Last reviewed 2026-04-19 · How we verify

ONO-4474 Part C

Ono Pharmaceutical Co. Ltd · Phase 1 active Small molecule

ONO-4474 Part C is a Small molecule drug developed by Ono Pharmaceutical Co. Ltd. It is currently in Phase 1 development. Also known as: ONO-4474.

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	ONO-4474 Part C
Also known as	ONO-4474
Sponsor	Ono Pharmaceutical Co. Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in Healthy Volunteers (PHASE1)

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:

ONO-4474 Part C CI brief — competitive landscape report
ONO-4474 Part C updates RSS · CI watch RSS
Ono Pharmaceutical Co. Ltd portfolio CI

Frequently asked questions about ONO-4474 Part C

What is ONO-4474 Part C?

ONO-4474 Part C is a Small molecule drug developed by Ono Pharmaceutical Co. Ltd.

Who makes ONO-4474 Part C?

ONO-4474 Part C is developed by Ono Pharmaceutical Co. Ltd (see full Ono Pharmaceutical Co. Ltd pipeline at /company/ono-pharmaceutical-co-ltd).

Is ONO-4474 Part C also known as anything else?

ONO-4474 Part C is also known as ONO-4474.

What development phase is ONO-4474 Part C in?

ONO-4474 Part C is in Phase 1.

Manufacturer: Ono Pharmaceutical Co. Ltd — full pipeline
Also known as: ONO-4474

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