NDAINTRAMUSCULARSOLUTIONPriority Review
Approved
May 1973
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
ATROPEN (atropine) by Medcaptain Medical Technology is cholinergic antagonists [moa]. First approved in 1973.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ATROPEN is a branded atropine solution administered intramuscularly that works as a cholinergic antagonist to block acetylcholine effects in the nervous system. It is primarily used as an antidote for organophosphate and carbamate poisoning, as well as for certain cases of bradycardia and anticholinesterase overdose. The drug's anticholinergic mechanism restores autonomic balance by inhibiting parasympathetic signaling.
LOE Approaching
As a decades-old product approaching LOE with minimal current clinical expansion, the ATROPEN brand team is likely small and focused on defensive market maintenance rather than growth initiatives.
Mechanism of Action
Cholinergic Antagonists
Pharmacologic Class:
Anticholinergic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)
Started Sep 2025
234 enrolled
Myopia
Treating Intraoperative Bradycardia in Non-cardiac Surgery Patients With Atropine at Heart Rates Below 60 Versus 30 Beats Per Minute and Norepinephrine Requirements
Started Apr 2025
186 enrolled
Intraoperative Bradycardia
Electronic Spectacles Versus Low Dose Atropine in Young Myopes
Started Oct 2023
45 enrolled
Myopia
A Study of Atropine Sulfate in Healthy Chinese Volunteers
Started May 2023
30 enrolled
Pharmacokinetics
A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
Started May 2022
526 enrolled
Myopia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.