Drug · Small Molecule
Guadecitabine
CI-DRUG-00000660Explore in graph →NCIt C95209 CHEMBL3544916 CIViC Phase 3
Regulatory
Approvals (0)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
Data not yet available
No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.
What CancerIndex knows
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 | Phase3 | Phase 3 | 6 | 0 | 2 | 27 | 0 | — | — | Jan 4, 2011 |
| Leukemia | Phase3 | Phase 3 | 1 | 0 | 2 | 10 | 0 | — | — | Jan 4, 2011 |
| Malignant Lung Neoplasm | Phase2 | Phase 2 | 2 | 0 | 0 | 4 | 0 | — | — | Jan 26, 2017 |
| Malignant Kidney Neoplasm | Phase2 | Phase 2 | 1 | 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.
civicProvenance
- 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
- 21415852
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| DNMT3A P904L1 | ||||||||
| 5-Fluoro-2-Deoxycytidine + | ||||||||
Clinical trials
Trials with this intervention (27)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- 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 |
|---|---|---|---|---|---|---|---|---|
| NCT03220477 | Pembrolizumab (Immunotherapy Drug) in Combination With Guadecitabine and Mocetinostat (Epigenetic Drugs) for Patients With Advanced Lung Cancer. | active not recruiting | Phase 1 | 28 | Memorial Sloan Kettering Cancer CenterOTHER | 1 | Aug 5, 2026 | clinicaltrials |
| NCT02935361 | Guadecitabine and Atezolizumab in Treating Patients With Advanced Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia That Is Refractory or Relapsed |