Summary
Nicotine 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 Nicotine 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: 2 clinical trial publications. Publication years run from 1999 to 2001. 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 | 24.0 (trials 0.0, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | ChEMBL |
| Linked via biomarker / target | ADCY3 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 Nicotine to Primary Sclerosing Cholangitis (PSC) in the current OSMF trial extract.
Published literature
- Clinical trial publication No beneficial effects of transdermal nicotine in patients with primary sclerosing cholangitis: results of a randomized double-blind placebo-controlled cross-over studyVleggaar FP, van Buuren HR, van Berge Henegouwen GP et al. · European journal of gastroenterology & hepatology · 2001 · PMID 11246617
- Clinical trial publication Oral nicotine in treatment of primary sclerosing cholangitis: a pilot studyAngulo P, Bharucha AE, Jorgensen RA et al. · Digestive diseases and sciences · 1999 · PMID 10080157
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 ChEMBL, in this case via the biomarker or target ADCY3. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Nicotine approved for Primary Sclerosing Cholangitis (PSC)?
Nicotine 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 Nicotine in clinical trials for Primary Sclerosing Cholangitis (PSC)?
No registered clinical trial in this database tests Nicotine 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 Nicotine in Primary Sclerosing Cholangitis (PSC)?
The record for Nicotine in Primary Sclerosing Cholangitis (PSC) rests on 2 publications without a registered trial. This is a lead for hypothesis generation, not evidence of efficacy. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in ChEMBL, in this case via the biomarker or target ADCY3. 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.