selinexor
Trade name: Xpovio
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Jul 3, 2019
Selinexor (KPT-330) is a first in class XPO1 antagonist being evaluated in multiple later stage clinical trials in patients with relapsed and/or refractory hematological and solid tumor malignancies. — NCATS
Clinical trial activity
172 trials · 103 clinical orgs · 1 marketing orgs
Phase 1
78
Phase 2
115
Phase 3
15
Phase 4
1
Earliest trial started Jun 1, 2012 (NCT01607905)
Timeline
2010s
- Jan 1, 2012
Karyopharm Therapeutics Inc — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2014
Karyopharm Therapeutics Inc — Earliest Phase 2 Sponsor(trial)
- May 14, 2014
Orphan Drug Designation
- Jan 1, 2017
Karyopharm Therapeutics Inc — Earliest Phase 3 Sponsor(trial)
- Jul 3, 2019
Karyopharm Therapeutics Inc — Earliest FDA Approval
- Jul 3, 2019
Karyopharm Therapeutics Inc — Marketing Organization
- Jul 3, 2019
Karyopharm Therapeutics Inc — NDA Organization
Indications
Studied for
- Amyloid · Early Phase 1
- Amyloidosis · Phase 2
- Astrocytoma · Phase 1/Phase 2
- Brain Neoplasms · Phase 1
- Breast Neoplasms · Phase 2
- Carcinoma, Hepatocellular · Phase 1
- Carcinoma, Neuroendocrine · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 1/Phase 2
- Carcinoma, Pancreatic Ductal · Phase 2
- Carcinoma, Renal Cell · Phase 1
- Carcinoma, Small Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 2
- Carcinoma, Transitional Cell · Phase 1/Phase 2
- Castration · Phase 2
- Colorectal Neoplasms · Phase 2
- Coronavirus Infections · Phase 2
- COVID-19 · Phase 3
- Diabetic Foot · Phase 1/Phase 2
- Diffuse Intrinsic Pontine Glioma · Phase 1/Phase 2
- Drug Misuse · Phase 1/Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 1/Phase 2
- Drug Therapy · Phase 1/Phase 2
- Endometrial Neoplasms · Phase 2
- Epstein-Barr Virus Infections · Phase 3
- Esophageal Neoplasms · Phase 1
- Fallopian Tube Neoplasms · Phase 1
- Fibrosarcoma · Phase 1/Phase 2
- Gastrointestinal Stromal Tumors · Phase 1/Phase 2
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Gliosarcoma · Phase 1
- Hamartoma · Phase 1
- Hemangiosarcoma · Phase 1/Phase 2
- Hematologic Neoplasms · Phase 1
- Hematopoietic Stem Cell Transplantation · Phase 1
- Histiocytosis, Langerhans-Cell · Phase 2
- Hodgkin Disease · Phase 1
- Immunoglobulin Light-chain Amyloidosis · Early Phase 1
- Leiomyosarcoma · Phase 1
- Leukemia · Phase 1/Phase 2
- Leukemia, Hairy Cell · Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Myeloid, Acute · Phase 3
- Leukemia, Myeloid, Chronic-Phase · Phase 1
- Leukemia, Myelomonocytic, Chronic · Phase 2
- Leukemia, Prolymphocytic · Phase 1
- Liposarcoma · Phase 3
- Lung Neoplasms · Phase 1/Phase 2
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 1/Phase 2
- Lymphoma, Extranodal NK-T-Cell · Phase 2
- Lymphoma, Follicular · Phase 1/Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 4
- Lymphoma, Large-Cell, Immunoblastic · Phase 1/Phase 2
- Lymphoma, Mantle-Cell · Phase 1/Phase 2
- Lymphoma, Non-Hodgkin · Phase 1/Phase 2
- Lymphoma, T-Cell · Phase 2
- Lymphoma, T-Cell, Peripheral · Phase 2/Phase 3
- Maximum Tolerated Dose · Phase 1/Phase 2
- Melanoma · Phase 2
- Multiple Myeloma · Phase 3
- Mutation · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Myoepithelioma · Phase 1/Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 3
- Neoplasms, Germ Cell and Embryonal · Phase 2
- Nerve Sheath Neoplasms · Phase 1
- Neurofibrosarcoma · Phase 2
- Osteosarcoma · Phase 1/Phase 2
- Ovarian Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 1/Phase 2
- Polycythemia Vera · Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Primary Myelofibrosis · Phase 2
- Prostatic Neoplasms · Phase 2
- Rectal Neoplasms · Phase 1
- Respiratory Tract Infections · Phase 3
- Rhabdoid Tumor · Phase 2
- Rhabdomyosarcoma · Phase 1/Phase 2
- Sarcoma · Phase 2
- Sarcoma, Alveolar Soft Part · Phase 2
- Sarcoma, Endometrial Stromal · Phase 1
- Sarcoma, Ewing · Phase 1
