Last reviewed 2026-05-19 · How we verify

CFI-402411

Treadwell Therapeutics, Inc · Phase 1 active Small molecule ✓ Verified May 2026

CFI-402411 is a Small molecule drug developed by Treadwell Therapeutics, Inc. It is currently in Phase 1 development. Also known as: 2411, 402411.

CFI-402411 is a small molecule inhibitor of the serine/threonine-protein kinase PLK4, and it is being studied in a Phase 1/2 clinical trial as a treatment for advanced solid malignancies. The trial is evaluating the safety and efficacy of CFI-402411 as a single agent, in combination with pembrolizumab.

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	CFI-402411
Also known as	2411, 402411
Sponsor	Treadwell Therapeutics, Inc
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies (PHASE1, 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:

CFI-402411 CI brief — competitive landscape report
CFI-402411 updates RSS · CI watch RSS
Treadwell Therapeutics, Inc portfolio CI

Frequently asked questions about CFI-402411

What is CFI-402411?

CFI-402411 is a Small molecule drug developed by Treadwell Therapeutics, Inc.

Who makes CFI-402411?

CFI-402411 is developed by Treadwell Therapeutics, Inc (see full Treadwell Therapeutics, Inc pipeline at /company/treadwell-therapeutics-inc).

Is CFI-402411 also known as anything else?

CFI-402411 is also known as 2411, 402411.

What development phase is CFI-402411 in?

CFI-402411 is in Phase 1.

Manufacturer: Treadwell Therapeutics, Inc — full pipeline
Also known as: 2411, 402411

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