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Data updated: Mar 10, 2026

XPOVIO

SELINEXOR Nuclear Export Inhibitors
Oncology Approved 2019-07-03
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
2
Priority Reviews
6
Years on Market

Details

Status
Prescription
First Approved
2019-07-03
Routes
ORAL
Dosage Forms
TABLET

Companies

KARYOPHARM THERAPS
Active Ingredient: SELINEXOR

XPOVIO Approval History

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What XPOVIO Treats

2 indications

XPOVIO is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Multiple Myeloma
  • Diffuse Large B-Cell Lymphoma
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

XPOVIO FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy . In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody . For the treatment of adult patients with relapsed or refractory diffuse large B-cell ly...

XPOVIO Patents & Exclusivity

Latest Patent: Aug 2035
Exclusivity: Dec 2027

Patents (864 active)

US10519139 Expires Aug 14, 2035
US11753401 Expires Aug 14, 2035
US11746102 Expires Aug 14, 2035
US11807629 Expires Aug 14, 2035
US8999996 Expires Jul 3, 2033
US9079865 Expires Jul 26, 2032
US10544108 Expires Jul 26, 2032
US11034660 Expires Jul 26, 2032
US11787771 Expires Jul 26, 2032
US12291508 Expires Jul 26, 2032
+ 854 more patents

Exclusivity

ODE-257 Until Jul 2026
ODE-310 Until Jun 2027
ODE-346 Until Dec 2027
ODE* Until Jun 2027
ODE* Until Dec 2027
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA212306 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.