Atropen

(Atropine)

ApprovedSmall molecule

Atropine is used to treat certain types of poisoning (like nerve gas or pesticide exposure) and to dilate pupils during eye exams. It can also help reduce symptoms like excessive sweating, salivation, and muscle twitching caused by specific conditions.[2] Atropen is currently approved and in use across 30 indications[4].[1]

Atropen is one of 478 small molecule programs targeting Myopia. It is currently in Approved.

Indications

Total Trials

Active Trials

477

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

MyopiaActive, not recruiting

Breast CancerCompleted

ToxicityActive, not recruiting

MydriasisActive, not recruiting

Catecholaminergic Polymorphic Ventricular TachycardiaActive, not recruiting

Gastrointestinal DiseaseActive, not recruiting

Refractive ErrorActive, not recruiting

Vitreous FloatersApproved

Pituitary DwarfismApproved

Amyotrophic Lateral SclerosisApproved

MyopiaApproved

Active, not recruiting

Breast CancerPhase 2

Completed

ToxicityApproved

Active, not recruiting

MydriasisApproved

Active, not recruiting

Catecholaminergic Polymorphic Ventricular TachycardiaPreclinical

Active, not recruiting

Gastrointestinal DiseaseApproved

Active, not recruiting

Refractive ErrorPreclinical

Active, not recruiting

Vitreous FloatersApproved

Approved

Pituitary DwarfismApproved

Approved

Amyotrophic Lateral SclerosisApproved

Approved

Showing 10 of 28 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Atropen

FFresenius Kabi Taiwan Ltd.

Approved

2 2

Voltaren

Novartis

Preclinical

1 3

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 4

Duragesic-100

CCephalon

Preclinical

2 5

Spravato

WWim Janssens

Preclinical

2 6

Tricor

JJagotec

Preclinical

1 7

Cortef

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

Preclinical

1 8

Chantix

PPrism Pharmaceuticals

Preclinical

1 9

Rilvegostomig

AstraZeneca

Preclinical

1 10

Vfend

PPrism Pharmaceuticals

Preclinical

—

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

Timeline

Expected Milestones

Q4 2026

PreclinicalRecruiting

Organophosphate Poisoning

NCT07777835

Phase 2Active, not recruiting

Myopia

NCT06579287

Q3 2027

Phase 1Recruiting

Metabolism

NCT02823665

Phase 1Recruiting

Insulin Secretion

NCT00992901

Q1 2028

Phase 2Not yet recruiting

Breast Cancer

NCT07367178

Phase 2Active, not recruiting

Myopia

NCT05815784

Clinical

Trials by Indication[1]

Myopia12 trials

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

Active, not recruiting·SSunhawk Vision Biotech, Inc.·Phase 2·NCT06579287·140 enrolled

Low Concentration Atropine for Myopia Progression in School Children

Completed·—·N/A·NCT02130167·60 enrolled

the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control

Completed·TTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation·N/A·NCT02055378·73 enrolled

Show 9 more trials

Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate

Completed·TThe Hong Kong Polytechnic University·N/A·NCT03374306·71 enrolled

Topical 0.01% Atropine for the Control of Fast Progressing Myopia

Terminated·UUniversity Hospital, Strasbourg, France·Phase 2/3·NCT04173780·60 enrolled

Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia

Completed·—·Phase 4·NCT07406399·120 enrolled

Changes in Eye Shape With Myopia Management Interventions

Active, not recruiting·OOhio State University·Phase 4·NCT06450132·75 enrolled

Daily Low-level Red Light and 0.01% Low-dose Atropine for Myopia Prevention

Completed·—·N/A·NCT06727019·138 enrolled

Study of Myopia Prevention in Children With Low Concentration of Atropine

Unknown status·MMin-Sheng General Hospital·Phase 4·NCT00541177·60 enrolled

Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)

Completed·JJaeb Center for Health Research·Phase 3·NCT03334253·200 enrolled

Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%

Active, not recruiting·AAnn & Robert H Lurie Children's Hospital of Chicago·Phase 2·NCT05815784·348 enrolled

A Randomized Placebo-controlled Trial of Spectacles With Highly Aspherical Lenslet Target (H.A.L.T.) MAX Technology or 0.05% Atropine to Slow Progression of Myopia in Children

Recruiting·JJaeb Center for Health Research·Phase 3·NCT07095894·348 enrolled

Amblyopia7 trials

An Evaluation of Treatment of Amblyopia in Children 7 To <18 Years Old

Completed·JJaeb Center for Health Research·Phase 3·NCT00094692·507 enrolled

Combined Patching-Atropine for Residual Amblyopia

Terminated·JJaeb Center for Health Research·Phase 3·NCT00506675·55 enrolled

Amblyopia (Lazy Eye) Treatment Study

Completed·NNational Eye Institute (NEI)·Phase 3·NCT00001864·20 enrolled

Show 4 more trials

Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

Completed·JJaeb Center for Health Research·Phase 3·NCT00315328·233 enrolled

Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

Completed·JJaeb Center for Health Research·Phase 3·NCT00944710·73 enrolled

Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old

Completed·JJaeb Center for Health Research·Phase 3·NCT00315302·240 enrolled

Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia

Completed·JJaeb Center for Health Research·Phase 3·NCT00000170·419 enrolled

Atropine5 trials

Use of Atropine in Tredmill Stress Testing

Completed·HHaEmek Medical Center, Israel·Phase 3·NCT00623207·103 enrolled

The Effects of Low Dose Atropine on Choroidal Thickness

Completed·SState University of New York College of Optometry·Phase 4·NCT03544827·36 enrolled

Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants

Completed·SState University of New York at Buffalo·Phase 4·NCT01819064·60 enrolled

Show 2 more trials

Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Unknown status·UUniversity of Manitoba·Phase 4·NCT01595399·70 enrolled

Trial Comparing Daily Atropine Versus Weekend Atropine

Completed·JJaeb Center for Health Research·Phase 4·NCT00094614·168 enrolled

Bradycardia3 trials

Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia

Terminated·YYonsei University·N/A·NCT03322150·2 enrolled

Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia

Completed·YYonsei University·N/A·NCT03322098·54 enrolled

Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

Completed·—·Phase 4·NCT03984526·102 enrolled

Sedation3 trials

Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia

Completed·SSira Bang·Phase 4·NCT02522858·120 enrolled

Adjunctive Atropine During Ketamine Sedation

Completed·SSeoul National University Hospital·Phase 4·NCT00834470·140 enrolled

Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation

Completed·—·N/A·NCT01191398·52 enrolled

38 more indications

Breast Cancer2 trials

Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer

Not yet recruiting·MMedSIR·Phase 2·NCT07367178·30 enrolled

The Impact of Intravenous Anaesthesia on Angiogenesis in Patients With Breast Cancer (TIVA/TCI-BC)

Completed·IIuliu Hatieganu University of Medicine and Pharmacy·Phase 2·NCT02839668·120 enrolled

Laparoscopic Cholecystectomy2 trials

Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy

Completed·—·Phase 4·NCT02327923·90 enrolled

Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00724932·140 enrolled

Cesarean Section2 trials

Different Approaches to Maternal Hypotension During Cesarean Section

Completed·UUniversity of Parma·Phase 4·NCT00991627·36 enrolled

Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia

Completed·—·Phase 2·NCT02622126·60 enrolled

Poisoning1 trial

Outcome of Moderate Severity in OPC Poisoning Patients When Treated With Pralidoxime

Completed·—·Phase 2·NCT06111352·96 enrolled

Remifentanil1 trial

Atropine-effect During Propofol/Remifentanil Induction

Completed·UUniversity Medical Center Groningen·N/A·NCT01871922·60 enrolled

Hand Surgery1 trial

Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery

Completed·—·Phase 3·NCT02658721·60 enrolled

Neuromuscular Block1 trial

Recovery of Muscle Function After Deep Neuromuscular Block by Means of Diaphragm Ultrasonography

Unknown status·UUniversity of Florence·Phase 4·NCT02698969·58 enrolled

Ventilator-Associated Pneumonia1 trial

Atropine for Preventing Ventilator-Associated Pneumonia

Completed·UUniversidade de Passo Fundo·Phase 2·NCT02704923·40 enrolled

Prevention1 trial

Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy

Completed·MMedical University of Vienna·Phase 4·NCT00575523·31 enrolled

Glycopyrrolate1 trial

Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

Unknown status·SSeoul National University Hospital·N/A·NCT02228473·76 enrolled

Clinical Trial1 trial

The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

Completed·SShanghai Eye Disease Prevention and Treatment Center·N/A·NCT04699357·219 enrolled

