Drug · Small Molecule
Momelotinib
CI-DRUG-00000765Explore in graph →CHEMBL1078178 Approved
Regulatory
Approvals (5)
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
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as OJJAARA (DIN 02552965) under ATC L01EJ04 MOMELOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 21, 2025 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as OJJAARA (DIN 02552973) under ATC L01EJ04 MOMELOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 21, 2025 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as OJJAARA (DIN 02552981) under ATC L01EJ04 MOMELOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 21, 2025 | health-canada-dpd |
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 20 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 2 | 3 | 3 | 0 | 7 | 5 | CA, EU, US | Sep 15, 2023 | Feb 19, 2014 |
| Leukemia | Phase2 | Phase 2 | 2 | 2 | 0 | 2 | 0 | — | — | May 22, 2024 |
| Malignant Lung Neoplasm | Phase1 | Phase 1 | 0 | 0 | 0 | 1 | 0 | — | — | Mar 11, 2015 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (7)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06150157 | A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms | recruiting | Phase 1 | 300 | Janssen Research & Development, LLCINDUSTRY | 10 | Sep 25, 2026 | clinicaltrials |
| NCT06235801 | A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia | recruiting |