Last reviewed 2026-04-23 · How we verify

[18F]PSMA-PET

Region Västerbotten · Phase 3 active Small molecule

[18F]PSMA-PET is a Small molecule drug developed by Region Västerbotten. It is currently in Phase 3 development for Prostate cancer imaging.

binds to prostate-specific membrane antigen (PSMA) to visualize prostate cancer

binds to prostate-specific membrane antigen (PSMA) to visualize prostate cancer Used for Prostate cancer imaging.

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	[18F]PSMA-PET
Sponsor	Region Västerbotten
Target	PSMA
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

This is achieved through a positron emission tomography (PET) imaging technique, allowing for the detection of PSMA-expressing cells in the body. PSMA is a protein that is highly expressed in prostate cancer cells, making it an ideal target for imaging and treatment.

Approved indications

Prostate cancer imaging

Common side effects

Injection site reaction

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

[18F]PSMA-PET CI brief — competitive landscape report
[18F]PSMA-PET updates RSS · CI watch RSS
Region Västerbotten portfolio CI

Frequently asked questions about [18F]PSMA-PET

What is [18F]PSMA-PET?

[18F]PSMA-PET is a Small molecule drug developed by Region Västerbotten, indicated for Prostate cancer imaging.

How does [18F]PSMA-PET work?

binds to prostate-specific membrane antigen (PSMA) to visualize prostate cancer

What is [18F]PSMA-PET used for?

[18F]PSMA-PET is indicated for Prostate cancer imaging.

Who makes [18F]PSMA-PET?

[18F]PSMA-PET is developed by Region Västerbotten (see full Region Västerbotten pipeline at /company/region-v-sterbotten).

What development phase is [18F]PSMA-PET in?

[18F]PSMA-PET is in Phase 3.

What are the side effects of [18F]PSMA-PET?

Common side effects of [18F]PSMA-PET include Injection site reaction.

What does [18F]PSMA-PET target?

[18F]PSMA-PET targets PSMA.

Target: All drugs targeting PSMA
Manufacturer: Region Västerbotten — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Prostate cancer imaging

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