Summary
Adalimumab 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). No registered clinical trial in this database tests Adalimumab specifically in Primary Sclerosing Cholangitis (PSC). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study. The literature layer holds 2 publications for this pair: 1 Cochrane review and 1 meta-analysis. Publication years run from 2010 to 2024. 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 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 | 29.0 (trials 0.0, literature 9.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 2 (1 Cochrane review, 1 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ATG16L1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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
No registered trial links Adalimumab to Primary Sclerosing Cholangitis (PSC) in the current OSMF trial extract.
Published literature
- Meta-analysis Efficacy and safety of biologics in primary sclerosing cholangitis with inflammatory bowel disease: A systematic review and meta-analysisShah A, Jones MP, Callaghan G et al. · Hepatology communications · 2024 · PMID 38206197
- Cochrane review Extraintestinal manifestations of inflammatory bowel disease: epidemiology, diagnosis, and managementLarsen S, Bendtzen K, Nielsen OH · Annals of medicine · 2010 · PMID 20166813
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 ATG16L1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Adalimumab approved for Primary Sclerosing Cholangitis (PSC)?
Adalimumab 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 Adalimumab in clinical trials for Primary Sclerosing Cholangitis (PSC)?
No registered clinical trial in this database tests Adalimumab specifically in Primary Sclerosing Cholangitis (PSC). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study.
What does the evidence show for Adalimumab in Primary Sclerosing Cholangitis (PSC)?
Synthesis-level literature links Adalimumab to Primary Sclerosing Cholangitis (PSC), but no registered trial in this database tests the pair, so the evidence is observational, pooled from other indications, or pre-dates registry practice. 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 ATG16L1. 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.