Cyklx

(Articaine)

Phase 3Small molecule

MMeitheal

Cyklx is one of 31 small molecule programs targeting Pulpitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

PulpitisActive, not recruiting

PulpitisPhase 3

Active, not recruiting

Competition

Competitive Landscape

50 competitors in Pulpitis

#DrugCompanyPhaseTrials

Toradol

Roche

Approved

1 2

Decadron

QQuince Therapeutics S.p.A.

Approved

2 3

Tylenol

KKenvue Brands

Approved

1 4

Xylocaine

Marcaine

Osmitrol

BB. Braun Medical Inc.

Medrol

1 8

Advil

KKenvue Brands

Phase 3

2 9

Adrenaline

SSamson Clinical Operations Pty Ltd

Phase 3

2 10

Deltasone

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

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

Clinical

Trials by Indication[1]

Anesthesia4 trials

Topical Pharyngeal Anesthesia With Articaine for Gastroscopy

Completed·HHelsinki University Central Hospital·Phase 4·NCT01350050·18 enrolled

Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Endodontics

Withdrawn·VVirginia Commonwealth University·Phase 2·NCT04105985

Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric

Terminated·VVirginia Commonwealth University·Phase 2·NCT03962634·3 enrolled

Show 1 more trial

Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General

Withdrawn·VVirginia Commonwealth University·Phase 2·NCT04104789

Pulpitis3 trials

Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis

Completed·—·N/A·NCT04822415·330 enrolled

Anesthetic Efficacy of 1,8mL and 3,6mL of Articaine in Inferior Alveolar Nerve Block in Irreversible Pulpitis

Completed·IIsabel Peixoto Tortamano·N/A·NCT02422823·90 enrolled

4% Articaine and 2% Lidocaine by Intraligamentary Technique in Irreversible Pulpitis

Completed·—·Phase 3·NCT02807298·25 enrolled

Dexmedetomidine2 trials

Articaine Plus Dexmedetomidine in Supraclavicular Block

Recruiting·—·N/A·NCT06423859·66 enrolled

Articaine vs Dexmedetomidine Supplemented Articaine

Completed·—·Phase 1·NCT04171349·50 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

Completed·VVanderbilt University Medical Center·N/A·NCT02726620·22,435 enrolled

Ambulatory Surgery1 trial

A Comparison of 4% Articaine Versus 0.5%Bupivacaine for Ambulatory Surgery Under Supraclavicular Block

Completed·—·Phase 1·NCT04189198·60 enrolled

4 more indications

Infiltration1 trial

Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction

Completed·—·Phase 4·NCT05443009·76 enrolled

Tics1 trial

Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

Completed·UUniversity of Michigan·Phase 4·NCT01951820·64 enrolled

Efficacy1 trial

Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L in Extraction of Lower First Primary Molars

Unknown status·—·N/A·NCT03942991·20 enrolled

Lidocaine1 trial

Articaine vs Lidocaine for Pediatric Dental Procedures

Withdrawn·—·Phase 4·NCT03318952

Regulatory

FDA Approval Timeline[4]

Aug 15, 2025

CYKLX

NDA NDA218643

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Articaine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Articaine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Articaine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218643). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Cyklx. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Meitheal company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: MMeitheal

Patent Landscape[5]

Patent Cliff

Mar 27, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12403126Mar 27, 2039

11826347Mar 27, 2039

11096922Mar 27, 2039

Cyklx

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Anesthesia4 trials

Pulpitis3 trials

Dexmedetomidine2 trials

Blood Pressure1 trial

Ambulatory Surgery1 trial

Infiltration1 trial

Tics1 trial

Efficacy1 trial

Lidocaine1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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