Summary
Epirubicin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Sepsis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Sepsis. ClinicalTrials.gov lists 1 registered trial linking Epirubicin to Sepsis: 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT05033808). It plans or enrolled 45 participants. Registered activity dates to 2022. The literature layer holds 6 publications for this pair: 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2002 to 2021. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Sepsis ranks 518 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Not applicable — sepsis is an acute life-threatening syndrome; hospital mortality 15-25% for sepsis, 30-45% for septic shock with standard care; long-term complications (post-sepsis syndrome) in 50-70% of survivors.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 35.0 (trials 2.0, literature 13.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 1 other |
| Linked publications | 6 (5 clinical trial publications, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ADORA2A |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT05033808 | Epirubicin for the Treatment of Sepsis & Septic Shock 2022 | status unknown | Phase 2 | 45 |
Published literature
- Clinical trial publication A Randomized Phase II Study of Sequential Eribulin Versus Paclitaxel Followed by FAC/FEC as Neoadjuvant Therapy in Patients with Operable HER2-Negative Breast CancerLim B, Song J, Ibrahim NK et al. · The oncologist · 2021 · PMID 33140515
- Clinical trial publication Neoadjuvant cisplatin and fluorouracil versus epirubicin, cisplatin, and capecitabine followed by resection in patients with oesophageal adenocarcinoma (UK MRC OE05): an open-label, randomised phase 3 trialAlderson D, Cunningham D, Nankivell M et al. · The Lancet. Oncology · 2017 · PMID 28784312
- Clinical trial publication Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trialUntch M, Jackisch C, Schneeweiss A et al. · The Lancet. Oncology · 2016 · PMID 26869049
- Clinical trial publication A randomised pilot Phase II study of doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC) given 2 weekly with pegfilgrastim (accelerated) vs 3 weekly (standard) for women with early breast cancerJones RL, Walsh G, Ashley S et al. · British journal of cancer · 2009 · PMID 19165198
- Clinical trial publication Bortezomib in combination with epirubicin, dexamethasone and thalidomide is a highly effective regimen in the treatment of multiple myeloma: a single-center experienceLü S, Wang J, Xu X et al. · International journal of hematology · 2009 · PMID 19082817
- Randomized controlled trial Treatment of patients with advanced or bulky Hodgkin disease with a 12-week doxorubicin, bleomycin, vinblastine, and dacarbazine-like chemotherapy regimen followed by extended-field, full-dose radiotherapy: long-term results of the Groupe Ouest et Est des Leucémies et Autres Maladies de Sang H90-A/B Multicenter Randomized TrialDjeridane M, Oudard S, Escoffre-Barbe M et al. · Cancer · 2002 · PMID 12412171
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADORA2A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Epirubicin approved for Sepsis?
Epirubicin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Sepsis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Sepsis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Epirubicin in clinical trials for Sepsis?
ClinicalTrials.gov lists 1 registered trial linking Epirubicin to Sepsis: 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT05033808). It plans or enrolled 45 participants. Registered activity dates to 2022.
What does the evidence show for Epirubicin in Sepsis?
Trials of Epirubicin in Sepsis are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADORA2A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.