Summary
Aldesleukin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Primary Sclerosing Cholangitis (PSC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Primary Sclerosing Cholangitis (PSC). ClinicalTrials.gov lists 1 registered trial linking Aldesleukin to Primary Sclerosing Cholangitis (PSC): 1 has completed. The most advanced is Phase 2 (NCT01988506). It plans or enrolled 81 participants. Registered activity dates to 2014. No published literature item is linked to Aldesleukin and Primary Sclerosing Cholangitis (PSC) in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Primary Sclerosing Cholangitis 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: Progressive cholestatic disease; median time to liver failure or transplant 12-15 years; spontaneous remission essentially zero; biliary strictures progress in majority; cholangiocarcinoma risk 10-15% lifetime.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 23.5 (trials 3.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | CD40 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01988506 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases 2014 | completed | Phase 2 | 81 |
Published literature
No publication is linked to this pair yet.
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 DGIdb, in this case via the biomarker or target CD40. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Aldesleukin approved for Primary Sclerosing Cholangitis (PSC)?
Aldesleukin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Primary Sclerosing Cholangitis (PSC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Primary Sclerosing Cholangitis (PSC). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Aldesleukin in clinical trials for Primary Sclerosing Cholangitis (PSC)?
ClinicalTrials.gov lists 1 registered trial linking Aldesleukin to Primary Sclerosing Cholangitis (PSC): 1 has completed. The most advanced is Phase 2 (NCT01988506). It plans or enrolled 81 participants. Registered activity dates to 2014.
What does the evidence show for Aldesleukin in Primary Sclerosing Cholangitis (PSC)?
Aldesleukin has 1 completed registered trial for Primary Sclerosing Cholangitis (PSC) but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CD40. 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.