Last reviewed · How we verify
Nicotine Patch (nicotine-patch)
Nicotine Patch (generic name: nicotine-patch) is a Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11 drug developed by Pfizer Inc.. It is currently in preclinical development.
Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11
Nicotine Patch is a nicotine replacement therapy that delivers nicotine transdermally to reduce withdrawal symptoms and cravings during smoking cessation. As a direct nicotine agonist, it provides a controlled, steady dose of nicotine without the combustion byproducts of cigarettes, making it an effective non-smoking alternative for managing the physiological dependence on nicotine.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | nicotine-patch |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11 |
| Therapeutic area | Neuroscience |
| Phase | preclinical |
Mechanism of action
Nicotine addiction works through your brain's reward system. When you smoke, nicotine rapidly reaches your brain and binds to nicotinic receptors, creating feelings of pleasure and satisfaction while also relieving uncomfortable withdrawal symptoms like irritability, anxiety, and intense cravings. When you quit smoking suddenly, your brain loses this regular nicotine supply, triggering withdrawal symptoms that make quitting extremely difficult. The nicotine patch solves this problem by delivering a steady, consistent amount of nicotine directly through your skin into your bloodstream over several hours. Instead of the dramatic spike-and-crash cycle of smoking, the patch maintains stable nicotine levels throughout the day. This steady supply prevents withdrawal symptoms from developing while you're working on breaking the behavioral habits of smoking itself. By separating nicotine replacement from the act of smoking, the patch lets your brain gradually adjust to lower nicotine levels while you build new routines and coping strategies. Most people use patches of decreasing strength over several weeks or months, slowly tapering their nicotine dependence until they can stop completely. This approach addresses the chemical addiction while you address the psychological and behavioral aspects of smoking separately.
Approved indications
Pipeline indications
- Tobacco Use Cessation — preclinical
Common side effects
Key clinical trials
- An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation (Phase 3)
- Reward Sensitivity and Pharmacotherapy for Smoking Cessation (Phase 4)
- Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit (Phase 4)
- Adaptive Pharmacotherapy for Smoking Cessation (Phase 2)
- Stop Smoking Therapy for Ontario Patients (N/A)
- Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medication (Phase 4)
- Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO) (Phase 2)
- Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer (Phase EARLY1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nicotine Patch CI brief — competitive landscape report
- Nicotine Patch updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Nicotine Patch
What is Nicotine Patch?
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What drug class is Nicotine Patch in?
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Related
- Drug class: All Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11 drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing