TheraRadar
Data updated: May 26, 2026

NICOTINE POLACRILEX

CNS Approved 1999-03-15
Jump to: Indications Approvals Trials Competitors Safety Patents
31
Indications
--
Phase 3 Trials
27
Years on Market

Details

Status
Over-the-counter
First Approved
1999-03-15
Routes
BUCCAL, ORAL
Dosage Forms
GUM, CHEWING, TROCHE/LOZENGE

Companies

L PERRIGO CO P AND L PERRIGO R AND D PPI-DAC PLD ACQUISITIONS Aurobindo Pharma Dr. Reddy's IVAX SUB TEVA PHARMS FERTIN PHARMA
Active Ingredient: NICOTINE POLACRILEX

NICOTINE POLACRILEX Approval History

2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
296 FDA actions from 1999 to 2026
May 2026 SUPPL
Label · Labeling
Feb 2026 SUPPL
Label · Labeling
Jul 2025 ORIGINAL
Update

What NICOTINE POLACRILEX Treats

31 FDA approvals

Originally approved for its first indication in 1999 . Covers 31 distinct patient populations.

  • Other (31)
📋

Clinical Trial Registry

39 trials
Trial Sponsor ID Phase Status Title
NCT07585006 CENA OSU-25353 NCI-2026-00343 Ph 1 not yet recruiting Comparative Evaluation of Nicotine Analogs
NCT03652740 results posted IRB00165287 R01DA003890 Ph 1 completed Effects of Commonly Used Medications on Mood and Choice
NCT05999383 CANNIC 23-38884 1R01DA056451-01A1 Ph 2 recruiting Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
NCT03635333 results posted 2000023077-2 2U54DA036151-06 Ph 1 completed Effects of E-Cigarette Flavors on Adults TCORS 2.0
NCT03281694 HP-0009999 Ph 1 withdrawn The Use of AVL-3288 to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
NCT04521647 2000028570 2U54DA036151-06 Ph 1 completed Effects of Menthol in E-cigarettes on Smoking Behaviors
NCT03634839 results posted 2000023077-1 2U54DA036151-06 Ph 1 completed Effects of E-cigarette Flavors on Youth TCORS 2.0
NCT03235505 EFFECT WI218780 Ph 4 completed Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
NCT03091699 Exercise and Nicotine Ph 3 completed Effects of Exercise and Nicotine on Cognition in Smokers
NCT04124432 results posted IRB00220975 R21DA044377 Ph 1 completed Behavioral Pharmacology of Cannabis and Nicotine
NCT06259630 NEVE IRB15-1337 Ph 4 withdrawn Nicotine Virtual Reality Conditioned Place Preference
NCT02955329 V-PAX results posted 18-24854 3R01DA039264-02S1 Ph 3 completed Vaping THC From Electronic Cigarettes
NCT02018263 1212011268 Ph 1 completed Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans
NCT04709471 STUDY00001093 Ph 2 completed E-cigarette Nicotine Study
NCT04696380 CHRMS 00000555 Ph 2 completed Do Flavors Increase the Addiction Potential of Nicotine?
NCT01989507 VLNC R01DA034628-01A1 Ph 2 completed Very Low-Nicotine Cigarettes in Smokers With SUD
NCT02521662 ASCEND-II U1111-1172-9632 Ph 3 completed The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation
NCT03168191 1307012312-2 Ph 1 completed Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
NCT02179034 1307012312 Ph 1 completed Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
NCT02816138 results posted DepMIND Ph 4 completed Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)
NCT00618631 999908060 08-DA-N060 Ph 1 completed Effects of Smoking on Opioid Receptor Binding: A PET Study
NCT02346539 2014P002495-01 5K01DA029645-04 Ph 1 completed Effect of Nicotine on Brain Reward Pathways
NCT00969137 0905005103 R03DA027474, DCNBR / CNB Ph 1 completed Sensitivity to Intravenous Nicotine: Genetic Moderators
NCT01359709 ASCC-CM-NRT Ph 1 completed Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking
NCT01925781 results posted 13-16684 Ph 4 terminated e-Cigarettes Versus NRT Gum for Smoking Cessation
NCT02511704 IMIMFTCL/CIG-E/1 Ph 1 completed Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine: Electronic Cigarette and Cigarette
NCT02108626 001/2014 Ph 4 completed Electronic Cigarettes in Daily Dependent Smokers
NCT01400243 NMW results posted NIH/NIDA 1R01DA031006 - 01 R01DA031006 Ph 4 completed Nicotine Patch for Marijuana Withdrawal
NCT01702519 results posted RH01418 Ph 1 completed A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
NCT01451814 results posted NCI-156241-1 Ph 2 completed Development of Positive Psychotherapy for Smoking Cessation
NCT01669122 results posted RH01333 Ph 2 completed Pharmacokinetic Study of 4 mg Nicotine Lozenge.
NCT00715871 SB07211 Ph 2 completed Clinical Study of Smoke-Break Liquid Cigarettes
NCT00985985 results posted CHN-Nicotine Mint Lozenge-002 Ph 3 completed Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation
NCT01702532 results posted RH01589 Ph 3 completed Nicotine Mouth Film for Craving Relief.
NCT01476202 NRT results posted S2111378 Ph 2 completed Provoked Craving Relief Study by NRT
NCT01075659 NICTDP2011 Ph 2 completed Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge
NCT01321931 NICTDP1081 2010-023026-20 Ph 1 completed Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products
NCT01296698 results posted A6431112 Ph 3 terminated Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking
NCT00957918 NP002-09-001 Ph 1, Ph 2 completed Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NICOTINE POLACRILEX FDA Label Details

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Data Sources

FDA Approval: ANDA076779 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.