Summary
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Parkinson's Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Parkinson's Disease. ClinicalTrials.gov lists 7 registered trials linking Nicotine to Parkinson's Disease: 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01216904). The largest enrolment is 160 participants (NCT01560754). Registration activity spans 2009 to 2020. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2013. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Parkinson Disease ranks 540 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 neurodegeneration — no spontaneous remission; untreated motor decline averages 3-5 UPDRS points/year; non-motor symptoms (depression, cognitive decline, autonomic dysfunction) also progressive.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 41.5 (trials 19.5, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 7 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 1 (1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ACHE |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01216904 | Nicotine Treatment of Impulsivity in Parkinson's Disease 2010 | status unknown | Phase 4 | 20 |
| NCT03865121 | Pilot Trial of Transnasal Nicotine in Parkinson Disease 2019 | completed | Phase 2 | 6 |
| NCT00873392 | Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease 2009 | completed | Phase 2 | 40 |
| NCT01560754 | Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease 2012 | status unknown | Phase 2 | 160 |
| NCT05180643 | Mindfulness Meditation (MBSR) and Parkinson's Disease (PD) 2020 | completed | Not applicable | 31 |
| NCT02452125 | The Effects of Nicotine Chewing Gum in Parkinson's Disease 2015 | completed | Not applicable | 10 |
| NCT00957918 | Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy 2009 | completed | PHASE1, PHASE2 | 65 |
Published literature
- Clinical trial publication Effect of nicotine on the pharmacokinetics of levodopaKyaw WT, Nagai M, Kaneta M et al. · Clinical neuropharmacology · 2013 · PMID 23503546
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 ACHE. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Nicotine approved for Parkinson's Disease?
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Parkinson's Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Parkinson's Disease. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Nicotine in clinical trials for Parkinson's Disease?
ClinicalTrials.gov lists 7 registered trials linking Nicotine to Parkinson's Disease: 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01216904). The largest enrolment is 160 participants (NCT01560754). Registration activity spans 2009 to 2020.
What does the evidence show for Nicotine in Parkinson's Disease?
Nicotine has 5 completed trials and 1 linked publication for Parkinson's Disease. 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 Open Targets and ChEMBL, in this case via the biomarker or target ACHE. 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 2026-07-05. Page built 2026-10-07.