FDA · United States
epinephrine — FDA regulatory status
epinephrine (NEFFY) 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
- NEFFY
- Originator
- Ars Pharmaceuticals Irl Limited
- Mechanism
- Adrenergic receptor agonist
- Target
- Adrenergic receptor
- Structured fields
- 8
Sponsor / originator context: Ars Pharmaceuticals Irl Limited. 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 agonist. Target: Adrenergic receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 45 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 |
|---|---|---|---|
| APHP220827 | Phase 3 | PARItec | 2023-506512-40-00 |
| CHRD 2419 | Phase 3 | Novo Nordisk A/S | 2024-515249-41-00 |
| E004 (Epinephrine Inhalation Aerosol) HFA-MDI | Phase 3 | Amphastar France Pharmaceuticals | NCT01460511 |
| Epinephrine | Phase 3 | Chinese University of | NCT04032119 |
| Epinephrine HFA-MDI (E004) | Phase 3 | Amphastar France Pharmaceuticals | NCT01737905 |
| IIBSP-IPV-2024-178 | Phase 3 | George Institute for | 2025-521572-56-00 |
| NORADRENALINA TARTRATO MONICO 2 mg/ml Concentrato per soluzione per infusione | Phase 3 | Anaxis Pharma | 2023-503895-25-00 |
| SL0044 | Phase 3 | Anaxis Pharma | 2023-508191-11-00 |
| SL0046 | Phase 3 | Anaxis Pharma | 2023-506368-14-00 |
| Topical Beremagene Geperpavec | Phase 3 | Krystal Biotech Netherlands | NCT03536143, NCT04491604 |
| Topical application of Periplaneta americana-derived Meilian Fuxin Solution | Phase 3 | Chinese Academy of | NCT07353671 |
| Topical roflumilast | Phase 3 | Arcutis Biotherapeutics | NCT04286607 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 4732903 | COKRISTALLE VON PITOLISTANTHYDROCHLORID | EP |
| 12427121 | Enhanced delivery epinephrine compositions | US |
| 12023309 | Enhanced delivery epinephrine compositions | US |
| 4302750 | ORALE DÜNNFILME ENTHALTEND ADRENALIN | EP |
| 11266611 | More potent and less toxic formulations of epinephrine and methods of medical use | US |
| 11191737 | Enhanced delivery epinephrine compositions | US |
| 2020024256 | TETRAHYDRATE OF H3 LIGAND, ITS PROCESS OF PREPARATION AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME | US |
| 3378477 | NEUE THERAPEUTISCHE VERWENDUNGEN VON H3-LIGANDEN | EP |
| 8367734 | Stable epinephrine suspension formulation with high inhalation delivery efficiency | US |
| 2014653 | Neue Dicarbonsäurederivate als S1P1 Rezeptor Agonisten | EP |
| 6759396 | Compositions based on a synergistic mixture of at least one VDR ligand and a retinoid | US |
| 6593359 | Use of a RAR-&ggr;-specific agonist ligand for increasing the rate of apoptosis | US |
Related hubs
FAQ
What is the FDA approval status of epinephrine?
epinephrine 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 epinephrine 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 epinephrine?
This spoke lists 45 published programs associated with epinephrine in our pipeline index.