · Small Molecule
Ruxolitinib
CI-DRUG-00000529Explore in graph →NCIt C77888 CHEMBL1789941 CIViC Approved
Regulatory
Approvals (20)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | Polycythemia Vera | polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. | approved | May 1, 2026 | openfda |
| US FDA | — | intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. • steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. • chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 hours 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 | 73 | 43 | 18 | 173 | 20 | CA, EU, US | Nov 16, 2011 | Sep 26, 2002 |
| Leukemia | Phase4 | Phase 4 | 31 | 18 | 2 | 60 | 0 | — | — | May 12, 2008 |
| Malignant Pancreatic Neoplasm | Phase3 | Phase 3 | 2 | 0 | 2 | 9 | 0 | — | — | 2011-07 |
| Non-Hodgkin Lymphoma | Phase2 | Phase 2 | 13 | 12 | 0 | 20 | 0 | — |
Curated evidence
Clinical evidence (14)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 22955920
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| CRLF2 Fusion1 | ||||||||
| Ruxolitinib | Acute Lymphoblastic Leukemia | |||||||
Clinical trials
Trials with this intervention (177)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04807777 | Study of Ruxolitinib in Solid Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma | terminated | Phase 2 | 3 | Columbia UniversityOTHER | 1 | Dec 27, 2024 | clinicaltrials |
| NCT06209606 | Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma | recruiting | Early Phase 1 |