Last reviewed 2026-06-02 · How we verify

[14C] NS-580

Nippon Shinyaku Co., Ltd. · Phase 1 active Small molecule

[14C] NS-580 is a Small molecule drug developed by Nippon Shinyaku Co., Ltd.. It is currently in Phase 1 development.

Nippon Shinyaku's [14C] NS-580 is a radiolabeled compound currently in preclinical development. No FDA label or clinical trials are available, and there is limited public information on its mechanism of action, safety profile, or commercial potential.

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	[14C] NS-580
Sponsor	Nippon Shinyaku Co., Ltd.
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:

[14C] NS-580 CI brief — competitive landscape report
[14C] NS-580 updates RSS · CI watch RSS
Nippon Shinyaku Co., Ltd. portfolio CI

Frequently asked questions about [14C] NS-580

What is [14C] NS-580?

[14C] NS-580 is a Small molecule drug developed by Nippon Shinyaku Co., Ltd..

Who makes [14C] NS-580?

[14C] NS-580 is developed by Nippon Shinyaku Co., Ltd. (see full Nippon Shinyaku Co., Ltd. pipeline at /company/nippon-shinyaku-co-ltd).

What development phase is [14C] NS-580 in?

[14C] NS-580 is in Phase 1.

Manufacturer: Nippon Shinyaku Co., Ltd. — full pipeline

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