Last reviewed 2026-05-14 · How we verify

[18F]RO6958948

Hoffmann-La Roche · Phase 1 active Small molecule

[18F]RO6958948 is a Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 1 development.

Likelihood of approval

12.6% 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).
Big-pharma sponsor +3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	[18F]RO6958948
Sponsor	Hoffmann-La Roche
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:

[18F]RO6958948 CI brief — competitive landscape report
[18F]RO6958948 updates RSS · CI watch RSS
Hoffmann-La Roche portfolio CI

Frequently asked questions about [18F]RO6958948

What is [18F]RO6958948?

[18F]RO6958948 is a Small molecule drug developed by Hoffmann-La Roche.

Who makes [18F]RO6958948?

[18F]RO6958948 is developed by Hoffmann-La Roche (see full Hoffmann-La Roche pipeline at /company/roche).

What development phase is [18F]RO6958948 in?

[18F]RO6958948 is in Phase 1.

Manufacturer: Hoffmann-La Roche — full pipeline

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