Cardiac Arrest1 trial

In-hospital Cardiac Arrest - Dynamics and State Transitions

Completed·SSt. Olavs Hospital··NCT00920244·285 enrolled

Nausea and vomiting1 trial

Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia for Caesarean Section

Completed·UUniversity of Parma·Phase 4·NCT00921102·216 enrolled

Catecholaminergic Polymorphic Ventricular Tachycardia1 trial

Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Completed·VVanderbilt University·N/A·NCT02927223·6 enrolled

Laparoscopic1 trial

Atropine in Laparoscopic Gynaecological Surgery

Unknown status·CClinica Santa Maria·Phase 4·NCT02769325·150 enrolled

Cognition1 trial

Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil

Completed·NNew York State Psychiatric Institute·Phase 4·NCT01845636·41 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

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

Metabolism1 trial

The Effects of Bariatric Surgeries on Glucose Metabolism

Recruiting·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT02823665·200 enrolled

Caesarean Delivery1 trial

Impact of Pre-spinal Atropine on Post Spinal Hemodynamics and Cardiac Output Measured by Electrical Cardiometry in Caesarean Delivery

Completed·—·Phase 3·NCT05658380·60 enrolled

Toxicity1 trial

Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity

Unknown status·AAya Sabry Mohamed Mohamed·Phase 4·NCT05006638·62 enrolled

Major Abdominal Surgery1 trial

Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery

Completed·EEnrique Alday Muñoz·Phase 4·NCT02361060·130 enrolled

Insulin Secretion1 trial

Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery

Recruiting·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT00992901·160 enrolled

Intravenous1 trial

Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome

Completed·PPetter Andreas Steen·Phase 2·NCT00121524·904 enrolled

Shoulder pain1 trial

Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain

Completed·UUniversity of Debrecen·Phase 4·NCT02445599·3 enrolled

Hypotension1 trial

Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Lower Limb Surgeries

Unknown status·—·Phase 4·NCT03580889·138 enrolled

TED1 trial

Atropin and Glucose Stimulated Insulinsecretion and the Cephalic Insulin Response

Unknown status·UUniversity Hospital, Gentofte, Copenhagen·N/A·NCT01534442·10 enrolled

Drug1 trial

The Effects of Iontophoresed Vasoactive Drugs on Cutaneus Blood Flow

Unknown status·UUniversity Hospital, Linkoeping·N/A·NCT04777383·90 enrolled

Concentration1 trial

The Effects of Low Concentration Atropine on Pupil Size and Accommodation

Completed·UUniversity of California, Berkeley·Phase 3·NCT02870478·32 enrolled

Muscle Relaxant1 trial

0.6 vs. 1.2 mg Atropine Together With Neostigmine 2.5 mg on Heart Rate in Patient Receiving Muscle Relaxant

Completed·MMahidol University·Phase 4·NCT02186132·40 enrolled

Double-blind1 trial

StahistRx Phase 2, Five-arm, Parallel Group, Active vs Active, Double-blind Study

Unknown status·MMagna Pharmaceuticals, Inc.·Phase 2·NCT02082054·125 enrolled

Treatment1 trial

Delaying the Onset of Nearsightedness Until Treatment Study

Withdrawn·OOhio State University·Phase 1·NCT06029530

Propranolol1 trial

Analysis of Atropine and Propranolol Induced Changes

Completed·NNational Institute on Aging (NIA)·Phase 1·NCT00251602·24 enrolled

Exercise Training1 trial

Role of Acetylcholine in Blood Flow Regulation in Healthy Adults: Effects of Age and Exercise Training

Withdrawn·—·Phase 1·NCT03972683

ESS1 trial

Red Light Intervention on Myopic Progression

Unknown status·SShanghai Eye Disease Prevention and Treatment Center·N/A·NCT05203432·104 enrolled

Insulin resistance1 trial

Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00689208·12 enrolled

Rocuronium1 trial

Intubation Time With Low Dose Rocuronium

Completed·GGachon University Gil Medical Center·N/A·NCT01464489·44 enrolled

Organophosphate Poisoning1 trial

Comparison of the Efficacy of Adjunctive Magnesium Sulphate With Standard Atropine and Pralidoxime Therapy vs Standard Therapy Alone in Acute Organophosphate Poisoning

Recruiting·MMuhammad Aamir Latif·Preclinical·NCT07777835·38 enrolled

Unspecified3 trials

Effects of Exendin(9-39) on Gastroduodenal Motility

Completed·LLudwig-Maximilians - University of Munich·Phase 1·NCT00468091·10 enrolled

Effect of the Motilin Receptor Agonist, Erythromycin, on Hunger and Food Intake; Study of Role of Cholinergic Pathways

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT02633579·28 enrolled

Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions

Completed·MMedical University of Vienna·Phase 2·NCT00431392·42 enrolled

Regulatory

FDA Approval Timeline[5]

May 15, 1973

ATROPEN

NDA NDA017106

May 10, 1979

ATROPEN

NDA NDA017106

Dec 27, 1979

ATROPEN

NDA NDA017106

Jun 6, 1984

ATROPEN

NDA NDA017106

Jan 14, 1985

ATROPEN

NDA NDA017106

Oct 6, 1986

ATROPEN

NDA NDA017106

Aug 19, 1987

ATROPEN

NDA NDA017106

Apr 4, 1989

ATROPEN

NDA NDA017106

Aug 17, 1990

ATROPEN

NDA NDA017106

Sep 19, 1990

ATROPINE SULFATE

NDA NDA020056

Mar 5, 1991

ATROPEN

NDA NDA017106

Dec 17, 1996

ATROPEN

NDA NDA017106

Mar 6, 1997

ATROPEN

NDA NDA017106

Apr 21, 1998

ATROPEN

NDA NDA017106

Aug 25, 1998

ATROPEN

NDA NDA017106

Mar 16, 1999

ATROPEN

NDA NDA017106

Apr 26, 1999

ATROPEN

NDA NDA017106

Oct 28, 1999

ATROPEN

NDA NDA017106

Aug 16, 2000

ATROPEN

NDA NDA017106

Aug 18, 2000

ATROPEN

NDA NDA017106

Oct 19, 2000

ATROPEN

NDA NDA017106

Jan 31, 2001

ATROPEN

NDA NDA017106

Feb 13, 2001

ATROPEN

NDA NDA017106

Jun 8, 2001

ATROPEN

NDA NDA017106

Jul 9, 2001

ATROPINE SULFATE

NDA NDA021146

Jan 7, 2002

ATROPEN

NDA NDA017106

Mar 4, 2002

ATROPEN

NDA NDA017106

Jun 28, 2002

ATROPEN

NDA NDA017106

Jun 19, 2003

ATROPEN

NDA NDA017106

Sep 17, 2004

ATROPEN

NDA NDA017106

Sep 17, 2004

ATROPEN

NDA NDA017106

Nov 14, 2013

ATROPEN

NDA NDA017106

Jul 18, 2014

ATROPINE SULFATE

NDA NDA206289

Aug 10, 2015

ATROPEN

NDA NDA017106

May 27, 2016

ATROPEN

NDA NDA017106

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

Nov 20, 2020

ATROPEN

NDA NDA017106

Mar 15, 2022

ATROPINE SULFATE

NDA NDA213581

Sources

References

[1]
ClinicalTrials.gov — 73 trial records for Atropine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Atropen drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Atropine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Atropine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213581). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Fresenius Kabi Taiwan Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Muscarinic Acetylcholine Receptor M2 Antagonist; Muscarinic Acetylcholine Receptor M3 Antagonist; Muscarinic Acetylcholine Receptor M1 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: FFresenius Kabi Taiwan Ltd.

Atropen

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q1 2028

Trials by Indication[1]

Myopia12 trials

Amblyopia7 trials

Atropine5 trials

Bradycardia3 trials

Sedation3 trials

Breast Cancer2 trials

Laparoscopic Cholecystectomy2 trials

Cesarean Section2 trials

Poisoning1 trial

Remifentanil1 trial

Hand Surgery1 trial

Neuromuscular Block1 trial

Ventilator-Associated Pneumonia1 trial

Prevention1 trial

Glycopyrrolate1 trial

Clinical Trial1 trial

Cardiac Arrest1 trial

Nausea and vomiting1 trial

Catecholaminergic Polymorphic Ventricular Tachycardia1 trial

Laparoscopic1 trial

Cognition1 trial

Blood Pressure1 trial

Metabolism1 trial

Caesarean Delivery1 trial

Toxicity1 trial

Major Abdominal Surgery1 trial

Insulin Secretion1 trial

Intravenous1 trial

Shoulder pain1 trial

Hypotension1 trial

TED1 trial

Drug1 trial

Concentration1 trial

Muscle Relaxant1 trial

Double-blind1 trial

Treatment1 trial

Propranolol1 trial

Exercise Training1 trial

ESS1 trial

Insulin resistance1 trial

Rocuronium1 trial

Organophosphate Poisoning1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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