Atropine Sulfate

(Atropine sulfate)

ApprovedSmall molecule

FFresenius Kabi USA, LLC

Atropine Sulfate is one of 33 small molecule programs targeting Arrhythmia. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

ArrhythmiaActive, not recruiting

MyopiaNot yet recruiting

ArrhythmiaPreclinical

Active, not recruiting

MyopiaPhase 3

Not yet recruiting

Competition

Competitive Landscape

20 competitors in Arrhythmia

#DrugCompanyPhaseTrials

Colcrys

Jazz Pharmaceuticals

Approved

1 2

Betapace

LLegacy Health System

Approved

1 3

Lanoxin

AAdvanz Pharma

Approved

—4

Lipitor

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

Approved

—5

Atropine Sulfate

FFresenius Kabi USA, LLC

Approved

1 6

Rythmol Sr

GGlaxo Dba Glaxosmithkline

Approved

1 7

Prostigmin

Merck & Co.

Preclinical

1 8

Robinul

Jazz Pharmaceuticals

Preclinical

1 9

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 10

Naropin

FFresenius Kabi USA, LLC

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Myopia

NCT03690089

Q3 2027

Phase 2/3Not yet recruiting

Myopia

NCT07164092

Clinical

Trials by Indication[1]

Atropine3 trials

A Study of Inhaled Atropine Sulfate in Healthy Adults

Completed·MMicroDose Defense Products L.L.C.·Phase 1·NCT00947596·18 enrolled

Pharmacokinetics of Atropine Oral Gel

Completed·UUniversity of Utah·Phase 1·NCT05164367·10 enrolled

Sublingual vs IV Atropine Bioavailability Study

Completed·BBiomedical Advanced Research and Development Authority·Phase 1·NCT04290039·15 enrolled

Myopia3 trials

Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom

Active, not recruiting·BBelfast Health and Social Care Trust·Phase 2·NCT03690089·289 enrolled

Study of Atropine Sulfate Eye Drops(0.01%) in Treating Near-work-induced Transient Myopia in Children

Completed·OOcumension Therapeutics (Suzhou) Co., Ltd·Phase 3·NCT06697522·148 enrolled

Efficacy of Topical Atropine Eye Drops for Control of Myopia Progression Among Children Attending Mansoura University Ophthalmic Center

Not yet recruiting·MMansoura University·Phase 2/3·NCT07164092·45 enrolled

Arrhythmia1 trial

The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia

Completed·JJun Xiao·N/A·NCT04505228·72 enrolled

Clinical Trial1 trial

Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201

Completed·LLaboratorios Sophia S.A de C.V.·Phase 1·NCT05470881·29 enrolled

Adverse Events1 trial

Adverse Events Related to Low Dose Atropine

Completed·SScripps Health··NCT05683535·148 enrolled

6 more indications

Caesarean Section1 trial

Intrathecal Levobupivacaine With Opioids for Caesarean Section

Completed·—·Phase 3·NCT01858090·93 enrolled

Vomiting1 trial

Intrathecal Atropine vs IV Metoclopramide for Nausea & Vomiting During CS

Completed·MMansoura University·Phase 4·NCT03932578·60 enrolled

Papilloma1 trial

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02858310·224 enrolled

Poisoning1 trial

Role of Intralipid in Management of Organophosphorus Poisoning

Withdrawn·AAmani Hassan Abdel-Wahab·Phase 2/3·NCT04393103

Dexmedetomidine1 trial

Effect of Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose on Hemodynamic Changes During Laryngoscopy and Tracheal Intubation in Adults. A Randomized Comparative Study.

Completed·KKasr El Aini Hospital·Phase 2·NCT06327399·70 enrolled

Unspecified2 trials

Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop

Completed·CCloudbreak Therapeutics, LLC·Phase 1/2·NCT05372991·84 enrolled

Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution

Withdrawn·LLaboratorios Sophia S.A de C.V.·Phase 1·NCT05481489

Regulatory

FDA Approval Timeline[4]

Sep 19, 1990

ATROPINE SULFATE

NDA NDA020056

Jul 9, 2001

ATROPINE SULFATE

NDA NDA021146

Sep 17, 2004

ATROPEN

NDA NDA017106

Jul 18, 2014

ATROPINE SULFATE

NDA NDA206289

Dec 1, 2016

ISOPTO ATROPINE

NDA NDA208151

Jan 26, 2018

ATROPINE SULFATE

NDA NDA209260

Jul 9, 2018

ATROPINE (AUTOINJECTOR)

NDA NDA212319

Sep 29, 2020

ATROPINE SULFATE

NDA NDA214652

Mar 15, 2022

ATROPINE SULFATE

NDA NDA213581

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Atropine sulfate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Atropine sulfate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Atropine sulfate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213581). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Fresenius Kabi USA, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: FFresenius Kabi USA, LLC

Atropine Sulfate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Trials by Indication[1]

Atropine3 trials

Myopia3 trials

Arrhythmia1 trial

Clinical Trial1 trial

Adverse Events1 trial

Caesarean Section1 trial

Vomiting1 trial

Papilloma1 trial

Poisoning1 trial

Dexmedetomidine1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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