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Drug

Atropine sulfate

Approved · EMA
Late-stage development
Also known as Antispas, Antrocol, Atreza, AtroPen+53 more

Antispas, Antrocol, Atreza, AtroPen, Atropine Care, Atropisol, Atrosept, Atrosulf-1, Barbidonna, Barophen, Bellalphen, Bellatal, Chardonna-2, Colidrops, Cystemms-V, D-Tal, Di-Atro, Dimotal, Dolsed, Donnaphen, Donnapine, Donnatal, DuoDote, Elixiral, Enlon-Plus, Haponal, Hyosophen, Hypersed, Isopto Atropine, Lomocot, Lomotil, Lonox, MHP-A, Malatal, Motofen, Ocu-Tropine, Phenobel, Phenohytro, Sal-Tropine, Servira, Spasmolin, Spasquid, Spastolate, Trac Tabs 2x, UAA, Urapine, Uretron, Uri-Sep SC, Uridon Modified, Urimar T, Urised, Uritin, Usept, Vi-Atro, Atropine sulphate, Dl-hyoscyamine sulfate, Dl-hyoscyamine sulphate.

RxNorm153971
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers

Clinical trial2026-03-09Results posted · ClinicalTrials.gov

Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.

Clinical trial2026-02-05Results posted · ClinicalTrials.gov

Approval: Ryjunea (EMA)

Regulatory2025-06-02EMA

Role of Intralipid in Management of Organophosphorus Poisoning

Clinical trial2025-01-01Withdrawn · ClinicalTrials.gov

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

Clinical trial2024-09-20Completed · ClinicalTrials.gov

A Randomized, Double-masked, Placebo-controlled, Parallel-group Study of Safety and Efficacy of Atropine Sulfate Eye Drops (0.01%) in the Treatment of Near-work-induced Transient Myopia (NITM) in Children

Clinical trial2024-03-26Completed · ClinicalTrials.gov

Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children: a Multi-centre Placebo Controlled Randomised Trial in the United Kingdom

Clinical trial2024-02-29Primary completion · ClinicalTrials.gov

A Randomized, Three-Sequence, Three-Period Crossover Study to Assess the Bioavailability and Pharmacokinetics of a Single Dose of Atropine Administered Sublingually in Healthy Adult Volunteers

Clinical trial2023-06-22Results posted · ClinicalTrials.gov

Phase I Clinical Trial to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-230 When Applied to the Ocular Surface of Healthy Volunteers.

Clinical trial2023-04-24Withdrawn · ClinicalTrials.gov

A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers

Clinical trial2023-01-20Completed · ClinicalTrials.gov

The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia

Clinical trial2020-06-20Completed · ClinicalTrials.gov

Intrathecal Atropine Versus Intravenous Metoclopramide for Prevention of Nausea and Vomiting During Caesarian Section Under Spinal Anesthesia

Clinical trial2019-08-28Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Atropine sulfate
Aliases & brands
AntispasAntrocolAtrezaAtroPenAtropine CareAtropisolAtroseptAtrosulf-1BarbidonnaBarophenBellalphenBellatalChardonna-2ColidropsCystemms-VD-TalDi-AtroDimotalDolsedDonnaphenDonnapineDonnatalDuoDoteElixiralEnlon-PlusHaponalHyosophenHypersedIsopto AtropineLomocotLomotilLonoxMHP-AMalatalMotofenOcu-TropinePhenobelPhenohytroSal-TropineServiraSpasmolinSpasquidSpastolateTrac Tabs 2xUAAUrapineUretronUri-Sep SCUridon ModifiedUrimar TUrisedUritinUseptVi-AtroAtropine sulphateDl-hyoscyamine sulfateDl-hyoscyamine sulphate
RxNorm CUI
153971
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-06-02
Latest approval
2025-06-02
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2025-06-02Approval
Approval: Ryjunea (EMA)
Indication: Ryjunea is indicated for slowing the progression of myopia in paediatric patients. Treatment may be initiated in children aged 3-14 years with a progression rate of 0.5 D or more… Show full indication

Ryjunea is indicated for slowing the progression of myopia in paediatric patients. Treatment may be initiated in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

13 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
13
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
5
Late-stage (III+)
10
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 13
Phase 14Phase 1 / 22Phase 22Phase 2 / 31Phase 32Phase 41Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Intrathecal Atropine Versus Intravenous Metoclopramide for Prevention of Nausea and Vomiting During Caesarian Section Under Spinal Anesthesia

CompletedPH IVMansoura Universityn=602019

Role of Intralipid in Management of Organophosphorus Poisoning

WithdrawnPH II/IIIAmani Hassan Abdel-Wahab2025

A Randomized, Double-masked, Placebo-controlled, Parallel-group Study of Safety and Efficacy of Atropine Sulfate Eye Drops (0.01%) in the Treatment of Near-work-induced Transient Myopia (NITM) in Children

CompletedPH IIIOcumension Therapeutics (Suzhou) Co., Ltdn=1482024

Comparison of Intrathecal Levobupivacaine Combined With Sufentanil, Fentanyl, or Placebo for Elective Caesarean Section: A Prospective, Randomized, Double-blind, Controlled Study

CompletedPH IIIBaskent Universityn=932010

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers

CompletedPH I/IINational Cancer Institute (NCI)n=2242025

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

CompletedPH IIKasr El Aini Hospitaln=702024

A Randomized, Double-masked, Placebo-controlled, Parallel-group Study of Safety and Efficacy of Atropine Sulfate Eye Drops (0.01%) in the Treatment of Near-work-induced Transient Myopia (NITM) in Children

CompletedPH IIIOcumension Therapeutics (Suzhou) Co., Ltdn=1482024

A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers

CompletedPH I/IICloudbreak Therapeutics, LLCn=842023

Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.

CompletedPH ILaboratorios Sophia S.A de C.V.n=292022

The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia

CompletedN/AJun Xiaon=722020
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.