Last reviewed 2026-04-19 · How we verify

Fadraciclib

Gustave Roussy, Cancer Campus, Grand Paris · Phase 1 active Small molecule

Fadraciclib is a Small molecule drug developed by Gustave Roussy, Cancer Campus, Grand Paris. It is currently in Phase 1 development. Also known as: CYC065.

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	Fadraciclib
Also known as	CYC065
Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (PHASE1, PHASE2)
Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects (EARLY_PHASE1)
A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS) (PHASE1, PHASE2)
A Study to Investigate Fadraciclib (CYC065), in Subjects With Advanced Solid Tumors and Lymphoma (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:

Fadraciclib CI brief — competitive landscape report
Fadraciclib updates RSS · CI watch RSS
Gustave Roussy, Cancer Campus, Grand Paris portfolio CI

Frequently asked questions about Fadraciclib

What is Fadraciclib?

Fadraciclib is a Small molecule drug developed by Gustave Roussy, Cancer Campus, Grand Paris.

Who makes Fadraciclib?

Fadraciclib is developed by Gustave Roussy, Cancer Campus, Grand Paris (see full Gustave Roussy, Cancer Campus, Grand Paris pipeline at /company/gustave-roussy-cancer-campus-grand-paris).

Is Fadraciclib also known as anything else?

Fadraciclib is also known as CYC065.

What development phase is Fadraciclib in?

Fadraciclib is in Phase 1.

Manufacturer: Gustave Roussy, Cancer Campus, Grand Paris — full pipeline
Therapeutic area: All drugs in Other
Also known as: CYC065

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