FDA · United States
selinexor — FDA regulatory status
selinexor (XPOVIO) 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
- XPOVIO
- Originator
- Shanghai Antengene Corporation Limited
- Mechanism
- Exportin-1 inhibitor
- Target
- Exportin-1
- Structured fields
- 8
Sponsor / originator context: Shanghai Antengene Corporation 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: Exportin-1 inhibitor. Target: Exportin-1. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 65 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 |
|---|---|---|---|
| M22-574 | Phase 3 | AbbVie Deutschland GmbH | 2023-506668-15-00 |
| SELINEXOR for endometrial cancer | Phase 3 | Karyopharm Therapeutics | 2024-513167-68-00 |
| Selinexor | Phase 3 | Karyopharm Therapeutics | NCT02606461 |
| Selinexor | Phase 3 | Karyopharm Therapeutics | NCT03555422, NCT05611931 |
| Selinexor | Phase 3 | Karyopharm Therapeutics | NCT02186834, NCT02336815 |
| Selinexor (combination therapy) | Phase 3 | Karyopharm Therapeutics | NCT04442022 |
| XPORT-MF-034 | Phase 3 | Karyopharm Therapeutics | 2023-506139-13-00 |
| CHOP+selinexor+5-Azacitidine | Phase 2 | Chinese Academy of | NCT05675813 |
| IST-342 | Phase 2 | Karyopharm Therapeutics | NCT05170789 |
| KCP-330-009 | Phase 2 | Karyopharm Therapeutics | 2024-512115-50-00 |
| Open Label Selinexor | Phase 2 | Karyopharm Therapeutics | NCT03193437 |
| PTCL S-IDE | Phase 2 | Telethon Foundation | 2024-513295-18-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12371420 | Polymorphs of Selinexor | US |
| 12291508 | Hydrazide containing nuclear transport modulators and uses thereof | US |
| 12076418 | Dually derivatized chitosan nanoparticles and methods of making and using the same for gene transfer in vivo | US |
| 11807629 | Polymorphs of Selinexor | US |
| 11787771 | Hydrazide containing nuclear transport modulators and uses thereof | US |
| 11753401 | Polymorphs of Selinexor | US |
| 11746102 | Polymorphs of selinexor | US |
| 11623011 | Dually derivatized chitosan nanoparticles and methods of making and using the same for gene transfer in vivo | US |
| 11078190 | Polymorphs of selinexor | US |
| 11052157 | Enhanced loading of intact, bacterially derived vesicles with small molecule compounds | US |
| 11034660 | Hydrazide containing nuclear transport modulators and uses thereof | US |
| 10647785 | High concentration chitosan-nucleic acid polyplex compositions | US |
Related hubs
FAQ
What is the FDA approval status of selinexor?
selinexor 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 selinexor 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 selinexor?
This spoke lists 65 published programs associated with selinexor in our pipeline index.