Summary
Prednisolone 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 Prednisolone to Primary Sclerosing Cholangitis (PSC): 1 has completed. The most advanced is Phase 4 (NCT02703194). It plans or enrolled 68 participants. Registered activity dates to 2016. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2018. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 26.5 (trials 4.5, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 1 (1 clinical trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02703194 | Leflunomide for Maintenance of Remission in IgG4 Related Disease 2016 | completed | Phase 4 | 68 |
Published literature
- Clinical trial publication Noncholesterol Sterols as Surrogate Markers in Patients with Severe Alcoholic HepatitisSahlman P, Nissinen M, Simonen P et al. · Lipids · 2018 · PMID 29663389
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 Prednisolone approved for Primary Sclerosing Cholangitis (PSC)?
Prednisolone 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 Prednisolone in clinical trials for Primary Sclerosing Cholangitis (PSC)?
ClinicalTrials.gov lists 1 registered trial linking Prednisolone to Primary Sclerosing Cholangitis (PSC): 1 has completed. The most advanced is Phase 4 (NCT02703194). It plans or enrolled 68 participants. Registered activity dates to 2016.
What does the evidence show for Prednisolone in Primary Sclerosing Cholangitis (PSC)?
Prednisolone has 1 completed trial and 1 linked publication for Primary Sclerosing Cholangitis (PSC). Completed trials may or may not have posted results; follow the NCT links to check. 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.