Last reviewed 2026-05-20 · How we verify

Xevinapan

Memorial Sloan Kettering Cancer Center · Phase 2 active Small molecule ✓ Verified May 2026

Xevinapan is a Small molecule drug developed by Memorial Sloan Kettering Cancer Center. It is currently in Phase 2 development.

Xevinapan is being studied in combination with cisplatin and external beam radiation therapy as a treatment for head and neck cancer. This combination treatment is being investigated in a Phase II clinical trial at the Memorial Sloan Kettering Cancer Center.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Xevinapan
Sponsor	Memorial Sloan Kettering Cancer Center
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of Xevinapant With Cisplatin and Radiation Therapy After Surgery in People With Head and Neck Cancer (PHASE2)

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:

Xevinapan CI brief — competitive landscape report
Xevinapan updates RSS · CI watch RSS
Memorial Sloan Kettering Cancer Center portfolio CI

Frequently asked questions about Xevinapan

What is Xevinapan?

Xevinapan is a Small molecule drug developed by Memorial Sloan Kettering Cancer Center.

Who makes Xevinapan?

Xevinapan is developed by Memorial Sloan Kettering Cancer Center (see full Memorial Sloan Kettering Cancer Center pipeline at /company/memorial-sloan-kettering-cancer-center).

What development phase is Xevinapan in?

Xevinapan is in Phase 2.

Manufacturer: Memorial Sloan Kettering Cancer Center — full pipeline
Therapeutic area: All drugs in Other

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