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(-)-Cotinine (COTININE)
(-)-Cotinine (generic name: COTININE) is a cotinine drug. It is currently in Phase 2 development.
(-)-Cotinine works by binding to and activating the neuronal acetylcholine receptor subunit alpha-2.
(-)-Cotinine is a small molecule compound with synonyms including cotinine, cotinina, and nicotine-related compound C. It is a metabolite of nicotine, related to the compound.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | COTININE |
|---|---|
| Drug class | cotinine |
| Target | Neuronal acetylcholine receptor subunit alpha-2 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 2 |
Mechanism of action
Imagine your brain cells have locks on them, and (-)-Cotinine has a key that fits into those locks. When it binds, it helps to activate the cells, which can help to regulate various bodily functions. This can be beneficial for people with certain conditions, but more research is needed to fully understand its effects.
Approved indications
Common side effects
Key clinical trials
- Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes (NA)
- Reward Sensitivity and Pharmacotherapy for Smoking Cessation (PHASE4)
- Incentive-based and Media Literacy Informed Approaches to Improve Vaping Cessation (NA)
- Lemongrass (Cymbopogon Citratus) on Nicotine Dependence, Cotinine Levels, and Related Biomarkers in Adult Smokers (NA)
- A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers
- PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers (NA)
- Efficacy of a Smoke-Free Homes Intervention (NA)
- Evaluation of Periodontal Health, Salivary Cotinine and S100A8/A9 Levels in Children Exposed to Passive Smoking
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:
- (-)-Cotinine CI brief — competitive landscape report
- (-)-Cotinine updates RSS · CI watch RSS
Frequently asked questions about (-)-Cotinine
What is (-)-Cotinine?
How does (-)-Cotinine work?
What is the generic name of (-)-Cotinine?
What drug class is (-)-Cotinine in?
What development phase is (-)-Cotinine in?
What does (-)-Cotinine target?
Related
- Drug class: All cotinine drugs
- Target: All drugs targeting Neuronal acetylcholine receptor subunit alpha-2
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing