FDA · United States
atropine sulfate — FDA regulatory status
atropine sulfate (ATROPINE INJECTION (BRIDGEWEST)) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- ATROPINE INJECTION (BRIDGEWEST)
- Originator
- Lacuna Pharma Pty Ltd
- Mechanism
- Muscarinic acetylcholine receptor M3 antagonist
- Target
- Muscarinic acetylcholine receptor M1
- Structured fields
- 8
Sponsor / originator context: Lacuna Pharma Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Muscarinic acetylcholine receptor M3 antagonist. Target: Muscarinic acetylcholine receptor M1. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 76 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| APHP210089 | Phase 3 | PARItec | 2024-513490-45-00 |
| ASCIMINIB HYDROCHLORIDE, ASCIMINIB | Phase 3 | Novartis India | 2024-511381-36-00 |
| Asciminib | Phase 3 | Novartis India | NCT03106779 |
| Atropine sulfate eye drops 0.01% | Phase 3 | Chinese Academy of | NCT06708156 |
| CABL001A2001B | Phase 3 | Novartis India | 2023-507557-16-00 |
| CD101.IV.3.08 | Phase 3 | Mundipharma | 2024-514471-18-00 |
| CLS2901C (human [allogeneic] chondrocyte sheets) | Phase 3 | CellSeed Europe | NCT06549686 |
| Pegylated Interferon Alfa-2a | Phase 3 | HOFFMANN-LA ROCHE | NCT02829775 |
| Solution de chlorure de sodium à 0 for Adult Patients kidney transplan… | Phase 3 | PARItec | 2023-506598-36-00 |
| Ventoclax | Phase 3 | Chinese Academy of | NCT07537257 |
| - | Phase 2 | George Institute for | 2024-520020-28-00 |
| 2G-MSC-GVHD | Phase 2 | George Institute for | 2025-523139-21-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12377068 | In vitro and xenograft anti-tumor activity of a halogenated-xanthene against refractory pediatric solid tumors | US |
| 12357650 | Methods and compositions for cancer therapies that include delivery of halogenated thymidines and thymidine phosphorlylase inhibitors in combination with radiation | US |
| 12252714 | Halogenation of complex organic compounds | US |
| 12247226 | Cellular reprogramming using temporal and transient plasmid vector expression system | US |
| 12221462 | Methods and compositions for dosing of allogeneic chimeric antigen receptor T cells | US |
| 12163153 | Methods of manufacturing allogeneic CAR T cells | US |
| 12138276 | Halogenated psilocybin derivatives and methods of using | US |
| 12133840 | Halogenated xanthene composition and method for treating hematologic cancers | US |
| 12070460 | Methods of treating skin cancer with Carboxypeptidase Vitellogenic Like (CPVL) inhibitors | US |
| 11998557 | Halogenated psilocybin derivatives and methods of using | US |
| 11974980 | In vitro and xenograft anti-tumor activity of a halogenated-xanthene against refractory pediatric solid tumors | US |
| 11975106 | Uses of halogenated xanthenes in oncology and virology | US |
Related hubs
FAQ
What is the FDA approval status of atropine sulfate?
atropine sulfate currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get atropine sulfate regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to atropine sulfate?
This spoke lists 76 published programs associated with atropine sulfate in our pipeline index.