pharma · Myelofibrosis · Acute Myeloid Leukemia
Karyopharm Therapeutics Inc
Karyopharm Therapeutics is a pharma organization headquartered in Newton, USA. Primary therapeutic focus areas include Myelofibrosis, Acute Myeloid Leukemia, Multiple Myeloma, Thymoma, Myeloma Multiple. NovaPharmaNews li
Phase 1 · small molecule · Liposarcoma
Selinexor (XPOVIO, internal code AAAS0199) is an oral small-molecule antineoplastic agent developed by Karyopharm Therapeutics Inc. The drug has been evaluated in a Phase 1 clinical trial for liposarcoma, a rare soft-tissue malignancy. The program was terminated as of November 27, 2020, according to the latest disclose
Internal code AAAS0199
Selinexor (XPOVIO, internal code AAAS0199) is an oral small-molecule antineoplastic agent developed by Karyopharm Therapeutics Inc. The drug has been evaluated in a Phase 1 clinical trial for liposarcoma, a rare soft-tissue malignancy. The program was terminated as of November 27, 2020, according to the latest disclosed milestone. Despite the termination of this specific liposarcoma indication trial, selinexor has achieved regulatory approval in multiple jurisdictions: it is approved by the FDA (NDA212306), the EMA (EMEA/H/C/005127, authorized August 14, 2023 under the brand name Nexpovio), and the TGA in Australia (first listed September 1, 2022). The drug is marketed by Karyopharm in the United States, Stemline Therapeutics B.V. in Europe, and Antengene in Australia. Selinexor is classified as an antineoplastic and immunomodulating agent (ATC L01). The mechanism of action, specific molecular target, and detailed clinical rationale for the liposarcoma indication are not yet disclosed in the available facts. The termination of the Phase 1 liposarcoma trial does not preclude ongoing development or approved use of selinexor in other oncologic indications.
Liposarcoma represents a significant unmet medical need within the soft-tissue sarcoma category. As a rare malignancy, treatment options are limited, and novel therapeutic approaches are clinically valuable. The termination of Karyopharm's Phase 1 liposarcoma program suggests either insufficient efficacy signals, tolerability concerns, or strategic resource reallocation by the sponsor. However, selinexor's regulatory approvals in the US, EU, and Australia indicate the drug has demonstrated clinical benefit in other oncologic indications, establishing proof-of-concept for the molecule. The competitive landscape for liposarcoma and related sarcomas includes approved agents such as Imbruvica (ibrutinib, Janssen-Cilag), Afinitor (everolimus, Novartis), Inlyta (axitinib, Pfizer), and Kyprolis (carfilzomib, Amgen), among others. Selinexor's oral route of administration and mechanism of action position it as a potential option for patients with advanced or refractory disease, though the liposarcoma indication was not advanced to later-phase development. The commercial significance of selinexor's approved indications in major markets (US, EU, Australia) demonstrates market access and revenue generation potential, though the specific liposarcoma program did not reach pivotal development.
Drug Class: Antineoplastic and immunomodulating agent (ATC L01)
Modality: Small-molecule oral agent
Route of Administration: Oral
Brand Names: XPOVIO (US/Australia), Nexpovio (EU)
Mechanism of Action: Not yet disclosed in available facts
Molecular Target: Not yet disclosed in available facts
Related Therapies: Selinexor competes in the oncology space with agents including ibrutinib (Imbruvica), everolimus (Afinitor), axitinib (Inlyta), carfilzomib (Kyprolis), and paclitaxel-based regimens.
Regulatory Approvals: FDA-approved (NDA212306); EMA-approved as Nexpovio (EMEA/H/C/005127, August 14, 2023); TGA-approved in Australia (September 1, 2022, PBS codes 13085Q, 13086R, 13099K, 13103P, 13104Q, 13105R)
Patent Status: Not yet disclosed
Also known as: lip sarcoma, liposarcoma, malignant, sarcoma of lip
Prevalence: Annual incidence: 1-9 / 100 000 (Europe) — source: Orphanet, validated.
