Drug · Other
Pegfilgrastim
CI-DRUG-00000706Explore in graph →CHEMBL1201568 Approved
Regulatory
Approvals (27)
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
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | — | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). | approved | Aug 18, 2025 | ema |
| EU EMA | — | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). | approved | Mar 28, 2025 | ema |
| EU EMA | — | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). | approved | Mar 28, 2022 | ema |
| EU EMA |
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 16 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 | 33 | 18 | 44 | 220 | 27 | CA, EU, US | Jan 31, 2002 | 1999-09 |
| Non-Hodgkin Lymphoma | Phase4 | Phase 4 | 9 | 4 | 4 | 34 | 0 | — | — | 2002-06 |
| Malignant Breast Neoplasm | Phase4 | Phase 4 | 5 | 2 | 13 | 52 | 0 | — | — | 2001-10 |
| Malignant Lung Neoplasm | Phase4 | Phase 4 | 2 | 1 | 1 | 14 | 0 | — |
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 (223)
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 |
|---|---|---|---|---|---|---|---|---|
| NCT01682044 | Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma | completed | Phase 2 | 20 | Roswell Park Cancer InstituteOTHER | 1 | Oct 9, 2017 | clinicaltrials |
| NCT00151242 | Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia |