Drug · Small Molecule
Roflumilast
CI-DRUG-00000525Explore in graph →NCIt C76890 CHEMBL193240 CIViC Approved
Regulatory
Approvals (10)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
openfdaProvenance
- 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 | — | Efficacy supplement 2026-06-29 (see label) | approved | Jun 29, 2026 | openfda |
| US FDA | — | Efficacy supplement 2025-10-04 (see label) | approved | Oct 4, 2025 | openfda |
| US FDA | — | Efficacy supplement 2025-05-22 (see label) | approved | May 22, 2025 | openfda |
| US FDA | — | Efficacy supplement 2024-07-09 (see label) | approved | Jul 9, 2024 | openfda |
| US |
Data updated 2 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 1 | 2 | 2 | 0 | 4 | 10 | US | Feb 28, 2011 | 2013-07 |
| Leukemia | Phase1 | Early Phase 1 | 1 | 1 | 0 | 1 | 0 | — | — | Jan 24, 2018 |
| Non-Hodgkin Lymphoma | Phase1 | Phase 1 | 1 | 1 | 0 | 1 | 0 | — | — | Jun 20, 2025 |
ComputedclinicaltrialsProvenance
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
- 38461159
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| STK11 Loss1 | ||||||||
| Roflumilast | Pancreatic Ductal Adenocarcinoma | |||||||
Clinical trials
Trials with this intervention (4)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT06977711 | Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL) | recruiting | Phase 1 | 10 | The University of Texas Health Science Center at San AntonioOTHER | 1 | Jun 22, 2026 | clinicaltrials |
| NCT06643221 | Exercise as an Immune Adjuvant for Allogeneic Cell Therapies(Allo-X) |