Last reviewed 2026-04-23 · How we verify

[18F]-APN-1607

JYAMS PET Research & Development Limited · Phase 3 active Small molecule

[18F]-APN-1607 is a Small molecule drug developed by JYAMS PET Research & Development Limited. It is currently in Phase 3 development for PET imaging.

This drug is a radioligand used for positron emission tomography (PET) imaging.

This drug is a radioligand used for positron emission tomography (PET) imaging. Used for PET imaging.

Likelihood of approval

58.3% 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).

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	[18F]-APN-1607
Sponsor	JYAMS PET Research & Development Limited
Modality	Small molecule
Phase	Phase 3

Mechanism of action

It binds to the target of interest, allowing for visualization and quantification of the target's expression or distribution in the body.

Approved indications

PET imaging

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:

[18F]-APN-1607 CI brief — competitive landscape report
[18F]-APN-1607 updates RSS · CI watch RSS
JYAMS PET Research & Development Limited portfolio CI

Frequently asked questions about [18F]-APN-1607

What is [18F]-APN-1607?

[18F]-APN-1607 is a Small molecule drug developed by JYAMS PET Research & Development Limited, indicated for PET imaging.

How does [18F]-APN-1607 work?

This drug is a radioligand used for positron emission tomography (PET) imaging.

What is [18F]-APN-1607 used for?

[18F]-APN-1607 is indicated for PET imaging.

Who makes [18F]-APN-1607?

[18F]-APN-1607 is developed by JYAMS PET Research & Development Limited (see full JYAMS PET Research & Development Limited pipeline at /company/jyams-pet-research-development-limited).

What development phase is [18F]-APN-1607 in?

[18F]-APN-1607 is in Phase 3.

Manufacturer: JYAMS PET Research & Development Limited — full pipeline
Indication: Drugs for PET imaging

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