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dose-escalated selinexor treatment

Sheba Medical Center · Phase 1 active Small molecule Quality 55/100

dose-escalated selinexor treatment is a XPO1 inhibitor Small molecule drug developed by Sheba Medical Center. It is currently in Phase 1 development. Also known as: KPT-330.

Selinexor blocks XPO1 (exportin-1), preventing nuclear export of tumor suppressor proteins and causing cancer cell death.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic namedose-escalated selinexor treatment
Also known asKPT-330
SponsorSheba Medical Center
Drug classXPO1 inhibitor
ModalitySmall molecule
PhasePhase 1

Mechanism of action

Selinexor selectively inhibits XPO1, a nuclear export protein that transports tumor suppressor proteins, growth regulators, and mRNAs out of the cell nucleus. By blocking XPO1, selinexor forces nuclear retention and activation of tumor suppressor proteins, leading to cancer cell apoptosis while sparing normal cells.

Approved indications

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about dose-escalated selinexor treatment

What is dose-escalated selinexor treatment?

dose-escalated selinexor treatment is a XPO1 inhibitor drug developed by Sheba Medical Center.

How does dose-escalated selinexor treatment work?

Selinexor blocks XPO1 (exportin-1), preventing nuclear export of tumor suppressor proteins and causing cancer cell death.

Who makes dose-escalated selinexor treatment?

dose-escalated selinexor treatment is developed by Sheba Medical Center (see full Sheba Medical Center pipeline at /company/sheba-medical-center).

Is dose-escalated selinexor treatment also known as anything else?

dose-escalated selinexor treatment is also known as KPT-330.

What drug class is dose-escalated selinexor treatment in?

dose-escalated selinexor treatment belongs to the XPO1 inhibitor class. See all XPO1 inhibitor drugs at /class/xpo1-inhibitor.

What development phase is dose-escalated selinexor treatment in?

dose-escalated selinexor treatment is in Phase 1.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing