Last reviewed 2026-05-31 · How we verify

JNJ-78934804

Janssen Research & Development, LLC · Phase 2 active Biologic ✓ Verified May 2026 Quality 0/100

JNJ-78934804 is a Biologic drug developed by Janssen Research & Development, LLC. It is currently in Phase 2 development.

JNJ-78934804 is being studied in a Phase 3 clinical trial for the treatment of moderately to severely active Crohn's disease. The study is comparing JNJ-78934804 to guselkumab and golimumab in participants with Crohn's disease.

Likelihood of approval

18.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
Janssen Research & Development, LLC 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	JNJ-78934804
Sponsor	Janssen Research & Development, LLC
Modality	Biologic
Phase	Phase 2

Approved indications

No approved indications tracked.

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:

JNJ-78934804 CI brief — competitive landscape report
JNJ-78934804 updates RSS · CI watch RSS
Janssen Research & Development, LLC portfolio CI

Frequently asked questions about JNJ-78934804

What is JNJ-78934804?

JNJ-78934804 is a Biologic drug developed by Janssen Research & Development, LLC.

Who makes JNJ-78934804?

JNJ-78934804 is developed by Janssen Research & Development, LLC (see full Janssen Research & Development, LLC pipeline at /company/johnson-johnson).

What development phase is JNJ-78934804 in?

JNJ-78934804 is in Phase 2.

Manufacturer: Janssen Research & Development, LLC — full pipeline

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