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Nicorette

(Nicotine Polacrilex Gum)

PreclinicalSmall molecule

Nicorette is one of 20 small molecule programs targeting Tinnitus. It is currently in Preclinical.

2

Indications

3

Total Trials

2

Active Trials

19

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[3][1]

Indication

TinnitusCompleted

SmokingRecruiting

TinnitusPreclinical

Completed

SmokingPreclinical

Recruiting

Competition

Competitive Landscape

13 competitors in Tinnitus

#DrugCompanyPhaseTrials

Levitra

Paxil

SSebela Pharmaceuticals Development LLC

Decadron

AAspen Global Incorporated

Xylocaine

MMEDRx USA, Inc.

Rayos

RRoxane Laboratories

Pletal

IV Lidocaine

WWake Forest University Health Sciences

Syntocinon

SShana McCormack, MD

Nicorette

Piribedil

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Smoking

NCT07075575

PreclinicalNot yet recruiting

Tinnitus

NCT07877701

Clinical

Trials by Indication[1]

Tinnitus2 trials

A Randomized, Double-Blind, Placebo-Controlled, Within-Subject Crossover Trial of a Single 4 mg Dose of Nicotine Polacrilex Gum on Auditory Oddball P3, Oddball Task Performance, and Resting-State EEG in Non-Smoking Adults With Chronic Tinnitus

Not yet recruiting·XXianhui Wang·Preclinical·NCT07877701·20 enrolled

A Randomized, Double-Blind, Placebo-Controlled, Within-Subject Crossover Trial of a Single 4 mg Dose of Nicotine Polacrilex Gum on Psychoacoustic Tinnitus Loudness and Selective Attention in Non-Smoking Adults With Chronic Subjective Tinnitus

Completed·XXianhui Wang·Preclinical·NCT07772089·29 enrolled

Smoking1 trial

Quit-Smoking Study for Native Hawaiians

Recruiting·UUniversity of Hawaii·N/A·NCT07075575·75 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 9, 1996

NICORETTE

NDA NDA018612

Feb 9, 1996

NICORETTE

NDA NDA020066

Oct 31, 2002

NICORETTE

NDA NDA021330

May 18, 2009

NICORETTE

NDA NDA022360

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Nicotine Polacrilex Gum. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nicotine Polacrilex Gum compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nicotine Polacrilex Gum. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022360). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Nicorette. U.S. Food & Drug Administration.
[6]
SEC EDGAR — HALEON company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: HHALEON

Patent Landscape[5]

Patent Cliff

Apr 30, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8323683Apr 30, 2028

8940772Apr 30, 2029

8501164Jun 14, 2029

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