FDA · United States
nicotine — FDA regulatory status
nicotine (NICABATE P) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- NICABATE P
- Originator
- HALEON AUSTRALIA PTY LTD
- Mechanism
- Neuronal acetylcholine receptor; alpha4/beta2 agonist
- Target
- Neuronal acetylcholine receptor; alpha4/beta2
- Structured fields
- 8
Sponsor / originator context: HALEON AUSTRALIA PTY LTD. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Neuronal acetylcholine receptor; alpha4/beta2 agonist. Target: Neuronal acetylcholine receptor; alpha4/beta2. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 99 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 10-week smoking cessation group therapy combined with NicoDerm CQ | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00110630 |
| Extended treatment | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00459953 |
| Internet-based smoking treatment | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00297453 |
| Nicotine Patch | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT03897439, NCT04839198 |
| Nicotine patch | Phase 3 | Jasper Therapeutics | NCT06053567 |
| Nicotine polacrilex, Bupropion | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00086385 |
| Varenicline | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT01314001 |
| Varenicline | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00731055, NCT01162239 |
| nicotine transdermal system | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00067158, NCT00086411 |
| tobacco abstinent contingent | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00497068 |
| 42 mg transdermal nicotine replacement | Phase 2 | BRIGHT MINDS BIOSCIENCES | NCT01213524 |
| CHRMS19-0129 | Phase 2 | BRIGHT MINDS BIOSCIENCES | NCT04090879 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12274710 | Compound for regulating body weight imbalance, composition thereof and application thereof | US |
| 12084670 | Regulating alkaloids | US |
| 11865155 | Plant extract obtained from Morus plant leaves which has an IC50 value to inhibit a-glucosidase I at a concentration of less than 90 uG/ml, compositions containing same, method of extraction and uses thereof | US |
| 11712467 | Methods of rational nicotine hapten design and uses thereof | US |
| 11667924 | Increasing levels of nicotinic alkaloids in plants | US |
| 11597916 | Nicotine degrading enzyme variants | US |
| 11572568 | Regulating alkaloids | US |
| 11357848 | Methods of rational nicotine hapten design and uses thereof | US |
| 11090349 | Plant extract obtained from Morus plant leaves, compositions containing same, method of extraction and uses thereof | US |
| 10907170 | Increasing levels of nicotinic alkaloids in plants | US |
| 10829774 | Increasing levels of nicotinic alkaloids in plants | US |
| 10731172 | Regulating alkaloids | US |
Related hubs
FAQ
What is the FDA approval status of nicotine?
nicotine currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get nicotine regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to nicotine?
This spoke lists 99 published programs associated with nicotine in our pipeline index.