A usually painless malignant tumor that arises from adipose tissue. Microscopically, it may contain a spectrum of neoplastic adipocytes ranging from lipoblasts to pleomorphic malignant adipocytes. Morphologic variants include: well differentiated, dedifferentiated, pleomorphic, and myxoid liposarcoma. The metastatic potential is higher in less differentiated tumors.
ClinicalTrials.gov lists 56 registered studies for Liposarcoma (AACT aggregate).
Phase breakdown: PHASE2 (23), PHASE1 (14), NA (9), PHASE1/PHASE2 (7), PHASE3 (2), PHASE2/PHASE3 (1)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0005060), Orphanet — liposarcoma, NCT00060944, NCT00093080, NCT00132704, NCT00356031, NCT00400569, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Liposarcoma Phase 1 trial terminated
The Phase 1 liposarcoma program (NCT03880123) was terminated; no reason or efficacy data disclosed.
TGA approval (Australia)
Selinexor approved and listed on the Australian Register of Therapeutic Goods (ARTG) by Antengene.
EMA approval (Europe)
Selinexor approved by the European Medicines Agency as Nexpovio (EMEA/H/C/005127) under Stemline Therapeutics B.V.
The competitive landscape for selinexor in oncology includes multiple approved antineoplastic agents across different mechanisms. In the soft-tissue sarcoma and related malignancy space, key competitors identified in the facts include: Imbruvica (ibrutinib, Janssen-Cilag), an approved Bruton tyrosine kinase inhibitor; Afinitor (everolimus, Novartis), an approved mTOR inhibitor; Inlyta (axitinib, Pfizer), an approved tyrosine kinase inhibitor; Kyprolis (carfilzomib, Amgen), an approved proteasome inhibitor; and Paclitaxel Accord (paclitaxel, Accord Healthcare), a microtubule-stabilizing chemotherapy. Additional competitors include Lysodren, Lynozyfic (Regeneron), Vyxeos Liposomal (Jazz Pharmaceuticals), Unituxin (United Therapeutics), and Ofev (Boehringer Ingelheim). The termination of selinexor's Phase 1 liposarcoma trial suggests the drug did not demonstrate sufficient competitive advantage or clinical benefit in this specific indication relative to existing standard-of-care options. However, selinexor's regulatory approvals in major markets indicate clinical utility in other oncologic indications, establishing the molecule as a viable therapeutic option in the broader antineoplastic market.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| PFIZER AUSTRALIA PTY LTD | Pfizer Australia Pty Ltd | — | approved |
| IMBRUVICA | Janssen-Cilag Pty Ltd | — | approved |
| AFINITOR | Novartis Pharmaceuticals | — | approved |
| LYSODREN | S.A. | — | approved |
| INLYTA | Pfizer Australia Pty Ltd | — | approved |
| LYNOZYFIC | Regeneron UK Limited | — | approved |
| VYXEOS LIPOSOMAL (PREVIOUSLY VYXEOS) | Jazz Pharmaceuticals Ireland Limited | — | approved |
| KYPROLIS | Amgen | — | approved |
| UNITUXIN | United Therapeutics Europe Ltd | — | approved |
| PACLITAXEL ACCORD | Accord Healthcare Pty. | — | approved |
| OFEV | Boehringer Ingelheim Pty Ltd | — | approved |
| ARX-IMATINIB | Alphapharm Pty Ltd | — | approved |
| ERIBULIN MESYLATE | — | Tubulin inhibitor | Approved |
| DOXORUBICIN HYDROCHLORIDE | — | DNA topoisomerase II alpha inhibitor | Phase 3 |
| DOXORUBICIN | — | DNA topoisomerase II alpha inhibitor | Phase 3 |
| ABEMACICLIB | — | Cyclin-dependent kinase 4 inhibitor | Phase 3 |
| SELINEXOR | — | Exportin-1 inhibitor | Phase 2 |
| RIDAFOROLIMUS | — | Serine/threonine-protein kinase mTOR inhibitor | Phase 2 |
| RIBOCICLIB | — | Cyclin-dependent kinase 6 inhibitor | Phase 2 |
| RETIFANLIMAB | — | Programmed cell death protein 1 antagonist | Phase 2 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
United States: Selinexor is FDA-approved under NDA212306, marketed as XPOVIO by Karyopharm Therapeutics.
