Data updated: May 26, 2026
XPOVIO (selinexor)
Nuclear Export Inhibitors
Trial Activity: Stable 55 active trials
First-in-Class Orphan Drug Priority Review Accelerated Approval Fast Track
Oncology
Approved 2019-07-03
Xpovio is a nuclear export inhibitor indicated for adults with multiple myeloma (MM) and certain types of aggressive lymphoma. For MM, it is used in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. It is also indicated in combination with dexamethasone for patients with relapsed or refractory MM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Additionally, Xpovio is indicated as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
How XPOVIO Works
Selinexor is a reversible inhibitor of exportin 1 (XPO1), a protein that mediates the nuclear export of tumor suppressor proteins (TSPs), growth regulators, and mRNAs of oncogenic proteins. By blocking XPO1, selinexor leads to the nuclear accumulation and activation of TSPs and a reduction in the levels of cytoplasmic oncoproteins (such as c-myc and cyclin D1). This results in cell cycle arrest and apoptosis in cancer cells. In multiple myeloma, selinexor has demonstrated synergistic cytotoxic effects when combined with dexamethasone or bortezomib.
Development Insights
Karyopharm Therapeutics Inc conducting 30 trials (25%)
220 indications explored (Broad Platform)
→ multiple myeloma (16 trials)
→ acute myeloid leukemia (11 trials)
→ refractory multiple myeloma (5 trials)
4
Indications
--
Phase 3 Trials
2
Priority Reviews
6
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-07-03
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- TABLET
XPOVIO Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
48 FDA actions from 2019 to 2026 · 3 indication expansions
What XPOVIO Treats
2 indicationsXPOVIO 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
XPOVIO Competitive Set
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Indication competitors
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What's emerging in XPOVIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XPOVIO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to XPOVIO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
118 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05432804 | NCI-2022-05066 NCI-2022-05066, PHII-222 | Ph 1, Ph 2 | recruiting | Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment |
| NCT05099003 | NCI-2021-11337 NCI-2021-11337, ACNS1821 | Ph 1, Ph 2 | recruiting | A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG) |
| NCT06169215 | NCI-2023-07073 NCI-2023-07073, 10612 | Ph 2 | active not recruiting | Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma |
| NCT05333458 | NCI-2022-03217 NCI-2022-03217, 000726 | Ph 2 | recruiting | Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial |
| NCT07574528 | B2026-235 | Ph 2 | not yet recruiting | A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma |
| NCT05985161 | 22-393 | Ph 2 | recruiting | A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors |
| NCT02227251 | KCP-330-009 2014-001977-15 | Ph 2 | active not recruiting | Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT02343042 STOMP | KCP-330-017 | Ph 1, Ph 2 | active not recruiting | Selinexor and Backbone Treatments of Multiple Myeloma Patients |
| NCT04898894 | SELCLAX NCI-2021-03435 | Ph 1 | active not recruiting | Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia |
| NCT07554482 | TRhos-NKTCL-XPO1 | Ph 2 | not yet recruiting | Selinexor Combined With Reduced-Dose Radiotherapy For Early-Stage Extranodal NK/T-Cell Lymphoma |
| NCT06552559 SIENA | CISL2301 | Ph 1, Ph 2 | recruiting | Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma |
| NCT05611931 XPORT-EC-042 | XPORT-EC-042 GOG-3083, ENGOT-EN20 | Ph 3 | recruiting | Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma |
| NCT06239272 | NRSTS2021 NCI-2024-02554 | Ph 1, Ph 2 | recruiting | NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) |
| NCT02436707 | LY17 | Ph 2 | active not recruiting | Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma |
| NCT03555422 ENGOT-EN5 | KCP-330-024 ENGOT-EN5, BGOG-EN5 | Ph 3 | completed | Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO] |
| NCT04562389 SENTRY | XPORT-MF-034 2020-003883-19, 2023-506139-13-00 | Ph 3 | active not recruiting | Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis |
| NCT04925193 results posted | 20-2202.cc P30CA046934 | Ph 2 | active not recruiting | Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma |
| NCT07200102 | 202511028 | Ph 1 | recruiting | Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma |
| NCT07479979 | BTCRC-MM21-528 | Ph 1, Ph 2 | recruiting | Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma |
| NCT07447817 | STUDY-26-00174 5P01CA108671, MPN-RC 126 | Ph 2 | not yet recruiting | Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias |
| NCT06158841 CERVINO | M22-574 2023-506668-15-00 | Ph 3 | recruiting | Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma |
