FDA · United States
carvedilol — FDA regulatory status
carvedilol (APO-CARVEDILOL) 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
- APO-CARVEDILOL
- Originator
- Alphapharm Pty Ltd
- Mechanism
- Adrenergic receptor beta antagonist
- Target
- Adrenergic receptor alpha-1
- Structured fields
- 8
Sponsor / originator context: Alphapharm 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: Adrenergic receptor beta antagonist. Target: Adrenergic receptor alpha-1. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 17 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 |
|---|---|---|---|
| APHP230833 | Phase 3 | PARItec | 2023-508798-94-00 |
| D910DC00001 | Phase 3 | AstraZeneca | 2023-507689-26-00 |
| D910VC00001 | Phase 3 | AstraZeneca | 2023-508701-24-00 |
| EMERALD-1 | Phase 3 | AstraZeneca | 2023-509053-32-00 |
| IBCSG 59-19 | Phase 3 | Impact Therapeutics | 2024-510776-20-00 |
| ASND0038 | Phase 2 | Anaxis Pharma | 2023-506092-10-00 |
| Carvedilol | Phase 2 | BRIGHT MINDS BIOSCIENCES | NCT00000294 |
| Carvedilol | Phase 2 | NORTHWEST BIOTHERAPEUTICS | NCT01221792 |
| Coreg | Phase 2 | BRIGHT MINDS BIOSCIENCES | NCT00442923 |
| IRSSP-001 | Phase 2 | George Institute for | 2024-511477-29-00 |
| controlled release carvedilol | Phase 2 | BRIGHT MINDS BIOSCIENCES | NCT01171183 |
| Carvedilol 25 mg tablets | Phase 1 | Teva Pharma | NCT00834795, NCT00834873 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12410474 | Methods, kits, and devices for diagnosing, prognosing, and treating psychiatric disorders in a patient | US |
| 12377036 | Melanin hair dye with thickeners | US |
| 12370267 | Inhibition of fibrosis and AF by TGF-beta inhibition in the posterior left atrium (PLA) | US |
| 12351574 | Selective ligands for modulation of GIRK channels | US |
| 12337019 | Vehicles for applying bacteria to skin, scalp, and hair | US |
| 12331279 | Systems for producing cellular immunotherapeutics and methods of use thereof | US |
| 12319711 | Spherical nucleic acids with tailored and active protein coronae | US |
| 12291533 | Substituted fused pyrimidine compounds and uses thereof | US |
| 12281310 | Use of trinucleotide repeat RNAs to treat cancer | US |
| 12264344 | Protein/oligonucleotide core-shell nanoparticle therapeutics | US |
| 12252522 | Myokines for treating cell proliferative and metabolic diseases and disorders | US |
| 12252492 | Substituted fused pyrrolo-diazepinones and uses thereof | US |
Related hubs
FAQ
What is the FDA approval status of carvedilol?
carvedilol 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 carvedilol 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 carvedilol?
This spoke lists 17 published programs associated with carvedilol in our pipeline index.