DUODOTE (atropine)
DUODOTE is indicated for the treatment of Organophosphorus Nerve Agent Poisoning; Organophosphorus Insecticide Poisoning.
How DUODOTE Works
DuoDote employs a dual-action mechanism to treat organophosphorus poisoning. Atropine competitively blocks the effects of excess acetylcholine at muscarinic cholinergic receptors in the central and peripheral nervous systems, smooth muscle, and glands. Pralidoxime chloride reactivates acetylcholinesterase that has been inactivated by phosphorylation, thereby restoring the body's ability to hydrolyze acetylcholine. Notably, pralidoxime is ineffective once the phosphorylated enzyme has undergone "aging" and may not be effective against all nerve agents, such as soman.
Details
- Status
- Prescription
- First Approved
- 2006-09-28
- Routes
- INTRAMUSCULAR
- Dosage Forms
- INJECTABLE
DUODOTE Approval History
What DUODOTE Treats
2 indicationsDUODOTE is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organophosphorus Nerve Agent Poisoning
- Organophosphorus Insecticide Poisoning
DUODOTE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
23 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07095894 | MTS2 | Ph 3 | not yet recruiting | A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control |
| NCT07367178 SATROPIN | MEDOPP824 2025-524109-33-00 | Ph 2 | not yet recruiting | Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer |
| NCT06579287 | SHJ002-MY201 | Ph 2 | active not recruiting | A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control |
| NCT05815784 | 2022-5570 | Ph 2 | recruiting | Myopia Control: a Comparison Study Between Atropine and MiSight |
| NCT06111352 OPC | 59.18.1100.031.18.011.22.2268 | Ph 2 | completed | Outcome of Moderate Severity in OPC Poisoning Patients When Treated With Pralidoxime |
| NCT03334253 MTS1 results posted | MTS1 2U10EY011751 | Ph 3 | completed | Low-Dose Atropine for Treatment of Myopia |
| NCT05658380 | R216/2022 | Ph 3 | completed | Impact of Pre-spinal Atropine on Post Spinal Hemodynamics and Cardiac Output Measured by Electrical Cardiometry in Caesarean Delivery |
| NCT01819064 results posted | Atropine in infants | Ph 4 | completed | Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants |
| NCT02870478 | IND 128961 | Ph 3 | completed | The Effects of Low Concentration Atropine on Pupil Size and Accommodation |
| NCT02839668 TIVA/TCI-BC | IuliuHatieganu Cluj-Napoca | Ph 2 | completed | The Impact of Intravenous Anaesthesia on Angiogenesis in Patients With Breast Cancer (TIVA/TCI-BC) |
| NCT00944710 ATS16 results posted | NEI-144 2U10EY011751 | Ph 3 | completed | Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old |
| NCT03544827 | 1168531-2 | Ph 4 | completed | The Effects of Low Dose Atropine on Choroidal Thickness |
| NCT02327923 | IERB/284/014 | Ph 4 | completed | Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy |
| NCT01845636 results posted | 6577 W81XWH-12-0142 | Ph 4 | completed | Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil |
| NCT00724932 results posted | P05699 19.4.318, MK-8616-002 | Ph 3 | completed | Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699) |
| NCT02445599 | DEOEC RKEB/IKEB 4044-2013 | Ph 4 | completed | Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain |
| NCT02361060 | PRIN-SUGAR-2014 | Ph 4 | completed | Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery |
| NCT02622126 | IRB0000871175 | Ph 2 | completed | Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia |
| NCT02704923 | CAAE 40374815.3.0000.5342 | Ph 2 | completed | Atropine for Preventing Ventilator-Associated Pneumonia |
| NCT02658721 | IVRA | Ph 3 | completed | Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery |
| NCT02522858 | IIT-2015-101 | Ph 4 | completed | Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia |
| NCT00834470 | Atropine-01 | Ph 4 | completed | Adjunctive Atropine During Ketamine Sedation |
| NCT00991627 | ANEST-OST-02 | Ph 4 | completed | Different Approaches to Maternal Hypotension During Cesarean Section |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DUODOTE FDA Label Details
Indications & Usage
FDA Label (PDF)DUODOTE is indicated for the treatment of Organophosphorus Nerve Agent Poisoning; Organophosphorus Insecticide Poisoning.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.