Last reviewed 2026-05-29 · How we verify

Fluoro-L-thymidine-(18F)

Assistance Publique - Hôpitaux de Paris · Phase 3 active Small molecule Under review

Fluoro-L-thymidine-(18F) is a PET imaging agent / radiopharmaceutical Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 3 development for PET imaging of tumor proliferation in various cancers, Assessment of treatment response in oncology.

Fluoro-L-thymidine-(18F) is a fluorine-18 labeled nucleoside analog that accumulates in rapidly dividing cells, enabling PET imaging of cellular proliferation.

Fluoro-L-thymidine-(18F), also known as 3'-Deoxy-3'-18f-Fluorothymidine, is a radiopharmaceutical used in PET scans to study various types of cancer, including brain tumors, non-small cell lung cancer, and rectal cancer. It is used to assess the accuracy of imaging techniques in determining the extent of cancer.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Fluoro-L-thymidine-(18F)
Sponsor	Assistance Publique - Hôpitaux de Paris
Drug class	PET imaging agent / radiopharmaceutical
Target	Thymidine kinase 1 (TK1)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

This radiopharmaceutical is a thymidine analog incorporating the positron-emitting isotope fluorine-18, allowing non-invasive visualization of tumor burden and proliferative activity via positron emission tomography (PET). The compound is taken up preferentially by cells with high DNA synthesis rates, making it useful for oncologic imaging and monitoring treatment response.

Approved indications

PET imaging of tumor proliferation in various cancers
Assessment of treatment response in oncology

Common side effects

No common side effects on file.

Key clinical trials

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:

Fluoro-L-thymidine-(18F) CI brief — competitive landscape report
Fluoro-L-thymidine-(18F) updates RSS · CI watch RSS
Assistance Publique - Hôpitaux de Paris portfolio CI

Frequently asked questions about Fluoro-L-thymidine-(18F)

What is Fluoro-L-thymidine-(18F)?

Fluoro-L-thymidine-(18F) is a PET imaging agent / radiopharmaceutical drug developed by Assistance Publique - Hôpitaux de Paris, indicated for PET imaging of tumor proliferation in various cancers, Assessment of treatment response in oncology.

How does Fluoro-L-thymidine-(18F) work?

Fluoro-L-thymidine-(18F) is a fluorine-18 labeled nucleoside analog that accumulates in rapidly dividing cells, enabling PET imaging of cellular proliferation.

What is Fluoro-L-thymidine-(18F) used for?

Fluoro-L-thymidine-(18F) is indicated for PET imaging of tumor proliferation in various cancers, Assessment of treatment response in oncology.

Who makes Fluoro-L-thymidine-(18F)?

Fluoro-L-thymidine-(18F) is developed by Assistance Publique - Hôpitaux de Paris (see full Assistance Publique - Hôpitaux de Paris pipeline at /company/assistance-publique-h-pitaux-de-paris).

What drug class is Fluoro-L-thymidine-(18F) in?

Fluoro-L-thymidine-(18F) belongs to the PET imaging agent / radiopharmaceutical class. See all PET imaging agent / radiopharmaceutical drugs at /class/pet-imaging-agent-radiopharmaceutical.

What development phase is Fluoro-L-thymidine-(18F) in?

Fluoro-L-thymidine-(18F) is in Phase 3.

What does Fluoro-L-thymidine-(18F) target?

Fluoro-L-thymidine-(18F) targets Thymidine kinase 1 (TK1) and is a PET imaging agent / radiopharmaceutical.

Drug class: All PET imaging agent / radiopharmaceutical drugs
Target: All drugs targeting Thymidine kinase 1 (TK1)
Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for PET imaging of tumor proliferation in various cancers
Indication: Drugs for Assessment of treatment response in oncology

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