European Union: Selinexor is EMA-approved as Nexpovio (EMEA/H/C/005127), authorized on August 14, 2023, under marketing authorization holder Stemline Therapeutics B.V.
Australia: Selinexor is TGA-approved, first listed on September 1, 2022, under sponsor Antengene (AUS) Pty. Ltd., with six PBS codes assigned (13085Q, 13086R, 13099K, 13103P, 13104Q, 13105R).
China (NMPA): Selinexor is in clinical trials in China; two NCT-registered trials are ongoing (NCT04562870, NCT06449482). Regulatory approval status not yet disclosed.
Japan (PMDA): Regulatory status not yet disclosed.
Liposarcoma Indication: The Phase 1 liposarcoma trial (NCT03880123) was terminated on November 27, 2020. No regulatory filing or approval for liposarcoma is indicated in the available facts.
Selinexor is an oral antineoplastic agent approved by the FDA, EMA, and TGA for oncologic indications. The specific approved indications are not detailed in the available facts. A Phase 1 trial in liposarcoma was terminated in November 2020.
Yes. Selinexor is FDA-approved (NDA212306), EMA-approved as Nexpovio (EMEA/H/C/005127, authorized August 14, 2023), and TGA-approved in Australia (first listed September 1, 2022).
The mechanism of action of selinexor is not yet disclosed in the available facts.
The specific molecular target of selinexor is not yet disclosed in the available facts.
Selinexor is developed and marketed by Karyopharm Therapeutics Inc in the US (brand name XPOVIO), by Stemline Therapeutics B.V. in Europe (brand name Nexpovio), and by Antengene in Australia.
Selinexor is administered orally.
The liposarcoma Phase 1 trial (NCT03880123) was terminated in November 2020 without reported results. The specific pivotal trials supporting regulatory approvals in the US, EU, and Australia are not detailed in the available facts.
Selinexor is classified as an antineoplastic and immunomodulating agent (ATC L01).
The Phase 1 liposarcoma trial (NCT03880123) was terminated on November 27, 2020. No efficacy or safety data has been reported.
Competitors in the oncology space include Imbruvica (ibrutinib), Afinitor (everolimus), Inlyta (axitinib), Kyprolis (carfilzomib), and Paclitaxel Accord, among others.
Selinexor is in clinical trials in China (NCT04562870, NCT06449482). Regulatory approval status in China is not yet disclosed.
Selinexor is marketed as XPOVIO in the US and Australia, and as Nexpovio in Europe.
The internal code for the selinexor liposarcoma program is AAAS0199.
Selinexor was first listed on the Australian Register of Therapeutic Goods on September 1, 2022, under sponsor Antengene (AUS) Pty. Ltd.
Selinexor (Nexpovio) was authorized by the European Medicines Agency on August 14, 2023, under EMEA/H/C/005127.
Selinexor is FDA-approved under NDA212306.
Selinexor → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: The termination of selinexor's Phase 1 liposarcoma program in November 2020 suggests Karyopharm made a strategic decision to deprioritize this indication, possibly due to insufficient efficacy signals, tolerability concerns, or competitive pressures. This decision allowed the company to focus resources on other oncologic indications where selinexor ultimately achieved regulatory approval in the US, EU, and Australia.
Competitive Implications: Selinexor's approved status in major markets establishes it as a viable competitor in the antineoplastic space, though the liposarcoma indication was not advanced. The crowded competitive landscape with multiple approved tyrosine kinase inhibitors, proteasome inhibitors, and other mechanisms suggests that selinexor's clinical profile in other indications may offer differentiation not evident in liposarcoma.
Future Catalysts: Potential future catalysts include label expansions in approved markets, results from ongoing clinical trials in China (NCT04562870, NCT06449482), and potential regulatory submissions in additional jurisdictions such as Japan. The mechanism of action and molecular target remain undisclosed, limiting assessment of future development potential.
Expected Milestones: No expected next milestones are disclosed for the liposarcoma program. Monitoring of selinexor's label expansions and clinical trial progress in other indications may provide insight into the drug's broader development trajectory.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.