- Small Cell Lung Carcinoma · Phase 2
- Smoldering Multiple Myeloma · Phase 2
- Stomach Neoplasms · Phase 1
- Thrombocytopenia · Phase 2
- Thymoma · Phase 2
- Uterine Cervical Neoplasms · Phase 2
- Waldenstrom Macroglobulinemia · Phase 1/Phase 2
- Wilms Tumor · Phase 2
Mechanism of action
- Exportin-1ANTAGONIST
XPO1 antagonist
Approval history
- approvedPriority reviewAcceleratedFast trackJul 3, 2019
Chemistry & pharmacology
Loading structure…
SMILES
FC(F)(F)C1=CC(=CC(=C1)C2=NN(C=N2)\C=C/C(=O)NNC3=NC=CN=C3)C(F)(F)F- Mol. weight
- 443.306 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- WikipediaSelinexor ↗
- NCATS31TZ62FO8F ↗
- ChEMBLCHEMBL3545185 ↗
Also known as
- kcp-330
- kpt-330
- kpt-330
- kpt-330
- kpt-330
- selinexor
- selinexor
- selinexor
- selinexor
- selinexor
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07200102 | Phase 1 | Dec 31, 2025 | Karyopharm Therapeutics Inc, Washington University in St. Louis |
| NCT07276698 | Phase 2 | Dec 30, 2025 | Jiao Tong University |
| NCT07172412 | Phase 2 | Nov 30, 2025 | Tianjin Medical University |
| NCT07236931 | N/A | Nov 20, 2025 | Huazhong University of Science and Technology |
| NCT07138209 | Phase 3 | Oct 31, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT07191431 | N/A | Sep 22, 2025 | Jiao Tong University |
| NCT07204041 | Phase 2 | Aug 1, 2025 | Chinese Academy of Medical Sciences |
| NCT07011056 | Phase 3 | Jul 18, 2025 | Government of China |
| NCT07002099 | Phase 2 | Jun 1, 2025 | Soochow University |
| NCT07094464 | Phase 1 | Jun 1, 2025 | People's Liberation Army of China |
| NCT06966154 | Phase 1/Phase 2 (Phase 2) | May 26, 2025 | Fudan University |
| NCT06900088 | Phase 2 | Apr 25, 2025 | China Academy of Chinese Medical Sciences |
| NCT06853678 | N/A | Feb 28, 2025 | Tianjin Medical University |
| NCT06813079 | Phase 2 | Feb 17, 2025 | University of Toronto |
| NCT06744894 | Phase 2 | Jan 1, 2025 | Government of China |
| NCT06765928 | Phase 2 | Jan 1, 2025 | Jiao Tong University |
| NCT06664970 | Phase 2 | Nov 6, 2024 | Chinese Academy of Medical Sciences |
| NCT06652139 | Phase 2 | Nov 1, 2024 | Jiao Tong University |
| NCT06613035 | Phase 3 | Sep 30, 2024 | China Academy of Chinese Medical Sciences |
| NCT06573151 | Phase 2 | Sep 1, 2024 | Jiao Tong University |
Showing 20 of 172 trials
Page 1 / 9
Organizations
Research & Development (103)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Karyopharm Therapeutics Inc | For profit | 82 | 33 | 4 | 2012 |
| National Cancer Institute (NCI) | Government | 19 | 6 | 2 | 2014 |
| Antengene Corporation | For profit | 10 | 5 | 4 | 2019 |
| Jiao Tong University | Academic/Hospital | 10 | 10 | 2 | 2023 |
| Cornell University | Academic/Hospital | 6 | 6 | 2 | 2014 |
| Ohio State University | Academic/Hospital | 6 | 6 | 2 | 2014 |
| University of South Florida | Academic/Hospital | 6 | 6 | 2 | 2014 |
| St. Jude Children's Hospital | Academic/Hospital | 5 | 5 | 2 | 2014 |
| China Academy of Chinese Medical Sciences | Academic/Hospital | 4 | 4 | 3 | 2023 |
| Huazhong University of Science and Technology | Academic/Hospital | 4 | 2 | 3 | 2021 |
| Soochow University | Academic/Hospital | 4 | 4 | 2 | 2022 |
| Sun Yat-Sen University | Academic/Hospital | 4 | 3 | 1 | 2022 |
| University of Texas at Houston | Academic/Hospital | 4 | 2 | 2 | 2014 |
| University of Toronto | Academic/Hospital | 4 | 4 | 3 | 2014 |
| AbbVie | For profit | 3 | 1 | 2 | 2019 |
| Columbia University | Academic/Hospital | 3 | 1 | 2 | 2014 |
| Fudan University | Academic/Hospital | 3 | 2 | 1 | 2022 |
| GSO Global Clinical Research BV | Academic/Hospital | 3 | 2 | 2 | 2014 |
| Katholieke Universiteit Leuven | Academic/Hospital | 3 | 1 | 2 | 2014 |
| National University of Singapore | Academic/Hospital | 3 | 3 | 2 | 2014 |
103 organizations
Page 1 / 6
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Karyopharm Therapeutics Inc | For profit | MKTG | Jul 3, 2019 |
| Karyopharm Therapeutics Inc | For profit | NDA | Jul 3, 2019 |