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Low Nicotine Content Cigarettes
Low Nicotine Content Cigarettes is a Small molecule drug developed by Masonic Cancer Center, University of Minnesota. It is currently in Phase 1 development.
Low nicotine content cigarettes are being studied as a potential intervention for conditions such as smoking, nicotine dependence, and tobacco dependence. The intervention involves reducing the nicotine content in cigarettes, which is a small molecule with the chemical name nicotine bitartrate.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Low Nicotine Content Cigarettes |
|---|---|
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Infections and infestations
- OASIS Score Increase
- Gastrointestinal disorders
- BDI Category Increase
- Psychiatric disorders
- Respiratory, thoracic, and mediastinal disorders
- Musculoskeletal and connective tissue disorders
- Nervous system disorders
- Respiratory, thoracic and mediastinal disorders
- General disorders
- General disorders and administration
- Vascular disorders
Key clinical trials
- Cigarette Packaging of Low Nicotine Cigarettes (NA)
- Development of a Mobile Health Intervention for Electronic Cigarette Use Among Young Adults (NA)
- Effects of a Low Nicotine Standard and Tobacco Prices on Illegal Cigarette Purchasing (NA)
- Opioids, Low Nicotine Cigarettes, and Chronic Pain (NA)
- Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration (PHASE2)
- Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers (NA)
- Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women (PHASE1, PHASE2)
- Cardiovascular Effects of Very Low Nicotine Content Cigarettes (EARLY_PHASE1)
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:
- Low Nicotine Content Cigarettes CI brief — competitive landscape report
- Low Nicotine Content Cigarettes updates RSS · CI watch RSS
- Masonic Cancer Center, University of Minnesota portfolio CI
Frequently asked questions about Low Nicotine Content Cigarettes
What is Low Nicotine Content Cigarettes?
Who makes Low Nicotine Content Cigarettes?
What development phase is Low Nicotine Content Cigarettes in?
What are the side effects of Low Nicotine Content Cigarettes?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing