FDA · United States
carbamazepine — FDA regulatory status
carbamazepine (AVLOIRE) 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
- AVLOIRE
- Originator
- Novartis Pharmaceuticals
- Mechanism
- Sodium channel alpha subunit blocker
- Target
- Sodium channel alpha subunit
- Structured fields
- 8
Sponsor / originator context: Novartis Pharmaceuticals. 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: Sodium channel alpha subunit blocker. Target: Sodium channel alpha subunit. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 54 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 |
|---|---|---|---|
| 115747 | Phase 3 | Disc Medicine | 2024-514181-39-00 |
| 20170770 | Phase 3 | Amgen | 2023-507149-27-00 |
| 2025-I2M-C&T-B-090B | Phase 3 | Chinese Academy of | NCT07152613 |
| 206785 | Phase 3 | GSK Glaxo Smith | 2023-510230-84-00 |
| 221530 | Phase 3 | GSK Glaxo Smith | 2023-508613-17-00 |
| 221672 | Phase 3 | GSK Glaxo Smith | 2024-513018-36-00 |
| 222725 | Phase 3 | GSK Glaxo Smith | 2024-520417-41-00 |
| 224295 | Phase 3 | GSK Glaxo Smith | 2025-521108-23-00 |
| 230LE301 | Phase 3 | Biogen | 2023-505634-94-00 |
| 230LE303 | Phase 3 | Biogen | 2023-505695-30-00 |
| 230LE304 | Phase 3 | Biogen | 2023-505696-74-00 |
| 230LE306 | Phase 3 | Biogen | 2023-505635-13-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026112397 | COMPOSITIONS ET PROCÉDÉS DE PRODUCTION DE VIRUS ADÉNO-ASSOCIÉS | WO |
| 2026085433 | PROCÉDÉS POUR PRÉPARER DES CONJUGUÉS OLIGONUCLÉOTIDIQUES | WO |
| 2026060131 | ADDITIFS POUR LA PRODUCTION DE VECTEURS VIRAUX | WO |
| 2026055127 | PROCÉDÉ DE PRODUCTION D'UN MODULATEUR DE RÉCEPTEUR GABA | WO |
| 12384779 | Bicyclic compounds | US |
| 2025165930 | MÉTHODES DE TRAITEMENT DE L'AMYOTROPHIE SPINALE | WO |
| 12331126 | OX40-binding polypeptides and uses thereof | US |
| 2025111408 | COMPOSÉS POUR LE TRAITEMENT DE L'AMYOTROPHIE SPINALE ET DE LA MALADIE DE HUNTINGTON | WO |
| 2025111409 | COMPOSÉS HÉTÉROCYCLIQUES DE FORMULE (I) DESTINÉS À ÊTRE UTILISÉS DANS LE TRAITEMENT DE L'AMYOTROPHIE SPINALE PAR MODULATION DE L'ÉPISSAGE DE SMN2 | WO |
| 2025106633 | INHIBITEURS DE TYK2 | WO |
| 2025049275 | INHIBITEURS DE LA PROTÉINE DE LIAISON À L'ÉMOPAMIL ET LEURS UTILISATIONS | WO |
| 2025043148 | INHIBITEURS DE PROTÉINE DE LIAISON À L'ÉMOPAMIL ET LEURS UTILISATIONS | WO |
Related hubs
FAQ
What is the FDA approval status of carbamazepine?
carbamazepine 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 carbamazepine 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 carbamazepine?
This spoke lists 54 published programs associated with carbamazepine in our pipeline index.