Summary
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lupus Nephritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lupus Nephritis. ClinicalTrials.gov lists 2 registered trials linking Sirolimus to Lupus Nephritis: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00050713). The largest enrolment is 20 participants (NCT04892212). Registration activity spans 2002 to 2021. The literature layer holds 1 publication for this pair: 1 meta-analysis. The dated items are from 2020. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Lupus Nephritis ranks 50 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: Spontaneous remission essentially zero in class III/IV LN; progression to ESRD in 10-20% at 10 years on standard therapy; renal flares in 30-50% of patients achieving initial response.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 28.5 (trials 4.5, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 1 (1 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ACKR2 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00050713 | Sirolimus Therapy for Idiopathic and Lupus Membranous Nephropathy 2002 | completed | Phase 2 | 12 |
| NCT04892212 | Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis 2021 | status unknown | PHASE2, PHASE3 | 20 |
Published literature
- Meta-analysis Efficacy and safety of sirolimus in patients with systemic lupus erythematosus: A systematic review and meta-analysisJi L, Xie W, Zhang Z · Seminars in arthritis and rheumatism · 2020 · PMID 32911286
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 ACKR2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sirolimus approved for Lupus Nephritis?
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lupus Nephritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lupus Nephritis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sirolimus in clinical trials for Lupus Nephritis?
ClinicalTrials.gov lists 2 registered trials linking Sirolimus to Lupus Nephritis: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00050713). The largest enrolment is 20 participants (NCT04892212). Registration activity spans 2002 to 2021.
What does the evidence show for Sirolimus in Lupus Nephritis?
Sirolimus has both completed registered trials and synthesis-level publications linked to Lupus Nephritis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. 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 ACKR2. 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 2026-07-06. Page built 2026-10-07.