| NCT02835222 | IRB00039092 NCI-2016-00951, CCCWFU 22316 | Ph 2 | active not recruiting | Selinexor With Combination With Induction/Consolidation Therapy in Acute Myeloid Leukemia Patients |
| NCT07437170 | 2025-IRB-0134-P-01 | Ph 2 | active not recruiting | Selinexor Combined With Induction Chemotherapy for Children With NUP98-positive AML |
| NCT07138209 | QLS32015-301 | Ph 3 | recruiting | A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT03589222 | GEM- SELIBORDARA | Ph 2 | active not recruiting | SELIBORDARA: Selinexor, Bortezomib and Daratumumab in Multiple Myeloma |
| NCT04764942 | MC1882 NCI-2021-01268 | Ph 1, Ph 2 | active not recruiting | Selinexor, Pomalidomide, and Dexamethasone With or Without Carfilzomib for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, The SCOPE Trial |
| NCT05530421 SELVEDge | 20220595 | Ph 2 | recruiting | Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma |
| NCT04414475 | XPORT-MM-028 | Ph 2 | recruiting | A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM. |
| NCT04856189 results posted | UCDCC#289 NCI-2021-02845, UCDCC#289 | Ph 1, Ph 2 | terminated | Selinexor and Pembrolizumab for the Treatment of Cisplatin-Ineligible or Cisplatin-Refractory Locally Advanced or Metastatic Urothelial Carcinoma |
| NCT04216329 results posted | 200027 20-C-0027 | Ph 1 | active not recruiting | Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma |
| NCT04640779 | LS1981 P50CA097274, NCI-2020-09704 | Ph 1 | active not recruiting | Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma |
| NCT05028348 | EMN29 | Ph 3 | active not recruiting | A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma |
| NCT02199665 SINE | IRB14-0033 NCI-2014-01199, IRB14-0033 | Ph 1 | completed | Selinexor, Carfilzomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma |
| NCT04562870 | XPORT-MF-035 2020-003809-60, 2024-513605-31-00 | Ph 2 | active not recruiting | A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis |
| NCT04607772 | XPORT-DLBCL-025 | Ph 1, Ph 2 | withdrawn | Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT07204041 | NCCH0027 | Ph 2 | active not recruiting | Efficacy and Safety of XTD Regimen (Selinexor, Thalidomide and Dexamethasone) in Adult Patients With Relapsed/Refractory LCH |
| NCT07172412 | BUTTONS-001 | Ph 2 | not yet recruiting | Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung Cancer |
| NCT03147885 | 2016-125 P30CA022453 | Ph 1, Ph 2 | active not recruiting | Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma |
| NCT05698147 | KY2022-881 | Ph 1, Ph 2 | recruiting | Selinexor in Combination With MTX+Ritu to Treat R/R CNSL |
| NCT05900882 | SVRd | Ph 2 | recruiting | SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease |
| NCT06556199 | R202333 | Ph 1, Ph 2 | recruiting | A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma |
| NCT05035745 | MC01/05/20; IST-325 (KPT) | Ph 1, Ph 2 | recruiting | Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START) |
| NCT03627403 ESSENTIAL results posted | HCI114354 | Ph 2 | terminated | Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors |
| NCT02303392 results posted | OSU-14087 NCI-2014-01493 | Ph 1 | completed | Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma |
| NCT02419495 | 2014-0640 NCI-2015-00693, 2014-0640 | Ph 1 | terminated | Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies |
| NCT06449482 | IIT2022053 | Ph 1, Ph 2 | terminated | Selinexor、Venetoclax and Azactidine in the Treatment of ND AML Patients Who Are Not Eligible for Intense Chemotherapy |
| NCT06966154 | SHCA-NKT-202501 | Ph 1, Ph 2 | recruiting | A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of R/R NKTCL |
| NCT04811196 | METSSAR | Ph 1 | completed | A Study of Different Dosing Schedules of Selinexor in Sarcoma Patients |
| NCT06900088 | IIT2024099 | Ph 2 | not yet recruiting | Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients |
| NCT06813079 | ADOPT 24-5059 | Ph 2 | not yet recruiting | Using Tumor Models to Determine Treatments |
Showing 50 of 118 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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
Indications & Usage
FDA Label (PDF)XPOVIO is indicated for the treatment of Multiple Myeloma; Diffuse Large B-Cell Lymphoma.
View full patent landscape →
11 OB patents · 2 families ·
162 international docs across 40 countries
XPOVIO Patents & Exclusivity
Latest Patent: Aug 2035
Exclusivity: Dec 2027
Patents (11 active)
US10519139
Expires Aug 14, 2035
US11753401
Expires Aug 14, 2035
US11746102
Expires Aug 14, 2035
US11807629
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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
US9714226
Expires Jul 26, 2032
Exclusivity
ODE-257
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Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for XPOVIO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 864 active patents
Trial Analysis
- • 120 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment