Last reviewed 2026-04-19 · How we verify

KLH, ONO-4685

Ono Pharmaceutical Co. Ltd · Phase 1 active Biologic

KLH, ONO-4685 is a Biologic drug developed by Ono Pharmaceutical Co. Ltd. It is currently in Phase 1 development.

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	KLH, ONO-4685
Sponsor	Ono Pharmaceutical Co. Ltd
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects (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:

KLH, ONO-4685 CI brief — competitive landscape report
KLH, ONO-4685 updates RSS · CI watch RSS
Ono Pharmaceutical Co. Ltd portfolio CI

Frequently asked questions about KLH, ONO-4685

What is KLH, ONO-4685?

KLH, ONO-4685 is a Biologic drug developed by Ono Pharmaceutical Co. Ltd.

Who makes KLH, ONO-4685?

KLH, ONO-4685 is developed by Ono Pharmaceutical Co. Ltd (see full Ono Pharmaceutical Co. Ltd pipeline at /company/ono-pharmaceutical-co-ltd).

What development phase is KLH, ONO-4685 in?

KLH, ONO-4685 is in Phase 1.

Manufacturer: Ono Pharmaceutical Co. Ltd — full pipeline

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