Overview
Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.
Background
Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.
Indication
For the relief of nicotine withdrawal symptoms and as an aid to smoking cessation.
Associated Conditions
- Withdrawal Nicotine
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/02 | Phase 4 | Not yet recruiting | |||
2024/06/25 | Phase 4 | Recruiting | |||
2024/03/27 | Early Phase 1 | Not yet recruiting | |||
2024/03/18 | Phase 2 | Recruiting | |||
2024/03/01 | Phase 4 | Completed | |||
2024/02/15 | Not Applicable | Recruiting | |||
2024/02/14 | Phase 4 | Withdrawn | |||
2024/02/12 | Phase 4 | Recruiting | |||
2024/01/23 | Phase 4 | Active, not recruiting | |||
2023/12/18 | Phase 2 | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lucy Goods, Inc. | 72224-927 | ORAL | 2 mg in 1 1 | 4/28/2025 | |
| Lucy Goods, Inc. | 72224-933 | ORAL | 4 mg in 1 1 | 4/29/2025 | |
| Meijer Distribution Inc | 41250-456 | ORAL | 2 mg in 1 1 | 2/18/2025 | |
| Target Corporation | 11673-194 | TRANSDERMAL | 21 mg in 24 h | 6/10/2025 | |
| Sam's West Inc | 68196-194 | TRANSDERMAL | 21 mg in 24 h | 6/10/2025 | |
| Jiangxi Hemei Pharmaceutical Co., Ltd | 84010-137 | TOPICAL | 18 g in 100 1 | 6/19/2025 | |
| L. Perrigo Company | 0113-0029 | ORAL | 2 mg in 1 1 | 3/21/2025 | |
| Blip Products, Inc. | 82966-269 | ORAL | 2 mg in 1 1 | 2/27/2025 | |
| Target Corporation | 11673-195 | TRANSDERMAL | 14 mg in 24 h | 6/10/2025 | |
| Pharmacia & Upjohn Company LLC | 0009-5401 | NASAL | 10 mg in 1 mL | 5/31/2022 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NICOTINELL MINT 2mg CHEWING-GUM | FERTIN PHARMA A/S (7100) | SIN12569P | GUM, CHEWING | 2 mg | 7/27/2004 |
| Nicorette Icy Mint Medicated Chewing Gum 2mg | SIN14326P | GUM, CHEWING | 2mg | 3/12/2013 | |
| NICOTINELL MINT LOZENGE 1 mg | Swissco Services AG | SIN11732P | LOZENGE | 1 mg | 11/27/2001 |
| Nicorette Invisi Transdermal Patch 10mg/16 hours | SIN14294P | PATCH, EXTENDED RELEASE | 15.75 mg/9 sq cm | 1/17/2013 | |
| SKIIP NICOTINE MINI LOZENGE 2 MG (Cinnamon) | SIN17062P | LOZENGE | 2.00 mg | 8/14/2024 | |
| SKIIP NICOTINE MINI LOZENGE 2 MG (CHERRY) | SIN17060P | LOZENGE | 2.00 mg | 8/14/2024 | |
| SKIIP NICOTINE MINI LOZENGE 4 MG (Cherry) | SIN17061P | LOZENGE | 4.00 mg | 8/14/2024 | |
| SKIIP NICOTINE MINI LOZENGE 4 MG (Cinnamon) | SIN17063P | LOZENGE | 4.00 mg | 8/14/2024 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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