KCP-330

Karyopharm Therapeutics Inc · Phase 1 active Small molecule Quality 20/100

KCP-330 is a Small molecule drug developed by Karyopharm Therapeutics Inc. It is currently in Phase 1 development. Also known as: Selinexor.

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 name	KCP-330
Also known as	Selinexor
Sponsor	Karyopharm Therapeutics Inc
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

• Fatigue
• Nausea
• Diarrhoea
• Constipation
• Vomiting
• Dyspnoea
• Decreased appetite
• Hyponatraemia
• Anaemia
• Oedema peripheral
• Hypomagnesaemia
• Dysgeusia

Key clinical trials

• Selinexor and Backbone Treatments of Multiple Myeloma Patients (PHASE1, PHASE2)
• A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (PHASE2, PHASE3)
• A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma (PHASE1)
• Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma (PHASE2)
• Selinexor in Advanced Liposarcoma (PHASE2, PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

• KCP-330 CI brief — competitive landscape report
• KCP-330 updates RSS · CI watch RSS
• Karyopharm Therapeutics Inc portfolio CI

Frequently asked questions about KCP-330

What is KCP-330?

KCP-330 is a Small molecule drug developed by Karyopharm Therapeutics Inc.

Who makes KCP-330?

KCP-330 is developed by Karyopharm Therapeutics Inc (see full Karyopharm Therapeutics Inc pipeline at /company/karyopharm-therapeutics-inc).

Is KCP-330 also known as anything else?

KCP-330 is also known as Selinexor.

What development phase is KCP-330 in?

KCP-330 is in Phase 1.

What are the side effects of KCP-330?

Common side effects of KCP-330 include Fatigue, Nausea, Diarrhoea, Constipation, Vomiting, Dyspnoea.

Related

• Manufacturer: Karyopharm Therapeutics Inc — full pipeline
• Also known as: Selinexor