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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/05 | Early Phase 1 | Not yet recruiting | |||
2025/04/16 | Not Applicable | Recruiting | |||
2025/02/06 | Phase 3 | Not yet recruiting | |||
2025/01/08 | Not Applicable | Recruiting | |||
2024/12/20 | Not Applicable | Completed | |||
2024/09/19 | Not Applicable | Completed | |||
2024/09/19 | Phase 4 | Recruiting | |||
2024/09/05 | Not Applicable | Not yet recruiting | |||
2024/08/15 | Phase 3 | Active, not recruiting | |||
2024/08/09 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| H E B | 37808-863 | ORAL | 2 mg in 1 1 | 5/19/2025 | |
| Blip Products, Inc. | 82966-012 | ORAL | 2 mg in 1 1 | 3/17/2025 | |
| Dr. Reddy's Laboratories Inc. | 43598-487 | ORAL | 4 mg in 1 1 | 6/23/2025 | |
| Meijer Distribution Inc | 41250-424 | ORAL | 4 mg in 1 1 | 5/1/2025 | |
| H E B | 37808-739 | ORAL | 4 mg in 1 1 | 5/15/2025 | |
| Topco Associates LLC | 36800-269 | ORAL | 2 mg in 1 1 | 2/27/2025 | |
| Amazon.com Services LLC | 72288-623 | ORAL | 2 mg in 1 1 | 5/2/2025 | |
| BJWC | 68391-012 | ORAL | 2 mg in 1 1 | 3/17/2025 | |
| Walgreen Company | 0363-7269 | ORAL | 2 mg in 1 1 | 2/27/2025 | |
| Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-976 | ORAL | 4 mg in 1 1 | 1/29/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NICORETTE QUICKMIST MOUTHSPRAY 1MG/SPRAY | SIN16567P | SPRAY | 1mg/spray | 8/8/2022 | |
| Nicorette Invisi Transdermal Patch 25mg/16 hours | SIN14296P | PATCH, EXTENDED RELEASE | 39.37 mg/22.5 sq cm | 1/17/2013 | |
| SKIIP NICOTINE MINI LOZENGE 2 MG (MINT) | SIN16895P | LOZENGE | 2.00 mg | 10/30/2023 | |
| NICOTINELL TTS 20 TRANSDERMAL THERAPEUTIC SYSTEM 14 mg/24 hrs | LTS LOHMANN THERAPIE-SYSTEME AG | SIN06527P | PATCH | 35 mg/20 sq cm | 11/12/1991 |
| Nicorette Invisi Transdermal Patch 15mg/16 hours | SIN14295P | PATCH, EXTENDED RELEASE | 23.62mg / 13.5 sq cm | 1/17/2013 | |
| NICOTINELL TTS 10 TRANSDERMAL THERAPEUTIC SYSTEM 7 mg/24 hrs | LTS LOHMANN THERAPIE-SYSTEME AG | SIN06528P | PATCH | 17.5 mg/10 sq cm | 11/12/1991 |
| SKIIP NICOTINE MINI LOZENGE 4 MG (MINT) | SIN16971P | LOZENGE | 4.00 mg | 3/13/2024 | |
| NICOTINELL MINT 4MG CHEWING GUM | FERTIN PHARMA A/S (7100) | SIN12570P | GUM, CHEWING | 4 mg | 7/27/2004 |
| NICOTINELL TTS 30 TRANSDERMAL THERAPEUTIC SYSTEM 21 mg/24 hrs | LTS LOHMANN THERAPIE-SYSTEME AG | SIN06529P | PATCH | 52.5 mg/30 sq cm | 11/12/1991 |
| Nicorette Icy Mint Medicated Chewing Gum 4mg | SIN14327P | GUM, CHEWING | 4mg | 3/12/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Nicotine Chewing Gum | 国药准字HJ20160591 | 化学药品 | 咀嚼胶 | 9/7/2023 | |
| Nicotine Chewing Gum | 国药准字HJ20160632 | 化学药品 | 咀嚼胶 | 9/7/2023 | |
| Nicotine Chewing Gum | 国药准字HJ20160588 | 化学药品 | 咀嚼胶 | 9/7/2023 | |
| Nicotine Chewing Gum | 国药准字HJ20160589 | 化学药品 | 咀嚼胶 | 9/7/2023 | |
| Nicotine Chewing Gum | 国药准字HJ20160590 | 化学药品 | 咀嚼胶 | 9/7/2023 | |
| Nicotine Chewing Gum | 国药准字HJ20160633 | 化学药品 | 咀嚼胶 | 9/7/2023 | |
| Nicotine Chewing Gum | 国药准字J20170025 | 化学药品 | 咀嚼胶 | 4/24/2017 | |
| Nicotine Sublingual Tablets | 国药准字H20041568 | 化学药品 | 片剂 | 11/27/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NICOTINELL TTS 10 PAD | N/A | N/A | N/A | 11/15/1991 | |
| NICOTINELL MINT CHEWING GUM 2MG | N/A | N/A | N/A | 1/29/2001 | |
| NICOTINELL FRUIT CHEWING GUM 4MG | N/A | N/A | N/A | 1/29/2001 | |
| NICOTINELL FRUIT CHEWING GUM 2MG | N/A | N/A | N/A | 1/29/2001 | |
| NICOTINELL TTS 30 PAD | N/A | N/A | N/A | 11/15/1991 | |
| NICOTINELL MINT CHEWING GUM 4MG | N/A | N/A | N/A | 1/29/2001 | |
| NICOTINELL TTS 20 PAD | N/A | N/A | N/A | 11/15/1991 |