Last reviewed 2026-06-03 · How we verify

BAY1075553

Life Molecular Imaging SA · Phase 1 active Small molecule ✓ Verified Jun 2026

BAY1075553 is a Small molecule drug developed by Life Molecular Imaging SA. It is currently in Phase 1 development.

BAY1075553 is a compound being studied in a clinical trial for its safety, tolerability, and diagnostic performance in patients with prostate cancer using PET/CT imaging. The trial, NCT01287845, is sponsored by Lantheus Biosciences Ltd. and is registered on ClinicalTrials.gov.

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	BAY1075553
Sponsor	Life Molecular Imaging SA
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:

BAY1075553 CI brief — competitive landscape report
BAY1075553 updates RSS · CI watch RSS
Life Molecular Imaging SA portfolio CI

Frequently asked questions about BAY1075553

What is BAY1075553?

BAY1075553 is a Small molecule drug developed by Life Molecular Imaging SA.

Who makes BAY1075553?

BAY1075553 is developed by Life Molecular Imaging SA (see full Life Molecular Imaging SA pipeline at /company/life-molecular-imaging-sa).

What development phase is BAY1075553 in?

BAY1075553 is in Phase 1.

Manufacturer: Life Molecular Imaging SA — full pipeline

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