Last reviewed 2026-04-19 · How we verify

Cytarabine IT

C17 Council · Phase 1 active Small molecule

Cytarabine IT is a Small molecule drug developed by C17 Council. It is currently in Phase 1 development. Also known as: Cytosar.

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	Cytarabine IT
Also known as	Cytosar
Sponsor	C17 Council
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

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:

Cytarabine IT CI brief — competitive landscape report
Cytarabine IT updates RSS · CI watch RSS
C17 Council portfolio CI

Frequently asked questions about Cytarabine IT

What is Cytarabine IT?

Cytarabine IT is a Small molecule drug developed by C17 Council.

Who makes Cytarabine IT?

Cytarabine IT is developed by C17 Council (see full C17 Council pipeline at /company/c17-council).

Is Cytarabine IT also known as anything else?

Cytarabine IT is also known as Cytosar.

What development phase is Cytarabine IT in?

Cytarabine IT is in Phase 1.

Manufacturer: C17 Council — full pipeline
Also known as: Cytosar

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