Tetracaine Hydrochloride

(Tetracaine)

Phase 3Small molecule

BBausch Health Americas, Inc.

Tetracaine Hydrochloride is one of 31 small molecule programs targeting Sedation. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

CataractActive, not recruiting

CataractPhase 3

Active, not recruiting

Competition

Competitive Landscape

219 competitors in Cataract

#DrugCompanyPhaseTrials

Dexamethasone Phosphate

EEyegate Pharmaceuticals, Inc.

Phase 3

1 2

Tetracaine Hydrochloride

BBausch Health Americas, Inc.

Phase 3

1 3

Ripasudil

KKowa Research Institute, Inc.

Phase 3

2 4

Idose TR

GGlaukos Corporation

Phase 3

1 5

OCS-01

QQuan Dong Nguyen

Phase 3

1 6

XG-102

XXigen SA

Phase 3

2 7

Midalozam

Idorsia Pharmaceuticals Ltd.

Phase 3

2 8

Zolymbus

AbbVie

Preclinical

—9

Neurontin

VViatris Specialty LLC

Preclinical

3 10

Kenalog

BBassett Healthcare

Preclinical

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

Clinical

Trials by Indication[1]

Skin1 trial

Study to Determine the Effect of a Newly Formulated Tetracaine Product PET500 on Penile Skin Sensation

Completed·FFutura Medical Developments Ltd.·Phase 1·NCT04247230·20 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

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

Adverse Reaction1 trial

Ametop - Friend and Foe A Prospective Study of the Incidence of Adverse Reactions With Ametop

Completed·KKK Women's and Children's Hospital··NCT02750137·192 enrolled

Nerve Block1 trial

Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

Completed·WWest China Hospital·N/A·NCT02502487·258 enrolled

Bupivacaine1 trial

Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Terminated·WWake Forest University·Phase 4·NCT01005459·46 enrolled

6 more indications

Pilot Study1 trial

Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

Completed·LLahey Clinic·N/A·NCT00769392·28 enrolled

Efficacy1 trial

A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

Withdrawn· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 4·NCT00670696

Sedation1 trial

Sedation Compaired With Anesthesia With THRIVE in Endotracheal Intubation With Difficult Airways

Unknown status·PPeking University·N/A·NCT04924621·42 enrolled

Treatment1 trial

Treatment of Corneal Abrasions With Topical Tetracaine

Unknown status·NNew York Presbyterian Brooklyn Methodist Hospital·Phase 2/3·NCT02771392·120 enrolled

Anesthesia1 trial

Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·N/A·NCT01224847·92 enrolled

Cataract1 trial

Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery

Completed·LLaboratoires Thea·Phase 3·NCT02101359·609 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 29, 2016

TETRACAINE HYDROCHLORIDE

NDA NDA208135

Mar 12, 2019

TETRACAINE HYDROCHLORIDE

NDA NDA210821

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Tetracaine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tetracaine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tetracaine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210821). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBausch Health Americas, Inc.

Tetracaine Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Skin1 trial

Blood Pressure1 trial

Adverse Reaction1 trial

Nerve Block1 trial

Bupivacaine1 trial

Pilot Study1 trial

Efficacy1 trial

Sedation1 trial

Treatment1 trial

Anesthesia1 trial

Cataract1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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