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sublingual nicotine tablets
sublingual nicotine tablets is a Small molecule drug developed by Contract Research Organization el AB. It is currently in Phase 1 development. Also known as: Nicorette Sublingual Tablets.
Sublingual nicotine tablets are a small molecule intervention used to treat conditions such as smoking, COPD, tobacco dependence, and tobacco use disorder. They are administered under the tongue and contain nicotine bitartrate, a form of nicotine.
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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 | sublingual nicotine tablets |
|---|---|
| Also known as | Nicorette Sublingual Tablets |
| Sponsor | Contract Research Organization el AB |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers (PHASE1)
- Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge (PHASE1)
- Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy (PHASE4)
- Sublingual Nicotine Tablets Compared With Swedish Snus (PHASE1, PHASE2)
- Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg (NA)
- Nurse Smoking Cessation of Patients With Chronic Obstructive Pulmonary Disease (COPD) With Nicotine Replacement Therapy (NRT) and Behavioral Support (PHASE3)
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:
- sublingual nicotine tablets CI brief — competitive landscape report
- sublingual nicotine tablets updates RSS · CI watch RSS
- Contract Research Organization el AB portfolio CI
Frequently asked questions about sublingual nicotine tablets
What is sublingual nicotine tablets?
Who makes sublingual nicotine tablets?
Is sublingual nicotine tablets also known as anything else?
What development phase is sublingual nicotine tablets in?
Related
- Manufacturer: Contract Research Organization el AB — full pipeline
- Also known as: Nicorette Sublingual Tablets
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing